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| Model Number 1DLMC201 |
| Device Problems
No Apparent Adverse Event (3189); Insufficient Information (3190)
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| Patient Problems
Hernia (2240); Not Applicable (3189)
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| Event Date 09/19/2013 |
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Event Type
Injury
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Manufacturer Narrative
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(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.¿.
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Event Description
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It was reported to gore that the patient underwent incisional infraumbilical hernia repair on (b)(6) 2012, whereby an alleged gore device was implanted.The complaint alleges that on (b)(6) 2013, an additional procedure was performed whereby explant of the gore device was performed.It was reported the patient alleges the following injuries: recurrent hernia, mesh revision.Additional event specific information was not provided.
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Manufacturer Narrative
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Added date of birth.Removed explant date - operative records dated (b)(6) 2013 do not indicate removal of the gore device during the procedure.Corrected result code.Conclusion code remains unchanged.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) 2012, including origin of abdominal incision, were not provided.Operative records dated (b)(6) 2012 indicate the patient underwent repair of an incisional hernia.Postoperative diagnosis is noted as ¿incisional hernia with incarcerated small bowel and omentum.¿ operative findings state: ¿this patient had incisional hernia at the infraumbilical area.There was several herniation in the same vicinity.The largest one measure approximately 3 cm in diameter at the opening and contained small bowel and omentum.No evidence of any strangulation.Smaller adjacent weakening of the fascia was noted after connection.The defect is approximately 5 cm in diameter.¿ the (b)(6) 2012 operative notes state: ¿dissection was done down to the hernial sac that was separated from the surrounding structures and dissection was done to the surrounding fascia.The hernia sac was entered and all the hernial defect was connected into 1 defect.Dissection was done separating adhesion with these very dense between the omentum to the abdominal wall.This was done into the surrounding abdominal wall was free from the omentum.Dissection was done using harmonic scalpel and before reduction of the omentum, it was ensured that hemostasis was complete.After the omentum was reduced, the hernia defect was approximately 5 cm in diameter and 2 mm gore-tex patch was used to repair.The patch was 2 mm thick and approximately 15 cm in diameter.This was inserted with the smooth side facing peritoneal cavities and textures side facing outward.It was suture tucking under the hernial defect using gore-tex suture and total of 6 sutures were used to tuck the patch under the hernial ring.After ensuring that the patch is spread out smoothly under the fascial ring.After ensuring complete hemostasis, incision was closed with clips.¿ the records confirm a gore dualmesh® biomaterial (1dlmc201/8732055) was used during the procedure.Records between (b)(6) 2012 and (b)(6) 2013 were not provided.Operative records dated (b)(6) 2013 indicate the patient underwent ¿mesh repair of ventral incisional hernia with component separation and lateral rectus released.¿ indications for the procedure state the patient ¿is a 43 -year -old woman who has had previous mesh repair of large ventral hernia, which occurred following hysterectomy.She was referred to dr.(b)(6) for possible repeat repair.¿ the (b)(6) 2013 records state: ¿area over her lower midline hernia was opened sharply along with her previous scar.She had very thin attenuated skin and sac.The sac was therefore opened and __ [sic] adhesions were carefully dissected off the sac to the edges of the fascia.Bowel and omental adhesions were carefully taken down using sharp dissection.Once the fascial edges were free, there was evidence that the previous mesh was pulled away to the right side.Edges of fascia were carefully cleared up to the level of the rectus muscles.The anterior rectus sheath was opened on the left to allow expansion.Following this more medially, a plane was carefully dissected out below the rectus muscle and overlying the posterior fossa.The same procedure was performed on the right with lateral rectus released and dissection of the plane immediately posterior to the rectus muscle but anterior to the previously placed mesh which was peritonealized.¿ the (b)(6) 2013 operative records continue: ¿the previously placed mesh was brought laterally across the abdomen and secured to the left -sided anterior and posterior fascia at the further direct dissection.This created covered over the __ [sic] omentum.Prolene mesh was then carefully formed to the defect with a 3 cm overlap in all directions.He was placed over the previous peritonealized mesh and below the level of the rectus muscle.It was sutured to the anterior rectus anteriorly.We placed 3 cm underlay below the rectus in the anterior fascia was secured using prolene suture in interrupted fashion.The midline fascia was then closed with a running 0 prolene.¿ the records indicate an ethicon prolene mesh (non-gore device) was implanted during the procedure.There was no mention of infection and no mention that the gore device was removed during the procedure.A microbiology report dated (b)(6) 2013 regarding a wound specimen from an unknown source and collected (b)(6) 2013 states: ¿light growth of staphylococcus aurreus.¿ ¿light growth of coagulase negative staphylococcus.¿ the lab report indicates the patient was admitted to the medical center on (b)(6) 2013 and discharged on (b)(6) 2013.However, records from the patient¿s hospital stay during this time were not provided.Records between (b)(6) 2013 and (b)(6) 2017 were not provided.Records dated (b)(6) 2017 indicate the patient presented to the er with ¿right lower abdominal pain for 2 weeks started after straining, status post abdominal wall hernia surgery 2 years ago.A ct of the abdomen and pelvis performed (b)(6) 2017 states: ¿patient is status post umbilical hernia mesh repair in the past.There is a new 8 cm right lower quadrant spigelian hernia containing uncomplicated small bowel loops.¿ records detailing ¿abdominal wall hernia surgery 2 years ago¿ as referenced in (b)(6) 2017 records were not provided.Ct imaging records dated (b)(6) 2017 indicate ¿gallbladder is surgically absent¿.Operative records dated (b)(6) 2017 indicate the patient underwent treatment of an ¿open right spigelian hernia with mesh.¿ findings from the procedure state: ¿right sided spigelian hernia, repaired with preperitoneal mesh.¿ the records state: ¿there was no evidence of ischemia.The previous periumbilical mesh could be palpated, but felt well incorporated and was away from the area of the hernia.The preperitoneal plane was then defined circumferentially around the hernia defect, and a piece of ultrapro mesh was cut to size -8x10cm and placed in the preperitoneal plane.The transversalis and internal oblique layers were then closed together using #1 pds in running fashion.¿ the (b)(6) 2017 records confirm an ethicon ultrapro mesh (non-gore device) was used during the procedure.There was no mention of infection or device removal 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.
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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) 2012, including origin of abdominal incision, were not provided.Ct of abdomen/pelvis without contrast dated (b)(6) 2012 states: ¿history: right side abdominal pain, right lower quadrant for four months.History of complete hysterectomy, cholecystectomy.The records state: ¿¿the bowel shows no evidence of obstruction or perienteric inflammation.Normal appendix.No aneurysm.No adenopathy.¿ the records also state ¿¿infraumbilical hernia with a 3.3 centimeter orifice through which is a herniated fat and a small loop of bowel obstructed.¿ records between (b)(6) 2012 and (b)(6) 2013 were not provided.Ct of abdomen/pelvis with and without contrast dated (b)(6) 2013 states: ¿history: knot on belly, hernia repair in 2012, redness and inflammation at suture site near umbilical area.¿ the records state: ¿¿a large ventral hernia is present much larger that was present on (b)(6) 2012.The orifice which begins at the level of the umbilicus and extends inferiorly is over 7cm in diameter and contains at least 14cm area of herniated mesentery and small bowel.No evidence of bowel obstruction.No large bowel herniation.Evidence of attempted hernia repair with mesh placement is noted.The mesh is displaced along the right lateral margin of the hernia sac.The peritoneum and hernia extends up to just beneath the skin surface¿¿ the records state: ¿conclusion: 1) evidence of failed ventral periumbilical hernia repair with increase in size of the hernia orifice and sac containing several loops of small bowel and adjacent mesentery without evidence of obstruction.2) fatty liver.¿ discharge summary dated (b)(6) 2013 indicates the patient was admitted on 6/24/2013 for abdominal pain, recurrent incisional hernia.The record states: ¿this patient was admitted to observation bed because of abdominal pain.She had repair of incisional hernia in december last year with recurrence and herniation of the bowel and colon was noted.The hernial opening was wide open.She was admitted for observation.On the day of discharge, the patient has no further pain, tolerated oral intake well.She had redness of the skin at the previous incision.¿ discharge summary dated (b)(6) 2013 states: ¿however, with the reduction of hernia, this showed improvement.The patient will be discharged and followed in the office.The long-term plan is to refer her to university of virginia because of possible need for bioprosthetic patches for repair or component separation kind of surgery.She has been seen over there and was told that she has to stop smoking completely before they agreed to do the procedures.The patient will be followed in the office as needed.¿ ct of abdomen/pelvis without contrast dated (b)(6) 2013 states: ¿history: abdominal and hernia repair in (b)(6).The patient states it has come loose.Swelling in the umbilical area near the previous hernia.¿ the records state: ¿¿the bowel shows no evidence of obstruction or perienteric inflammation.Large ventral hernia noted at the level of the umbilicus.A 6.5 centimeter orifice is noted through which is a herniated transverse colon, small bowel, as well as omental fat.Evidence of attempted hernia repair is noted with radiopaque mesh along the right lateral aspect of this hernia.The hernia was present on (b)(6) 2013 but has increased in size.On the previous studies the hernia sac was approximately 15 x 9 centimeters, now 18 x 12 centimeters.No ascites.No evidence of strangulation or incarceration.The remainder of the bowel is unremarkable.Normal appendix.No aneurysm.No adenopathy.¿ medical records dated (b)(6) 2013 state: ¿the patient is a 43 year old white female, who presents on referral from (b)(6), with a complaint of a recurrent ventral incisional hernia with a single hernia defect.She states the onset of pain and a bulge began 1go and has been constant since onset.The bulge is worse with standing and better with binder.¿ medical records dated (b)(6) 2013 state: ¿[patient] states having previous surgery for hysterectomy.[patient] reports no complications with her previous surgery.[patient] has had two hospitalizations previously for these symptoms.The patient has had a previous repair of her hernia with probable alloderm repair witch quickly failed, at nortom community, approximately 6 months ago.¿ records also state ¿saw surgeons at uva who recommended lateral relaxing incision and reeves stoppa repair.Pt[patient] obese at 259 and smokes one ppd¿¿ medical records dated (b)(6) 2013 state: physical examination ¿gastrointestinal ¿ abdomen exam: obese abdomen which is non-tender to palpation with normal tone and without rigidity or guarding.Normal bowel sounds.No masses present.Liver and spleen: no hepatomegaly present.Liver is non-tender to palpation and spleen is not palpable.Hernias: incisional hernia present about 15 cm long starting below umbilicus.¿ medical records dated (b)(6) 2013 indicate patient admitted for chief complaint of drainage from wound.The records state: ¿this is a 43-year-old female who underwent open ventral hernia repair on september 19th of this year.She states that earlier today, she started draining copious amount of thick red cloudy drainage.She denies any fever or chills.She has otherwise been tolerating her diet.Denies any other complaints.¿ the medical records dated (b)(6) 2013 state: physical findings: ¿abdomen: soft, obese, nondistended.She has erythema extending approximately 2 to 3 cm on either side of the midline incision.She has thick reddish cloudy drainage draining from the inferior portion of the wound.¿ the records state ¿¿white blood cell count 9.9.¿ the records state: ¿this is a 43 year old female with postoperative wound infection, admitted to the hospital.We will start her on iv antibiotics.We will open the inferior portion of the wound and drain the fluid.We will then provide local wound care.We will also culture the drainage and tailor the antibiotics accordingly.¿ medical records dated (b)(6) 2013 indicate the patient underwent incision and drainage of ventral hernia incision site abscess.The records state ¿¿the incision was then opened and allowed to drain.It was packed wet to dry with dakin's.She received a picc line, and was able to be discharged home with home health for wound packing and administration of 'iv antibiotics.¿ ct abdomen and pelvis with contrast dated (b)(6) 2013 states ¿indication: 43-year old female with postop abdominal hernia repair infection.The records state ¿¿gi tract shows no wall thickening or dilated fluid filled loops of bowel.The appendix is normal.There is no free air, free fluid or adenopathy.There is fatty stranding along the anterior mesentery at the surgical site.There is anterior mesh.There is subcutaneous air fluid which extends from the cutaneous surface to the mesh in the abdomen.Multiple small air pockets are present.The record states: ¿impression: air and fluid seen in the subcutaneous soft tissues anterior to the hernia repair with mesh.The pocket measures approximately 11.2 x 2.6 x 9.0 cm.It has a subtle rim of enhancement consistent with an early abscess.¿ a culture report dated 10/8/2013 regarding a wound culture specimen collected on 10/5/2013 states: ¿gram stain (final) ¿ rare wbc, rare squamous epithelial cells, no organisms seen.Isolate (final) ¿light growth of staphylococcus aureus.Isolate (final) ¿light growth of coagulase negative staphylococcus.¿ medical records dated 10/15/2013 state: ¿the patient ls a 43 year old white female who returns for a routine post-operative follow-up visit after undergoing wound debrldement for incisional pain, she states since the procedure, wound debrldement , she has is [sic] feeling better, but not back to normal.¿ the records state: ¿no fever or chills.Doing ok with pain medications¿¿ ¿she has been performing wound care¿.¿ ¿on iv ab[antibiotics] for eleven more days.¿ medical records dated 10/15/2013 state: ¿physical examination ¿ approx[imately] 3x5cm incisional wound below umbilicus.Granulation tissue and scant serous fluid seen.Small amount of dead fat located at 3-4 o¿clock inside wound.No foul odor or discharge.¿ medical records dated 11/5/2013 state: ¿the patient is a 43 year old white female who returns for a routine post-operative up visit after undergoing incisional hernia repair with post op superficial wound infection for hernia on 09/19/2013.Since the last visit, 10/15/2013, she complains of no significant symptoms or problems since the surgery.¿ physical examination states: ¿abdominal exam: abdomen non-tender to palpation, scaphoid abdomen, tone normal without rigidity or guarding, normal bowel sounds, no masses present, open superficial wound 3 by 3 by 4 cm, clean , granulating.Hernias: no abdominal wall hernias are present.¿ ct scan of abdomen/pelvis without contrast dated 11/14/2013 for history of black stool, nausea, abdominal pain.The records state: ¿comparison with 10/06/2013.The patient is status post recent ventral hernia repair.The patient has an open wound in the midline of the abdomen extending down to the fascial plane.No loculated fluid collections are seen.Minimal surrounding inflammation in the subcutaneous fat to the left of this wound.No recurrent hernia.Mesh is in place.¿ medical records dated 12/5/2013 state: ¿the patient is a 43 year old white female who returns for a routine post-operative follow-up visit after undergoing incisional hernia repair for hernia approximately 3 months ago.Since the last visit, 11/05/2013, she complains of the following: closing skin opening from wound infection.Denies fever, or hernia recurrence, feels well.¿ physical examination states: ¿abdominal exam: abdomen non-tender to palpation, moderate abdominal obesity, tone normal wlthout rigidity or guarding, normal bowel sounds, no masses present one cm wide, 2.5 cm deep granulating tract lower mid incision.Hernias: no abdominal wall hernias are present.¿ records between (b)(6) 2013 and (b)(6) 2017 were not provided.Medical records dated (b)(6) 2017 state chief complaint: ¿my doctor said i had a hernia.¿ the records state: ¿the patient is a 46 year old caucaslan/whlte female who is referred bv rimon ibrahim with a history consistent with rlq bulge that has been present for 2 weeks and began with an unknown event.She complains of pain and the presence of a bulge.She notes that the bulge is partially reducible.The hernia is partially reducible with application of direct pressure.The pain occurs with dally activities.The patient denies having previous inguinal hernia surgery, prior midline hernia.Recent ct scan shows right spigelian hernia with small bowel loops.¿ 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.
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Manufacturer Narrative
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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.Previous patient code (2240) was reported based on the original complaint and are no longer applicable and/or not reportable per gore¿s investigation.The following information was determined from the medical records.Medical records: the known medical records span (b)(6) 2012 through (b)(6) 2017 and not all records received in this time span are relevant to the gore® dualmesh® biomaterial.Medical records from (b)(6) 2013 through (b)(6) 2017 were not provided.Patient information: medical history: gastroesophageal reflux disease [gerd], hyperlipidemia, fatty liver.Smoker: on (b)(6) 2012: one pack daily.On (b)(6) 2013: ¿stop smoking completely before they agreed to do the procedure.¿ on (b)(6) 2013: smokes one pack daily.Chronic obstructive pulmonary disease, no home oxygen use.Obesity.On (b)(6) 2013: 259 lbs.Diabetes.Prior surgical procedures: (b)(6) : complete hysterectomy.Unknown date: cholecystectomy.Implant preoperative complaints: on (b)(6) 2012: ¿history: right side abdominal pain, right lower quadrant for four months.Ct abdomen: "the bowel shows no evidence of obstruction or perienteric inflammation.Normal appendix.No aneurysm.No adenopathy.¿ ¿¿infraumbilical hernia with a 3.3 centimeter orifice through which is a herniated fat and a small loop of bowel obstructed.¿ implant procedure: incisional infraumbilical hernia repair with incarcerated small bowel and omentum.Implant: gore® dualmesh® biomaterial (1dlmc201/8732055) 15 cm x 19 cm oval.Implant date: (b)(6) 2012 [hospitalization dates unknown].Description of hernia being treated: ¿the hernia sac was entered and all the hernial defect was connected into 1 defect.Dissection was done separating adhesion with these [sic] very dense between the omentum to the abdominal wall.This was done into the surrounding abdominal wall was free from the omentum.¿ ¿several herniation in the same vicinity.The largest one measure approximately 3cm in diameter at the opening and contained small bowel and omentum.No evidence of any strangulation.Smaller adjacent weakening of the fascia was noted after connection.The defect is approximately 5cm in diameter.¿ implant size and fixation: ¿after the omentum was reduced, the hernia defect was approximately 5cm in diameter and 2mm gore-tex patch was used to repair.The patch was 2mm thick and approximately 15cm in diameter.This was inserted with the smooth side facing peritoneal cavities and textures side facing outward.It was suture [sic] tucking under the hernia defect using gore-tex suture and total of 6 sutures were used to tuck the patch under the hernia ring.After ensuring that the patch is spread out smoothly under the fascial ring.After ensuring complete hemostasis, incision was closed with clips.¿ relevant medical information: on (b)(6) 2013: ct abdomen: ¿history: knot on belly, hernia repair in 2012, redness and inflammation at suture site near umbilical area.¿ ¿¿a large ventral hernia is present much larger that was present on (b)(6) 2012.The orifice which begins at the level of the umbilicus and extends inferiorly is over 7cm in diameter and contains at least 14cm area of herniated mesentery and small bowel.No evidence of bowel obstruction.No large bowel herniation.Evidence of attempted hernia repair with mesh placement is noted.The mesh is displaced along the right lateral margin of the hernia sac.The peritoneum and hernia extends up to just beneath the skin surface¿¿ ¿conclusion: 1) evidence of failed ventral periumbilical hernia repair with increase in size of the hernia orifice and sac containing several loops of small bowel and adjacent mesentery without evidence of obstruction.2) fatty liver.¿ on (b)(6) 2013: admission for abdominal pain and recurrent incisional hernia.¿this patient was admitted to observation bed because of abdominal pain.She had repair of incisional hernia in december last year with recurrence and herniation of the bowel and colon was noted.The hernial opening was wide open.She was admitted for observation.On the day of discharge, the patient has no further pain, tolerated oral intake well.She had redness of the skin at the previous incision.¿ ct abdomen: the bowel shows no evidence of obstruction or perienteric inflammation.Large ventral hernia noted at the level of the umbilicus.A 6.5 centimeter orifice is noted through which is a herniated transverse colon, small bowel, as well as omental fat.Evidence of attempted hernia repair is noted with radiopaque mesh along the right lateral aspect of this hernia.The hernia was present on (b)(6) 2013 but has increased in size.On the previous studies the hernia sac was approximately 15 x 9 centimeters, now 18 x 12 centimeters.No ascites.No evidence of strangulation or incarceration.The remainder of the bowel is unremarkable.¿ on (b)(6) 2013: discharge summary: ¿the patient will be discharged and followed in the office.The long-term plan is to refer her to university of virginia because of possible need for bioprosthetic patches for repair or component separation kind of surgery.She has been seen over there and was told that she has to stop smoking completely before they agreed to do the procedures.¿ revision preoperative complaints: on (b)(6) 2013: ¿complaint of a recurrent ventral incisional hernia with a single hernia defect.She states the onset of pain and a bulge began 1go [sic] and has been constant since onset.The bulge is worse with standing and better with binder.¿ ¿the patient has had a previous repair of her hernia with probable alloderm repair which quickly failed, at (b)(6), approximately 6 months ago.¿ ¿saw surgeons at uva who recommended lateral relaxing incision and reeves stoppa repair.¿ exam: ¿incisional hernia present about 15 cm long starting below umbilicus.Pt.Obese at 259 and smokes one ppd.¿ revision procedure: mesh repair of ventral incisional hernia with component separation and lateral rectus released.Revision date: september 19, 2013 [hospitalization dates unknown] ¿area over her lower midline hernia was opened sharply along with her previous scar.She had very thin attenuated skin and sac.The sac was therefore opened and __ [sic] adhesions were carefully dissected off the sac to the edges of the fascia.Bowel and omental adhesions were carefully taken down using sharp dissection.Once the fascial edges were free, there was evidence that the previous mesh was pulled away to the right side.Edges of fascia were carefully cleared up to the level of the rectus muscles.The anterior rectus sheath was opened on the left to allow expansion.Following this more medially, a plane was carefully dissected out below the rectus muscle and overlying the posterior fossa.The same procedure was performed on the right with lateral rectus released and dissection of the plane immediately posterior to the rectus muscle but anterior to the previously placed mesh which was peritonealized.¿ ¿the previously placed mesh was brought laterally across the abdomen and secured to the left -sided anterior and posterior fascia at the further direct dissection.This created covered over the __ [sic] omentum.Prolene mesh was then carefully formed to the defect with a 3 cm overlap in all directions.He [sic] was placed over the previous peritonealized mesh and below the level of the rectus muscle.It was sutured to the anterior rectus anteriorly.We placed 3 cm underlay below the rectus in the anterior fascia was secured using prolene suture in interrupted fashion.The midline fascia was then closed with a running 0 prolene.¿ ¿the records indicate an ethicon prolene mesh (non-gore device) was implanted during the procedure.¿ relevant medical information: on (b)(6) 2013: hospital admission for postoperative wound infection.¿physical findings: abdomen: soft, obese, nondistended.She has erythema extending approximately 2 to 3 cm on either side of the midline incision.She has thick reddish cloudy drainage draining from the inferior portion of the wound.¿ ¿we will start her on iv antibiotics.We will open the inferior portion of the wound and drain the fluid.We will then provide local wound care.We will also culture the drainage and tailor the antibiotics accordingly. on (b)(6) 2013: incision and drainage of ventral hernia incision site abscess.¿the incision was then opened and allowed to drain.It was packed wet to dry with dakin's.She received a picc line, and was able to be discharged home with home health for wound packing and administration of iv antibiotics.¿ on (b)(6) 2013: ct abdomen: ¿air and fluid seen in the subcutaneous soft tissues anterior to the hernia repair with mesh.The pocket measures approximately 11.2 x 2.6 x 9.0 cm.It has a subtle rim of enhancement consistent with an early abscess.¿ on (b)(6) 2013: pathology: isolate (final) ¿light growth of staphylococcus aureus.Isolate (final) ¿light growth of coagulase negative staphylococcus.¿ on (b)(6) 2013: iv antibiotics continue.On (b)(6) 2013: no abdominal wall hernias are present.On (b)(6) 2013: ct abdomen: "¿ an open wound in the midline of the abdomen extending down to the fascial plane.No loculated fluid collections are seen.Minimal surrounding inflammation in the subcutaneous fat to the left of this wound.No recurrent hernia.Mesh is in place.¿ on (b)(6) 2013: ¿abdominal exam: abdomen non-tender to palpation, moderate abdominal obesity, tone normal without rigidity or guarding, normal bowel sounds, no masses present one cm wide, 2.5 cm deep granulating tract lower mid incision.Hernias: no abdominal wall hernias are present.¿ on (b)(6) 2017: ed visit: ¿right lower abdominal pain for 2 weeks started after straining, status post abdominal wall hernia surgery 2 years ago.¿ no operative records provided for surgery in 2015. on (b)(6) 2017: ct abdomen: ¿patient is status post umbilical hernia mesh repair in the past.There is a new 8 cm right lower quadrant spigelian hernia containing uncomplicated small bowel loops.¿ on (b)(6) 2017: ¿history consistent with rlq [right lower quadrant] bulge that has been present for 2 weeks and began with an unknown event.She complains of pain and the presence of a bulge.She notes that the bulge is partially reducible.¿ on (b)(6) 2017: ¿open right spigelian hernia with mesh.¿ ¿there was no evidence of ischemia.The previous periumbilical mesh could be palpated, but felt well incorporated and was away from the area of the hernia.The preperitoneal plane was then defined circumferentially around the hernia defect, and a piece of ultrapro mesh [non-gore device] was cut to size -8x10cm and placed in the preperitoneal plane.The transversalis and internal oblique layers were then closed together using #1 pds in running fashion.¿ 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 gore® dualmesh® biomaterial instructions for use also warns, ¿strict aseptic techniques should be followed.If an infection develops, it should be treated aggressively.An unresolved infection may require removal of the material.¿ 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.Procedure and specific patient factors may contribute to or cause infection, leading to contamination, exposure, lack of incorporation and/or seeding of device.Procedure related factors may include adherence to clinical guidelines on infection risk management, contamination of device prior to or during implant, and post-operative wound management.Patient risk factors may include diabetes, smoking, age, malnutrition, immunosuppressive therapy, post-operative instruction noncompliance, and hygiene.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.Based upon the information received, the device remains in the patient and was not available for evaluation.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.
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