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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES GORE-TEX SOFT TISSUE PATCH MESH, SURGICAL, POLYMERIC

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W.L. GORE & ASSOCIATES GORE-TEX SOFT TISSUE PATCH MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number 1310015020
Device Problems Contamination (1120); Insufficient Information (3190); Patient Device Interaction Problem (4001)
Patient Problems Erosion (1750); Unspecified Infection (1930); Pain (1994); No Code Available (3191)
Event Date 09/23/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4). (b)(6). Additional details regarding the patient's clinical course were ascertained from a review of medical records and are as follows: medical records dated (b)(6) 2011 indicate patient has ¿urinary tract infection, citrobacter¿. Record states patient urinalysis showed ¿too numerous to count white cells, 4 to 5 red cells, and many bacteria¿. Medical records dated (b)(6) 2011 states: ¿urostomy bag @ lower r abd. Site in tact. Draining cloudy w/ strings straw urine. Next to urostomy site is a quarter & ½ sized wound. ¿ microbiology records dated (b)(6) 2011 indicates culture result of ¿nephrostomy urine¿ detects ¿enterococcus faecalis¿ and culture result of ¿urine¿ detects ¿citrobacter koseri (c. Diversus)¿. Microbiology record dated (b)(6) 2012 indicates culture result of ¿l urine from l nephroureterostomy & l kidney¿ detects ¿escherichia coli¿ and ¿citrobacter koseri (c. Diversus)¿. On (b)(6) 2012: (b)(6) health. (b)(6), md. Office note. Indwelling ureteral stent changed every 6 weeks. Incisional hernia has gotten bigger and bigger as time goes on and now is quite large, probably 10 cm at least in diameter, in the middle, is going to require mesh repair. Creates a problem because of potential contamination from ileal conduit. Will have to repair because it¿s causing a lot of pain and is getting larger rapidly. No sign of recurrent disease. Weight (b)(6), stable. Diabetes and blood pressure controlled. Has no allergies, takes lisinopril, metformin, aspirin. Has had back & bladder surgery. ¿this man will have to have a drain, and i have explained to him there is at least a 20% chance of infection because it will require mesh. ¿ history and physical records dated (b)(6) 2013 state the patient was seen for an enlarging ventral hernia with pain. ¿this man is a (b)(6) hispanic male with diabetes and hypertension who had a bladder cancer requiring a total cystectomy and ileal conduit in 2010. ¿ ¿he has a stenosis of one of his ureters at the anastomosis to the ileal conduit and has an indwelling stent, which is left in place and changed every six weeks. He had a ventral hernia that became apparent very quickly after he had his surgery, and it has become larger at times, now it has become difficult for this man to apply his appliance, and he is having pain in his midline wound. He has a large defect he describes. The patient has had no bowel obstruction and no previous abdominal surgery. ¿ operative records dated (b)(6) 2013 indicate the patient underwent repair of a nonincarcerated ventral hernia with mesh. Findings from the procedure state: ¿approximately a 5 x 3 inch defect in the ventral abdominal wall from prior laparotomy incision. A single piece of mesh was used as an underlay with the edges rolled over on top of the fascia. ¿ records detailing the prior laparotomy were not provided. The (b)(6) 2013 operative report states: ¿a #15 blade scalpel was then utilized to incise the skin and sharply dissect down through the old scar. The patient just had skin and subcutaneous tissue. The intestine was encountered and was inspected to ensure no damage had occurred. The skin incision was extended. Once opened the defect in the patient's anterior abdominal wall was approximately 5x4 inches. The patient's abdominal wall fascia had retracted laterally. So, bovie electrocautery was utilized to mobilize the fascia from the subcutaneous tissue. Adhesions below the fascia were taken down sharply with metzenbaum scissors. Some omental bleeding was controlled with a 2-0 silk ligature. Once all adhesions were free and the fascia had been mobilized, a piece of gore dual-sided mesh approximately 15 x 20 cm was placed into the abdomen. A single piece mesh was placed in combination underlay and overlay. The mesh was placed below the fascia with the external borders of the mesh wrapping around the fascial edge. ¿ the (b)(6) 2013 records continue: ¿allis clamps were utilized to grab the fascia and mesh in a single bite and then a stitch of 0 prolene was used in a horizontal mattress fashion taking a bite of mesh and fascia. This was done in serial fashion. Each horizontal mattress was 1 cm apart. Circumferentially, the mesh was tightened to ensure appropriate tightness in all directions. Before completely sewing in the mesh, the abdominal cavity was inspected to ensure that no loops of intestine had been caught up in the suture line. The funnel stitches were secured in place. Normal saline was used to irrigate the mesh and the subcutaneous tissues. A 20-french blake drain was placed anterior to the mesh below the skin and subcutaneous tissues. This was sutured in place with an 0 prolene. The subcutaneous tissues were reapproximated using a running stitch of 3-0 vicryl. The skin was closed with staples. ¿ the records confirm a gore dualmesh® biomaterial (1dlmc07/10485246) was implanted during the procedure. On (b)(6) 2013: progress record. Leaking ileal conduit by which saturated dressing. Dressing saturated w/ urine removed. Staples intact. Reapply urostomy bag, keep midline dry. On (b)(6) 2013: discharge summary. Final diagnoses: cystectomy and urinary conduit in 2010. Summary: this man had an enlarging, painful ventral hernia, directly in the midline just opposite his urostomy. No obstruction, just pain. Admitted, underwent a midline incision, dissection of a huge hernia sac and repair with a large piece of dualmesh. Because of the proximity to the urostomy, given levaquin preop and it was continued. The patient had a ureteral stent in place also through the urostomy, so we were not able to close it when we did the surgery. He had an uncomplicated repair. Warnings were given regarding constipation. On (b)(6) 2013: (b)(6) health. J. (b)(6), md. Office note. 3 weeks postop repair of large ventral hernia with a dual mesh. Large defect in the midline required dualmesh. My concern was infection because of chronic urinary instrumentation. Has an indwelling stent in conduit and ureteral anastomosis because of stricturing and has to be changed every few weeks. Was changed 2 weeks ago. So far, no sign of infection in area of incision. Drain was removed at 10 days postop and he did well. No leakage, swelling, redness or fever. Return in 3 months with no lifting until end of (b)(6). Wt (b)(6) [(b)(4)]. On (b)(6) 2013: (b)(6) health. (b)(6), md. Office note. We are concerned about infection, but this man never really turned a hair with his healing. No sign of infection. Has a well-incorporated solid graft with no hernia now. Ureteral stent so far, has not infected mesh with manipulation of urinary tract. Wt (b)(6). On (b)(6) 2013: (b)(6) health. (b)(6), md. Office note. Has parastomal hernia around ileal conduit and wants it repaired. It¿s large and does need to be repaired. Will have him get back with dr. (b)(6) and consult with doctor who did surgery in (b)(6) and see if he has someone who repairs these and does a lot of it. If not, i will repair after that has been determined [(b)(4)]. On (b)(6) 2013: (b)(6) health. (b)(6), md. Office note. Parastomal hernia is getting larger & causing pain now. It¿s twice the size of his stoma. Big ventral hernia from cystectomy was repaired with mesh and has remained well healed. He is very pleased with that. Will pursue repair through a lateral incision. May have to use mesh and the patient understands the risk of infection is my big concern. He understands that. Diabetes well controlled. Wt (b)(6). History and physical records dated (b)(6) 2013 state the patient was seen for an enlarging right parastomal hernia. ¿this is a (b)(6) gentleman who i cared for in the past with a large ventral hernia who had a cystectomy and ileal conduit done in 2010 in (b)(6). He¿had a stenosis of his left ureteral conduit anastomosis. He had a large ventral hernia that became apparent quickly after he had his surgery and has gotten larger with time until it had to be repaired. We did that with mesh and he did very well and did not have any more problems, but began to develop some signs of parastomal hernia several months ago and it has gotten larger progressively and now is causing pain. His conduit still works. He still has to have his stents changed every 5 weeks and he has been doing well. ¿ ¿he is a diabetic and takes januvia. ¿ ¿his defect is reducible. ¿ exam notes state: ¿he has a well-healed midline incision with no sign of recurrence of his hernia. He has a 4 cm parastomal hernia lateral to his stoma right lower quadrant of the abdomen. ¿ operative records dated (b)(6) 2013 state the patient underwent primary repair of a right side parastomal hernia. The records state: ¿¿the patient's stoma was exposed. A pursestring of prolene was placed around the stoma to keep it from leaking during the procedure, and his stent was sutured to the skin off to the left side of the stoma. The patient had a betadine prep, drape, and t-shaped incision was made circumstoma laterally, and then extended laterally for about 3 inches. It was carried down through the skin and subcutaneous tissue. The hernia sac was exposed, was opened, and the hernia sac was excised from the lateral side of the ileal conduit. Once we had removed the hernia sac, we placed a stitch in the lateral aspect of the fascial defect and elevated it, and then using progressive medially marching sutures from lateral to medial we closed the defect of the hernia with prolene 0. I placed a 14 mm hegar dilator into the stoma and placed the last stitch to accommodate that size stoma and no larger. These were all tied, irrigated, cut, and the wound was then closed my running the subcutaneous tissue and the initial circumstomal incision first, and then the lateral incision was closed with subcu. The wound was then closed with a subcuticular of 3-0 vicryl in a similar fashion. ¿ on (b)(6) 2013: pathology. Specimen received: ventral parastomal hernia repair. Clinical diagnosis: parastomal ventral hernia. Final pathological diagnosis: fibroadipose tissue, designated from ventral parastomal hernia, excision. Fibrotic and chronically inflamed hernia sac. Gross specimen: the specimen is received labeled ventral parastomal hernia sac and consists of three red-tan to gray fragments of soft tissue and fibroadipose tissue measuring 3 x 3 1 cm in aggregate. These are serially sectioned to reveal a yellowish homogenous cut surface. Sections are submitted in a single cassette. Microscopic: sections contain mesothelial-lined fibroadipose tissue with areas of dense fibrosis and foci of mid chronic inflammation. On (b)(6) 2013: discharge summary. This patient was admitted through day surgery for intervention for a parastomal hernia. The hernia repair was successfully performed, and the patient is dismissed from day surgery in good condition with follow up appointments and medications. On (b)(6) 2013: (b)(6) health. (b)(6), md. Office note. Has done great, wound is healed. Having no problems & pleased with surgical procedure. Wt (b)(6). On (b)(6) 2014: (b)(6) health. (b)(6), md. Office note. Parastomal hernia has recurred. This is going to be very complex and difficult to repair. He is having stents changed next week. Told him to wait a week after stents & let us know if he got any fever or other problems. It¿s going to require lateral abdominal incision, looking in the abdomen, and then repair with mesh from the inside. This is very complex and difficult. He understands complexity of this problem. Wt (b)(6). On (b)(6) 2014: operative report. Pre/postop diagnosis: recurrent parastomal hernia. Procedure: repair of recurrent parastomal hernia with mesh. Complications: none. Findings: a 4 x 6 cm fascial defect lateral to the stoma. The hernia was repaired primarily with gore-texas [sic] mesh onlay. Statement of medical necessity: ¿history of bladder cancer who was treated with a bladder resection and urinary reconstruction with an ileal conduit. He developed a midline ventral hernia in the past that was repaired with a large piece of mesh. The patient also developed a parastomal hernia which was repaired primarily in the past. He presented to the clinic with a recurrence of his parastomal hernia. The risks, benefits, and alternatives to repair of this recurrent parastomal hernia were thoroughly discussed with the patient. He elected to proceed. Description of procedure: the patient was brought to the operating room and placed supine. All pressure points were padded. General endotracheal anesthesia was administered, and preoperative antibiotics were given. The patient¿s abdomen including the stoma was prepped and draped sterilely. A time-out was performed. We started by creating a 10 cm transverse incision beginning at the lateral aspect of the stoma and extending laterally. The incision was also extended around the stoma superiorly and inferiorly. We carried the incision through the subcutaneous tissues using electrocautery. We dissected a rather large hernia sac. We entered the hernia sac and reduced a portion of colon and omentum. The hernia sac was excised at the level of the fascia. This revealed a 6 x 4 cm horizontally oriented elliptical fascial defect. We proceeded to close the fascia horizontally with interrupted 0 prolene figure-of-eight sutures. We then mobilized the tissue around the stoma conduit. This allowed us enough room to tuck mesh tails around the stoma. A segment of 2 mm in thickness gore-tex mesh was cut to fit the repaired fascia. The tails of the mesh were looped superiorly and inferiorly to the mesh which lied just lateral to the stoma. The mesh was secured in an onlay fashion to the anterior aspect just superficial to the fascia with interrupted 0 prolene suture. The mesh sat well at the completion of that maneuver. A 15-french jp drain was draped over the mesh and brought out superior to the incision. Scarpa¿s layer was closed with a running 3-0 vicryl suture. We achieved adequate hemostasis. We injected the skin and subcutaneous tissues with 10 ml of 0. 25% marcaine. The skin was closed with a running 2-0 nylon suture. The drain was sutured in place using a single 0 prolene suture. A new stoma appliance was applied to the wound. The patient was awoken in the operating room and taken to the post anesthesia care unit in good condition. ¿ the records confirm a gore-tex® soft-tissue patch (1310015020/7273905) was implanted during the procedure. On (b)(6) 2014: pathology. Specimen received: parastomal hernia. Clinical diagnosis: recurrent parastomal hernia. Final pathological diagnosis: fibroadipose tissue labeled parastomal hernia, excision. Tissue from hernia repair. Chronic inflammation. Gross specimen: the specimen is received labeled parastomal hernia and consists of purple to yellow soft tissue that appears to be fibroadipose tissue partially covered by membranous-type soft tissue. Sections are submitted in a single cassette. Microscopic: sections contain fibroadipose tissue with a mesothelial lining. Chronic inflammation is present. No other abnormalities are noted. On (b)(6) 2014: daily focus assessment report. Provider aware of leaking stoma. Per physician, stoma nurse needs to be consulted. 10:42: abd. Dressing saturated with urine from urostomy. Wound care nurse called earlier for dressing change. 16:51: eakins used as filler around sutured incision. On (b)(6) 2014: discharge summary. Admission/postop diagnoses: recurrent parastomal ventral hernia. Summary: developed a recurrence and had an enlarging ventral hernia lateral to this area. It was quite large, probably 6 cm in size. We repaired this on (b)(6) 2014, through a lateral approach with stomal revision. We had to mobilize the intra-sac adhesions, which included the cecum, as well as the small bowel and the ileal conduit itself. We repaired it with prolene suture and reinforced it with a u-shaped piece of gor-tex mesh 2 mm thickness, patch mesh and prolene sutures. Drained the subcutaneous area, closed the subcutaneous skin and restored the stoma. Kept overnight, because of the magnitude of his operation for pain control, but by the morning was comfortable, not taking any narcotics and was dismissed home in the care of his family. The stoma nurse will see him today for application of a new appliance to try to prevent leak, because of the ___ [sic] in place. Follow-up in the office 12 to 13 days for suture removal. On (b)(6) 2014: (b)(6) health. (b)(6), md. Office note. Lateral part of stoma necrosed. Sutures removed today, debrided. Seems to be draining well to be outside. Medial 2/3 of stoma is viable, will probably heal by itself. My concern is it will get an infection around the gore-tex mesh that he got in that area and it will have to come out and we will have a worsening problem. It could not be approached from midline because of previous surgery and a piece of mesh for a big midline hernia he had last year. Wt (b)(6). On (b)(6) 2014: (b)(6) health. (b)(6), md. Office note. Necrosis of stoma healing nicely. No obvious pus, no fever, no pain. Will have ureteral stent changed today over a wire. It looks like we are going to get this thing healed without a major complication. I am still concerned about potential for infection around gore-tex mesh that he has lying on top of the repair. Wt (b)(6). On (b)(6) 2014: (b)(6) health. (b)(6), md. Office note. Necrosis of bowel conduit healed up. Stent still in place. Draining well and having well-controlled drainage into bag. Should be no problem getting well now. On (b)(6) 2014: history & physical. Hpi: presented to er after having shaking chills during the day, fever, multiple episodes of vomiting as well as weakness. On (b)(6), the patient underwent a successful ureterostomy tube change. Symptoms started yesterday prior to presenting to the emergency department at which time it was noted that the patient had a fever of 102. 6, heart rate of 109. Urinalysis in the ed showed large blood, positive nitrites, large leukocytes and many white blood cells. He was given a dose of levaquin in the ed. This morning, the patient states he is feeling better and is hungry. He has been on a clear liquid diet and is requesting regular food. Exam: does not appear toxic, just weak. T-max was recorded at 103 at midnight. Abdomen: soft, nontender, nondistended, with normoactive bowel sounds. Some blood in his urostomy bag. Foley is in place. Diagnostic studies: initial blood cultures gram-negative rods in 2 tubes. White blood cell count is 14. 6 with 15% bands. White blood cell count yesterday 12. 8. Impression: urinary tract infection. Sepsis secondary to #1. Acute kidney injury on chronic renal failure. On (b)(6) 2014: microbiology. Blood culture. Gram negative rod. Isolate (final) escherichia coli. On (b)(6) 2014: microbiology. Urine culture. Culture result (final) 10,000-50,000 cfu/ mi mixed gram negative rod. Isolate (final): proteus mirabilis, escherichia coli. On (b)(6) 2014: loopogram. Reason for exam: right renal damage. Impression: findings worrisome for a fistula between the ileal conduit in the sigmoid colon. On (b)(6) 2014: loopogram. Reason for exam: urinary tract infection, renal failure. Impression: the right upper collecting system and ureter are patent and communicate with the ileal conduit without obstruction. Fistula between the ileal conduit and the sigmoid colon. On (b)(6) 2014: ct abdomen/ pelvis w/o contrast. Reason for exam: renal failure, urinary tract infection. Impression: fistula with communication between the ileal conduit and sigmoid colon possibly through a diverticulum. On (b)(6) 2014: colon barium enema. Reason for exam: fistula. Impression: fistula from the sigmoid colon to the ileal conduit could not be demonstrated from this direction. On (b)(6) 2014: discharge summary. Hospital course: stable throughout hospital stay. Urine culture revealed proteus and escherichia coli. Found to have a fistula from his ileal conduit to his colon. It was felt that general surgery consultation would be needed in the future to consider repair of that, although that was going to be a large surgery. He feels good, is afebrile, wants to go home. Discharge diagnoses: sepsis secondary to urinary tract infection. Urinary tract infection with escherichia coli and proteus grown out of cultures. Acute kidney injury superimposed on chronic renal insufficiency. Fistula from the ileal conduit to the colon. Discharge medications: keflex 500 mg daily for now. On (b)(6) 2014: (b)(6) health. (b)(6), md. Office note. 4 ½ months postop repair of recurrent parastomal hernia with a piece of goretex mesh. Had infection which started in this area 2 weeks ago. Was seen and evaluated by dr. (b)(6), placed on antibiotics, and then came back to see her late last week with an area of extrusion or infection, she probed, cleaned and referred him back here. He has extruded his goretex mesh. Today, under topical anesthesia, i excised the mesh completely, incising the sutures in a circumferential area, and removed the entire piece of mesh from the area. I debrided all of the chronic inflammatory tissue, packed the wound, and we will start home nurse dressing changes and pack it and change it every day. He¿s going to have recurrent hernia and i think the only option would be to have the conduit redone, probably in (b)(6), where he had his original cystectomy and ileoconduit. Had a leak between ileoconduit and sigmoid colon on x-ray, but because of lack of infection and need for catheter stent, it was felt to leave it in place. On (b)(6) 2014: (b)(6) health. (b)(6), md. Office note. Defect is about 3 cm x 3 cm, flat-based, clean and doing well now. It should heal over without problems. Recommend dr. (b)(6) refer him back to (b)(6) to fix complex parastomal hernia. It could be repaired from the inside once it has healed through a right upper quadrant incision and approach from that direction. Wt (b)(6). On (b)(6) 2014: (b)(6) health. (b)(6), md. Office note. Wound is clean and almost completely closed. On (b)(6) 2015: (b)(6) health. (b)(6), md. Office note. Wound closed by itself. Loop of small bowel which is part of the ileal conduit was up against the skin, eroded through skin, developed a leak seen by urologist. Had left ureteral tube changed recently put through new pseudostoma into the conduit. Basically has a stoma medial to this open area. His concern is little prolapse of mucosa there. It is prolapsing mucosa. Along with the conduit it does internally intussuscept and come out. He should have no problem with this. Looks like a double barrel stoma. Told him repairing will be somewhat difficult because it¿s inside the intestine not at the end that is causing this area. To resect the other and do an end stoma could be done but would be with some obvious chance of injury to bowel below or to conduit which would be even worse. With lack of conduit he would have to have urostomy tubes which i think he would like to have. Right now this only herniates about 1. 5 cm above the skin and is functioning quite well. I would leave it alone. See him back in 2 months and if this is starting to do something bad like intussusception i would not want to repair this if at all possible. On (b)(6) 2015: (b)(6) health. (b)(6), md. Office note. No worse than 2 months ago. Not causing pain. Repair would be somewhat arduous. Can be done, would shorten ileal loop. Wt (b)(6). No sign of recurrence of hernia. Recommend observation. On (b)(6) 2016: wound care clinic progress note. Hpi: patient comes in now with a 1-1/2 inch opening on the medial side of urostomy with extruding mesh. Approximately 1 inch x ¾ inch of this was excised. The rest of it was still fairly deep within the abdominal wall and therefore i felt that dr. (b)(6) should evaluate this for removal. Diagnosis: infected abdominal wall hernia mesh. On (b)(6) 2016: missing operative report from abdominal wall mesh excision. Pathology. Procedure: abdominal wall mesh excision. Specimen received: abdominal wall mesh. Clinical diagnosis: abdominal wall mesh. Final pathological diagnosis: abdominal wall mesh. Gross specimen: the specimen is labeled abdominal wall mesh and consists of a membranous portion of stiff material which measures 2. 9 x 1. 89 cm with a thickness of 0. 1 cm. It has minimal portions of what appear to be blood clots. There is no gross evidence of exudate. No sections are submitted. On (b)(6) 2016: emergency record. Hpi: abdominal pain. This is a chronic problem at site of his urostomy where there is a small ulceration. Exam: abdomen: soft and nontender. Small ulceration noted to lateral aspect of urostomy. No active bleeding or infection noted. Disposition: discharged. On (b)(6) 2016: (b)(6) health. (b)(6), md. Office note. Seen by dr. (b)(6) about a month ago and had some piece of mesh removed in his office. He was worried about a little bleeding. I saw him months ago and thought he might well need revision of his loop at that point in time. Surgery was done elsewhere. Creatinine clearance is dropping. Has to have a stent placed in 1 of the ureters because of stenosis at end of the loop. This is being changed. He is doing well otherwise and was concerned about the need for having the mesh removed. I think this gentleman needs to have his loop revised. Send him back to original surgical intervention site to have uro-loop revised. They can repair inside of abdominal wall hernia area at that time. No mesh extruding now. Wt (b)(6). On (b)(6) 2016: radiology report. Exam: exchange of left nephron-ureterostomy catheter. Examination was not performed. Patient has a peristomal hernia with associated infection. Due to the active inflammatory changes at the ileal conduit stoma with inflammatory fluid present at this site, the catheter exchange was not performed. Patient was presently not on antibiotic therapy. Patient was given prescription for cipro 500 mg p. O. B. I. D. X 10 days. On (b)(6) 2016: microbiology. Blood culture. Source: blood, peripheral blood draw. Culture blood aerobic: final (b)(6) 2016 no growth. Culture blood anaerobic: final (b)(6) 2016 no growth. Hospital admission records dated (b)(6) 2016 state: ¿this is a (b)(6) male who presents for evaluation of recurrent parastomal hernia. The patient originally had cystectomy in 2011 with ileal conduit, had 2 times parastomal hernia repairs at san angelo, had recurrent parastomal hernia which has been getting worse since (b)(6). Endorses nausea, vomiting, intermittent fever, endorses purulent drainage from the stoma site. Also complains of burning pain, 8/10 at its peak around the stoma site. Pain aggravated by pressure and alleviated by nothing. Symptoms have been getting worse since (b)(6). ¿ ¿per urology note, also now with ileal conduit stoma stenosis and left ureteral stricture. He was seen¿this afternoon and it was deemed necessary to admit this patient for iv antibiotics and fluid resuscitation. ¿ ¿¿status post cystectomy and ileal conduit, multiple parastomal hernia repair's with mesh, now parastomal hernia mesh infection and open wound. We are consulted by urology for repair of parastomal hernia. It appears the patient has severe mesh infection. He will need explantation of the mesh during his revision of his ileal conduit. ¿ records detailing a parastomal mesh implantation, including identity, and subsequent parastomal hernia mesh infection as stated in medical records dated (b)(6) 2016 were not provided.
 
Event Description
It was reported to gore that the patient underwent open ventral hernia repair on (b)(6) 2013 whereby a gore dualmesh® biomaterial was implanted. The complaint alleges that on (b)(6) 2016, an additional procedure was performed whereby explant of the gore device was performed. It was reported the patient alleges the following injuries: abdominal pain, infected mesh, revision surgery, and loss of consortium. Additional event specific information was not provided.
 
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Brand NameGORE-TEX SOFT TISSUE PATCH
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
W.L. GORE & ASSOCIATES
flagstaff AZ
Manufacturer (Section G)
MPD APC B/P
p.o. box 1408
elkton MD 21922 1408
Manufacturer Contact
kathy titus
1500 n. 4th street
flagstaff, AZ 
9285263030
MDR Report Key8665921
MDR Text Key146917044
Report Number3003910212-2019-00159
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K963619
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 10/22/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/04/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date11/17/2014
Device Model Number1310015020
Device Catalogue Number1310015020
Device Lot Number7273905
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/18/2009
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 06/04/2019 Patient Sequence Number: 1
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