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| Model Number 1DLMC04 |
| Device Problems
No Apparent Adverse Event (3189); Insufficient Information (3190)
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| Patient Problems
Pain (1994); Vomiting (2144); Peritonitis (2252); Not Applicable (3189)
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| Event Date 02/25/2008 |
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Event Type
Injury
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Manufacturer Narrative
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(b)(4)".(b)(6).It should be noted that the gore dualmesh® biomaterial instructions for use includes warnings and addresses the following adverse reactions among others: ¿strict aseptic techniques should be followed.If an infection develops, it should be treated aggressively.An unresolved infection may require removal of the material.¿ ¿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.¿.
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Event Description
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It was reported to gore that the patient underwent laparoscopic incisional hernia repair on (b)(6) 2008 whereby a gore dualmesh® biomaterial was implanted.The complaint alleges that on (b)(6) 2008, an additional procedure was performed whereby explant of the gore device was performed.It was reported the patient alleges the following injuries: abdominal pain, vomiting, peritonitis, fever, adhesions, infected mesh, mesh removal, wound vac placement with home care required, and loss of consortium.Additional event specific information was not provided.
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Manufacturer Narrative
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H6: corrected results code.Conclusion code remains unchanged.E1: the initial reporter's complete address is (b)(6).It should be noted that the gore dualmesh® biomaterial instructions for use includes warnings and addresses the following adverse reactions among others: ¿strict aseptic techniques should be followed.If an infection develops, it should be treated aggressively.An unresolved infection may require removal of the material.¿ ¿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.
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Manufacturer Narrative
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A2: added date of birth.H6: corrected results code for manufacturing evaluation.Conclusion code remains unchanged.Added results code/conclusions code 2 for sterilization evaluation.Additional details regarding the patient's clinical course were ascertained from a review of medical records and are as follows: records prior to 2008, including records for the hysterectomy and left hemicolectomy noted in the 2/18/2008 records, were not provided.Admission records dated 2/18/2008 state: ¿this is a 47-year-old obese female who has had a previous hysterectomy and left hemicolectomy who mentioned that a bulge started in her abdomen after hysterectomy in 2004, and felt a pop when she was moving some furniture recently.She presents for an elective laparoscopic repair with a ventral defect.She is asymptomatic at this time.¿ operative records dated 2/18/2008 indicate the patient underwent laparoscopic repair of an incisional hernia.The records state: ¿this is a 47-year-old female who has had multiple previous abdominal operations including hysterectomy and colectomy.She now has a mid abdominal incisional hernia.¿ the 2/18/2008 operative report states: ¿there were multiple adhesions including loops of small bowel throughout the abdomen.We placed an additional 5-mm port in the right upper quadrant and a 12-mm port in the right lower quadrant under direct visualization.We continued the inferior port, we then took down several loops of bowel which were adhesed to the anterior abdominal wall to gain more free access.We then began to carefully take down the adhesions.The entire omentum was tacked up the abdominal wall along the previous midline incision encompassing the hernia, part of the stomach was pulled up, also intestinal adhesions at different points.We worked carefully with the scissors alternating with the cautery as needed, and eventually, we were able to completely free up the adhesions over a period of approximately 2 hours.All of the adhesions were dropped down.There was no evidence of bowel injury.¿ the 2/18/2008 operative records continue: ¿the defect was measured out, it was approximately 9 x 9 cm, and no other defects were repaired.We chose a 15 x 19 piece of gore-tex mesh for the repair.It was marked out in 8 quadrants and stitches of 0 surgilon were placed.It was then rolled up and passed through the 12-mm port site and unrolled stitches were pulled up using the endopass circumferentially so they would layout readily symmetrically.We then went around and tied the sutures.We then alternated the protack with absorbatack to tack up the spam between the sutures.We appeared to have good alignment, and as we had insufflated the abdomen, the c02 was evacuated.We closed the 12-mm port site with 0 dexon using endo close device.We then clean closed the puncture sites and closed the incision with running 4-0 dexon after injecting with marcaine.¿ the records indicate a gore dualmesh® biomaterial (1dlmc04/05273700) was implanted during the procedure.Operative records dated 2/25/2008 indicate the patient underwent ¿exploratory laparotomy, removal of mesh, small-bowel resection, and placement of left internal jugular catheter¿ for a diagnosis of perforated intestine.The records state: ¿this patient is 1 week status post laparoscopic incisional hernia repair.She developed worsening abdominal pain, vomiting, and presented to the emergency room with peritonitis.Ct scan showed perforation with extravasation.¿ the 2/25/2008 records state: ¿an upper midline incision was opened by excising the previous scar from the superior aspect down to just below the umbilicus.Subcutaneous tissues were then entered.We entered the hernial sac located in a part of our incision.It was opened, and cloudy fluid was found and was cultured.We then opened the fascia above and below the main hernial defect to the limits of our previous mesh.We then opened the mesh and cleared it lengthwise along its length.This enabled us to evacuate further fluid.There were marked adhesions, particularly along the left side of the mesh, and then taking those down, an intestinal perforation was found.It was not clear if this was a free perforation or whether it had been related to one of our staples on the left side.We then went around and carefully removed all of the mesh suture and staples circumferentially.Irritation was carried out.¿ the 2/25/2008 operative report continues: ¿there was fairly significant inflammatory response in the mid abdomen between the omentum, transverse colon, and several loops of small bowel.Most of these were chronic adhesions that were present.We began separating small bowel and colon until we had found the segment of the bowel that had the perforation and mesenteric edge several millimeters in diameter.There was scar tissue and fibrinous tissue around this area.We eventually freed it up enough and determined that we would need to do a small resection rather than attempt to repair.Proximal and distal margins of abdominal wall were identified.The mesentery was divided along the edge of the bowel with two clamps and 2-0 silk ties.¿ the 2/25/2008 operative records state: ¿we then resected a segment of approximately 8 cm of small intestine using gia 63.8 mm stapler on each end of the resection.We then imbricated our staple lines with 3-0 silk and placed stay sutures of 3-0 silk away from the margin.We made enterotomies and fired the gia 60 stapler longitudinally to create a side-to-side anastomosis with 3-0 silk placed at the apex.There appeared to be no evidence of obstruction with good viability.We then closed our defect with a running 3-0 dexon and imbricated with 3-0 silk.We appeared to have a viable type anastomosis upon completion.We then irrigated copiously with several liters of saline.Because of the marked inflammatory response and dense adhesions, we did not take down all the deep adhesions.¿ the 2/25/2008 records continue: ¿all of the other visceral surfaces were exposed and inspected including the anterior wall of the stomach, the right colon, and lower small bowel, and no evidence of other injury was found.The bowel was then returned to the abdomen.The omentum was put over the anastomotic site.It appeared after excising the hernial sac that we would be able to do a primary closure.This was carried out with interrupted figure-of-eights and number 1 maxon.We were able to place staples on the upper aspect of the incision where we did not make a full incision.Rest of the incision was left open and packed.¿ there was no mention of infection involving the gore device.Discharge summary records dated 3/14/2008 state: ¿the patient was admitted on february 25, 2008, through dr.Jon thompson¿s general surgery service, complaining of chills and abdominal pain.On admission, a ct scan was obtained which showed status post ventral hernia repair with a residual hernia and large gas and complex fluid collection, that measures approximately 10.8 x 13.3 cm.There is high density and most likely oral contrast from communication to the adjacent loop of bowel.Based on these findings, the patient was empirically started on vancomycin and zosyn as iv antibiotics with broad spectrum coverage.On hospital day number 1, the patient was taken back to the operating room for the above-mentioned procedures.¿ ¿the patient tolerated the procedure well¿¿ ¿overnight, the patient did develop what sounds like a seizure.The patient remained neurovascularly intact and no focal deficits were noticed on physical exam following a questionable seizure.It should be noted, the patient does have a past medical history of seizures.The abdominal wound was dressed with wet-to-dry dressings.¿ the 3/14/2008 discharge summary records continue: ¿on postoperative number 1, the patient had a mildly elevated fever, otherwise she is doing quite well.¿ ¿on postoperative day number 2, the patient was transferred out of the icu.The patient continued to have a low-grade fever throughout much of the hospital stay.Cultures came back revealing gram-positive cocci from the peritoneal cultures obtained in the operating room.The wound vac was placed in the open abdominal wound.The patient was continued with ng tube to suction as well as nothing per mouth.White blood cell count was elevated on postoperative day number 3 at 14.0, and the patient was started on peripheral nutrition secondary to the ileus.The patient remained stable and was continued on the vancomycin and zosyn; however, on postoperative number 6, the patient had an elevated white blood cell count again at 17.0, but her fever continued.A ct scan was obtained which showed 3 small fluid collections.Interventional radiology was consulted, at which time they placed four 10-french pigtail catheters into the various drains.The patient tolerated this procedure well and white blood cell count again began to decrease.¿ a culture report of the peritoneal specimens collected during the 2/25/2008 were not provided.The ct scan showing the 3 small fluid collections was not provided.Additionally, records from the ir procedure was not provided.The 3/14/2008 discharge summary records continue: ¿ct scan was again ordered on postoperative day number 11, which showed resolved fluid collections.A tube check through interventional radiology was obtained, and the zosyn was stopped.On postoperative day number 12, the patient had loose stools ultimately c.Difficile was obtained but the cultures came back negative.There was an episode of questionable yeast infection most likely candida vaginitis based on the patient¿s symptoms.The patient denied examination.Interventional radiology pulled 3 of the 4 pigtail catheter drains.The patient again was febrile on postoperative day number 14 but no elevated white count.The ct scan showing the resolved collections was not provided.The 3/14/2008 discharge summary records state: ¿on postoperative day number 16, the patient continued to complain of some mild leg soreness.A venous duplex scan of lower extremities was obtained which revealed no acute dvts.The patient became febrile at 38.5.Ct scan was once again obtained of abdomen and pelvis, which showed questionable cellulitis.For this reason, the patient was started on iv cipro as well as iv vancomycin.Blood cultures were returned on postoperative day 17, with gram-positive cocci in clusters in on one of two sets and interpreted as most likely a contaminant.The patient continued on the cipro and iv zosyn.Staples were taken off from the operation.The remaining pigtail catheter drain was removed secondary to minimal discharge.The patient¿s diet began improving, no nausea, no vomiting, and bowel movements were becoming more regular.¿ ¿on postoperative day 18 and 19, the patient had adequate p.O.Intake.The patient was having good urine output, good ambulation.Wound vac remained in place and is putting out only about 50 ml per day.The iv cipro was changed to p.O.Cipro.The patient was discharged to home on the zyvox.¿ records of the ct scan showing ¿questionable cellulitis¿ and blood cultures were not provided.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: ¿strict aseptic techniques should be followed.If an infection develops, it should be treated aggressively.An unresolved infection may require removal of the material.¿ ¿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.".
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Manufacturer Narrative
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Additional details regarding the patient's clinical course were ascertained from a review of medical records and are as follows: records prior to (b)(6) 2006, including records for the hysterectomy and left hemicolectomy noted in the (b)(6) 2008 records, were not provided.(b)(6) 2006: (b)(6) medical center.(b)(6) md.Radiology-ct abdomen/pelvis w contrast.Impression: 4 mm indeterminate lesion, left hepatic lobe.Most likely represents cyst or hemangioma though is indeterminate.Periumbilical hernia containing peritoneal fat and loop of small bowel.S/p left hemicolectomy.Discussion: 4 cm defect in the anterior abdominal wall fascia in periumbilical region and extending inferiorly, slightly eccentric to the right.Through the defect, there is herniation of peritoneal fat and a nondilated loop of small bowel.There is no evidence of obstruction or other complication.Records between (b)(6) 2006 and (b)(6) 2008 were not provided.On (b)(6) 2008: (b)(6) medical center.(b)(6), md.Clinic progress note.Hx ventral abdominal hernia.4 or 5 weeks after hysterectomy was lifting heavy wheelchair, felt sutures popping.More recently bothering her, she thinks it¿s getting bigger.Normal bowel movements, occasional nausea.Wt 226 lb.Abdomen obese.Bowel sounds positive all quadrants.Vaguely defined ventral hernia appreciated, easily reducible.Impression & plan: abdominal hernia.Refer to general surgery.On (b)(6) 2008: (b)(6) medical center.(b)(6), md; (b)(6), md.History & physical.Comes to the clinic for possible evaluation of hernia repair.Social hx: tobacco, half pack per day for the past 30 years, occasional alcohol, and occasional marijuana use.Wt 103 kg.Morbidly obese.Abdomen: soft, nontender, and nondistended, globus.Has well-healed midline scar with palpable periumbilical defect.Impression: incisional hernia in periumbilical area.Plan: will schedule for laparoscopic, possible open incisional hernia repair.On (b)(6) 2008: (b)(6) medical center.(b)(6), md; (b)(6), md.Discharge summary.Hospital course: underwent laparoscopic herniorrhaphy, was taken to medical-surgical floor and was slowly advanced on her diet.Was ambulating, voiding and finely passing flatus after surgery.Stable for discharge on postop day 2.On (b)(6) 2008: (b)(6) medical center.(b)(6), md.History & physical.Cc: chills and abdominal pain.Hpi: 2-day history of abdominal pain worsening over the last day, dull, aching, associated with nausea, vomiting.No stool 2 days.Gave herself enema yesterday, did not help.Has had fever, chills & dysuria for the last day.Denies redness or swelling at incision sites but complains of diffuse abdominal pain.Temp 102.1.Abdomen soft, diffusely tender to palpation with no rebound or guarding.Trocar sites clean, dry and intact except for right port site, open wound with exudate.No purulence, erythema or induration.Also has well-healed midline scar.White count 15.7.Impression & plan: likely perforation.Will plan to take her to or near future.Will begin fluid resuscitation, antibiotics and pain control.On (b)(6) 2008: (b)(6) medical center.(b)(6), md.Radiology-ct abdomen/pelvis w contrast.Impression: large postoperative pneumoperitoneum.S/p ventral hernia repair with residual hernia and large gas and complex fluid collection, see discussion.Infiltration of mesenteric fat and small ascites.Large amount of pneumoperitoneum consistent with recent surgery.Postop changes seen in anterior abdominal wall from hernia repair.Recurrent hernia which contains fluid and gas which communicates with the peritoneal cavity, measures in total 10.8 x 13.3 cm.Fluid within this collection is high density and may be oral contrast from communication from an adjacent loop of bowel, however, no definite area of communication is identified.High density fluid could also represent hemorrhagic fluid although felt to be less likely.Fistulogram may be helpful for further evaluation if indicated.Infiltration of mesenteric fat near this large gas and fluid collection as well as scattered interloop and pelvic ascites.No lymphadenopathy.On (b)(6) 2008: the (b)(6) medical center.(b)(6), md, phd.Pathology report.Accession no: s08-4261.Final diagnosis: a) hernia sac, herniorrhaphy: fragments of fibroadipose tissue with extensive acute inflammation, hemorrhage and granulation tissue formation.B) mesh, removal: mesh (gross only).C) small bowel partial resection: small bowel with extensive acute and chronic inflammation, hemorrhage, granulation tissue formation and focal foreign body giant cell reaction.Acute serositis.Perforation (identified grossly).Surgical margins are free of significant acute inflammation.History: perforated viscus.Source/ gross: the specimens are received in three separate containers, all labeled ¿carberryhurley, susan b.¿ part a is received fresh in a single container designated ¿hernia sac¿ and consists of two fragments (6.2 x 2.5 x 1.3 cm and 4.5 x 7.0 x 1.0 cm) of fibroconnective tissue.One surface of both fragments are pink to white, smooth and glistening.The opposite surface consists of yellow-pink fibroadipose tissue.Both fragments are serially sectioned to reveal no masses.Representative sections are submitted in cassette a1.Part b is received in the fresh state in a container labeled ¿carberryhurley, susan b.¿ and is designated ¿mesh and consists of a 16.3 x 12.3 x 0.1 cm fragment of surgical mesh material.No sections are submitted on this specimen.Part c is received fresh in a single container designated ¿small bowel¿ and consists of a fragment of small bowel measuring 11.5 cm in length x 4.0 cm in maximum circumference.The serosal surface is dusky red.There is red-yellow fibroadipose tissue along the length of the specimen (9.5 x 1.5 x 0.8 cm).Both the serosal surface and fibroconnective tissue are focally covered by yellow-green purulent material (8.5 x 2.0 cm).The specimen was not previously oriented.Both surgical resection margins contain surgical staple lines which are removed.The specimen is opened at the antimesenteric side to reveal dusky red inflamed mucosa.There is an area of possible perforation (0.3 x 0.2 cm) which is located 5.0 cm from one surgical margin and 6.5 cm from the opposite surgical margin.One surgical margin (closest to the area of perforation) is inked in black.The opposite surgical margin is inked in blue.The serosal area of perforation is inked in green.The specimen is pinned out to corkboard and allowed to fix in formalin prior to sectioning.Representative sections are submitted as per the code of sections.Code of sections: c1 surgical margin (inked in black), c2 surgical margin (inked in blue), c3-4 area of possible perforation, c5 colonic mucosa, representative sections.Microscopic: six b & e stained slides from six paraffin blocks examined.On (b)(6) 2008: (b)(6) medical center.(b)(6), md.Radiology-ct abdomen/pelvis w contrast.Impression: multiple loculated fluid collections with enhancing rims, concerning for infected/ inflammatory fluid.Intra-abdominal free air, slightly decreased.New bilateral pleural effusion, left greater than right.Discussion: multiple axial images of abdomen and pelvis obtained for evaluation of fever status post wash-out/mesh removal, comparison (b)(6) 2008.Anterior open abdominal midline wound noted with third spacing and fluid in subcutaneous tissues.Multiple fluid collections within abdomen with enhancing rims that are concerning for infection or at least inflammatory fluid pockets.Within the anterior portion of the abdomen, there is an 8 x 3 cm fluid collection with small amount of gas.Other areas of enhancing fluid collections include image 55 measuring 4.7 x 3.4 cm, right hemipelvis/ perirectal area measuring 8.9 x 3.5 cm, and on image 80 a smaller left pocket of fluid measuring 2.7 x 2 cm.No evidence for contrast extravasation within abdomen or pelvis.Previously visualized large pneumoperitoneum decreased in size.New postop changes noted within mesentery of small bowel as well as postop changes within anterior abdominal wall defect.New anterior right abdominal wall subcutaneous gas collection, likely from recent postop changes.03/04/2008: (b)(6) medical center.(b)(6), md.Procedure report.Picc line placement under ct and ultrasound guidance.Three peritoneal abscess drainages under ct guidance and a fourth retroperitoneal abscess drainage under ct guidance.Impression: 40 cm hickman-type picc line catheter placed through right basilic vein with tip of catheter placed in lover svc.10-f.Pigtail catheter placed into left upper abdominal abscess.10-f pigtail catheter placed into left lateral abdominal abscess.10-f pigtail catheter placed in right lower abdominal abscess.10-f pigtail catheter placed in presacral abscess.Asa 3.Procedure: localizing slices taken through abdomen.Left anterior upper abdominal abscess cavity was selected first.Overlying skin was prepped and draped in usual sterile fashion.Under ct guidance, an 18g turner needle was inserted into the abscess fluid.Specimen was removed for culture & sensitivity.18g turner needle exchanged over guidewire for a series of dilators and then for 10-f.Pigtail catheter.Left lateral abdominal abscess was selected next.18g turner needle inserted into abscess cavity under ct guidance, then exchanged for series of dilators and 10-f.Pigtail catheter.Specimens submitted for culture & sensitivity.Right lower anterior abdominal fluid collection then localized under ct guidance.Overlying skin was prepped and draped in usual sterile fashion.1% lidocaine used for local anesthetic.Under ct guidance, 19g tuner needle inserted into right lower anterior abdominal abscess and exchanged for series of dilators, and for 10-f.Pigtail drainage catheter.All 3 catheters sutured in placed & dressings applied.Patient placed in left lateral decubitus position.Selective slices taken through presacral region.Transgluteal approach utilized.Overlying skin prepped & draped in usual sterile fashion.Using ct guidance, 18g tuner needle exchanged for series of dilators, then for 10-f.Pigtail catheter.Specimen was removed and submitted for cultures & sensitivities.Catheter sutured in place and dressing applied.Patient transferred back to the ward in stable condition.Complications: no immediate complications.03/06/2008: (b)(6) medical center.(b)(6), md.Radiology-ct abdomen/pelvis w contrast.Indication: possible abscess.Impression: postop changes in the abdomen with resolution of multiple fluid collections.Surgical clips present left upper quadrant with moderate amount of pneumoperitoneum consistent with recent surgery.Postop changes small bowel, mid abdomen, no small bowel dilatation or obstruction.Postop changes of stranding of the mid anterior abdominal wall with open wound inferior mid abdomen.Punctate gas is present within the right abdominal anterior subcutaneous soft tissues.Four pigtail drainage catheters present, resolved adjacent fluid collections.Left mid abdominal and right perirectal drainage catheters about loops of small bowel with no fluid adjacent to the right lower abdominal and left anterior upper abdominal drainage catheters.No new fluid collections or abscess formation.On (b)(6) 2008: (b)(6) medical center.(b)(6), md.Radiology-xr fistula sinus tract study.Procedure: catheter abscessogram x 4.Drainage catheter removal x 3.Impression: minimal abscess cavities associated with all four drainage catheters.Three catheters removed given minimal daily volume output with the upper left abdominal drainage catheter remaining due to continued output.Asa 3.Procedure: the three drainage catheters with minimal daily volume output were removed and sterile dressings were placed.Findings: catheter #1 is located within the left abdomen.Contrast material injection demonstrates no residual cavity however, a stain of contrast material is noted just inferior to the catheter tip.Upon aspiration, there is near complete removal of the contrast stain.Given 25 ml output from this catheter over the past 24 hours, this catheter was left in place.Catheter abscessogram of catheter #2, located on the left and inferior to catheter #1, demonstrates a small residual cavity.Upon aspiration, there is near complete removal of contrast material.Given minimal daily volume output, this catheter was removed.Catheter abscessogram of catheter #3, located within the right lower pelvis, demonstrates minimal residual cavity.Upon aspiration, no significant removal of contrast material was identified.Given minimal daily volume output, this catheter was removed.Catheter abscessogram of catheter #4, placed transgluteally on the right, demonstrates a small residual cavity.Upon aspiration, there was no significant residual contrast material.Given minimal daily output, this catheter was removed.Complications: none.On (b)(6) 2008: (b)(6) medical center.Candace g.Grier, md.Radiology-ct abdomen/pelvis w/o contrast.Indication: abscess.Diagnosis: left upper quadrant pneumoperitoneum, which may be related to persistent drainage catheter left in anterior abdomen or recent drainage catheter removal ¿ please correlate clinically.Small amount of pelvic ascites.Soft tissue stranding and gas within anterior abdominal wall suggesting cellulitis without any body wall fluid collections.On (b)(6) 2008: (b)(6) medical center.(b)(6), md.Radiology-ct abdomen/pelvis w contrast.Indication: inflammation.Impression: persistent but smaller pneumoperitoneum.Removal of left upper quadrant drain.Improved stranding and gas in the subcutaneous tissues, no abscess seen.Discussion: surgical clips noted in left upper quadrant.Less gas in subcutaneous tissues of the anterior abdominal wall and also less inflammatory change.No bowel obstruction, no bowel wall thickening.On (b)(6) 2008: (b)(6) medical center.(b)(6), md.Progress note.Has been improving.Concerned about some pain in and around site of healing incision.States is stings and hurts when she tries to stretch abdominal wall out a bit.Eating well with no nausea, vomiting or diarrhea.Had some low grade fevers, 99.5.Completed zosyn about 2 weeks ago.Normal bowel movements.Concerned about some posterior cva tenderness present for 2-3 weeks.Wt 217 lb., down from jan 08.Abdomen soft, tender right around healing wounds.No evidence of infection presently.Appears vertical scar over umbilicus in midline is drawing together causing a fold in abdominal wall at that location.Small wound in right lower quadrant with tiny amount serous drainage on bandage which os over the top.At most recent visit with dr.(b)(6)he removed small scar and applied silver nitrate to that area.Does not appear to be infected.Impression & plan: complicated hernia repair with recent hospitalization.Appears to be doing very well clinically.She¿s not concerned about appearance but discomfort with standing up straight.Suggested we continue to let wound heal for another 6-8 weeks then consider sending her for scar revision.On (b)(6) 2008: (b)(6) medical center.(b)(6), md.Progress note.Wt 237.9 lb., up 20 lb from 04/2008.States wounds finally healed completely, as far as no open wounds, bleeding, just a few weeks ago.Scars appear to be drawn down somewhat, no open wounds presently.On (b)(6) 2010: (b)(6) medical center.(b)(6), md.Progress note.Concerned about ongoing abdominal pain & some masses or lumps she can feel in abdominal wall.Had problems in past with constipation.Objective: abdominal scar seems soft, less drawn.Probable hernias in mid right abdomen and right lower abdomen and possibly just suprapubic.Appear to be reducible although quite tender to palpation in these regions.Does not feel like solid masses, but abdominal contents perhaps pushing through hernias.Impression & plan: possible recurrent abdominal hernias.Tried to have a discussion with patient concerning findings and options for evaluation and/ or treatment.She becomes rather agitated and upset when discussing her abdominal hernia because of complications that she had from previous surgery.Agreed to abdominal ct scan.On (b)(6) 2010: (b)(6) medical center.(b)(6), md.Radiology-ct abdomen/pelvis w contrast.Impression: interval development of large umbilical hernia containing transverse colon and small bowel, nonobstructive.Abdomen: postsurgical changes in left upper quadrant adjacent to the spleen, postsurgical changes of bowel within a large umbilical hernia involving small bowel.Hernia is new compared to 03/26/2008 and contains mostly transverse colon and to a lesser degree a segment of small bowel.This is nonobstructive.Postsurgical changes in the region of the lower sigmoid.No ascites or lymphadenopathy.Pelvis: patient is post hysterectomy.Records between (b)(6) 2010 and (b)(6) 2013 were not provided.On (b)(6) 2013: (b)(6) medical center.(b)(6), md.Progress note.Abdomen soft, mildly tender in upper abdomen where there is a ventral hernia which is reducible but with pain.Impression: periumbilical hernia.Not interested in pursuing surgery at this time.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: ¿strict aseptic techniques should be followed.If an infection develops, it should be treated aggressively.An unresolved infection may require removal of the material.¿ ¿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.".
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Manufacturer Narrative
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Previous patient codes (1994, 2144, 2252, 1858, 1695, 1930, 3191 used for ¿wound vac placement with home care required¿ and ¿loss of consortium¿) were reported based on the original complaint and are no longer applicable and/or not reportable per gore¿s investigation.The investigation has been completed.Based upon gore¿s investigation there is no available information that reasonably suggests that a gore device may have caused or contributed to death, serious injury or reportable malfunction, and is no longer considered reportable.This event will be closed as no problem detected.The following information was determined from the medical records.Medical records: the known medical records span (b)(6) 2006 through (b)(6) 2018, and not all records received in this time span are relevant to gore® dualmesh® biomaterial.Records from (b)(6) 2006 through (b)(6) 2008; from (b)(6) 2010 through (b)(6) 2013; from (b)(6) 2013 through (b)(6) 2015 were not provided.Patient information: medical history: hypothyroidism.Nephrolithiasis.Seizure disorder.Chronic diarrhea.Periumbilical hernia.Smoker: ½ pack per day x30 years.Rheumatic fever.Obesity: (b)(6) 2008: 226 lbs, bmi 41.3, (b)(6) 2008: 227 lbs, bmi 41.5, and (b)(6) 2008: 238 lbs, bmi 43.5.Prior surgical procedures: 2000: hemicolectomy.2004: total abdominal hysterectomy.Implant preoperative complaints: on (b)(6) 2006: ct abdomen/pelvis: ¿4 cm defect in the anterior abdominal wall fascia in periumbilical region and extending inferiorly, slightly eccentric to the right.Through the defect, there is herniation of peritoneal fat and a nondilated loop of small bowel.There is no evidence of obstruction or other complication.¿ on (b)(6) 2008: ¿4 or 5 weeks after hysterectomy was lifting heavy wheelchair, felt sutures popping.More recently bothering her, she thinks it¿s getting bigger.¿ ¿vaguely defined ventral hernia appreciated, easily reducible.¿ on (b)(6) 2008: ¿tobacco, half pack per day for the past 30 years, occasional alcohol, and occasional marijuana use.¿ ¿has well-healed midline scar with palpable periumbilical defect.¿ implant procedure: laparoscopic repair of incisional hernia.Implant: gore® dualmesh® biomaterial (05273700/1dlmc04) 15cm x 19cm, oval.Implant date: (b)(6) 2008 [hospitalized (b)(6) 2008].Description of hernia being treated: ¿the entire omentum was tacked up the abdominal wall along the previous midline incision encompassing the hernia, part of the stomach was pulled up, also intestinal adhesions at different points.We worked carefully with the scissors alternating with the cautery as needed, and eventually, we were able to completely free up the adhesions over a period of approximately 2 hours.All of the adhesions were dropped down.There was no evidence of bowel injury.The defect was measured out, it was approximately 9 x 9 cm, and no other defects were repaired.¿ implant size and fixation: ¿we chose a 15 x 19 piece of gore-tex mesh for the repair.It was marked out in 8 quadrants and stitches of 0 surgilon were placed.It was then rolled up and passed through the 12-mm port site and unrolled stitches were pulled up using the endopass circumferentially so they would layout readily symmetrically.We then went around and tied the sutures.We then alternated the protack with absorbatack to tack up the spam [sic] between the sutures.We appeared to have good alignment.¿ post-operative period: [two days]. (b)(6) 2008: discharge summary: ¿stable for discharge on postop day 2.¿ explant preoperative complaints: on (b)(6) 2008: ¿2-day history of abdominal pain worsening over the last day, dull, aching, associated with nausea, vomiting.No stool 2 days.Gave herself enema yesterday, did not help.Has had fever, chills & dysuria for the last day.Denies redness or swelling at incision sites but complains of diffuse abdominal pain.Temp 102.1.Abdomen soft, diffusely tender to palpation with no rebound or guarding.Trocar sites clean, dry and intact except for right port site, open wound with exudate.No purulence, erythema or induration.Also has well-healed midline scar.White count 15.7.¿ on (b)(6) 2008: ct abdomen/pelvis: ¿s/p [status post] ventral hernia repair with residual hernia and large gas and complex fluid collection, see discussion.Infiltration of mesenteric fat and small ascites.Large amount of pneumoperitoneum consistent with recent surgery.Postop changes seen in anterior abdominal wall from hernia repair.Recurrent hernia which contains fluid and gas which communicates with the peritoneal cavity, measures in total 10.8 x 13.3 cm.Fluid within this collection is high density and may be oral contrast from communication from an adjacent loop of bowel, however, no definite area of communication is identified.High density fluid could also represent hemorrhagic fluid although felt to be less likely.¿ on (b)(6) 2008: ¿this patient is 1 week status post laparoscopic incisional hernia repair.She developed worsening abdominal pain, vomiting, and presented to the emergency room with peritonitis.Ct scan showed perforation with extravasation.¿ explant procedure: ¿exploratory laparotomy, removal of mesh, small-bowel resection, and placement of left internal jugular catheter.¿ explant date: (b)(6) 2008 [hospitalized (b)(6) 2008].¿we entered the hernial sac located in a part of our incision.It was opened, and cloudy fluid was found and was cultured.We then opened the fascia above and below the main hernial defect to the limits of our previous mesh.We then opened the mesh and cleared it lengthwise along its length.This enabled us to evacuate further fluid.There were marked adhesions, particularly along the left side of the mesh, and then taking those down, an intestinal perforation was found.It was not clear if this was a free perforation or whether it had been related to one of our staples on the left side.We then went around and carefully removed all of the mesh suture and staples circumferentially.Irritation [sic] was carried out.There was fairly significant inflammatory response in the mid abdomen between the omentum, transverse colon, and several loops of small bowel.Most of these were chronic adhesions that were present.We began separating small bowel and colon until we had found the segment of the bowel that had the perforation and mesenteric edge several millimeters in diameter.There was scar tissue and fibrinous tissue around this area.We eventually freed it up enough and determined that we would need to do a small resection rather than attempt to repair.Proximal and distal margins of abdominal wall were identified.The mesentery was divided along the edge of the bowel with two clamps and 2-0 silk ties.We then resected a segment of approximately 8 cm of small intestine using gia 63.8 mm stapler on each end of the resection.We then imbricated our staple lines with 3-0 silk and placed stay sutures of 3-0 silk away from the margin.We made enterotomies and fired the gia 60 stapler longitudinally to create a side-to-side anastomosis with 3-0 silk placed at the apex.There appeared to be no evidence of obstruction with good viability.We then closed our defect with a running 3-0 dexon and imbricated with 3-0 silk.We appeared to have a viable type anastomosis upon completion.¿ relevant medical information: on (b)(6) 2008: ct abdomen/pelvis: ¿anterior open abdominal midline wound noted with third spacing and fluid in subcutaneous tissues.Multiple fluid collections within abdomen with enhancing rims that are concerning for infection or at least inflammatory fluid pockets.Within the anterior portion of the abdomen, there is an 8 x 3 cm fluid collection with small amount of gas.Other areas of enhancing fluid collections include image 55 measuring 4.7 x 3.4 cm, right hemipelvis/perirectal area measuring 8.9 x 3.5 cm, and on image 80 a smaller left pocket of fluid measuring 2.7 x 2 cm.¿ on (b)(6) 2008: abscess drainage under ct guidance. ¿under ct guidance, an 18g turner needle was inserted into the abscess fluid.Specimen was removed for culture & sensitivity.18g turner needle exchanged over guidewire for a series of dilators and then for 10-f.Pigtail catheter.Left lateral abdominal abscess was selected next.18g turner needle inserted into abscess cavity under ct guidance, then exchanged for series of dilators and 10-f.Pigtail catheter.Specimens submitted for culture & sensitivity.Right lower anterior abdominal fluid collection then localized under ct guidance.¿ ¿under ct guidance, 19g tuner needle inserted into right lower anterior abdominal abscess and exchanged for series of dilators, and for 10-f.Pigtail drainage catheter.All 3 catheters sutured in placed & dressings applied.Patient placed in left lateral decubitus position.Selective slices taken through presacral region.Transgluteal approach utilized.Overlying skin prepped & draped in usual sterile fashion.Using ct guidance, 18g tuner needle exchanged for series of dilators, then for 10-f.Pigtail catheter.Specimen was removed and submitted for cultures & sensitivities.¿ on (b)(6) 2008: ct abdomen/pelvis: ¿anterior abdominal wall with open wound inferior mid abdomen.Punctate gas is present within the right abdominal anterior subcutaneous soft tissues.Four pigtail drainage catheters present, resolved adjacent fluid collections.Left mid abdominal and right perirectal drainage catheters about loops of small bowel with no fluid adjacent to the right lower abdominal and left anterior upper abdominal drainage catheters.No new fluid collections or abscess formation.¿ on (b)(6) 2008: ct abdomen/pelvis: ¿left upper quadrant pneumoperitoneum, which may be related to persistent drainage catheter left in anterior abdomen or recent drainage catheter removal ¿ please correlate clinically.Small amount of pelvic ascites.Soft tissue stranding and gas within anterior abdominal wall suggesting cellulitis without any body wall fluid collections.¿ on (b)(6) 2008: discharge summary: ¿the patient was admitted on (b)(6) 2008, through dr.(b)(6) general surgery service, complaining of chills and abdominal pain.On admission, a ct scan was obtained which showed status post ventral hernia repair with a residual hernia and large gas and complex fluid collection, that measures approximately 10.8 x 13.3 cm.There is high density and most likely oral contrast from communication to the adjacent loop of bowel.¿ ¿on postoperative number 1, the patient had a mildly elevated fever, otherwise she is doing quite well.On postoperative day number 2, the patient was transferred out of the icu.The patient continued to have a low-grade fever throughout much of the hospital stay.Cultures came back revealing gram-positive cocci from the peritoneal cultures obtained in the operating room.The wound vac was placed in the open abdominal wound.The patient was continued with ng tube to suction as well as nothing per mouth.White blood cell count was elevated on postoperative day number 3 at 14.0, and the patient was started on peripheral nutrition secondary to the ileus.The patient remained stable and was continued on the vancomycin and zosyn; however, on postoperative number 6, the patient had an elevated white blood cell count again at 17.0, but her fever continued.A ct scan was obtained which showed 3 small fluid collections.Interventional radiology was consulted, at which time they placed four 10-french pigtail catheters into the various drains.The patient tolerated this procedure well and white blood cell count again began to decrease.Ct scan was again ordered on postoperative day number 11, which showed resolved fluid collections.A tube check through interventional radiology was obtained, and the zosyn was stopped.On postoperative day number 12, the patient had loose stools ultimately c.Difficile was obtained but the cultures came back negative.There was an episode of questionable yeast infection most likely candida vaginitis based on the patient¿s symptoms.The patient denied examination.Interventional radiology pulled 3 of the 4 pigtail catheter drains.The patient again was febrile on postoperative day number 14 but no elevated white count.On postoperative day number 16, the patient continued to complain of some mild leg soreness.A venous duplex scan of lower extremities was obtained which revealed no acute dvts.The patient became febrile at 38.5.Ct scan was once again obtained of abdomen and pelvis, which showed questionable cellulitis.For this reason, the patient was started on iv cipro as well as iv vancomycin.Blood cultures were returned on postoperative day 17, with gram-positive cocci in clusters in on one of two sets and interpreted as most likely a contaminant.The patient continued on the cipro and iv zosyn.Staples were taken off from the operation.The remaining pigtail catheter drain was removed secondary to minimal discharge.The patient¿s diet began improving, no nausea, no vomiting, and bowel movements were becoming more regular.On postoperative day 18 and 19, the patient had adequate p.O.Intake.The patient was having good urine output, good ambulation.Wound vac remained in place and is putting out only about 50 ml per day.The iv cipro was changed to p.O.Cipro.The patient was discharged to home on the zyvox.¿ on (b)(6) 2008: ct abdomen/pelvis: ¿persistent but smaller pneumoperitoneum.Removal of left upper quadrant drain.Improved stranding and gas in the subcutaneous tissues, no abscess seen.¿ on (b)(6) 2008: ¿had some low grade fevers, 99.5.Completed zosyn about 2 weeks ago.Normal bowel movements.Concerned about some posterior cva tenderness present for 2-3 weeks.¿ ¿small wound in right lower quadrant with tiny amount serous drainage on bandage which is over the top.At most recent visit with dr.Thompson he removed small scar and applied silver nitrate to that area.Does not appear to be infected.¿ 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.¿ 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.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.
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