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| Device Problems
Improper or Incorrect Procedure or Method (2017); Microbial Contamination of Device (2303); Insufficient Information (3190)
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| Patient Problems
Adhesion(s) (1695); Unspecified Infection (1930); Pain (1994)
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| Event Date 05/31/2007 |
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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 although the brand name and lot# of a gore device has not been provided, the instructions for use for the vast majority of gore¿s eptfe patch products that are indicated for the reconstruction of soft tissue deficiencies include the following warnings among others: ¿possible 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.¿ ¿strict aseptic techniques should be followed.If an infection develops, it should be treated aggressively.An unresolved infection may require removal of the material.¿.
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Event Description
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It was reported to gore that the patient underwent incisional hernia repair on an unknown date in 2005 whereby an alleged gore device was implanted.The complaint alleges that on (b)(6) 2007, an additional procedure was performed whereby explant of the gore device was performed.It was reported the patient alleges the following injuries: abdominal pain, extensive adhesions, abdominal wall fluid retention, bowel resection, mesh infection, mesh removal, and loss of consortium.Additional event specific information was not provided.
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Manufacturer Narrative
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Added other relevant history.Conclusion code remains unchanged.
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Manufacturer Narrative
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Corrected age and added date of birth.Added patient medical and surgical history.Corrected date.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 10/11/2006 were not provided, including product identification records and operative report detailing the implant of the alleged gore device in 2005.Additionally, records regarding the following prior procedures were not provided: hysterectomy, cholecystectomy, and partial colectomy referred to in the 10/11/2006 records; ¿prior extensive abdominal surgery, presence of prosthetic mesh¿ referred to in the 4/26/2007 records; and distal ileum resection with hemicolectomy in 2003 referred to in the 8/25/2008 records.Records dated 10/11/2006 indicate a ct of the abdomen and pelvis was performed for a history of crohn¿s disease and right lower quadrant pain.Impression from the ct states: ¿1) postsurgical changes of partial colectomy without evidence of bowel wall thickening, abdominal inflammation or abscess.2) fatty infiltration of liver.3) surgical changes of hysterectomy and cholecystectomy.¿ records dated 12/6/2006 indicate a small bowel imaging series was performed for a history of nausea with pain.Findings from the series state: ¿a preliminary film of the abdomen demonstrates no abnormally dilated loops of bowel.No abnormal radiopacities are seen in the abdomen.Multiple series views of the small bowel obtained after the ingestion of contrast demonstrate an unremarkable mucosal pattern without evidence of mass, obstruction, malabsorbtion or inflammatory bowel disease.¿ operative records dated 4/26/2007 indicate the patient underwent exploratory laparotomy, lysis of adhesions, and ileocolic resection for a diagnosis of crohn¿s disease.Operative findings state: ¿1.Extensive intraabdominal adhesions.2.Matted small bowel in region of the previous anastomosis with creeping fat consistent with crohn¿s disease.3.Seemingly previous end-to-end anastomosis.¿ the records state: ¿the patient is a 46-year-old caucasian female with known crohn¿s disease.She has had intractable symptoms of abdominal pain and diarrhea as well as bloating, despite maximal medical therapy, and she was referred for evaluation of possible surgical resection, given the intractable nature to her problem.¿ ¿she was felt to be at fairly high risk for a complication given her morbid obesity, prior extensive abdominal surgery, presence of prosthetic mesh, and her known crohn¿s disease.Understanding these potential risks, she was agreeable to surgery.¿ the 4/26/2007 operative records state: ¿a midline incision was created with a #10 blade, extending over her prior surgical scar.Cautery dissection was used to continue through the subcutaneous fat down to the level of the abdominal fascia.The fascia was incised in the mid line and then continued down until such time that we discovered her prior ptfe mesh.This was grasped on either side with a kocher clamp and divided centrally with a knife.With the mesh divided, we then continued the division in a cephalad and caudal direction with curved mayo scissors.Blunt dissection was undertaken to clear the midline of these adhesions.These adhesions came down fairly easily.In the region of the mesh more laterally and away from the mesh there were additional fairly extensive omental adhesions that were taken down with the assistance of metzenbaum scissors.Carefully, we identified the transverse colon omentum and freed it from its adhesions and were able to retract it cephalad, exposing the underlying small intestines.We then freed the small intestines of most of the intraabdominal adhesions.¿ the 4/26/2007 records continue: ¿we followed this distally to the region of the prior anastomosis, which was in the right upper quadrant, essentially in the gallbladder fossa.With a combination of sharp dissection and cautery dissection, this anastomosis was freed.By incising the peritoneum along its mesentery, it was able to be mobilized medially to the midline of the wound.There were matted portions of intestines containing creeping fat.The area was firm.There was no visible abscess.It was clear that this was the sick area seen endoscopically and via ct scan.The anastomosis was resected back to normal bowel in either direction.Approximately 6-8 inches of small intestines total was resected, and 5-6 inches of colon.This was performed by dividing its mesentery using a clamp-clamp-tie technique, and the intestine was divided with a gia stapling device.We then approximated the small intestines and transverse colon with interrupted sutures.Then cut out a small segment of its staple line, and using a gia stapling device, performed our side-to-side enterocolostomy.It should be noted that a wound protector was placed prior to division of any limb of bowel.With the enterocolostomy performed, the remaining entercolotomy was closed with a ta stapling device.The peritoneum was reapproximated using interrupted vicryl sutures.The staple line was oversewn with interrupted vicryl sutures.The wound was irrigated.The abdomen was irrigated thoroughly.It was evacuated of irrigant.It was hemostatic.¿ ¿the fascia and previous mesh was reapproximated using running looped #1 pds sutures.¿ there was no mention of infection in the 4/26/2007 records.Operative records dated 5/31/2007 indicate the patient underwent ¿open resection of infected mesh and repair of incisional hernia with 6-inch x 8-inch collamend mesh (biologic-underlay repair) [non-gore device].¿ postoperative diagnoses are noted as ¿1.Infected prosthetic mesh.2.Incisional hernia.¿ operative findings state: ¿a 3-inch x 5-inch supraumbilical defect repaired (as above).¿ the records state: ¿the patient is a 46-year-old caucasian female with a history of intractable crohn¿s disease and ventral hernia.She underwent bowel resection for this intractable crohn¿s disease and developed an infection of her gore-tex mesh in the postoperative period.Given its intolerance to infection, the mesh required removal and she was felt to be a suitable candidate for this procedure and repair of the remaining fascial defect with a biologic-type mesh.¿ the 5/31/2007 operative report states: ¿a wound culture was obtained for gram-stain, aerobic and anaerobic organisms.A midline incision was created immediately over her prior midline scar connecting the two intervening segments of open wound at the superior and inferior aspect of this prior incision.Bovie electrocautery was used to continue down to the level of the gore-tex mesh.There was a small separation of the gore-tex mesh seemingly related to infection and the mesh was loosely attached to the surrounding tissues, again consistent with her diagnosis of infected mesh.Slowly and meticulously, the mesh was circumferentially resected, removing the spiral titanium tacks as each was encountered.Great care was taken during the adhesiolysis to avoid any bowel injury.The gore-tex mesh was removed in its entirety.The wound was then irrigated thoroughly.A #10 flat jackson-pratt drain was placed in the wound base.Fascial flaps were created in all directions using the bovie electrocautery.At that time, using an underlay technique of interrupted horizontal mattress, a segment of 6-inch x 8-inch collamend mesh was secured to the fascia circumferentially.After an additional irrigation, i then closed the fascia using a running #1 pds suture.¿ the records indicate the explanted infected mesh was sent to pathology for gross examination.Records for the wound culture taken during the 5/31/2007 procedure were not provided.Additionally, the pathology report detailing the gross examination of the explanted infected mesh and product identification records for the alleged ¿gore-tex mesh¿ were not provided.Records dated 7/10/2007 indicate an upper gi imaging series with small bowel follow-through was performed for indications of ¿crohn¿s disease, pain with eating, history of partial bowel resection.¿ findings from the series state: ¿scout image reveals evidence of prior anterior abdominal wall hernia repair and postsurgical changes in the right pelvis.¿ impression from the series states: ¿1.Three-plus gastroesophageal reflux with a small sliding-type hiatal hernia.2.No definite evidence of active crohn¿s disease in this patient with postsurgical changes¿¿ records dated 7/25/2007 and 7/26/2007 indicate cts of the abdomen and pelvis were performed for a history of abdominal pain.Findings from the ct state: ¿there is a lobulated hypodense peripherally enhancing lesion intimately associated with the anterior abdominal wall with surrounding inflammatory changes.It measures 6 x 4 x 8 cm.An anastomosis is identified in the right upper quadrant.¿ impression from the imaging states: ¿lobulated enhancing mass intimately associated with the anterior abdominal wall likely representing an abscess.Unopacified bowel and partial herniation although unlikely could have a similar appearance.¿ records dated 7/27/2007 indicate a ct of the abdomen and pelvis was performed for a history of abdominal wall fluid collection and possible abdominal wall hernia.Conclusion from the ct states: ¿1.Stable appearance of abdominal wall fluid collection, hematoma, seroma or less likely abscess.2.No evidence of abdominal wall hernia containing bowel or leak of bowel contrast into abdominal wall fluid collection.¿ records dated 7/27/2007 indicate a ct guided fluid collection drainage was performed to address an abdominal wall fluid collection.Conclusion from the procedure states: ¿1.Successful placement midline abdominal wall fluid collection as above using ct guidance.2.Fluid was yellow and serous in nature, sent for cultures and stains.No drain was placed.¿ the culture report for the specimens collected on 7/27/2007 were not provided.Records dated 8/22/2008 indicate a ct of the abdomen and pelvis were performed for ¿history of crohn¿s disease, prior hernia repair with inflammatory process in the anterior abdomen, possible fistula.¿ findings from the ct state: ¿there is again noted patient¿s known biologic hernia repair material in the anterior abdominal wall that appears to have stable intervening fluid density.There has certainly been significant increase in the inflammatory changes and fat stranding in the subcutaneous fat adjacent to this, suggesting a cellulitis.Along the superior aspect of this, there is new focal extrusion of portion of this biologic hernia repair into the anterior abdominal wall subcutaneous fat.There is no evidence of recurrent hernia of any intra-abdominal content.Regarding the patient¿s crohn¿s disease: ¿mild wall thickening of the neoterminal ileum and some mesenteric enlarged lymph nodes consistent with the patient¿s history of crohn¿s disease but no fistula noted.¿ records dated 8/25/2008 indicate a small bowel imaging series was performed for ¿history of crohn¿s disease.The patient had approximately 2 feet of distal ileum resected with hemicolectomy in 2003.¿ the findings from the series state: ¿surgical clips are seen of the abdomen.¿ impression from the series states: prior partial right hemicolectomy and distal small bowel resection.The anastomosis is patent and there is no evidence of an acute inflammatory process at this time.¿ records dated 9/5/2008 indicate an ultrasound guided fluid collection/aspiration was performed for a history of abdominal wall collection.Conclusion from the ultrasound states: ¿aspiration performed of hypoechoic structure in the midline.Very minimal fluid could be aspirated either due to extremely viscous nature or abnormal echogenicity representing cellulitis and not true abscess.Follow up ct recommended.¿ records dated 11/13/2008 indicate a ct scan of the abdomen and pelvis were performed for a history of abdominal wall hernia and stage iii renal failure.Findings from the ct state: ¿the patient is status post anterior abdominal wall hernia repair.The previously identified anterior abdominal wall subcutaneous fluid collection has resolved.The fluid within the mesh has also resolved.There is thickening of the anterior abdominal wall.At the site of the previous fluid collection, there is what likely represents packing material with an open anterior abdominal wall wound.There is no evidence of abscess.Records dated 2/11/2009 indicate a ct scan of the abdomen and pelvis were performed for a history of ventral wound.Impression from the ct states: ¿1.Resolved anterior abdominal fluid collection and mesh fluid collection.2.Abdominal wound containing probable packing material with no significant surrounding inflammatory changes.There is thickening around the abdominal wound cavity and thickening of the anterior abdominal wall below the hernia repair.3.Status post right hemicolectomy with right mesentery stranding and lymph notes that may be related to surgery.4.No intra-abdominal free fluid.4.Probable left renal cyst.The solid organs are otherwise normal.¿ 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 although the brand name and lot# of a gore device has not been provided, the instructions for use for the vast majority of gore¿s eptfe patch products that are indicated for the reconstruction of soft tissue deficiencies include the following warnings among others: ¿possible 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.¿ ¿strict aseptic techniques should be followed.If an infection develops, it should be treated aggressively.An unresolved infection may require removal of the material.¿ 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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A5b: added race.B7: added medical history.D1: added brand name.D2: added common device name.D6: added implant date.G5: added pma/510(k) #, added selection for combination product.H6: codes 4118/3221 - product identification records for the alleged gore device was not provided.Therefore, a review of the manufacturing records could not be performed.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: records dated (b)(6) 2005 state the patient was seen ¿for follow-up of an incisional hernia.She denies any new complaints.Her examination today is unchanged.I have reviewed her ct films which are notable for an incisional hernia above the umbilicus which contains small bowel.There do not appear to be any other hernia defects.I have recommended proceeding with incisional herniorrhaphy.¿ operative records dated (b)(6)2005 state the patient underwent laparoscopic incisional herniorrhaphy.¿the patient had undergone a small bowel resection in 2003 for crohn¿s disease.Since that time, she had developed a bulge at the upper aspect of her midline incision.On examination, she was noted to have an incarcerated incisional hernia.This had been documented on an abdominal ct scan.I had recommended proceeding with herniorrhaphy.¿ the (b)(6)2005 operative report states: ¿the patient was found to have adhesions of the omentum to the anterior abdominal wall.These were taken down using careful use of sharp dissection and the harmonic scalpel.Reaching the midline, the patient was found to have four fascial defects.The largest defect contained a loop of small bowel.This was freed from the hernia defect using a combination of blunt and sharp dissection.There did not appear to be any evidence of injury to the bowel once it was completely freed.At this point, the edges of the defects were identified using a spinal needle passed through the abdominal wall.A gore-tex dual mesh was then selected to allow overlap in all directions by 3-cm.The resulting mesh measured 15 x 15-cm.Then.0 gore-tex transfixing sutures were then placed at the cardinal points on the mesh.The mesh was then introduced into the peritoneal cavity.It was oriented appropriately and the transfixing sutures were retrieved using a gore-tex suture passer.The suture was tied approximating the mesh to the anterior abdominal wall.The edges of the mesh were then further approximated to the anterior abdominal wall using a spiral tacker.Several tacks were placed in the mid aspect of the mesh to minimize seroma formation.¿ ¿the skin was reapproximated using surgical staples.The patient appeared to have tolerated the procedure well.¿ product identification records for the alleged ¿gore-tex dual mesh¿ were not provided.Records dated (b)(6)2005 state the patient was seen for follow up ¿after undergoing a laparoscopic incisional herniorrhaphy.She reports that she is doing very well and denies any complaints.On examination, her abdomen is soft, nondistended and nontender.The trochar [sic] sites are healing nicely.¿ records dated (b)(6) 2005 state the patient was seen postoperatively ¿after undergoing a laparoscopic incisional herniorrhaphy.She reports that she is doing fairly well except for a pulling sensation at her umbilicus with certain positions.She describes the discomfort as sometimes being moderate in severity.She denies any recurrent bulging at the repair site.She has not nausea, vomiting or constipation.On examination, the trochar [sic] sites are well healed.The abdomen is soft, nondistended and nontender.With bilateral leg raises, i feel no evidence of a bulge along the incision.I suspect that some of her discomfort is coming from the mesh pulling against the abdominal wall.I have explained to her that this should improve with time, although she may always have some sensation of ¿tightness¿ in that area.Overall, she seems to be doing fairly well.¿ records dated (b)(6)2006 state the patient was seen for evaluation of ¿possible adhesive type abdominal pain.¿ she has had a longstanding problem with epigastric and right lower quadrant abdominal pain associated with nausea, bloating and diarrhea 7 to 10 times per day.¿ ¿she recently underwent an abdominopelvic ct scan which demonstrated postsurgical changes with no evidence of bowel wall thickening, inflammation or abscess.¿ ¿abdomen: there is diffuse abdominal tenderness to deep palpation without evidence of peritonitis.There is a midline incision with no evidence of hernia.There is no palpable abdominal mass.¿ ¿my suspicion, given her symptom complex, is that it is not related to abdominal adhesions and therefore have not recommended exploratory laparoscopy.¿ records dated (b)(6) 2006 state the patient was seen for follow up ¿of her small bowel enteroclysis.Her symptoms have really been unchanged and continue to be dominated by diarrhea, nausea and bloating.She also has some gastroesophageal reflux disease with the sensation of burning in her throat¿¿ ¿i have reviewed with [the patient] her negative ct scan and negative small bowel enteroclysis.I do not think her symptom complex is related to an adhesive etiology.¿ records dated (b)(6) 2007 state: ¿she is a 46 year old female with a history of crohn¿s disease involving her terminal ileum.She has had an ileocolectomy in the past, as well as a hysterectomy.In 2005, she had a laparoscopic ventral hernia repair with gore-tex mesh by dr.(b)(6) she notes that she has had problems since her initial operation with abdominal pain, nausea, vomiting and diarrhea when she eats.She had colonoscopy a few months back which showed active disease within her neoterminal ileum.¿ ¿a ct scan apparently showed some postoperative change, but no obvious wall thickening or abscess formation.On examination today, [the patient¿s] weight is 245 pounds which is actually up.She believes she is retaining fluid.¿ ¿her abdomen is soft and obese.She has no palpable mass.She has no palpable hernia.¿ ¿ideally, we would treat her medically.Surgery does carry increased risk, including the risk of infection, anastomotic leak, as well as potential complications with her gore-tex mesh.¿ records dated (b)(6) 2007 state the patient was seen for follow up regarding her crohn¿s disease.¿it is my understanding that we really have exhausted all reasonable medical therapies for her crohn¿s disease and we are really left with resection for control.Her symptoms really are unchanged and include profound diarrhea and abdominal pain, as well as daily vomiting.¿ ¿plan: bowel resection with possible ostomy.I had a long discussion with [the patient] in the office today regarding the risks of surgery which are substantial.These risks include but are not limited to bleeding, infection, anesthetic type risks, the need for more surgery in the future, anastomotic leak, fistula formation, infection of her prosthetic mesh requiring removal, intra-abdominal abscess, recurrence of crohn¿s disease, worsening of her crohn¿s disease, and continued gastrointestinal symptomatology.She understands all of these risks and is agreeable to surgery.¿ discharge summary records dated (b)(6) 2007 state: ¿the patient was admitted following planned elective ileocolic resection for intractable crohn¿s disease.She had some acute renal failure postoperatively likely related to low blood pressure and dehydration that prompted nephrology consultation.Her acute renal failure resolved with iv fluids in a self-limited fashion.¿ ¿she developed some wound erythema at the inferior aspect of her incision prompting opening of the incision.Approximately 20 ml of red-brown purulent fluid was evacuated.It was cultured and found to be coag negative staph.Wound vac was placed.Over the ensuing 36 hours she also developed some erythema from the midportion of the incision.This was also opened with the evacuation of additional red-brown pus.Wound vac was also continued on this area.Infectious disease consultation was obtained and she was initiated on invanz and vancomycin.A picc line was inserted.Home vac therapy was planned.By may 7 she was felt to be a suitable candidate for discharge.¿ ¿she understands that given her prosthetic mesh underlying the wound that this vac therapy may not be successful and she will require resection of her mesh and placement of a biologic mesh in that event.¿ the (b)(6) 2007 discharge summary records state the following procedures were performed during hospitalization: ¿1.Exploratory laparotomy, lysis of adhesions and ileocolic resection (b)(6)2007.2.Drainage of wound infection (b)(6) 2007 and (b)(6)2007.3.Initiation of vac therapy (b)(6)2007.¿ discharge diagnoses state: ¿1.Crohn¿s disease.2.Wound infection.3.Acute renal failure (resolved).¿ culture report dated (b)(6) 2007 regarding abdominal swab specimens collected (b)(6)2007 state: ¿isolate #significant organism identified.Mixed growth suggestive of colonization or indigenous flora.Isolate #2 bacteroides distasonis.¿ records dated (b)(6) 2007 state the patient underwent exploratory laparoscopy and lysis of adhesions and an ileocolic resection on (b)(6) 2007.She has a postoperative wound infection that appears to involve her mesh.¿ ¿on examination¿.Copious amounts of brown purulent material was evacuated from the lower aspect of her opened incision.Similar fluid was also evacuated from the upper portion of the opened incision.A fingertip was placed down into the upper portion of the incision and the gore-tex mesh could be palpated.Impression: infected mesh.Plan: this problem will not resolve with local wound care or antibiotics.She will require additional operative therapy for resection of this mesh and placement of a biologic prosthesis.¿ a pathology report dated (b)(6)2007 regarding a specimen collected (b)(6)2007 states: ¿specimen(s) received: explanted infected abdominal mesh.¿ ¿gross description: one container is labeled ¿explanted infected abdominal mesh.¿ the specimen is received in fixative for gross examination only and consists of a 14.5 x 5 x 0.1 cm portion of surgical mesh with multiple metallic loops along the periphery.The mesh is fenestrated and contains sutures.There is a scant amount of attached soft tissue.No specimen is submitted for microscopic exam.¿ ¿final diagnosis: explanted infected abdominal mesh: synthetic mesh with metallic clips, 14.5 cm greatest dimension, gross identification only.¿ records dated (b)(6) 2007 state: ¿overall, she seems to be doing well in terms of her wound healing.The incision is nearly completely granulated.There is no sign of hernia recurrence.There is no erythema or drainage to suggest infection.¿ ¿¿the incision is healed nicely.There are three small punctate areas of ongoing granulation.¿ records dated (b)(6)2007 state the patient was seen for follow up.¿she underwent an open resection of a segment of active crohn¿s disease due to intractability.She secondarily developed a postoperative infection of her ventral hernia prosthesis and required explantation.She has recovered nicely from the follow-up operation with repair of her underlying hernia using a biologic prosthesis.¿ ¿on examination, her incision has nearly completed granulated.There are two persistent areas of small opening which are being packed.¿ ¿there is no erythema or drainage to suggest infection.Her abdominal exam is nontender.There is no distention.There are normal bowel sounds.¿ ¿given her symptoms of chills and intermittent episodes of low grade abdominal pain, i do think it is prudent to proceed with an abdominopelvic ct scan.¿ culture report dated (b)(6)2007 regarding a specimen collected (b)(6) 2007 states: ¿specimen/source: fluid/abdomen.¿ ¿no anaerobic growth.¿ records dated (b)(6)2007 state the patient was seen for follow up.¿the aspirated seroma microbiology was negative.On examination, there is no erythema or drainage at the incision to suggest infection.There is no sign of recurrence of the hernia.There is appropriate tenderness.¿ records dated (b)(6) 2008 state the patient was seen for follow up.¿she has what appears to be an abdominal wall abscess or impending enterocutaneous fistula with increasing swelling and warmth at the superior aspect of her old surgical scar.She will be admitted to the hospital¿¿ additional records dated (b)(6) 2008 state: ¿according to the patient, she was in her usual state of health until approximately 1 month ago where she began feeling weak and tired and developed some lower abdominal pain.¿ ¿according to the patient, her abdominal pain discomfort worsened over the last 48 hours and has been associated with some fever to 101.7 last night.¿ ¿abdomen is soft.There is tenderness in the epigastrium overlying an area of nodularity and warmth at the superior aspect of her prior midline scar.This extends approximately 5 cm in greatest diameter.It is seemingly fluctuant.There is mild blanching.There is tenderness elsewhere across the abdomen but no peritoneal signs.¿ ¿impression: abdominal wall abscess versus impending enterocutaneous fistula.¿ records dated (b)(6) 2008 state: ¿she was treated in the hospital for cellulitis of the abdominal wall.By her account, she is feeling much better.The fever is gone.The pain is much improved.¿ ¿she is about to start some additional immunologic therapy for her crohn¿s disease.Active infection is obviously a contraindication to this, and we will proceed with sampling of the abdominal wall seroma to ensure that it is safe to begin this treatment.The presence of this erythema and fever may also be a reaction to the autolysis of the biologic mesh.¿ culture reports dated (b)(6)2008 and (b)(6)2008 regarding specimens collected (b)(6)2008 states: ¿specimen/source: fluid/seroma.¿ ¿no growth.¿ ¿no cells seen, no organisms seen.¿ records dated (b)(6)2008 state the patient was seen for follow up.¿she has had some serous and occasional milky drainage from the area of her prior ultrasound guided aspiration.The erythema has not improved.She continues to feel poorly.I feel that on examination, there is fluctuance beneath a very thin layer of skin above the level of her umbilicus.I have reviewed her cat scan and there is no suspicion for a protruding viscus in this area, and she is a suitable candidate for incision and drainage.¿ a longitudinal incision was created over the point of maximal fluctuance.Interestingly, there was no large fluid collection beneath the skin, only very edematous tissue.There was a small amount of complex material that was evacuated.My suspicion is that this represents autolysis of the underlying biologic mesh.The area was packed with half inch nugauze.¿ culture report dated (b)(6)2008 regarding a specimen collected (b)(6)2008 states: ¿specimen source: abd.Abscess.¿ ¿result: no growth to date.¿ records dated (b)(6)2008 state: ¿she has an incision and drainage site which continues to leak a small amount of yellowish fluid.This is consistent with her previous hernia mesh (biologic).For whatever reason, they stopped packing the incision.¿ records dated (b)(6)2008 state: ¿she has a midline abdominal wall incision and drainage site that is granulating.She is getting local wound care at home.She has had no fevers.She is feeling much better.On examination¿.The wound base looks much better.There is granulation tissue around the perimeter of the incision and centrally.¿ records dated (b)(6) 2008 state the patient was seen for follow up regarding ¿an open wound related to seemingly autolysis of her biologic prosthesis.She has had some recent abdominal pain¿¿ ¿¿there is an excellent bed of granulation tissue around the perimeter of the wound.The base of the wound is very soft and does not look markedly changed since her last visit.The 2 x 2 dressing which was removed from the incision had some neon green fluid present on it, likely consistent with pseudomonas colonization.I believe this is a suitable incision for a wound vac.¿ records dated (b)(6)2008 state the patient was seen for follow up.¿she has begun her immunologic therapy for her crohn¿s disease.Her incision and drainage site int eh midline of her abdomen is healing.It does have a sinus tract deep and cephalad.It is several centimeters in depth.There is some skin irritation where the vac adhesive dressing lies.¿ ¿she had some other complaints or orthostasis and abdominal pain, presumably related to her crohn¿s disease and diarrhea.¿ records dated (b)(6)2008 stated the patient was seen for ¿an abdominal wound seemingly related to autolysis of biologic mesh.An incision and drainage was performed with evacuation of a fairly sizeable amount of complex liquid material.This was culture negative.¿ ¿there continues to be a deep sinus tract of approximately 2 to 3 cm that accommodates several inches of half inch nugauze packing.There are no cellulitic changes.She has had a couple episodes of presyncope.¿ records dated (b)(6)2008 state the patient was seen for a wound check.¿the wound continues to drain yellow fluid.Her abdominal pain is unchanged and she is requesting more pain medicines.¿ records dated (b)(6)2008 state: ¿the area on the abdomen is punctate and only approximately 1 to 2 mm.In size.It still drains a very small amount of milky fluid.There is no foul odor.I reviewed with her her abdominopelvic cat scan.She apparently went to the emergency department over the weekend and was told she was constipated.She continues to have problems with severe diarrhea.¿ ¿impression: slowly dissolving abdominal wall biologic prosthesis.¿ records dated (b)(6)2009 state the patient was seen for follow up.¿apparently, her immunotherapy has been discontinued.By her account, the sinus tract is less productive of fluid but is still quite deep.There appears to be some increasing mucoid drainage present on the gauze strip.I believe she would be a good candidate to resume her antibacterial silver dressings and we will begin that.I am hopeful that the autolysis of the biologic mesh is complete.Certainly, this would allow for more complete healing of the area, which is only a centimeter or two in greatest diameter.¿ records dated (b)(6)2009 state the patient has ¿¿crohn¿s disease and a chronically draining sinus tract in her abdominal wall.She underwent an abdominopelvic cat scan.There was some suspicion of a fistula due to what was felt to be contrast in the sinus tract.This was more likely silver impregnated packing.The amount of fluid coming from the area is stable.There has been no air or succus that emanates from the area.I believe we have given this incision plenty of time to heal and it has not satisfactorily done so.We should, in my estimation, proceed with an excision of the sinus tract and possible removal of a stitch granuloma.¿ operative records dated(b)(6)2009 state the patient underwent excision of a stitch granuloma.¿the patient is a 48-year-old caucasian female with crohn¿s disease.She had a complicated ileocolic resection with mesh infection requiring explantation and replacement with a biologic prosthesis.Following this procedure she had a localized inflammatory reaction with autolysis of the mesh which was treated by drainage.This sinus tract from which this drainage occurred has healed very poorly despite the use of wound v.A.C.And aggressive local wound care.She is felt suitable for excision of this sinus tract with closure of the wound.¿ findings from the procedure state: ¿approximate 3 to 4 cm sinus tract, continuing down to the level of the abdominal fascia.Sinus tract surrounded by hypergranulation tissue.¿ the (b)(6)2009 operative report states: ¿an elliptical incision was created using a #10 blade encompassing the visible sinus tract.Using the bovie electrocautery the subcutaneous tissues were divided, continuing down to the level of the abdominal fascia.The sinus tract was amputated at this level.The sinus tract continued down to the level of the fascia and just below it for another 0.25 cm.The hypergranulation tissue there was cauterized and the abdominal fascia was closed using 2-0 vicryl figure-of-eight sutures.I was comfortable with these sutures being away from the abdominal viscera.The subcutaneous fat and tissues were reapproximated using 3-0 vicryl plus suture, after a thorough irrigation of the wound.¿ a pathology report dated (b)(6)2009 regarding a granuloma specimen collected (b)(6)2009 states: ¿gross description: the specimen is received in formalin labeled with the patient¿s name and additionally labeled ¿abdominal granuloma¿.The specimen consists of two portions of pink-tan to yellow-tan lobulated soft tissue, which are 5.2 x 2 x 1.5 cm and 2.2 x 2 x 0.9 cm.The larger tissue fragment is partially surfaced by a 3 x 1 cm pink-tan skin ellipse.The epidermal surface is notable for a 0.3 x 0.2 cm defect which is probe patent completely through the specimen.The smaller tissue fragment contains an indwelling blue suture.Sectioning the tissue fragments reveals a pink-tan fibrous cut surface with no obvious lesions.¿ ¿microscopic description: submitted abdominal granuloma: sections reveal hyperkeratosis, epithelial acanthosis, and, within the dermis, cicatricial dermal scarring.Centrally, areas of inflamed granulation-type tissue are seen.Scattered multinucleate ¿foreign body¿ giant cells are evident.There are irregular spaces with nondescript lining present within the dermis with surrounding inflammation and multinucleate ¿foreign body¿ giant cells.Within the sections examined, there is no evidence of malignancy.¿ ¿final diagnosis: submitted abdominal granuloma: cicatricial scarring with inflamed granulation tissue and scattered multinucleate ¿foreign body¿ giant cells, consistent with retained suture.¿ records dated (b)(6)2009 state: ¿she underwent excision of a sinus tract and associated stitch granuloma on (b)(6)2009.¿ ¿she appears to be doing well overall.¿ ¿there is no erythema or drainage to suggest infection.The central open area tunnels approximately two inches posteriorly.There is healthy friable granulation tissue at the border of each open area.She has no fever.¿ records dated (b)(6)2009 state the patient was seen for wound care.¿she is having some problems getting the packing into the sinus tract.The wound orifice appears to be closing.¿ a pathology report dated (b)(6)2009 regarding a sinus tract specimen collected (b)(6)states: ¿gross description: received is a formalin filled container labeled abdominal wall sinus tract.The specimen consists of three tan-yellow, irregular, soft to rubbery fragments of tissue measuring from 0.5 to 1.0 x 0.3 x 0.3 cm.¿ ¿microscopic examination: sections show portions of acutely and chronically inflamed granulation tissue.There are scattered multinucleated histocytes.No cyst wall and no keratinous material is identified.There is no evidence of malignancy.¿ ¿diagnosis: sinus tract, abdominal wall biopsies: acutely and chronically inflamed granulation tissue with foreign body type inflammatory reaction.Negative for atypia and malignancy.¿ records dated (b)(6)2009 state the patient was seen for evaluation of her chronic abdominal wound.¿overall, she seems to be doing well.She is performing wet to dry dressing changes¿on examination, there is some neon green drainage on the deep portion of the 2 x 2 consistent with a pseudomonas colonization.There is a healthy-appearing bed of granulation tissue continuing down thet cylindrical section of the wound to its base.This is friable and normal in appearance.¿ records dated(b)(6)2009 state the patient was seen for follow up.¿she is seemingly making some progress with her local wound care.The wound is much more shallow on today¿s visit, going down only about a centimeter or so.There is very little drainage present on the packing material.I suspect that this will heal over the course of the next several days.¿ records dated (b)(6)2013 state the patient ¿has had multiple prior abdominal operations related to crohn¿s disease and an incisional hernia.She has had a mesh infection in the past treated with excision of mesh and placement of biologic prosthesis.She presents now with a recurrent incisional hernia.¿ 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.¿ the gore® dualmesh® biomaterial instructions for use also states: ¿strict aseptic techniques should be followed.If an infection develops, it should be treated aggressively.An unresolved infection may require removal of the material.¿ 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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H6: updated patient codes.H6: updated device code.H6: updated conclusion codes.H6: additional conclusion code 4316: no term / code available for ¿withdrawn complaint¿.Previous patient code / codes (1695, 1994, 3191: other ["abdominal wall fluid retention" and "loss of consortium") were reported based on the original complaint and are no longer applicable per gore¿s investigation.This claim was withdrawn, and the alleged product complaint is no longer being pursued at this time.No further investigation is required at this time.In the absence of additional information or medical records from the complainant, this event file will be closed with the information provided.The following information was determined from the medical records.Medical records: the known medical records span january 7, 2005 through january 7, 2013 and not all records received in this time span are relevant to the unknown ¿gore-tex dual mesh.¿ patient information: medical history: crohn's disease, morbid obesity, on (b)(6) 2007: ¿245 pounds which is actually up¿, intractable symptoms of abdominal pain, diarrhea, and bloating, asthma, sleep apnea, gastroesophageal reflux disease [gerd], hypertension, hiatal hernia, chronic renal disease, mild chronic anemia.Prior surgical procedures: hysterectomy, cholecystectomy, "prior extensive abdominal surgery"; ¿multiple abdominal [surgeries] secondary to crohn¿s disease¿.2003: distal ileum resection with hemicolectomy.Implant preoperative complaints: on (b)(6) 2005: ¿follow-up of an incisional hernia.¿ ¿i have reviewed her ct films which are notable for an incisional hernia above the umbilicus which contains small bowel.There do not appear to be any other hernia defects.I have recommended proceeding with incisional herniorrhaphy.¿ on (b)(6) 2005: ¿small bowel resection in 2003 for crohn¿s disease.Since that time, she had developed a bulge at the upper aspect of her midline incision.On examination, she was noted to have an incarcerated incisional hernia.¿ implant procedure: laparoscopic incisional herniorrhaphy [unknown ¿gore-tex dual mesh¿].Implant date: on (b)(6) 2005 [hospitalization unknown].Description of hernia being treated: ¿the patient was found to have adhesions of the omentum to the anterior abdominal wall.These were taken down using careful use of sharp dissection and the harmonic scalpel.Reaching the midline, the patient was found to have four fascial defects.The largest defect contained a loop of small bowel.This was freed from the hernia defect using a combination of blunt and sharp dissection.There did not appear to be any evidence of injury to the bowel once it was completely freed.At this point, the edges of the defects were identified using a spinal needle passed through the abdominal wall.Implant size and fixation: a gore-tex dual mesh was then selected to allow overlap in all directions by 3-cm.The resulting mesh measured 15 x 15-cm.Then.0 gore-tex transfixing sutures were then placed at the cardinal points on the mesh.The mesh was then introduced into the peritoneal cavity.It was oriented appropriately and the transfixing sutures were retrieved using a gore-tex suture passer.The suture was tied approximating the mesh to the anterior abdominal wall.The edges of the mesh were then further approximated to the anterior abdominal wall using a spiral tacker.Several tacks were placed in the mid aspect of the mesh to minimize seroma formation.¿ ¿the skin was reapproximated using surgical staples.The patient appeared to have tolerated the procedure well.¿ product identification records for the alleged ¿gore-tex dual mesh¿ were not provided.No post-operative records.Relevant medical information: on (b)(6) 2005: ¿after undergoing a laparoscopic incisional herniorrhaphy.She reports that she is doing fairly well except for a pulling sensation at her umbilicus with certain positions.¿ ¿on examination, the trochar [sic] sites are well healed.The abdomen is soft, nondistended and nontender.With bilateral leg raises, i feel no evidence of a bulge along the incision.I suspect that some of her discomfort is coming from the mesh pulling against the abdominal wall.I have explained to her that this should improve with time, although she may always have some sensation of ¿tightness¿ in that area.¿ on (b)(6) 2006: ct abdomen / pelvis [a/p]: ¿1) postsurgical changes of partial colectomy without evidence of bowel wall thickening, abdominal inflammation or abscess.2) fatty infiltration of liver.3) surgical changes of hysterectomy and cholecystectomy.¿ on (b)(6) 2006: ¿possible adhesive type abdominal pain.¿ ¿she has had a longstanding problem with epigastric and right lower quadrant abdominal pain associated with nausea, bloating and diarrhea 7 to 10 times per day.¿ ¿abdomen: there is diffuse abdominal tenderness to deep palpation without evidence of peritonitis.There is a midline incision with no evidence of hernia.There is no palpable abdominal mass.¿ ¿my suspicion, given her symptom complex, is that it is not related to abdominal adhesions and therefore have not recommended exploratory laparoscopy.¿ on (b)(6) 2006: ¿her symptoms have really been unchanged and continue to be dominated by diarrhea, nausea and bloating.She also has some gastroesophageal reflux disease with the sensation of burning in her throat.¿ ¿i have reviewed with [the patient] her negative ct scan and negative small bowel enteroclysis.I do not think her symptom complex is related to an adhesive etiology.¿ on (b)(6) 2007: ¿in 2005, she had a laparoscopic ventral hernia repair with gore-tex mesh by dr.(b)(6).She notes that she has had problems since her initial operation with abdominal pain, nausea, vomiting and diarrhea when she eats.She had colonoscopy a few months back which showed active disease within her neoterminal ileum.¿ ¿a ct scan apparently showed some postoperative change, but no obvious wall thickening or abscess formation.On examination today, [the patient¿s] weight is 245 pounds which is actually up.She believes she is retaining fluid.¿ ¿her abdomen is soft and obese.She has no palpable mass.She has no palpable hernia.¿ ¿ideally, we would treat her medically.Surgery does carry increased risk, including the risk of infection, anastomotic leak, as well as potential complications with her gore-tex mesh.¿ on (b)(6) 2007: ¿it is my understanding that we really have exhausted all reasonable medical therapies for her crohn¿s disease and we are really left with resection for control.Her symptoms really are unchanged and include profound diarrhea and abdominal pain, as well as daily vomiting.¿ ¿plan: bowel resection with possible ostomy.I had a long discussion with [the patient] in the office today regarding the risks of surgery which are substantial.These risks include but are not limited to bleeding, infection, anesthetic type risks, the need for more surgery in the future, anastomotic leak, fistula formation, infection of her prosthetic mesh requiring removal, intra-abdominal abscess, recurrence of crohn¿s disease, worsening of her crohn¿s disease, and continued gastrointestinal symptomatology.She understands all of these risks and is agreeable to surgery.¿ ¿she was felt to be at fairly high risk for a complication given her morbid obesity, prior extensive abdominal surgery, presence of prosthetic mesh, and her known crohn¿s disease.Understanding these potential risks, she was agreeable to surgery.¿ on (b)(6) 2007: exploratory laparotomy, lysis of adhesions, and ileocolic resection: [hospitalization on (b)(6) 2007].¿the fascia was incised in the mid line and then continued down until such time that we discovered her prior ptfe mesh.This was grasped on either side with a kocher clamp and divided centrally with a knife.With the mesh divided, we then continued the division in a cephalad and caudal direction with curved mayo scissors.Blunt dissection was undertaken to clear the midline of these adhesions.These adhesions came down fairly easily.In the region of the mesh more laterally and away from the mesh there were additional fairly extensive omental adhesions that were taken down with the assistance of metzenbaum scissors.¿ ¿carefully, we identified the transverse colon omentum and freed it from its adhesions and were able to retract it cephalad, exposing the underlying small intestines.We then freed the small intestines of most of the intraabdominal adhesions¿ approximately 6-8 inches of small intestines total was resected, and 5-6 inches of colon.This was performed by dividing its mesentery using a clamp-clamp-tie technique, and the intestine was divided with a gia stapling device.We then approximated the small intestines and transverse colon with interrupted sutures.Then cut out a small segment of its staple line, and using a gia stapling device, performed our side-to-side enterocolostomy.It should be noted that a wound protector was placed prior to division of any limb of bowel.With the enterocolostomy performed, the remaining entercolotomy was closed with a ta stapling device.The peritoneum was reapproximated using interrupted vicryl sutures.The staple line was oversewn with interrupted vicryl sutures.The wound was irrigated.The abdomen was irrigated thoroughly.It was evacuated of irrigant.It was hemostatic.¿ ¿the fascia and previous mesh was reapproximated using running looped #1 pds sutures.¿ ¿1.Extensive intraabdominal adhesions.2.Matted small bowel in region of the previous anastomosis with creeping fat consistent with crohn¿s disease.3.Seemingly previous end-to-end anastomosis.¿ on (b)(6) 2007: ¿she developed some wound erythema at the inferior aspect of her incision prompting opening of the incision.Approximately 20 ml of red-brown purulent fluid was evacuated.It was cultured and found to be coag negative staph.Wound vac was placed.Over the ensuing 36 hours she also developed some erythema from the midportion of the incision.This was also opened with the evacuation of additional red-brown pus.Home vac therapy was planned.On (b)(6), she was felt to be a suitable candidate for discharge.¿ ¿she understands that given her prosthetic mesh underlying the wound that this vac therapy may not be successful and she will require resection of her mesh and placement of a biologic mesh in that event.¿ on (b)(6) 2007: culture: ¿isolate #1 significant organism identified.Mixed growth suggestive of colonization or indigenous flora.Isolate #2 bacteroides distasonis.¿ explant preoperative complaints: on (b)(6) 2007: ¿underwent exploratory laparoscopy and lysis of adhesions and an ileocolic resection on (b)(6) 2007.She has a postoperative wound infection that appears to involve her mesh.¿ ¿on examination copious amounts of brown purulent material was evacuated from the lower aspect of her opened incision.Similar fluid was also evacuated from the upper portion of the opened incision.A fingertip was placed down into the upper portion of the incision and the gore-tex mesh could be palpated.Impression: infected mesh.Plan: this problem will not resolve with local wound care or antibiotics.She will require additional operative therapy for resection of this mesh and placement of a biologic prosthesis.¿ on (b)(6) 2007: ¿she underwent bowel resection for this intractable crohn¿s disease and developed an infection of her gore-tex mesh in the postoperative period.Given its intolerance to infection, the mesh required removal and she was felt to be a suitable candidate for this procedure and repair of the remaining fascial defect with a biologic-type mesh.¿ explant procedure: ¿open resection of infected mesh and repair of incisional hernia with 6-inch x 8-inch collamend mesh (biologic-underlay repair) [non-gore device].¿ explant date: on (b)(6) 2007.¿bovie electrocautery was used to continue down to the level of the gore-tex mesh.There was a small separation of the gore-tex mesh seemingly related to infection and the mesh was loosely attached to the surrounding tissues, again consistent with her diagnosis of infected mesh.Slowly and meticulously, the mesh was circumferentially resected, removing the spiral titanium tacks as each was encountered.Great care was taken during the adhesiolysis to avoid any bowel injury.The gore-tex mesh was removed in its entirety.The wound was then irrigated thoroughly.A #10 flat jackson-pratt drain was placed in the wound base.Fascial flaps were created in all directions using the bovie electrocautery.At that time, using an underlay technique of interrupted horizontal mattress, a segment of 6-inch x 8-inch collamend mesh was secured to the fascia circumferentially.¿ postoperative diagnoses are noted as ¿1.Infected prosthetic mesh.2.Incisional hernia.¿ operative findings state: ¿a 3-inch x 5-inch supraumbilical defect repaired (as above).¿ relevant medical information: on (b)(6) 2007: pathology: ¿final diagnosis: explanted infected abdominal mesh: synthetic mesh with metallic clips, 14.5 cm greatest dimension, gross identification only.¿ on (b)(6) 2007: ¿overall, she seems to be doing well in terms of her wound healing.¿ ¿the incision is healed nicely.There are three small punctate areas of ongoing granulation.¿ on (b)(6) 2007: ¿she secondarily developed a postoperative infection of her ventral hernia prosthesis and required explantation.She has recovered nicely from the follow-up operation with repair of her underlying hernia using a biologic prosthesis.¿ ¿there are two persistent areas of small opening which are being packed.¿ ¿given her symptoms of chills and intermittent episodes of low grade abdominal pain¿ ¿want proceed with an abdominopelvic ct scan.¿ on (b)(6) 2007: ct a/p: ¿lobulated enhancing mass intimately associated with the anterior abdominal wall likely representing an abscess.Unopacified bowel and partial herniation although unlikely could have a similar appearance.¿ on (b)(6) 2007: ct abdomen / pelvis: ct guided fluid collection drainage was performed: ¿1.Successful placement midline abdominal wall fluid collection as above using ct guidance.2.Fluid was yellow and serous in nature, sent for cultures and stains.No drain was placed.¿ on (b)(6) 2007: culture: ¿no anaerobic growth.¿ on (b)(6) 2007: ¿the aspirated seroma microbiology was negative.On examination, there is no erythema or drainage at the incision to suggest infection.There is no sign of recurrence of the hernia.There is appropriate tenderness.¿ on (b)(6) 2008: ¿she has what appears to be an abdominal wall abscess or impending enterocutaneous fistula with increasing swelling and warmth at the superior aspect of her old surgical scar.She will be admitted to the hospital.¿ ¿according to the patient, she was in her usual state of health until approximately 1 month ago where she began feeling weak and tired and developed some lower abdominal pain.¿ ¿according to the patient, her abdominal pain discomfort worsened over the last 48 hours and has been associated with some fever to 101.7 last night.¿ ¿abdomen is soft.There is tenderness in the epigastrium overlying an area of nodularity and warmth at the superior aspect of her prior midline scar.This extends approximately 5 cm in greatest diameter.It is seemingly fluctuant.There is mild blanching.There is tenderness elsewhere across the abdomen but no peritoneal signs.¿ ¿impression: abdominal wall abscess versus impending enterocutaneous fistula.¿ on (b)(6) 2008: ct a/p: ¿there is again noted patient¿s known biologic hernia repair material in the anterior abdominal wall that appears to have stable intervening fluid density.There has certainly been significant increase in the inflammatory changes and fat stranding in the subcutaneous fat adjacent to this, suggesting a cellulitis.Along the superior aspect of this, there is new focal extrusion of portion of this biologic hernia repair into the anterior abdominal wall subcutaneous fat.There is no evidence of recurrent hernia of any intra-abdominal content.¿ ¿mild wall thickening of the neoterminal ileum and some mesenteric enlarged lymph nodes consistent with the patient¿s history of crohn¿s disease but no fistula noted.¿ on (b)(6) 2008: ¿she was treated in the hospital for cellulitis of the abdominal wall.By her account, she is feeling much better.¿ ¿she is about to start some additional immunologic therapy for her crohn¿s disease.Active infection is obviously a contraindication to this, and we will proceed with sampling of the abdominal wall seroma to ensure that it is safe to begin this treatment.The presence of this erythema and fever may also be a reaction to the autolysis of the biologic mesh.¿ on (b)(6) 2008: ¿aspiration performed of hypoechoic structure in the midline.¿ on (b)(6) 2008: culture, collected on (b)(6) 2008: ¿no growth.¿ ¿no cells seen, no organisms seen.¿ on (b)(6) 2008: incision and drainage: ¿a longitudinal incision was created over the point of maximal fluctuance.Interestingly, there was no large fluid collection beneath the skin, only very edematous tissue.There was a small amount of complex material that was evacuated.My suspicion is that this represents autolysis of the underlying biologic mesh.The area was packed with half inch nugauze.¿ on (b)(6) 2008: culture report, on (b)(6) 2008: ¿result: no growth to date.¿ on (b)(6) 2008: ¿ an open wound related to seemingly autolysis of her biologic prosthesis.She has had some recent abdominal pain.¿ ¿there is an excellent bed of granulation tissue around the perimeter of the wound.The base of the wound is very soft and does not look markedly changed since her last visit.The 2 x 2 dressing which was removed from the incision had some neon green fluid present on it, likely consistent with pseudomonas colonization.I believe this is a suitable incision for a wound vac.¿ on (b)(6) 2008: ¿she has begun her immunologic therapy for her crohn¿s disease.Her incision and drainage site in the midline of her abdomen is healing.It does have a sinus tract deep and cephalad.It is several centimeters in depth.There is some skin irritation where the vac adhesive dressing lies.¿ ¿she had some other complaints or orthostasis and abdominal pain, presumably related to her crohn¿s disease and diarrhea.¿ on (b)(6) 2008: ¿an abdominal wound seemingly related to autolysis of biologic mesh.An incision and drainage was performed with evacuation of a fairly sizeable amount of complex liquid material.This was culture negative.¿ ¿there continues to be a deep sinus tract of approximately 2 to 3 cm that accommodates several inches of half inch nugauze packing.There are no cellulitic changes.She has had a couple episodes of presyncope.¿ on (b)(6) 2008: ct a/p: ¿there is no evidence of abscess.¿ on (b)(6) 2008: ¿the wound continues to drain yellow fluid.Her abdominal pain is unchanged and she is requesting more pain medicines.¿ on (b)(6) 2008: ¿impression: slowly dissolving abdominal wall biologic prosthesis.¿ on (b)(6) 2009: ¿apparently, her immunotherapy has been discontinued.By her account, the sinus tract is less productive of fluid but is still quite deep.There appears to be some increasing mucoid drainage present on the gauze strip.I believe she would be a good candidate to resume her antibacterial silver dressings and we will begin that.I am hopeful that the autolysis of the biologic mesh is complete.Certainly, this would allow for more complete healing of the area, which is only a centimeter or two in greatest diameter.¿ on (b)(6) 2009: ct a/p: ¿1.Resolved anterior abdominal fluid collection and mesh fluid collection.2.Abdominal wound containing probable packing material with no significant surrounding inflammatory changes.There is thickening around the abdominal wound cavity and thickening of the anterior abdominal wall below the hernia repair.3.Status post right hemicolectomy with right mesentery stranding and lymph notes that may be related to surgery.¿ on (b)(6) 2009: ¿we should, in my estimation, proceed with an excision of the sinus tract and possible removal of a stitch granuloma.¿ on (b)(6) 2009: excision of a stitch granuloma.¿approximate 3 to 4 cm sinus tract, continuing down to the level of the abdominal fascia.Sinus tract surrounded by hypergranulation tissue.¿ ¿the sinus tract was amputated at this level.The sinus tract continued down to the level of the fascia and just below it for another 0.25 cm.The hypergranulation tissue there was cauterized and the abdominal fascia was closed using 2-0 vicryl figure-of-eight sutures.¿ on (b)(6) 2009: pathology: ¿cicatricial scarring with inflamed granulation tissue and scattered multinucleate ¿foreign body¿ giant cells, consistent with retained suture.¿ on (b)(6) 2009: ¿some neon green drainage on the deep portion of the 2 x 2 consistent with a pseudomonas colonization.¿ on (b)(6) 2009: ¿she is seemingly making some progress with her local wound care.¿ ¿i suspect that this will heal over the course of the next several days.¿ on (b)(6) 2013: ¿has had multiple prior abdominal operations related to crohn¿s disease and an incisional hernia.She has had a mesh infection in the past treated with excision of mesh and placement of biologic prosthesis.She presents now with a recurrent incisional hernia.¿ conclusion: it should be noted that the gore® dualmesh® biomaterial instructions for use include 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: ¿when using this device as a permanent implant and exposure occurs, treat to avoid contamination, or device removal may be necessary.¿ the gore® dualmesh® biomaterial instructions for use further state, ¿strict aseptic techniques should be followed.If an infection develops, it should be treated aggressively.An unresolved infection may require removal of the material.¿ the gore® dualmesh® biomaterial instructions for use also states, ¿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 mesh.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.¿ 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.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.After multiple requests, product identification information was not provided for this device and thus it could not be confirmed to be a gore hernia device.Review of the manufacturing and sterilization records could not be performed as a valid lot number was not provided.In an abundance of caution for product surveillance tracking and trending purposes only, this event has been analyzed, coded and reported as necessary assuming it is a gore hernia device.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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