MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES GORE DUALMESH BIOMATERIAL; MESH, SURGICAL, POLYMERIC

Model Number 1DLMC02

Device Problems Improper or Incorrect Procedure or Method (2017); Insufficient Information (3190)

Patient Problems Pain (1994); Hernia (2240)

Event Date 02/27/2015

Event Type  Injury  

Manufacturer Narrative

(b)(6).It should be noted that the gore® dualmesh® biomaterial instructions for use includes warnings and addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence.¿.

Event Description

It was reported to gore that the patient underwent open ventral hernia repair on (b)(6) 2014, whereby a gore® dualmesh® biomaterial was implanted.The complaint alleges that on (b)(6) 2015, an additional procedure occurred whereby the gore device was explanted.It was reported the patient alleges the following injuries: pain, migration of mesh, removal of mesh, additional surgery.Additional event specific information was not provided.

Manufacturer Narrative

Added medical history.Updated results code.Conclusion code remains unchanged.Added medical record information.Additional details regarding the patient's clinical course were ascertained from a review of medical records and are as follows: medical records dated on (b)(6) 2013 indicated the patient was seen in the emergency room for diverticulitis.Chief complaint ¿abd[ominal] pain.¿ the records state the patient ¿is a 49 yo male who started experiencing abdominal pain on 5 days ago.He has had associated chills an [sic] diaphoresis on and off since that time.Bowel movements have been infrequent and he has hat [sic] difficulty with urination.Unmeasured fevers.Has also had nausea and vomiting with difficulty keeping anything down.¿ the records state ¿ct - perforated diverticulitis with focal free air and developing abscess.Assessment/diagnosis: perforated diverticulitis with developing abscess.¿ medical records dated on (b)(6) 2013 state: ¿ct scan last pm noted increase in size of abscess.Pt was transferred to mercy ada earlier today to have a percutaneous drainage performed.Pt just returned from that procedure.He has no new complaints.¿ exam: abd[domen] soft, minimally tender in llq [left lower quadrant], no rebound or guarding noted; perc drain in place with purulent material within it.¿ culture report dated on (b)(6) 2013 for swab (anaerobe), specimen wound-deep/surgical collected on (b)(6) 2013 states: ¿culture results: no strict anaerobes.¿ medical records dated on (b)(6) 2014 state: ¿pt being sent to (b)(6) ada for drain replacement.¿ medical records dated on (b)(6) 2014 state: ¿the patient was seen and examined again due to diffuse abdominal pain from earlir [sic].Patient c/o pain worse than when he came in the beginning of his stay which was the worst it had been.He is pale and in distress, obviously painful with moving.Due to continued increasing abdominal pain, i will take him to or tonight.¿ operative records dated on (b)(6) 2014 indicate the patient underwent exploratory laparotomy with abdominal lavage and lysis of adhesions.Preoperative/postoperative diagnosis ¿perforated diverticulitis with abscess and peritonitis.¿ operative findings state: ¿significant adhesions in the pelvis from inflammatory tissues.There was phlegmon and pus within the pelvis without a large collection of pus.The rectum was severely inflamed with mild inflammation of the distal sigmoid colon.There was a blurring of plains in the pelvis due to phlegmon.¿ operative records dated on (b)(6) 2014 state: ¿the ir- placed drain was removed.A midline incision was made and carried down to the fascia using the bovie cutery device.Once the linea alba was reached, bovie cautery was used to divide through the linea alba to the preperitoneal fat.Once the preperitoneal fat was reached, a finger was placed through the defect and used to protect the underlying contents as the linea alba was incised superiorly and inferiorly.A bookwalter retractor was then p l aced and the blades placed in various areas, holding the abdominal wall out of the operative field.Exploration of the abdomen revealed very significant inflammatory tissue in the pelvis with tissues in the upper abdomen being in good condition.Palpation of the liver revealed a smooth liver.The left upper quadrant had no abnormalities, either.¿ operative records dated on (b)(6) 2014 continue: ¿concentration was placed back to the pelvis.Most of the structures in the pelvis were adherent due to significant inflammation.Cautious dissection was used to separate the structures in the pelvis, including the colon and small bowel, as well as the mesentery.This went as far as the cecum on the right.Once within the pelvic cavity, a small amount of pus was noted.Further separation of tissues revealed 2 small areas of blackened mesentery without significant abscess.The tissues that were adherent in these areas were blackened, as well; however, there was no evidence of perforation nor was there evidence of necrosis of these surrounding tissues.¿ operative records dated on (b)(6) 2014 state: ¿cultureses were taken and necrotic tissue excised.The rectum was found to be extremely edematous as far as could be reached down into the pelvis.It was indurated, as well, making the whole structure quite stiff.The distal sigmoid colon was mildly edematous without the obvious effect that the rectum had.The entire colon was run several times, especially paying attention to the sigmoid colon and to the intraabdominal portion of the rectum, and there was no evidence of stool leakage or current perforation.¿ operative records dated on (b)(6) 2014 state: ¿there was obviously previous perforation, but no evidence of current leak.The pelvis and lower abdominal cavity were then lavaged using 7l of warm saline, which was subsequently evacuated.Performed and found to be correct.The fascia was closed with #1 looped pds in a running fashion.The subcutaneous tissue was then irrigated and the irrigant subsequently evacuated.The skin was closed with staples.¿ culture reports dated on (b)(6) 2014 for specimen of wound-superficial, collected on (b)(6) 2014 states: ¿gram stain: rare wbc.No organisms observed.Culture results: 1.Rare staphyidcoccus aureus (mrsa) 2.Rare staphyidcoccus epidermidis 3.3+ growth from broth entrococcus faecium.¿ culture swab (anaerobe) report dated on (b)(6) 2014 for specimen of wound-deep surgical, collected on (b)(6) 2014 states: ¿culture results: no strict anaerobes.¿ medical records dated on (b)(6) 2014 state: ¿assessment: perforated diverticulitis, acute renal failure, polymicrobial, multidrug resistant intraabdominal infection d/t perforated viscus including vanco intermediate mrsa, htn.¿ medical records dated on (b)(6) 2014 state: ¿i anticipate he will be her for about another week until the inflammation in his sigmoid colon subsides due to the severity of his infection, drug ristance [sic] of the bacteria that grew out and need for iv antibiotics.¿ ct abdomen/pelvis dated on (b)(6) 2014 states: ¿impression: postsurgical changes with surgical drain within the pelvis and resolution of previously noted abscesses.There is persistent thicking of the sigmoid colon.This does not appear to be obstruction.¿ medical records indicate patient discharged on (b)(6) 2014.To follow up in 7-10 days with physician.Medical records dated on (b)(6) 2014 state: ¿visit note.Chief complaint: diverticulitis, polymicrobial multidrug resistant intraabdominal infection.Wound assessment: healing.Still has mild deep abdominal tenderness mild tenderness around incision no cdr around incision.¿ medical records dated on (b)(6) 2014 state: ¿49 yom here for 2 month f/u.49 yrs old male came for f/u of chronic issues including htn, gerd, hypothyroidism, asthma, chronic neck pain.Pt was recently inpt with perforated diverticula and abscess.He reports doing well currently.He is eating regular diet and having regular bm.He has upcoming ego and colonoscopy scheduled on 2/12 with surgeons.He reports doing well with other meds.Denies any other complaints at this time.¿ operative records dated on (b)(6) 2014 indicate the patient underwent egd, colonoscopy for preoperative diagnosis ¿nausea, vomiting, follow up diverticulitis.¿ postoperative diagnosis ¿normal egd, diverticulosis, hemorrhoids.¿ medical records dated on (b)(6) 2014 state: ¿chief complaint: 49 yod male here today for 3 mo f/u.C/0 possible abdominal hernia.¿ the record state: ¿49 yrs old male came for f/u of chronic issues including htn, gerd, hypothyroidism, asthma, chronic neck pain.Pt reports a possible hernia with a small amount of protrusion at upper portion of midline abd incision.Pt reports this causes mild pain at times.He also reports intermittent lower pelvic pain that is not present currently.He reports taking po but reports that he occasionally wakes up with nausea and vomiting in the am.He reports normal bm with no changes.Denies any fever, melena or hematochezia.He had ego and colonoscopy last month and with findings of dysmotility secondary to opioids.He recommends gastric emptying study.Pt reports doing well otherwise with current meds.Denies any other concerns at this time.¿ medical records dated on (b)(6) 2014 state reason for admission: ventral hernia.The records state ¿pt is a 49 y/o man who presents with a ventral hernia.Pt recently underwent a laparotomy for a perforated diveticulitis in jan 2014.He has developed a hernia through the midline incision.Pt notes a bulge but not much discomfort with this.Referred for repair.¿ operative records dated on (b)(6) 2014 indicate the patient underwent ventral hernia repair with mesh.Preoperative/postoperative diagnosis ¿ventral hernia.¿ the records state: ¿the patient is a 49-year-old man who presents with a ventral hernia.The patient previously underwent a laparotomy for perforated diverticulitis.He has developed a hernia through the midline incision.He presents for elective repair.¿ operative records dated on (b)(6) 2014 state: ¿a midline incision was made in the midepigastric portion of the incision, which is where the hernia was located.The dissection was then carried down through the subcutaneous tissues until the hernia sac was encountered.This was opened and was found to contain only omental fat.The omental fat was reduced back into the abdomen.Palpation of the incision from the undersurface revealed a second small defect, about 1 cm inferior to the primary defect.The 2 defects were then connected to make 1 large defect which measured 6 cm x 2 cm.¿ operative records dated on (b)(6) 2014 state: ¿the under surface of the fascia was then cleared of omental adhesins [sic] for several centimeters in all directions.A piece of dualmesh was then cut to the appropriate size and brought into the operative field.This was then placed in an underlay fashion and secured to the fascia with several interrupted 0 pds sutures.Once the mesh was in place, the wound was copiously irrigated with normal saline.The fascial defect was then closed with several interrupted 0 pds sutures in a horizontal mattress fashion.¿ operative records dated on (b)(6) 2014 continue: ¿the deep subcutaneous layer was then closed with several interrupted 3-0 vicryl sutures.The deep dermal layer likewise was closed with interrupted 3-0 vicryl sutures.Prior to closing the skin the subcutaneous and fascial structures were copiously infiltrated with 1% lidocaine and 0.25% marcaine local anesthetic.The skin incision was then closed with staples.Sterile dressings were placed.¿ the records confirm a gore® dualmesh® biomaterial (1dlmc02/11636032) was used during the procedure.Medical records dated on (b)(6) 2014 state: ¿chief complaint: 50 y/o male presents to clinic for f/u to stomach issues, diverticulitis.Patient had hernia surgery approx one month ago.Patient rates continued pain 6/10 at this visit.Patient takes oxycontin/oxycodone for good pain relief, no new allergies, no new medications.The records state: ¿he says he developed another abdominal hernia about 1 1/2 wks ago.He is s/p vhr with mesh on (b)(6) 2014.¿ the records state ¿abd: soft, nontender.Noted midline surgical scar, and 2inch bulge right of scar.¿ ct pelvis dated on (b)(6) 2015 states: ¿impression: unchanged appearance of extraluminal collection inferior to the sigmoid colon, better evaluated on todays prior ct abdomen/pelvis.¿ echogram abdomen dated on (b)(6) 2015 states: ¿impression: fluid-filled loops of bowel/colon in the left lower quadrant.Extraluminal fluid collection or abscess cannot be excluded.¿ operative records dated on (b)(6) 2015 indicate the patient underwent 1.Exploratory laparotomy 2.Lysis of adhesions.3.Pelvic abscess incision and drainage.4.Hartmann procedure.Preoperative/postoperative diagnosis ¿acute diverticulitis with abscess.¿ operative records dated on (b)(6) 2015 state: ¿the patient is a 50-year-old man who presented a few weeks ago with acute diverticulitis with abscess.The patient has had a previous similar episode approximately 1 year ago.At that time, he was brought for an exploratory laparotomy; however, no sigmoid resection was performed.He was washed out, drains were placed, and then the patient recovered from that surgery.Now 1 year later he presents once again with acute diverticulitis with abscess.He was admitted to the hospital a few weeks ago for iv antibiotic therapy and attempted percutaneous drainage.¿ operative records dated on (b)(6) 2015 state: ¿however, the abscesses were located in such a way that percutaneous drainage was not possible; therefore, he was continued on antibiotic therapy.He seemed to improve with iv antibiotic therapy alone.He was sent home on po antibiotics.The patient presented to the clinic a few days ago with ongoing symptoms.He was admitted to the hospital and found to have a higher white blood cell count than when he was discharged a few weeks ago.Also, repeat ultrasound exam shows continued fluid around the colon.He is, therefore, brought for an exploratory laparotomy, abscess drainage, and possible hartmann procedure.¿ operative records dated on (b)(6) 2015 state: ¿a midline incision was made through the patient's previous midline incision, and dissection was then carried down through the subcutaneous tissues until the midline fascia was reached.He was found to have a large hernia in the upper midline with a piece of mesh in place which did not contain the hernia.The fascia was opened for the entire length of the incision.The mesh which appeared to be not doing anything was removed.¿ operative records dated on (b)(6) 2015 state: ¿there was a significant amount of adhesive tissue immediately underneath the incision; therefore, a moderate adhesiolysis was performed, concentrating especially in the left lower quadrant area in the midline incision.Once the adhesions had been released enough that the dissection could proceed, the sigmoid colon was grasped.The white line of toldt was then taken down.The attachments to the posterior peritoneum were then released.Inspection of the pelvic area revealed a thickened portion of distal sigmoid colon down into the pelvis.As the adhesions surrounding this portion of colon were released, 2 pus pockets were encountered.¿ operative records dated on (b)(6) 2015 state: ¿samples of this purulence were obtained for aerobic and aerobic culture.The pus pockets were well drained.There was 1 lateral to the sigmoid colon and 1 between the colon and the bladder.Once again, these were drained adequately, and the dissection was then continued.The dissection was then carried distally.It should be noted that the adhesive tissue surrounding the distal sigmoid colon and rectum was quite dense.Therefore, this portion of the procedure proceeded slowly.Above this area which was just at the level of the pelvic rim the remaining sigmoid and descending colon was quite soft and appeared to have no diverticular disease.¿ operative records dated on (b)(6) 2015 continue: ¿therefore, a portion was chosen in the proximal 1/3 of the sigmoid for the transection of the colon.A window was created at this level and the 75 mm gia stapler was brought across the colon and clamped in place.This was then held in place for a few seconds and then fired.The stapler was opened, and the colon was transected at this level.Here, the dissection was carried toward the root of the mesentery.The inferior mesenteric artery was then divided along with some other smaller branches with clamps and 2-0 silk free ties.The dissection along the mesentery was then carried distally down into the pelvis.¿ operative records dated on (b)(6) 2015 state: ¿the area to the left of the sigmoid colon was then carefully dissected for the ureter.However, no structure which appeared to be the ureter was encountered.There was a significant amount of adhesive tissue which did hinder the dissection in this area.Nonetheless, i was fairly confident that the ureter would not be injured during the remainder of the dissection.Therefore, the mesentery was then divided, and the tissues between the rectum and pelvis were then divided with the bovie electrocautery until we were beyond the thickest portion of induration within the distal sigmoid colon.At this level, the colon did narrow down, and it was felt that the curvilinear stapler would fit across this portion of rectum.¿ operative records dated on (b)(6) 2015 state: ¿therefore, the 40 mm curved linear stapler was brought into the field and placed across the colon distal to the indurated area.This was then clamped, held in place for several seconds and then fired.This was opened and the specimen was able to be removed.This was opened on the back table, and there appeared to be no mass within the colon itself, merely a significant amount of edema.This was then handed off as a specimen.At the rectal stump which was quite far down into the pelvis, 2 marking sutures of 3-0 prolene were placed at each end of the staple line.The abdomen was then copiously irrigated with normal saline.All irrigation fluid was evacuated from the wound.¿ operative records dated on (b)(6) 2015 state: ¿a 10 mm jackson-pratt drain was brought into the field and brought to lie within the dissection bed in the pelvis.This was secured to the skin with a 2-0 nylon drain stitch.A quarter-sized colostomy was then created in the left lower quadrant.This button of skin was removed with the bovie electrocautery.The dissection was then carried down through the subcutaneous tissues until the rectus sheath was encountered.A cruciate incision was made, and the underlying rectus muscle and posterior fascia were then dissected.The opening was made to a width of 2 fingerbreadths, and the distal descending colon was then brought through this colostomy tunnel and held in place with a babcock clamp.¿ operative records dated on (b)(6) 2015 state: ¿the abdomen was then closed.The fascia was closed with a running o looped pds suture.The deep dermal layer was reapproximated with interrupted 3-0 vicryl sutures.Finally the skin was closed with staples.The colostomy was then matured.The staple line was removed, and the edges of the colon were secured to the deep dermal layer of the colostomy opening with several interrupted 3-0 vicryl sutures.Investigation of the colostomy revealed this to be widely patent.The colostomy apparatus was then cut to the appropriate size and placed around the colostomy.The bag was also snapped into place.Sterile dressings were then placed.The jp drain was placed to bulb suction.¿ operative records dated on (b)(6) 2015 indicate the patient underwent colostomy reversal.Preoperative and postoperative diagnosis ¿colostomy status post hartmann procedure.¿ the records state: ¿the patient is a 50-year-old man who presents with a colostomy status post hartmann procedure performed approximately 4 months ago.He has healed well.The colostomy has been working correctly, and since it has been beyond 12 weeks, the patient presents for elective colostomy reversal.¿ records indicate an ethicon vicryl mesh was used during the procedure.There is no mention of a gore device in the records.Ct abdomen/pelvis dated on (b)(6) 2015 states: ¿impression: 1.Interval progressive enlargement of ventral hernia with mild bulging of nonobstructed colon and small bowel.2.Interval resolution of previous percolic sigmoid fluid collection.¿ operative records dated on (b)(6) 2015 indicate the patient underwent ventral hernia repair with mesh (stoppa repair).Preoperative/postoperative diagnosis ¿recurrent ventral hernia.¿ the records state: ¿the patient is a 51-year-old man who presents with a recurrent ventral hernia.This was originally repaired approximately 1 year ago with mesh.This repair failed and patient more recently underwent a hartmann procedure followed by colostomy reversal about 3 months later.At the time of the colostomy reversal, a small hernia was noted between his previous colostomy site and the midline incision.However, this was quite small and was observed.This has gone on to become a fairly large hernia which is quite symptomatic.Therefore, the patient presents for an elective hernia repair, and we will be performing the more aggressive stoppa repair for this.¿ the records indicate an ethicon prolene mesh was used during the procedure.There is no mention of a gore device in the records.A potential relationship, if any, between the alleged injuries or complications and the gore device is unclear from the provided information at this time.It should be noted that the gore® dualmesh® biomaterial instructions for use includes warnings and addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence.¿ w.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.

Manufacturer Narrative

B7: added medical history.H6: conclusion code remains unchanged.H10/11: added medical record information.Additional details regarding the patient's clinical course were ascertained from a review of medical records and are as follows: (b)(6) 2013: [ni].[ni].Radiology-echogram abdomen ltd.(liver, gallbladder).Impression: small non-shadowing echogenic density upper pole of right kidney may represent a non-obstructing stone or small angiomyolipoma.Mild hepatic steatosis.[complete radiology report not available for review.] (b)(6) 2013: [ni].[ni].Radiology-ct abdomen w/ contrast.Impression: current examination is ct of abdomen and area of concern of perforated sigmoid diverticulitis was not imaged.Recommend follow-up ct to include the pelvis.Fatty infiltration of liver.[complete radiology report not available for review.] (b)(6) 2014: (b)(6)center.(b)(6).Operative report.Excision of mesentery lesion; peritoneal lavage; exploratory laparotomy; lysis of peritoneal adhesions; excision/ destruction of peritoneal tissue/ necrotic mesentery.[complete operative report not available for review.] (b)(6) 2014: (b)(6), md.Operative report.Percutaneous abdominal drainage.[complete operative report not available for review.] (b)(6) 2014: [ni].[ni].Radiology-ct abdomen/ pelvis w/ contrast.Impression: post-surgical changes w/ surgical drain within pelvis & resolution of previously noted abscesses.Persistent thickening of the sigmoid.[complete radiology report not available for review.] (b)(6) 2013-(b)(6) 2014: [missing records: records regarding sepsis including (b)(6) 2013 & (b)(6)2014 percutaneous abdominal drainage and (b)(6) 2014 laparotomy operative reports were not provided.] (b)(6) 2015: (b)(6)center.[ni].Office visit.Abdominal ultrasound, abdominal abscess.(b)(6) 2015: (b)(6) center.[ni].Hospitalization summary (b)(6) 2015-(b)(6) 2015.Dx: acute diverticulitis w/ abscess of intestine; incisional hernia w/o mention of obstruction or gangrene; ventral hernia.(b)(6) 2014: (b)(6) center.[ni].Office visit.Hernia eval.Upper portion incisional hernia.(b)(6) 2014: [ni].[ni].Office visit.Staple removal from hernia repair.(b)(6) 2015: (b)(6) center.[ni].Office visit.Colostomy reversal evaluation.Pain 5/10.(b)(6) 2015: [ni].[ni].(b)(6)hospitalization.Reports he had corrective surgery to reverse colostomy, had staples removed yesterday.Rates pain 5/10.(b)(6) 2015: [ni].[ni].Office visit.1 week f/u wound check.States pain 4/10, sore, tender.(b)(6) 2015: [ni].[ni].Office visit.1 month f/u gerd.C/o pain when coughing due to umbilical hernia.(b)(6) 2015: (b)(6) center.Ni.Office visit.Hernia eval.States pain 5/10 in abd.(b)(6) 2015: (b)(6) center.[ni].Hospitalization summary (b)(6) 2015 ¿ (b)(6) 2015.Dx: incisional hernia w/o obstruction or gangrene, recurrent ventral hernia (k43.2); peritoneal adhesions (post-procedural) (post-infection), abdominal wall adhesions; nicotine dependence, cigarettes, uncomplicated, smoker; unspecified/ uncomplicated asthma; gerd w/o esophagitis; acquired absence of other specified parts of digestive tract, s/p hartmann procedure.(b)(6)15: (b)(6)center.(b)(6), md.Operative report.Supplement abdominal wall w/ synthetic substitute, open approach; ventral hernia repair w/ mesh.Release peritoneum, open approach; extensive adhesiolysis.Ventral hernia reduction; re-repair.[complete operative report not available for review.] (b)(6) 2015: [ni].[ni].Office visit.F/u hernia repair.States pain 5/10, located near incision sites.States average drainage about 20 ml.A potential relationship, if any, between the alleged injuries or complications and the gore device is unclear from the provided information at this time.It should be noted that the gore dualmesh® biomaterial instructions for use includes warnings and addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence.¿ w.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.

Manufacturer Narrative

H6: updated patient codes.H6: updated device code.H6: updated conclusion codes.Previous patient code (1994) was reported based on the original complaint and is no longer applicable per gore¿s investigation.The investigation has been completed.In the absence of additional information or medical records from the complainant, this event file will be closed with the information provided.Medical records: the known medical records span november 13, 2013 to november 10, 2015, and not all records received in this time span are relevant to gore® dualmesh® biomaterial.The (b)(6) 2014 and (b)(6) 2015 operative reports were not provided.Hospitalization records for the (b)(6) 2015 - (b)(6) 2015 admission were not provided.Patient information: medical history: hypertension [htn], gastroesophageal reflux disease [gerd], hypothyroidism, osteoarthritis, smoker, 1 pack/day : (b)(6) 2015: nicotine dependence, cigarettes, uncomplicated, smoker.History of alcohol abuse, asthma, methicillin resistant staphylococcus aureus [mrsa], (b)(6) 2015: diverticulitis of intestine with abscess, incisional/ventral hernia, surgical history: laparotomy for perforated diverticulitis, cervical surgery x 3.Relevant medical information: (b)(6) 2013: echogram abdomen ltd.¿impression: small non-shadowing echogenic density upper pole of right kidney may represent a non-obstructing stone or small angiomyolipoma.Mild hepatic steatosis.¿ (b)(6) 2013: er visit: ¿abd[ominal] pain.¿ ¿.49 yo male who started experiencing abdominal pain on 5 days ago.He has had associated chills an [sic] diaphoresis on and off since that time.Bowel movements have been infrequent and he has hat [sic] difficulty with urination.Unmeasured fevers.Has also had nausea and vomiting with difficulty keeping anything down.¿ ct abdomen: ¿perforated diverticulitis with focal free air and developing abscess.¿ (b)(6) 2013: ct abdomen: ¿area of concern of perforated sigmoid diverticulitis was not imaged.Recommend follow-up ct to include the pelvis.Fatty infiltration of liver.¿ (b)(6) 2013: ¿ct scan last pm noted increase in size of abscess.Pt was transferred to mercy ada earlier today to have a percutaneous drainage performed.Pt just returned from that procedure.¿ ¿abd[abdomen] soft, minimally tender in llq [left lower quadrant], no rebound or guarding noted; perc drain in place with purulent material within it.¿ (b)(6) 2013: culture wound: ¿no strict anaerobes.¿ (b)(6) 2014: ¿pt being sent to (b)(4) ada for drain replacement.¿ (b)(6) 2014: ¿the patient was seen and examined again due to diffuse abdominal pain from earlir[sic].Patient c/o pain worse than when he came in the beginning of his stay which was the worst it had been.He is pale and in distress, obviously painful with moving.Due to continued increasing abdominal pain, i will take him to or tonight.¿ (b)(6) 2014: ¿excision of mesentery lesion; peritoneal lavage; exploratory laparotomy; lysis of peritoneal adhesions; excision/ destruction of peritoneal tissue/ necrotic mesentery.¿ (b)(6) 2014: percutaneous abdominal drainage.(b)(6) 2014: exploratory laparotomy with abdominal lavage and lysis of adhesions [hospitalization (b)(6) 2014].Preoperative/postoperative diagnosis ¿perforated diverticulitis with abscess and peritonitis.¿ operative findings state: ¿significant adhesions in the pelvis from inflammatory tissues.There was phlegmon and pus within the pelvis without a large collection of pus.The rectum was severely inflamed with mild inflammation of the distal sigmoid colon.There was a blurring of plains in the pelvis due to phlegmon." (b)(6) 2014: culture: collected (b)(6) 2014: 1.Rare staphylococcus aureus (mrsa) 2.Rare staphylococcus epidermidis 3.3+ growth from broth enterococcus faecium.¿ (b)(6) 2014: ct abdomen/ pelvis: ¿post-surgical changes w/ surgical drain within pelvis & resolution of previously noted abscesses.Persistent thickening of the sigmoid." (b)(6) 2014: ¿assessment: perforated diverticulitis, acute renal failure, polymicrobial, multidrug resistant intraabdominal infection d/t perforated viscus including vanco intermediate mrsa, htn.¿ (b)(6) 2014: ¿i anticipate he will be her [sic] for about another week until the inflammation in his sigmoid colon subsides due to the severity of his infection, drug ristance [sic, resistance] of the bacteria that grew out and need for iv antibiotics.¿ (b)(6) 2014: ct abdomen/pelvis: ¿postsurgical changes with surgical drain within the pelvis and resolution of previously noted abscesses.There is persistent thickening of the sigmoid colon.This does not appear to be obstruction.¿ (b)(6) 2014: discharge: to follow up in 7-10 days with physician.(b)(6) 2014: ¿visit note.Chief complaint: diverticulitis, polymicrobial multidrug resistant intraabdominal infection.Wound assessment: healing.Still has mild deep abdominal tenderness, mild tenderness around incision no cdr around incision.¿ (b)(6) 2014: ¿.F/u of chronic issues including htn, gerd, hypothyroidism, asthma, chronic neck pain.Pt was recently inpt with perforated diverticula and abscess.He reports doing well currently.He is eating regular diet and having regular bm.¿ (b)(6) 14: egd, colonoscopy for preoperative diagnosis ¿nausea, vomiting, follow up diverticulitis.¿ ¿normal egd, diverticulosis, hemorrhoids.¿ (b)(6) 2014: ¿c/o possible abdominal hernia.¿ ¿pt reports a possible hernia with a small amount of protrusion at upper portion of midline abd incision.Pt reports this causes mild pain at times.He also reports intermittent lower pelvic pain that is not present currently.He reports taking po but reports that he occasionally wakes up with nausea and vomiting in the am.He reports normal bm with no changes.¿ "he had egd and colonoscopy last month and with findings of dysmotility secondary to opioids.He recommends gastric emptying study.¿ implant preoperative complaints: (b)(6) 2014: ¿pt is a 49 y/o man who presents with a ventral hernia.Pt recently underwent a laparotomy for a perforated diverticulitis in (b)(6) 2014.He has developed a hernia through the midline incision.Pt notes a bulge but not much discomfort with this.Referred for repair.¿ (b)(6) 2014: ¿the patient is a 49-year-old man who presents with a ventral hernia.The patient previously underwent a laparotomy for perforated diverticulitis.He has developed a hernia through the midline incision.He presents for elective repair.¿ (b)(6) 2014¿ ¿abd: soft, nontender.Noted midline surgical scar, and 2inch bulge right of scar.¿ implant procedure: ventral hernia repair with mesh.Implant: gore® dualmesh® biomaterial (1dlmc02/11636032) 8 x 12 cm.Implant date: (b)(6) 2014.Description of hernia being treated: ¿a midline incision was made in the midepigastric portion of the incision, which is where the hernia was located.The dissection was then carried down through the subcutaneous tissues until the hernia sac was encountered.This was opened and was found to contain only omental fat.The omental fat was reduced back into the abdomen.Palpation of the incision from the undersurface revealed a second small defect, about 1 cm inferior to the primary defect.The 2 defects were then connected to make 1 large defect which measured 6 cm x 2 cm.¿ implant size and fixation: ¿the under surface of the fascia was then cleared of omental adhesins [sic] for several centimeters in all directions.A piece of dualmesh was then cut to the appropriate size and brought into the operative field.This was then placed in an underlay fashion and secured to the fascia with several interrupted 0 pds sutures.Once the mesh was in place, the wound was copiously irrigated with normal saline.The fascial defect was then closed with several interrupted 0 pds sutures in a horizontal mattress fashion.¿ ¿the deep subcutaneous layer was then closed with several interrupted 3-0 vicryl sutures.The deep dermal layer likewise was closed with interrupted 3-0 vicryl sutures.Prior to closing the skin the subcutaneous and fascial structures were copiously infiltrated with 1% lidocaine and 0.25% marcaine local anesthetic.The skin incision was then closed with staples.Sterile dressings were placed.No postoperative records.Relevant medical information: (b)(6) 2014: ¿patient had hernia surgery approx one month ago.Patient rates continued pain 6/10 at this visit.Patient takes oxycontin/oxycodone for good pain relief.¿ ¿he says he developed another abdominal hernia about 1 1/2 wks ago.He is s/p vhr with mesh on (b)(6) 2014.¿ explant preoperative complaints: (b)(6) 2015: ct pelvis ¿impression: unchanged appearance of extraluminal collection inferior to the sigmoid colon, better evaluated on today's prior ct abdomen/pelvis.¿ (b)(6) 2015: abdominal ultrasound, abdominal abscess.[no report].(b)(6) 2015: hospitalization summary (b)(6) 2015.¿acute diverticulitis w/ abscess of intestine; incisional hernia w/o mention of obstruction or gangrene; ventral hernia.¿ (b)(6) 2015: echogram abdomen: ¿impression: fluid-filled loops of bowel/colon in the left lower quadrant.Extraluminal fluid collection or abscess cannot be excluded.¿ (b)(6) 2015: preoperative diagnosis ¿acute diverticulitis with abscess.¿ (b)(6) 2015: ¿the patient is a 50-year-old man who presented a few weeks ago with acute diverticulitis with abscess." ¿however, the abscesses were located in such a way that percutaneous drainage was not possible; therefore, he was continued on antibiotic therapy.He seemed to improve with iv antibiotic therapy alone.He was sent home on po antibiotics.The patient presented to the clinic a few days ago with ongoing symptoms.He was admitted to the hospital and found to have a higher white blood cell count than when he was discharged a few weeks ago.Also, repeat ultrasound exam shows continued fluid around the colon.He is, therefore, brought for an exploratory laparotomy, abscess drainage, and possible hartmann procedure.¿ explant procedure: ¿1.Exploratory laparotomy 2.Lysis of adhesions 3.Pelvic abscess incision and drainage.4.Hartmann procedure.¿ explant date: (b)(6) 2015 [hospitalization dates unknown].¿a midline incision was made through the patient's previous midline incision, and dissection was then carried down through the subcutaneous tissues until the midline fascia was reached.He was found to have a large hernia in the upper midline with a piece of mesh in place which did not contain the hernia.The fascia was opened for the entire length of the incision.The mesh which appeared to be not doing anything was removed.¿ ¿there was a significant amount of adhesive tissue immediately underneath the incision; therefore, a moderate adhesiolysis was performed, concentrating especially in the left lower quadrant area in the midline incision.Once the adhesions had been released enough that the dissection could proceed, the sigmoid colon was grasped.The white line of toldt was then taken down.The attachments to the posterior peritoneum were then released.Inspection of the pelvic area revealed a thickened portion of distal sigmoid colon down into the pelvis.As the adhesions surrounding this portion of colon were released, 2 pus pockets were encountered.¿ ¿samples of this purulence were obtained for aerobic and aerobic culture.The pus pockets were well drained.There was 1 lateral to the sigmoid colon and 1 between the colon and the bladder.Once again, these were drained adequately, and the dissection was then continued.The dissection was then carried distally.It should be noted that the adhesive tissue surrounding the distal sigmoid colon and rectum was quite dense.Therefore, this portion of the procedure proceeded slowly.Above this area which was just at the level of the pelvic rim the remaining sigmoid and descending colon was quite soft and appeared to have no diverticular disease.¿ ¿therefore, a portion was chosen in the proximal 1/3 of the sigmoid for the transection of the colon.A window was created at this level and the 75 mm gia stapler was brought across the colon and clamped in place.This was then held in place for a few seconds and then fired.The stapler was opened, and the colon was transected at this level.Here, the dissection was carried toward the root of the mesentery.The inferior mesenteric artery was then divided along with some other smaller branches with clamps and 2-0 silk free ties.The dissection along the mesentery was then carried distally down into the pelvis.¿ ¿the area to the left of the sigmoid colon was then carefully dissected for the ureter.However, no structure which appeared to be the ureter was encountered.There was a significant amount of adhesive tissue which did hinder the dissection in this area.Nonetheless, i was fairly confident that the ureter would not be injured during the remainder of the dissection.Therefore, the mesentery was then divided, and the tissues between the rectum and pelvis were then divided with the bovie electrocautery until we were beyond the thickest portion of induration within the distal sigmoid colon.At this level, the colon did narrow down, and it was felt that the curvilinear stapler would fit across this portion of rectum.¿ ¿therefore, the 40 mm curved linear stapler was brought into the field and placed across the colon distal to the indurated area.This was then clamped, held in place for several seconds and then fired.This was opened and the specimen was able to be removed.This was opened on the back table, and there appeared to be no mass within the colon itself, merely a significant amount of edema.This was then handed off as a specimen.At the rectal stump which was quite far down into the pelvis, 2 marking sutures of 3-0 prolene were placed at each end of the staple line.The abdomen was then copiously irrigated with normal saline.All irrigation fluid was evacuated from the wound.¿ ¿a 10 mm jackson-pratt drain was brought into the field and brought to lie within the dissection bed in the pelvis.This was secured to the skin with a 2-0 nylon drain stitch.A quarter-sized colostomy was then created in the left lower quadrant.This button of skin was removed with the bovie electrocautery.The dissection was then carried down through the subcutaneous tissues until the rectus sheath was encountered.A cruciate incision was made, and the underlying rectus muscle and posterior fascia were then dissected.The opening was made to a width of 2 fingerbreadths, and the distal descending colon was then brought through this colostomy tunnel and held in place with a babcock clamp.¿ ¿the abdomen was then closed.The fascia was closed with a running o looped pds suture.The deep dermal layer was reapproximated with interrupted 3-0 vicryl sutures.Finally the skin was closed with staples.The colostomy was then matured.The staple line was removed, and the edges of the colon were secured to the deep dermal layer of the colostomy opening with several interrupted 3-0 vicryl sutures.Investigation of the colostomy revealed this to be widely patent.The colostomy apparatus was then cut to the appropriate size and placed around the colostomy.The bag was also snapped into place.Sterile dressings were then placed.The jp drain was placed to bulb suction.¿ no postoperative records.Relevant medical information: (b)(6) 2015: ¿colostomy reversal evaluation.Pain 5/10.¿ (b)(6) 2015: colostomy reversal.Preoperative and postoperative diagnosis ¿colostomy status post hartmann procedure.¿ ¿.Presents with a colostomy status post hartmann procedure performed approximately 4 months ago.He has healed well.The colostomy has been working correctly, and since it has been beyond 12 weeks, the patient presents for elective colostomy reversal.¿ 06/16/15: ¿reports he[patient] had corrective surgery to reverse colostomy, had staples removed yesterday.Rates pain 5/10.¿ (b)(6) 2015: ¿1 month f/u gerd.C/o pain when coughing due to umbilical hernia.¿ (b)(6) 2015: ct abdomen/pelvis: ¿impression: 1.Interval progressive enlargement of ventral hernia with mild bulging of nonobstructed colon and small bowel.2.Interval resolution of previous percolic sigmoid fluid collection¿¿ (b)(6) 2015: ¿hernia eval.States pain 5/10 in abd.¿ (b)(6) 2015: ventral hernia repair with mesh (stoppa repair).¿.Presents with a recurrent ventral hernia.This was originally repaired approximately 1 year ago with mesh.This repair failed and patient more recently underwent a hartmann procedure followed by colostomy reversal about 3 months later.At the time of the colostomy reversal, a small hernia was noted between his previous colostomy site and the midline incision.However, this was quite small and was observed.This has gone on to become a fairly large hernia which is quite symptomatic.Therefore, the patient presents for an elective hernia repair, and we will be performing the more aggressive stoppa repair for this.¿ [ethicon prolene mesh].(b)(6) 2015: hospitalization summary (b)(6) 2015.¿incisional hernia w/o obstruction or gangrene, recurrent ventral hernia; peritoneal adhesions (post-procedural) (post-infection), abdominal wall adhesions; nicotine dependence, cigarettes, uncomplicated, smoker; unspecified/ uncomplicated asthma; gerd w/o esophagitis; acquired absence of other specified parts of digestive tract, s/p hartmann procedure.¿ (b)(6) 2015: supplement abdominal wall w/ synthetic substitute, open approach; ventral hernia repair w/ mesh.¿release peritoneum, open approach; extensive adhesiolysis.Ventral hernia reduction; re-repair.¿ (b)(6) 2015: ¿f/u hernia repair.States pain 5/10, located near incision sites.¿ conclusion: it should be noted that the gore® dualmesh® biomaterial instructions for use includes warnings and addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence.¿ the instructions for use further state: ¿use only nonabsorbable sutures, such as gore-tex® suture, with a noncutting needle (such as taper or piercing point) of appropriate size to anchor the device.The use of absorbable sutures may lead to inadequate anchoring of gore® dualmesh® biomaterial to the host tissue and necessitate reoperation.For best results, use monofilament sutures.Suture size should be determined by surgeon preference and the nature of the reconstruction.¿ the instructions for use also contain the following precaution, ¿do not use absorbable sutures or cutting needles to secure the device in place.¿ medical records that indicate mesh ¿movement¿ or that the device led to a recurrence may reflect a recurrence as a function of a patient¿s poor tissue quality leading to fascial dehiscence or loss of anchorage of fixation, or may be related to the hernia type, individual patient comorbidities, and technical and procedural aspects of the repair.These factors include but are not limited to, fixation type, mesh shape/sizing used, and defect closure decisions.Additionally, a new, unrelated hernia can occur but may be referred to as a recurrent hernia.Individual medical decisions, if inconsistent and/or non-conforming to the device manufacturer¿s recommendations, ifu, or recognized best practices, may result in or contribute to an adverse event.As with any surgical procedure, there are always risks of complications for surgical repair of hernias and soft tissue deficiencies, with or without mesh.These may include but are not limited to, adhesions and related harms, bleeding, bowel obstruction, dysphagia, erosion or extrusion and related harms, exposure or protrusion and related harms, fever, fistula, gerd recurrence, recurrence, ileus, increased procedure time and related harms, irritation or inflammation, infection, pain, paresthesia, perforation, revision / re-intervention, seroma or hematoma and related harms, wound complications and wound dehiscence.Many of the potential complications are associated with the patient¿s underlying disease progression, co-morbidities, additional medical history and/or other surgical procedures.The above inherent risks are typically detailed in standard informed consent documents.The device was not able to be returned to gore for evaluation; therefore, a direct product analysis could not be conducted.Review of the manufacturing records verified that the lot met all pre-release specifications.The investigation concluded that there is no relationship between the device history record findings and the event.All available information has been placed on file for use in product surveillance tracking, trending and follow-up.W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.

Manufacturer Narrative

H6: updated patient codes.H6: updated device code.H6: updated conclusion codes.Previous patient code (1994) was reported based on the original complaint and is no longer applicable per gore¿s investigation.The investigation has been completed.In the absence of additional information or medical records from the complainant, this event file will be closed with the information provided.Medical records: the known medical records span (b)(6) 2013 to (b)(6), 2015, and not all records received in this time span are relevant to gore® dualmesh® biomaterial.The (b)(6) 2014 and (b)(6) 2015 operative reports were not provided.Hospitalization records for the (b)(6) 2015 - (b)(6) 2015 admission were not provided.Patient information: medical history: hypertension [htn], gastroesophageal reflux disease [gerd] , hypothyroidism, osteoarthritis, smoker , 1 pack/day, (b)(6) 2015: nicotine dependence, cigarettes, uncomplicated, smoker.History of alcohol abuse, asthma , methicillin resistant staphylococcus aureus [mrsa], (b)(6) 2015: diverticulitis of intestine with abscess, incisional/ventral hernia, surgical history: laparotomy for perforated diverticulitis cervical surgery x 3.Relevant medical information: (b)(6) 2013: echogram abdomen ltd.¿impression: small non-shadowing echogenic density upper pole of right kidney may represent a non-obstructing stone or small angiomyolipoma.Mild hepatic steatosis.¿ (b)(6) 2013: emergency room visit: ¿abd[ominal] pain.¿ ¿.49 yo male who started experiencing abdominal pain on 5 days ago.He has had associated chills an [sic] diaphoresis on and off since that time.Bowel movements have been infrequent and he has hat [sic] difficulty with urination.Unmeasured fevers.Has also had nausea and vomiting with difficulty keeping anything down.¿ ct abdomen: ¿perforated diverticulitis with focal free air and developing abscess.¿ (b)(6) 2013: ct abdomen: ¿.Area of concern of perforated sigmoid diverticulitis was not imaged.Recommend follow-up ct to include the pelvis.Fatty infiltration of liver.¿ (b)(6) 2013: ¿ct scan last pm noted increase in size of abscess.Pt was transferred to mercy ada earlier today to have a percutaneous drainage performed.Pt just returned from that procedure.¿ ¿abd[abdomen] soft, minimally tender in llq [left lower quadrant], no rebound or guarding noted; perc drain in place with purulent material within it.¿ (b)(6) 2013: culture wound: ¿no strict anaerobes.¿ (b)(6) 2014: ¿pt being sent to ir@ mercy ada for drain replacement.¿ (b)(6) 2014: ¿the patient was seen and examined again due to diffuse abdominal pain from earlir[sic].Patient c/o pain worse than when he came in in the beginning of his stay which was the worst it had been.He is pale and in distress, obviously painful with moving.Due to continued increasing abdominal pain, i will take him to or tonight.¿ (b)(6) 2014: ¿excision of mesentery lesion; peritoneal lavage; exploratory laparotomy; lysis of peritoneal adhesions; excision/ destruction of peritoneal tissue/ necrotic mesentery.¿ (b)(6) 2014: percutaneous abdominal drainage.(b)(6) 2014: exploratory laparotomy with abdominal lavage and lysis of adhesions [hospitalization (b)(6) 2014] preoperative/postoperative diagnosis ¿perforated diverticulitis with abscess and peritonitis.¿ operative findings state: ¿significant adhesions in the pelvis from inflammatory tissues.There was phlegmon and pus within the pelvis without a large collection of pus.The rectum was severely inflamed with mild inflammation of the distal sigmoid colon.There was a blurring of plains in the pelvis due to phlegmon." (b)(6) 2014: culture: collected (b)(6) 2014: 1.Rare staphylococcus aureus (mrsa) 2.Rare staphylococcus epidermidis 3.3+ growth from broth enterococcus faecium.¿ (b)(6) 2014: ct abdomen/ pelvis: ¿post-surgical changes w/ surgical drain within pelvis & resolution of previously noted abscesses.Persistent thickening of the sigmoid." (b)(6) 2014: ¿assessment: perforated diverticulitis, acute renal failure, polymicrobial, multidrug resistant intraabdominal infection d/t perforated viscus including vanco intermediate mrsa, htn.¿ (b)(6) 2014: ¿i anticipate he will be her [sic] for about another week until the inflammation in his sigmoid colon subsides due to the severity of his infection, drug ristance [sic, resistance] of the bacteria that grew out and need for iv antibiotics.¿ (b)(6) 2014: ct abdomen/pelvis: ¿postsurgical changes with surgical drain within the pelvis and resolution of previously noted abscesses.There is persistent thickening of the sigmoid colon.This does not appear to be obstruction.¿ (b)(6) 2014: discharge: to follow up in 7-10 days with physician.(b)(6) 2014: ¿visit note.Chief complaint: diverticulitis, polymicrobial multidrug resistant intraabdominal infection.Wound assessment: healing.Still has mild deep abdominal tenderness, mild tenderness around incision no cdr around incision.¿ (b)(6) 2014: ¿.F/u of chronic issues including htn, gerd, hypothyroidism, asthma, chronic neck pain.Pt was recently inpt with perforated diverticula and abscess.He reports doing well currently.He is eating regular diet and having regular bm.¿ (b)(6) 2014: egd, colonoscopy for preoperative diagnosis ¿nausea, vomiting, follow up diverticulitis.¿ ¿normal egd, diverticulosis, hemorrhoids.¿ (b)(6) 2014: ¿c/o possible abdominal hernia.¿ ¿pt reports a possible hernia with a small amount of protrusion at upper portion of midline abd incision.Pt reports this causes mild pain at times.He also reports intermittent lower pelvic pain that is not present currently.He reports taking po but reports that he occasionally wakes up with nausea and vomiting in the am.He reports normal bm with no changes.¿ "he had egd and colonoscopy last month and with findings of dysmotility secondary to opioids.He recommends gastric emptying study.¿ implant preoperative complaints: (b)(6) 2014: ¿pt is a 49 y/o man who presents with a ventral hernia.Pt recently underwent a laparotomy for a perforated diverticulitis in jan 2014.He has developed a hernia through the midline incision.Pt notes a bulge but not much discomfort with this.Referred for repair.¿ (b)(6) 2014: ¿the patient is a 49-year-old man who presents with a ventral hernia.The patient previously underwent a laparotomy for perforated diverticulitis.He has developed a hernia through the midline incision.He presents for elective repair.¿ (b)(6) 2014¿ ¿abd: soft, nontender.Noted midline surgical scar, and 2inch bulge right of scar.¿ implant procedure: ventral hernia repair with mesh.Implant: gore® dualmesh® biomaterial (1dlmc02/11636032) 8 x 12 cm.Implant date: (b)(6) 2014 description of hernia being treated: ¿a midline incision was made in the midepigastric portion of the incision, which is where the hernia was located.The dissection was then carried down through the subcutaneous tissues until the hernia sac was encountered.This was opened and was found to contain only omental fat.The omental fat was reduced back into the abdomen.Palpation of the incision from the undersurface revealed a second small defect, about 1 cm inferior to the primary defect.The 2 defects were then connected to make 1 large defect which measured 6 cm x 2 cm.¿ implant size and fixation: ¿the under surface of the fascia was then cleared of omental adhesins [sic] for several centimeters in all directions.A piece of dualmesh was then cut to the appropriate size and brought into the operative field.This was then placed in an underlay fashion and secured to the fascia with several interrupted 0 pds sutures.Once the mesh was in place, the wound was copiously irrigated with normal saline.The fascial defect was then closed with several interrupted 0 pds sutures in a horizontal mattress fashion.¿ ¿the deep subcutaneous layer was then closed with several interrupted 3-0 vicryl sutures.The deep dermal layer likewise was closed with interrupted 3-0 vicryl sutures.Prior to closing the skin the subcutaneous and fascial structures were copiously infiltrated with 1% lidocaine and 0.25% marcaine local anesthetic.The skin incision was then closed with staples.Sterile dressings were placed.No postoperative records.Relevant medical information: (b)(6) 2014: ¿patient had hernia surgery approx one month ago.Patient rates continued pain 6/10 at this visit.Patient takes oxycontin/oxycodone for good pain relief.¿ ¿he says he developed another abdominal hernia about 1 1/2 wks ago.He is s/p vhr with mesh on (b)(6) 2014.¿ explant preoperative complaints: (b)(6) 2015: ct pelvis ¿impression: unchanged appearance of extraluminal collection inferior to the sigmoid colon, better evaluated on today's prior ct abdomen/pelvis.¿ (b)(6) 2015: abdominal ultrasound, abdominal abscess.[no report] (b)(6) 2015: hospitalization summary (b)(6).¿acute diverticulitis w/ abscess of intestine; incisional hernia w/o mention of obstruction or gangrene; ventral hernia.¿ (b)(6) 2015: echogram abdomen: ¿impression: fluid-filled loops of bowel/colon in the left lower quadrant.Extraluminal fluid collection or abscess cannot be excluded.¿ (b)(6) 2015: preoperative diagnosis ¿acute diverticulitis with abscess.¿ (b)(6) 2015: ¿the patient is a 50-year-old man who presented a few weeks ago with acute diverticulitis with abscess." ¿however, the abscesses were located in such a way that percutaneous drainage was not possible; therefore, he was continued on antibiotic therapy.He seemed to improve with iv antibiotic therapy alone.He was sent home on po antibiotics.The patient presented to the clinic a few days ago with ongoing symptoms.He was admitted to the hospital and found to have a higher white blood cell count than when he was discharged a few weeks ago.Also, repeat ultrasound exam shows continued fluid around the colon.He is, therefore, brought for an exploratory laparotomy, abscess drainage, and possible hartmann procedure.¿ explant procedure: ¿1.Exploratory laparotomy 2.Lysis of adhesions 3.Pelvic abscess incision and drainage.4.Hartmann procedure.¿ explant date: (b)(6), 2015 ¿a midline incision was made through the patient's previous midline incision, and dissection was then carried down through the subcutaneous tissues until the midline fascia was reached.He was found to have a large hernia in the upper midline with a piece of mesh in place which did not contain the hernia.The fascia was opened for the entire length of the incision.The mesh which appeared to be not doing anything was removed.¿ ¿there was a significant amount of adhesive tissue immediately underneath the incision; therefore, a moderate adhesiolysis was performed, concentrating especially in the left lower quadrant area in the midline incision.Once the adhesions had been released enough that the dissection could proceed, the sigmoid colon was grasped.The white line of toldt was then taken down.The attachments to the posterior peritoneum were then released.Inspection of the pelvic area revealed a thickened portion of distal sigmoid colon down into the pelvis.As the adhesions surrounding this portion of colon were released, 2 pus pockets were encountered.¿ ¿samples of this purulence were obtained for aerobic and aerobic culture.The pus pockets were well drained.There was 1 lateral to the sigmoid colon and 1 between the colon and the bladder.Once again, these were drained adequately, and the dissection was then continued.The dissection was then carried distally.It should be noted that the adhesive tissue surrounding the distal sigmoid colon and rectum was quite dense.Therefore, this portion of the procedure proceeded slowly.Above this area which was just at the level of the pelvic rim the remaining sigmoid and descending colon was quite soft and appeared to have no diverticular disease.¿ ¿therefore, a portion was chosen in the proximal 1/3 of the sigmoid for the transection of the colon.A window was created at this level and the 75 mm gia stapler was brought across the colon and clamped in place.This was then held in place for a few seconds and then fired.The stapler was opened, and the colon was transected at this level.Here, the dissection was carried toward the root of the mesentery.The inferior mesenteric artery was then divided along with some other smaller branches with clamps and 2-0 silk free ties.The dissection along the mesentery was then carried distally down into the pelvis.¿ ¿the area to the left of the sigmoid colon was then carefully dissected for the ureter.However, no structure which appeared to be the ureter was encountered.There was a significant amount of adhesive tissue which did hinder the dissection in this area.Nonetheless, i was fairly confident that the ureter would not be injured during the remainder of the dissection.Therefore, the mesentery was then divided, and the tissues between the rectum and pelvis were then divided with the bovie electrocautery until we were beyond the thickest portion of induration within the distal sigmoid colon.At this level, the colon did narrow down, and it was felt that the curvilinear stapler would fit across this portion of rectum.¿ ¿therefore, the 40 mm curved linear stapler was brought into the field and placed across the colon distal to the indurated area.This was then clamped, held in place for several seconds and then fired.This was opened and the specimen was able to be removed.This was opened on the back table, and there appeared to be no mass within the colon itself, merely a significant amount of edema.This was then handed off as a specimen.At the rectal stump which was quite far down into the pelvis, 2 marking sutures of 3-0 prolene were placed at each end of the staple line.The abdomen was then copiously irrigated with normal saline.All irrigation fluid was evacuated from the wound.¿ ¿a 10 mm jackson-pratt drain was brought into the field and brought to lie within the dissection bed in the pelvis.This was secured to the skin with a 2-0 nylon drain stitch.A quarter-sized colostomy was then created in the left lower quadrant.This button of skin was removed with the bovie electrocautery.The dissection was then carried down through the subcutaneous tissues until the rectus sheath was encountered.A cruciate incision was made, and the underlying rectus muscle and posterior fascia were then dissected.The opening was made to a width of 2 fingerbreadths, and the distal descending colon was then brought through this colostomy tunnel and held in place with a babcock clamp.¿ ¿the abdomen was then closed.The fascia was closed with a running o looped pds suture.The deep dermal layer was reapproximated with interrupted 3-0 vicryl sutures.Finally the skin was closed with staples.The colostomy was then matured.The staple line was removed, and the edges of the colon were secured to the deep dermal layer of the colostomy opening with several interrupted 3-0 vicryl sutures.Investigation of the colostomy revealed this to be widely patent.The colostomy apparatus was then cut to the appropriate size and placed around the colostomy.The bag was also snapped into place.Sterile dressings were then placed.The jp drain was placed to bulb suction.¿ no postoperative records.Relevant medical information: (b)(6) 2015: ¿colostomy reversal evaluation.Pain 5/10.¿ (b)(6) 2015: colostomy reversal.Preoperative and postoperative diagnosis ¿colostomy status post hartmann procedure.¿ ¿.Presents with a colostomy status post hartmann procedure performed approximately 4 months ago.He has healed well.The colostomy has been working correctly, and since it has been beyond 12 weeks, the patient presents for elective colostomy reversal.¿ (b)(6) 2015: ¿reports he[patient] had corrective surgery to reverse colostomy, had staples removed yesterday.Rates pain 5/10.¿ (b)(6) 2015: ¿1 month f/u gerd.C/o pain when coughing due to umbilical hernia.¿ (b)(6) 2015: ct abdomen/pelvis: ¿impression: 1.Interval progressive enlargement of ventral hernia with mild bulging of nonobstructed colon and small bowel.2.Interval resolution of previous percolic sigmoid fluid collection¿¿ (b)(6) 2015: ¿hernia eval.States pain 5/10 in abd.¿ (b)(6) 2015: ventral hernia repair with mesh (stoppa repair).¿.Presents with a recurrent ventral hernia.This was originally repaired approximately 1 year ago with mesh.This repair failed and patient more recently underwent a hartmann procedure followed by colostomy reversal about 3 months later.At the time of the colostomy reversal, a small hernia was noted between his previous colostomy site and the midline incision.However, this was quite small and was observed.This has gone on to become a fairly large hernia which is quite symptomatic.Therefore, the patient presents for an elective hernia repair, and we will be performing the more aggressive stoppa repair for this.¿ [ethicon prolene mesh].(b)(6) 2015: hospitalization summary (b)(6).¿incisional hernia w/o obstruction or gangrene, recurrent ventral hernia; peritoneal adhesions (post-procedural) (post-infection), abdominal wall adhesions; nicotine dependence, cigarettes, uncomplicated, smoker; unspecified/ uncomplicated asthma; gerd w/o esophagitis; acquired absence of other specified parts of digestive tract, s/p hartmann procedure.¿ (b)(6) 2015: supplement abdominal wall w/ synthetic substitute, open approach; ventral hernia repair w/ mesh.¿release peritoneum, open approach; extensive adhesiolysis.Ventral hernia reduction; re-repair.¿ (b)(6) 2015: ¿f/u hernia repair.States pain 5/10, located near incision sites.¿ conclusion: it should be noted that the gore® dualmesh® biomaterial instructions for use includes warnings and addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence.¿ the instructions for use further state: ¿use only nonabsorbable sutures, such as gore-tex® suture, with a noncutting needle (such as taper or piercing point) of appropriate size to anchor the device.The use of absorbable sutures may lead to inadequate anchoring of gore® dualmesh® biomaterial to the host tissue and necessitate reoperation.For best results, use monofilament sutures.Suture size should be determined by surgeon preference and the nature of the reconstruction.¿ the instructions for use also contain the following precaution, ¿do not use absorbable sutures or cutting needles to secure the device in place.¿ medical records that indicate mesh ¿movement¿ or that the device led to a recurrence may reflect a recurrence as a function of a patient¿s poor tissue quality leading to fascial dehiscence or loss of anchorage of fixation, or may be related to the hernia type, individual patient comorbidities, and technical and procedural aspects of the repair.These factors include but are not limited to, fixation type, mesh shape/sizing used, and defect closure decisions.Additionally, a new, unrelated hernia can occur but may be referred to as a recurrent hernia.Individual medical decisions, if inconsistent and/or non-conforming to the device manufacturer¿s recommendations, ifu, or recognized best practices, may result in or contribute to an adverse event.As with any surgical procedure, there are always risks of complications for surgical repair of hernias and soft tissue deficiencies, with or without mesh.These may include but are not limited to, adhesions and related harms, bleeding, bowel obstruction, dysphagia, erosion or extrusion and related harms, exposure or protrusion and related harms, fever, fistula, gerd recurrence, recurrence, ileus, increased procedure time and related harms, irritation or inflammation, infection, pain, paresthesia, perforation, revision / re-intervention, seroma or hematoma and related harms, wound complications and wound dehiscence.Many of the potential complications are associated with the patient¿s underlying disease progression, co-morbidities, additional medical history and/or other surgical procedures.The above inherent risks are typically detailed in standard informed consent documents.The device was not able to be returned to gore for evaluation; therefore, a direct product analysis could not be conducted.Review of the manufacturing records verified that the lot met all pre-release specifications.W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.

Manufacturer Narrative

Previous patient code (1994) was reported based on the original complaint and is no longer applicable per gore¿s investigation.The investigation has been completed.In the absence of additional information or medical records from the complainant, this event file will be closed with the information provided.Medical records: the known medical records span (b)(6) 2013 to (b)(6) 2015, and not all records received in this time span are relevant to gore® dualmesh® biomaterial.The (b)(6) 2014 and (b)(6) 2015 operative reports were not provided.Hospitalization records for the (b)(6) 2015 - (b)(6) 2015.Admission were not provided.Patient information: medical history: hypertension [htn]; gastroesophageal reflux disease [gerd]; hypothyroidism; osteoarthritis; smoker; 1 pack/day; (b)(6) 2015: nicotine dependence, cigarettes, uncomplicated, smoker.History of alcohol abuse; asthma; methicillin resistant staphylococcus aureus [mrsa]; (b)(6) 2015: diverticulitis of intestine with abscess, incisional/ventral hernia.Surgical history: laparotomy for perforated diverticulitis; cervical surgery x 3.Relevant medical information: (b)(6) 2013: echogram abdomen ltd.¿impression: small non-shadowing echogenic density upper pole of right kidney may represent a non-obstructing stone or small angiomyolipoma.Mild hepatic steatosis.¿ (b)(6) 2013: er visit: ¿abd[ominal] pain.¿ ¿.49 yo male who started experiencing abdominal pain on 5 days ago.He has had associated chills an [sic] diaphoresis on and off since that time.Bowel movements have been infrequent and he has hat [sic] difficulty with urination.Unmeasured fevers.Has also had nausea and vomiting with difficulty keeping anything down.¿ ct abdomen: ¿perforated diverticulitis with focal free air and developing abscess.¿ (b)(6) 2013: ct abdomen: ¿.Area of concern of perforated sigmoid diverticulitis was not imaged.Recommend follow-up ct to include the pelvis.Fatty infiltration of liver.¿ (b)(6) 2013: ¿ct scan last pm noted increase in size of abscess.Pt was transferred to mercy ada earlier today to have a percutaneous drainage performed.Pt just returned from that procedure.¿ ¿abd[abdomen] soft, minimally tender in llq [left lower quadrant], no rebound or guarding noted; perc drain in place with purulent material within it.¿ (b)(6) 2013: culture wound: ¿no strict anaerobes.¿ (b)(6) 2014: ¿pt being sent to ir@ mercy ada for drain replacement.¿ (b)(6) 2014: ¿the patient was seen and examined again due to diffuse abdominal pain from earlir[sic].Patient c/o pain worse than when he came in in the beginning of his stay which was the worst it had been.He is pale and in distress, obviously painful with moving.Due to continued increasing abdominal pain, i will take him to or tonight.¿ (b)(6) 2014: ¿excision of mesentery lesion; peritoneal lavage; exploratory laparotomy; lysis of peritoneal adhesions; excision/ destruction of peritoneal tissue/ necrotic mesentery.¿ (b)(6) 2014: percutaneous abdominal drainage.(b)(6) 2014: exploratory laparotomy with abdominal lavage and lysis of adhesions [hospitalization (b)(6) 2014] preoperative/postoperative diagnosis ¿perforated diverticulitis with abscess and peritonitis.¿ operative findings state: ¿significant adhesions in the pelvis from inflammatory tissues.There was phlegmon and pus within the pelvis without a large collection of pus.The rectum was severely inflamed with mild inflammation of the distal sigmoid colon.There was a blurring of plains in the pelvis due to phlegmon." (b)(6) 2014: culture: collected 1/3/14: 1.Rare staphylococcus aureus (mrsa) 2.Rare staphylococcus epidermidis 3.3+ growth from broth enterococcus faecium.¿ (b)(6) 2014: ct abdomen/ pelvis: ¿post-surgical changes w/ surgical drain within pelvis & resolution of previously noted abscesses.Persistent thickening of the sigmoid." (b)(6) 2014: ¿assessment: perforated diverticulitis, acute renal failure, polymicrobial, multidrug resistant intraabdominal infection d/t perforated viscus including vanco intermediate mrsa, htn.¿ (b)(6) 2014: ¿i anticipate he will be her [sic] for about another week until the inflammation in his sigmoid colon subsides due to the severity of his infection, drug ristance [sic, resistance] of the bacteria that grew out and need for iv antibiotics.¿ (b)(6) 2014: ct abdomen/pelvis: ¿postsurgical changes with surgical drain within the pelvis and resolution of previously noted abscesses.There is persistent thickening of the sigmoid colon.This does not appear to be obstruction.¿ (b)(6) 2014: discharge: to follow up in 7-10 days with physician.(b)(6) 2014: ¿visit note.Chief complaint: diverticulitis, polymicrobial multidrug resistant intraabdominal infection.Wound assessment: healing.Still has mild deep abdominal tenderness, mild tenderness around incision no cdr around incision.¿ (b)(6) 2014: ¿.F/u of chronic issues including htn, gerd, hypothyroidism, asthma, chronic neck pain.Pt was recently inpt with perforated diverticula and abscess.He reports doing well currently.He is eating regular diet and having regular bm.¿ (b)(6) 2014: egd, colonoscopy for preoperative diagnosis ¿nausea, vomiting, follow up diverticulitis.¿ ¿normal egd, diverticulosis, hemorrhoids.¿ (b)(6) 2014: ¿c/o possible abdominal hernia.¿ ¿pt reports a possible hernia with a small amount of protrusion at upper portion of midline abd incision.Pt reports this causes mild pain at times.He also reports intermittent lower pelvic pain that is not present currently.He reports taking po but reports that he occasionally wakes up with nausea and vomiting in the am.He reports normal bm with no changes.¿ "he had egd and colonoscopy last month and with findings of dysmotility secondary to opioids.He recommends gastric emptying study.¿ implant preoperative complaints: (b)(6) 2014: ¿pt is a 49 y/o man who presents with a ventral hernia.Pt recently underwent a laparotomy for a perforated diverticulitis in jan 2014.He has developed a hernia through the midline incision.Pt notes a bulge but not much discomfort with this.Referred for repair.¿ (b)(6) 2014: ¿the patient is a 49-year-old man who presents with a ventral hernia.The patient previously underwent a laparotomy for perforated diverticulitis.He has developed a hernia through the midline incision.He presents for elective repair.¿ (b)(6) 2014¿ ¿abd: soft, nontender.Noted midline surgical scar, and 2inch bulge right of scar.¿ implant procedure: ventral hernia repair with mesh.Implant: gore® dualmesh® biomaterial (1dlmc02/11636032) 8 x 12 cm.Implant date: (b)(6) 2014.Description of hernia being treated: ¿a midline incision was made in the midepigastric portion of the incision, which is where the hernia was located.The dissection was then carried down through the subcutaneous tissues until the hernia sac was encountered.This was opened and was found to contain only omental fat.The omental fat was reduced back into the abdomen.Palpation of the incision from the undersurface revealed a second small defect, about 1 cm inferior to the primary defect.The 2 defects were then connected to make 1 large defect which measured 6 cm x 2 cm.¿ implant size and fixation: ¿the under surface of the fascia was then cleared of omental adhesins [sic] for several centimeters in all directions.A piece of dualmesh was then cut to the appropriate size and brought into the operative field.This was then placed in an underlay fashion and secured to the fascia with several interrupted 0 pds sutures.Once the mesh was in place, the wound was copiously irrigated with normal saline.The fascial defect was then closed with several interrupted 0 pds sutures in a horizontal mattress fashion.¿ ¿the deep subcutaneous layer was then closed with several interrupted 3-0 vicryl sutures.The deep dermal layer likewise was closed with interrupted 3-0 vicryl sutures.Prior to closing the skin the subcutaneous and fascial structures were copiously infiltrated with 1% lidocaine and 0.25% marcaine local anesthetic.The skin incision was then closed with staples.Sterile dressings were placed.No postoperative records.Relevant medical information: (b)(6) 2014: ¿patient had hernia surgery approx one month ago.Patient rates continued pain 6/10 at this visit.Patient takes oxycontin/oxycodone for good pain relief.¿ ¿he says he developed another abdominal hernia about 1 1/2 wks ago.He is s/p vhr with mesh on (b)(6) 2014.¿ explant preoperative complaints: (b)(6) 2015: ct pelvis ¿impression: unchanged appearance of extraluminal collection inferior to the sigmoid colon, better evaluated on today's prior ct abdomen/pelvis.¿ (b)(6) 2015: abdominal ultrasound, abdominal abscess.[no report] (b)(6) 2015: hospitalization summary (b)(6) 2015-(b)(6) 2015.¿acute diverticulitis w/ abscess of intestine; incisional hernia w/o mention of obstruction or gangrene; ventral hernia.¿ (b)(6) 2015: echogram abdomen: ¿impression: fluid-filled loops of bowel/colon in the left lower quadrant.Extraluminal fluid collection or abscess cannot be excluded.¿ (b)(6) 2015: preoperative diagnosis ¿acute diverticulitis with abscess.¿ (b)(6) 2015: ¿the patient is a 50-year-old man who presented a few weeks ago with acute diverticulitis with abscess." ¿however, the abscesses were located in such a way that percutaneous drainage was not possible; therefore, he was continued on antibiotic therapy.He seemed to improve with iv antibiotic therapy alone.He was sent home on po antibiotics.The patient presented to the clinic a few days ago with ongoing symptoms.He was admitted to the hospital and found to have a higher white blood cell count than when he was discharged a few weeks ago.Also, repeat ultrasound exam shows continued fluid around the colon.He is, therefore, brought for an exploratory laparotomy, abscess drainage, and possible hartmann procedure.¿ explant procedure: ¿ exploratory laparotomy.Lysis of adhesions.Pelvic abscess incision and drainage.Hartmann procedure.¿ explant date: (b)(6) 2015.¿a midline incision was made through the patient's previous midline incision, and dissection was then carried down through the subcutaneous tissues until the midline fascia was reached.He was found to have a large hernia in the upper midline with a piece of mesh in place which did not contain the hernia.The fascia was opened for the entire length of the incision.The mesh which appeared to be not doing anything was removed.¿ ¿there was a significant amount of adhesive tissue immediately underneath the incision; therefore, a moderate adhesiolysis was performed, concentrating especially in the left lower quadrant area in the midline incision.Once the adhesions had been released enough that the dissection could proceed, the sigmoid colon was grasped.The white line of toldt was then taken down.The attachments to the posterior peritoneum were then released.Inspection of the pelvic area revealed a thickened portion of distal sigmoid colon down into the pelvis.As the adhesions surrounding this portion of colon were released, 2 pus pockets were encountered.¿ ¿samples of this purulence were obtained for aerobic and aerobic culture.The pus pockets were well drained.There was 1 lateral to the sigmoid colon and 1 between the colon and the bladder.Once again, these were drained adequately, and the dissection was then continued.The dissection was then carried distally.It should be noted that the adhesive tissue surrounding the distal sigmoid colon and rectum was quite dense.Therefore, this portion of the procedure proceeded slowly.Above this area which was just at the level of the pelvic rim the remaining sigmoid and descending colon was quite soft and appeared to have no diverticular disease.¿ ¿therefore, a portion was chosen in the proximal 1/3 of the sigmoid for the transection of the colon.A window was created at this level and the 75 mm gia stapler was brought across the colon and clamped in place.This was then held in place for a few seconds and then fired.The stapler was opened, and the colon was transected at this level.Here, the dissection was carried toward the root of the mesentery.The inferior mesenteric artery was then divided along with some other smaller branches with clamps and 2-0 silk free ties.The dissection along the mesentery was then carried distally down into the pelvis.¿ ¿the area to the left of the sigmoid colon was then carefully dissected for the ureter.However, no structure which appeared to be the ureter was encountered.There was a significant amount of adhesive tissue which did hinder the dissection in this area.Nonetheless, i was fairly confident that the ureter would not be injured during the remainder of the dissection.Therefore, the mesentery was then divided, and the tissues between the rectum and pelvis were then divided with the bovie electrocautery until we were beyond the thickest portion of induration within the distal sigmoid colon.At this level, the colon did narrow down, and it was felt that the curvilinear stapler would fit across this portion of rectum.¿ ¿therefore, the 40 mm curved linear stapler was brought into the field and placed across the colon distal to the indurated area.This was then clamped, held in place for several seconds and then fired.This was opened and the specimen was able to be removed.This was opened on the back table, and there appeared to be no mass within the colon itself, merely a significant amount of edema.This was then handed off as a specimen.At the rectal stump which was quite far down into the pelvis, 2 marking sutures of 3-0 prolene were placed at each end of the staple line.The abdomen was then copiously irrigated with normal saline.All irrigation fluid was evacuated from the wound.¿ ¿a 10 mm jackson-pratt drain was brought into the field and brought to lie within the dissection bed in the pelvis.This was secured to the skin with a 2-0 nylon drain stitch.A quarter-sized colostomy was then created in the left lower quadrant.This button of skin was removed with the bovie electrocautery.The dissection was then carried down through the subcutaneous tissues until the rectus sheath was encountered.A cruciate incision was made, and the underlying rectus muscle and posterior fascia were then dissected.The opening was made to a width of 2 fingerbreadths, and the distal descending colon was then brought through this colostomy tunnel and held in place with a babcock clamp.¿ ¿the abdomen was then closed.The fascia was closed with a running o looped pds suture.The deep dermal layer was reapproximated with interrupted 3-0 vicryl sutures.Finally the skin was closed with staples.The colostomy was then matured.The staple line was removed, and the edges of the colon were secured to the deep dermal layer of the colostomy opening with several interrupted 3-0 vicryl sutures.Investigation of the colostomy revealed this to be widely patent.The colostomy apparatus was then cut to the appropriate size and placed around the colostomy.The bag was also snapped into place.Sterile dressings were then placed.The jp drain was placed to bulb suction.¿ no postoperative records.Relevant medical information: (b)(6) 2015: ¿colostomy reversal evaluation.Pain 5/10.¿ (b)(6) 2015: colostomy reversal.Preoperative and postoperative diagnosis ¿colostomy status post hartmann procedure.¿ ¿presents with a colostomy status post hartmann procedure performed approximately 4 months ago.He has healed well.The colostomy has been working correctly, and since it has been beyond 12 weeks, the patient presents for elective colostomy reversal.¿ (b)(6) 2015: ¿reports he[patient] had corrective surgery to reverse colostomy, had staples removed yesterday.Rates pain 5/10.¿ (b)(6) 2015: ¿1 month f/u gerd.C/o pain when coughing due to umbilical hernia.¿ (b)(6) 2015: ct abdomen/pelvis: ¿impression: interval progressive enlargement of ventral hernia with mild bulging of nonobstructed colon and small bowel.Interval resolution of previous percolic sigmoid fluid collection¿¿ (b)(6) 2015: ¿hernia eval.States pain 5/10 in abd.¿ (b)(6) 2015: ventral hernia repair with mesh (stoppa repair).¿.Presents with a recurrent ventral hernia.This was originally repaired approximately 1 year ago with mesh.This repair failed and patient more recently underwent a hartmann procedure followed by colostomy reversal about 3 months later.At the time of the colostomy reversal, a small hernia was noted between his previous colostomy site and the midline incision.However, this was quite small and was observed.This has gone on to become a fairly large hernia which is quite symptomatic.Therefore, the patient presents for an elective hernia repair, and we will be performing the more aggressive stoppa repair for this.¿ [ethicon prolene mesh].(b)(6) 2015: hospitalization summary (b)(6) 2015¿(b)(6) 2015.¿incisional hernia w/o obstruction or gangrene, recurrent ventral hernia; peritoneal adhesions (post-procedural) (post-infection), abdominal wall adhesions; nicotine dependence, cigarettes, uncomplicated, smoker; unspecified/ uncomplicated asthma; gerd w/o esophagitis; acquired absence of other specified parts of digestive tract, s/p hartmann procedure.¿ (b)(6) 2015: supplement abdominal wall w/ synthetic substitute, open approach; ventral hernia repair w/ mesh.¿release peritoneum, open approach; extensive adhesiolysis.Ventral hernia reduction; re-repair.¿ (b)(6) 2015: ¿f/u hernia repair.States pain 5/10, located near incision sites.¿ conclusion: it should be noted that the gore® dualmesh® biomaterial instructions for use includes warnings and addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence.¿ the instructions for use further state: ¿use only nonabsorbable sutures, such as gore-tex® suture, with a noncutting needle (such as taper or piercing point) of appropriate size to anchor the device.The use of absorbable sutures may lead to inadequate anchoring of gore® dualmesh® biomaterial to the host tissue and necessitate reoperation.For best results, use monofilament sutures.Suture size should be determined by surgeon preference and the nature of the reconstruction.¿ the instructions for use also contain the following precaution, ¿do not use absorbable sutures or cutting needles to secure the device in place.¿ medical records that indicate mesh ¿movement¿ or that the device led to a recurrence may reflect a recurrence as a function of a patient¿s poor tissue quality leading to fascial dehiscence or loss of anchorage of fixation, or may be related to the hernia type, individual patient comorbidities, and technical and procedural aspects of the repair.These factors include but are not limited to, fixation type, mesh shape/sizing used, and defect closure decisions.Additionally, a new, unrelated hernia can occur but may be referred to as a recurrent hernia.Individual medical decisions, if inconsistent and/or non-conforming to the device manufacturer¿s recommendations, ifu, or recognized best practices, may result in or contribute to an adverse event.As with any surgical procedure, there are always risks of complications for surgical repair of hernias and soft tissue deficiencies, with or without mesh.These may include but are not limited to, adhesions and related harms, bleeding, bowel obstruction, dysphagia, erosion or extrusion and related harms, exposure or protrusion and related harms, fever, fistula, gerd recurrence, recurrence, ileus, increased procedure time and related harms, irritation or inflammation, infection, pain, paresthesia, perforation, revision/re-intervention, seroma or hematoma and related harms, wound complications and wound dehiscence.Many of the potential complications are associated with the patient¿s underlying disease progression, co-morbidities, additional medical history and/or other surgical procedures.The above inherent risks are typically detailed in standard informed consent documents.The device was not able to be returned to gore for evaluation; therefore, a direct product analysis could not be conducted.Review of the manufacturing records verified that the lot met all pre-release specifications.W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.

• Brand Name: GORE DUALMESH BIOMATERIAL
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 8372274
• MDR Text Key: 137246811
• Report Number: 3003910212-2019-00030
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00733132600953
• UDI-Public: 00733132600953
• Combination Product (y/n): N
• PMA/PMN Number: K992189
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 04/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2018
• Device Model Number: 1DLMC02
• Device Catalogue Number: 1DLMC02
• Device Lot Number: 11636032
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 50 YR
• Patient Weight: 84