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U.S. Department of Health and Human Services

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

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W. L. GORE & ASSOCIATES, INC. GORE-TEX® SOFT TISSUE PATCH MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number 1415020010
Device Problem Insufficient Information (3190)
Patient Problems Erosion (1750); Inflammation (1932)
Event Date 05/30/2014
Event Type  Injury  
Manufacturer Narrative
Additional details regarding the patient's clinical course were ascertained from a review of medical records and are as follows: relevant medical information: (b)(6) 2007: (b)(6) medical offices. (b)(6), md. Office notes. Presented for follow up hypertension. Has lost 15 pounds and change diet; some exercise. (b)(6) 2007: (b)(6). (b)(6) md. Radiology- ct urogram. Indication: hematuria. Impression: approximately 1. 5 x 3. 3 cm irregular mass arising from the left posterolateral wall of the urinary bladder, highly suggestive of a neoplasm lesion. Recommended urology evaluation. A low density, most likely benign lesion in the right adrenal gland, measuring 1. 4 x 1. 9 cm as described above. (b)(6) 2007: [facility not indicated]. (b)(6) md. Office notes. Consultation; (b)(6) male with gross hematuria 3 hours ago. No prior work-up, ct urogram has been ordered. Weight (b)(6) pounds, bmi 30. 13. Medications include aspirin 81 mg. Exam: abdomen soft, nontender, nondistended. Impression: gross hematuria. Plan: cystoscopy. (b)(6) 2007: (b)(6). (b)(6) md. History and physical. (b)(6) male with gross hematuria on cystoscopy was found to have a 3-cm left posterolateral tumor who presented for a transurethral resection of the bladder tumor, possible bladder biopsies and possible left ureteral stent placement. Risks and benefits of the procedure including infection, bleeding, risk of injury to the bladder have been discussed with the patient and the patient¿s wife they agree to proceed with the procedure. Surgical history of umbilical hernia repair, vasectomy. Current medications include baby aspirin, which he will hold as of today. 25 year use of half pack per day. (b)(6) 2007: (b)(6). (b)(6), md. Procedure report. Preoperative diagnosis: hematuria. Postoperative diagnosis: same. Procedure: cystoscopy. Surgeon: s. Justin lee, md. Anesthesia: local, 2% lidocaine jelly. Findings: post void residual by visual inspection: moderate. Anterior urethra: normal, no strictures. Prostatic urethra: 2. 5 cm; obstructive. 3 cm bladder tumor just posterolateral to left [illegible] with necrotic area on surface. No stone, or foreign body. Trabeculation: 2+. (b)(6) 2007: (b)(6). (b)(6), md. Operative report. Preoperative diagnosis: bladder tumor. Postoperative diagnosis: bladder tumor. Operation performed: transurethral resection of bladder tumor and bladder biopsy. Surgeon: s. Justin lee, md. Anesthesia: general. Findings: 1. A 3 cm bladder tumor, somewhat sessile, wide-based in appearance with a necrotic tip just posterior to the left ureteral orifice. 2. A 1 cm bladder tumor at the left lateral wall, papillary. 3. No other evidence of bladder tumor, no evidence of erythema. Specimens: bladder tumor, bladder tumor base, left lateral wall tumor, posterior wall, right lateral wall. Drains: 20-french foley catheter. Estimated blood loss: minimal. (b)(6) 2007: (b)(6). (b)(6) md. Pathology. Final diagnosis: a. Bladder, biopsy: invasive urothelial carcinoma, high grade, with squamous differentiation. B. Bladder, base, biopsy: invasive urothelial cell carcinoma, high grade, with squamous differentiation infiltrating apparent muscle. C. Bladder, wall, posterior, lateral, left biopsy: poorly oriented fragment of bladder mucosa showing urothelial carcinoma with involvement of lamina propria. D. Bladder, wall, posterior, biopsy: fragments of bladder mucosa showing reactive atypia. No dysplasia is identified. E. Bladder, wall, lateral, right biopsy: fragment of bladder mucosa showing urothelial atypia. No dysplasia is identified. (b)(6) 2007: (b)(6) medical offices. Nurse notes- chemotherapy notes. Cycle 1, day 1. Treatment: cisplatin/gemzar. No complications. Weight stable. (b)(6) 2007: (b)(6) medical offices. Nurse notes- chemotherapy notes. Cycle 1, day 8. Treatment: compazine and gemcitabine. No complications. Weight stable. (b)(6) 2007: (b)(6) medical offices. Nurse notes- chemotherapy notes. Cycle 2, day 1. Treatment: chemo. No complications. Weight stable. (b)(6) 2007: (b)(6) medical offices. (b)(6), pa. Office notes. Weight (b)(6) pounds, 4. 8 ounces. Patient is to have neo adjunctive chemotherapy for three cycles prior to surgery. Follow up with urology after chemotherapy is complete for cystectomy. (b)(6) 2007: (b)(6) medical offices. Nurse notes- chemotherapy notes. Cycle 2, day 8. Treatment: gemcitabine and compazine. No complications. Weight stable. (b)(6) 2007: (b)(6) medical offices. Nurse notes- chemotherapy notes. Cycle 3, day 1. Treatment: hydration, cisplatin and gemzar. No complications. Weight stable. (b)(6) 2007: (b)(6) medical offices. Nurse notes- chemotherapy notes. Cycle 3, day 8. Treatment: chemo. No complications. Weight stable. (b)(6) 2008: (b)(6) medical offices. (b)(6), md. Office notes. Preoperative for laparoscopic, possible open, cystoprostatectomy, bilateral pelvic lymph node dissection, ileus conduit. Risks and benefits of the surgery including anesthesia risk of myocardial infarction, stroke, possible even death have been discussed with the patient. Risks of infection bleeding, transfusion, bowel obstruction, ureteral-ileal anastomotic stricture discussed. Exam: abdomen soft, nontender, nondistended. (b)(6) 2008: (b)(6) offices. (b)(6), md. Office notes. Oncology follow up. Doing fine without persistent hematuria and has been evaluated by dr. Lee again for cystectomy and he was here to discuss other options. Weight (b)(6)pounds,(b)(6) ounces. Exam: bowel sounds are normal. Soft, no tenderness. Plan: ct chest, abdomen and pelvis with contrast. (b)(6) 2008: (b)(6) offices. (b)(6), md. Radiology- ct chest, abdomen, pelvis with contrast. Comparison: ct urogram 1/3/08. Impression: mild lingular scarring or atelectasis. The chest study is otherwise unremarkable. Interval cystectomy with creation of right lower quadrant ostomy. There has been development of lobulated fluid collection in right lateral aspect of pelvis as detailed above. This measures 15 cm craniocaudal x 6. 0 cm ap x 5. 3 cm transverse and likely represents either post-operative lymphocele or seroma. This does not have enhancing wall or associated stranding to suggest abscess. Recommend clinical correlation. Stable benign appearing fatty density lesion in right adrenal, likely representing myelolipoma. Stable right renal cyst and bilateral subcentimeter renal low density lesions which are too small to be characterized but likely also represent cyst. Atherosclerotic calcifications. (b)(6) 2008: (b)(6) medical offices. (b)(6), md. Office notes. Ne hematuria, flank pain fever or chills. Denies weakness, weight loss or gain and night sweats. Exam: abdominal soft, nontender, nondistended. Stoma pink, healthy. Left side tender but no induration, no swelling no mass. Abdominal ultrasound reveals decrease size of fluid collection, likely seroma. Option of percutaneous drainage versus observation discussed with patient. Risks, benefits, alternatives of treatment discussed. Patient wishes to observe. Plan: ct urogram in 6 months. (b)(6) 2009: (b)(6) medical offices. (b)(6), md. Office notes. Weight (b)(6) pounds. Presents for follow up on blood pressure. Has been gaining weight and not exercising. (b)(6) 2009: (b)(6) medial offices. (b)(6), md. Radiology- ct urogram. Impression: no evidence of metastatic disease to the abdomen or pelvis. Post-surgical changes with right lower quadrant ostomy with reimplanted ureters. The distal aspect of left ureter is not fully visualized, likely due to techniques. There is likely a small peristomal hernia, containing fat. Small umbilical hernia containing fat. Fluid collection within right aspect of the pelvic as seen in previously but has significant decreased in size since the previous study. Low density lesion within right adrenal gland as seen previously, likely representing adenoma. Fatty infiltration of the liver. (b)(6) 2010: (b)(6) medical offices. (b)(6), md. Radiology- ct chest, abdomen, pelvis with contrast. Comparison: ct of (b)(6) 2008. Indication: rule out metastasis within 2 weeks. Impression: there is no focal hepatic lesion. There is evidence of right adrenal nodule containing fat measuring 1. 7 x 1. 5 cm consistent with an adrenal myelolipoma. There is evidence of cortical cysts within the right kidney. Status post cystectomy and right lower quadrant ostomy. There is no adenopathy within the chest, abdomen, or pelvis. Evidence degenerative changes of the spine. (b)(6) 2010: (b)(6) medical offices. (b)(6), md. Office notes. Has been doing well overall but has a palpable bulge to right of the stoma. Also reports erectile dysfunction. Ct reviewed from 2/10 showed parastomal hernia of bowel. Weight (b)(6)pounds. Exam: abdomen soft, nontender, nondistended. Right parastomal hernia reducible. Impression: postoperative incisional hernia. Plan: options regarding parastomal hernia discussed. Signs of incarcerated hernia reviewed with patient and wife. General surgery for possible joint venture if he wants surgical repair. (b)(6) 2010: kaiser permanente- lakeview medical offices. Henry honchun fang, md. Office notes. Presents with parastomal hernia, noted some discomfort and bulge. No obstructive symptoms. Weight (b)(6) pounds, bmi 31. 57. Exam: abdomen soft, nontender, nondistended, no masses or organomegaly. Urinostomy noted, bulge noted laterally, no pain. Impression: parastomal hernia. Plan: the usual risks, benefits and alternatives of surgery were discussed. Patient undecided about surgery, contact number given to patient for more questions of if decides to have surgery. (b)(6)2011: (b)(6) medical offices. (b)(6), md. Radiology- ct chest, abdomen, pelvis with contrast. Indication: rule out metastasis within 3 weeks. Comparison: ct (b)(6) 2010. Findings: small periumbilical abdominal hernia is again noted with only fat herniating out. No bowel obstruction. Impression: no evidence of metastasis. Interval increase in size of a benign left renal cyst as described above. Otherwise, no significant interval changes since (b)(6) 2010. (b)(6) 2011: (b)(6) medical center. (b)(6). Phone call. Contacted (b)(6) in order to schedule procedure parastomal hernia repair laparoscopic, umbilical hernia repair with (b)(6), md. He agreed to surgery on (b)(6) 2011 with pre-operative appointment scheduled on (b)(6) 2011. A confirmation letter has been sent. (b)(6) 2011: (b)(6) medical office. (b)(6), md. Office notes. Presents with parastomal hernia, noted some discomfort and bulge. No obstructive symptoms. Weight (b)(6) pounds. Exam: abdomen soft, nontender, nondistended, no mass or organomegaly. Urinostomy noted, bulge noted laterally, no pain. Plan: consented for surgery. (b)(6) 2011: (b)(6) medical center. (b)(6), md. History and physical. Presents with parastomal hernia, noted some discomfort and bulge. Weight (b)(6) pounds. Exam: abdomen soft, non-tender, non-distended, no masses or organomegaly, urinostomy notes, bulge noted laterally, no pain. Impression/plan: parastomal hernia. Usual risks, benefits and alternative of surgery were discussed. Consented for surgery. (b)(6) 2011: (b)(6) medical center. (b)(6), crna. Anesthesia record. Asa ii. (b)(6) 2011: (b)(6) medical center. (b)(6), md. Operative report. Surgeons: (b)(6), dr. (b)(6), dr. (b)(6); assistant dr. (b)(6). Preoperative diagnosis: parastomal hernia and abdominal ventral hernia. Postoperative diagnosis: same as above. Operation performed: laparoscopic parastomal hernia and abdominal ventral hernia repair. Anesthesia: general endotracheal. Estimated blood loss: 50cc. Specimens: none. Indications: this is a (b)(6) male h/o of bladder cancer, and creating or urostomy. Now found to have parastomal hernia, causing bulge and occasional discomfort, also with ventral hernia. Complications: none. Findings: parastomal hernia/defect and 3cm ventral hernia defect. Detail of operation: ¿after consent was obtained, the patient was taken to the operating room where he was induced under satisfactory general anesthesia. Antibiotics were provided, abdomen was prepped and draped in the usual sterile fashion; and a foley catheter was placed into the urostomy. Gauze was placed over along with tegaderm. An ioban dressing was placed afterwards over the abdomen. A left mid abdominal incision was made, and using hassan technique, was able to get intraabdominally and insufflation started. Scope was then placed and there was no evidence if intra-abdominal injury. 5mm trocars were placed in the upper and lower left quadrant with visualization from scope. Midline adhesions were taken down from the ventral hernia. The hernia defect was visualized around the urostomy, and was already reduced. Using a 12x6cm mesh, sutures were placed on the mesh. The mesh was marked, rolled up and inserted into the abdominal cavity. The rough side of the mesh was placed against the abdominal wall and the smooth side against the intestines and omentum. The sutures were delivered through the abdominal wall via separate stab incisions. The mesh was placed and fitted around the stoma. The mesh was tacked to the abdominal wall using approximately 12 tacks. The sutures were then tied. The repair looked good and extended at least 4 cm beyond the edge of the hernia defect all the way around. Of note, there was minor bleeding that required suturing to allow for hemostasis, but there was evidence of good hemostasis afterwards. We then did the same procedure for the ventral defect more midline. Using about a 9x6cm mesh, mesh was marked, rolled up and inserted into the abdominal cavity. The rough side of the mesh was placed against the abdominal wall and the smooth side against the intestines and omentum. The sutures were delivered through the abdominal wall via separate stab incisions. Tacks were placed to secure the mesh to the abdominal wall. The ports were removed and the fascia was closed. Vicryl sutures used to re-approximate the fascia of the hassan port. Subcuticular sutures and steri-strips were applied. The sponge and needle counts were reported as correct. Patient was extubated in the or, and returned to baseline mental and physical function. ¿ (b)(6) 2011: (b)(6) medical. Implant log. Implants: mesh surgical parietex od4. 8 in ventral hernia composite 3d weave round polyester; mesh surgical parietex od3. 6 in ventral hernia round resorbable 3d weaver sterile polyester. (b)(6) 2011: (b)(6) medical center. (b)(6), md. Discharge summary. Date of admission: (b)(6) 2011. Discharge diagnosis: parastomal and ventral hernia. Hospital course: there was no intraoperative complications. Patient¿s course went well. Tolerated diet, ambulated. Pain controlled. Condition on discharge: good/stable. Disposition: home. Discharge medications: norco/colace as prescribed. Follow up: dr. (b)(6) clinic in 1-2 weeks. Activities: ambulate, no lifting heavier than 10 pounds for 4 weeks. Showering okay. Light exercise okay. Allow steri-strips to fall off by themselves. (b)(6) 2011: kaiser permanente-lakeview medical. Phone call. Spoke with patient, states having small area of rash and blister noted at stoma appliance area. States getting better, denies any signs of infection. Advised to keep area clean and dry, and watch for any worsening symptoms. Patient offered to come here today for check, but patient will follow up if getting worse over the weekend. Advised urgent care if needed. Patient also has follow up next week with (b)(6) pa. (b)(6) 2011: (b)(6) medical. (b)(6) pa. Office notes. Weight (b)(6)pounds. Doing well, moving bowels without problems, afebrile, residual tenderness only. Abdomen soft, non-tender, incisions healing without infection, bowel sound present, repairs intact. Patent urostomy. May increase activity level gradually. Return to clinic as needed. (b)(6) 2011: (b)(6) medical. (b)(6), md. Office notes. Doing well since surgery. Stoma pink, drains well. Ct scan on 3/11 negative. (b)(6) 2012: (b)(6) medical office. (b)(6), md. Office notes. No complaints today; chronic mild macrocytic anemia. Exam: abdomen soft, bowel sounds are normal. No tenderness. Impression/plan: stable ct in 6/12. Ct chest abdomen and pelvis with contrast. (b)(6) 2012: (b)(6) medical. (b)(6), md. Radiology- ct chest/abdomen/pelvis with contrast. Indication: within 3 weeks to rule out metastasis if after hours, there need to be md to md contact for scheduling. Comparison: (b)(6) 2011 ct chest abdomen and pelvis. Impression: overall, stable ct chest, abdomen and pelvis since (b)(6) 2011. No evidence of intrathoracic lymphadenopathy. Status post cystectomy and right lower quadrant ostomy, unchanged. No significant change in prominent in numbers bilateral inguinal lymph nodes. Mild enlarged left anterior pelvic sidewall lymph node is unchanged from the prior exam, 15 x 19 mm. Stable right adrenal adenoma. Status post anterior abdominal wall hernia repair. Decrease in size of a fat only small periumbilical hernia. (b)(6) 2012: (b)(6) kraemer med office. (b)(6), md. Office notes. On exam there is a reducible parastomal hernia just to the right of the stoma. Stoma is pink. Plan: doing well. Warned patient of risks of parastomal hernia and discussed signs of incarcerated hernia. I asked patient to make another appointment with dr. (b)(6) regarding the parastomal hernia. (b)(6) 2012: (b)(6) medical offices. (b)(6), do. Office notes. Presents with right abdominal discomfort x2 months. States abdominal pain off and off x 2 month. Sitting in recliner seems to exacerbate pain. Pushing on stomach can help alleviate pain. Pain is a tenderness, non-radiating in the right middle quadrant of his abdomen. No present pain now. Exercises 30 minutes 5 days per week at a moderate or strenuous level. Weight (b)(6)pounds, bmi 28. 84. Exam: abdomen soft, bowel sounds are normal. He exhibits no mass. There is no tenderness. No rebound and no guarding. Impression/plan: suspect pain due to abdominal hernia although no hernia was appreciated on exam. Abdominal ultrasound. (b)(6) 2013: (b)(6) medical. (b)(6), md. Emergency room visit. Presents with 3 days of abdominal pain, abdominal distension. Initially started with a lot of vomiting 3 days ago. That seemed to resolve but distention persisted. Several small bowel movements today. Has stoma for urine. History of incisional hernias. Weight (b)(6) pounds. Exam: abdomen is moderately distended; bowel sounds normal. Mild diffuse tenderness. Ureterostomy draining of right lower quadrant. No obvious hernias felt there. Impression: generalized abdominal pain, urinary tract infection. Plan: ct abdomen/pelvis pending. Cipro 400 mg intravenous now. (b)(6) 2013: (b)(6) medical. (b)(6), md. Radiology- ct abdomen/pelvis with contrast. Indication: abdominal pain, vomiting, abdominal distension. History of bladder cancer and hernias. Impression: partial/developing small bowel obstruction proximal to the hernia involving the ostomy in the right lower quadrant. (b)(6) 2013: (b)(6) medical. (b)(6), md. History and physical. History of bladder cancer status post ileal conduit creation complicated by a parastomal hernia. Emergency department workup demonstrated leukocytosis, possible urinary tract infection, and possible small bowel obstruction found on ct scan. Surgery consulted for evaluation of bowel obstruction. History essential hypertension (b)(6) 2005, urinary bladder cancer (b)(6) 2012, chronic colon polyps (b)(6) 2012, chronic anemia (b)(6) 2005. Former smoker, smoked 0. 50 pack per day for 10 years; quit (b)(6) 2004. Exam: abdomen obese, soft, distended, tenderness to palpation in right lower quadrant around his parastomal hernia site and midumbilical area, no masses or organomegaly, no guarding, no peritoneal signs. Impression: history of ventral hernia and parastomal hernia repair with partial small bowel obstruction in stable condition. Plan: admit, pain control, nothing by mouth, intravenous fluids, nasogastric tube. (b)(6) 2013: (b)(6) medical. (b)(6), md. Progress notes. No issues overnight. Mild abdominal discomfort with bloating. Nasogastric tube output 700cc. Mild temp overnight to 100f. White blood cell 12. 7 h. Impression: possible incarcerated bowel in his parastomal hernia currently doing well. (b)(6) 2013: (b)(6) medical. (b)(6) md. Radiology- kub. Indication: please evaluate for small bowel obstruction, please follow contrast to colon. Impression: nonspecific ileus bowel gas pattern identified. The fact that the contrast material is in the colon suggests there is no complete small bowel obstruction. Bowel distention slightly decreased compared to the previous ct scan. Postsurgical changes. (b)(6) 2013: (b)(6) medical. (b)(6), rd. Progress note- nutrition. Nothing by mouth/clear liquid equal to or greater than 3 days. Medications administered include famotidine and heparin injection. Weight (b)(6) pounds, 11. 2 ounces, bmi 29. 80. Impression: inadequate oral food/beverage intake, decrease appetite or inadequate energy intake. (b)(6) 2013: (b)(6) medical. (b)(6), md. Discharge summary. Admission date: (b)(6) 2013. Discharge date: (b)(6) 2013. Diagnosis: small bowel obstruction. Course of hospital stay: admitted with ct findings consistent with small bowel obstruction. Nasogastric tube placed and treated with conservative treatment. Kub done on 5/8 showing contrast from previous ct scan reaching the colon. Subsequently has nasogastric tube clamped and tolerated well. Diet then advanced and he tolerated without any nausea or vomiting. On day of discharge patient was passing flatus and tolerating a diet. Disposition: home. Follow up: resume normal diet, resume light activities, and take over the counter stool softeners if issues with constipation. Follow up 1-2 weeks in general surgery clinic. (b)(6) 2013: (b)(6) med office. (b)(6), md. Office notes. Weight (b)(6) pounds, (b)(6)ounces. Positive bulge at ostomy site. Impression/plan: recurrence of hernia. Treatment options discussed. Patient think over and decide. All questions answered. (b)(6) 2013: (b)(6) med office. (b)(6), md. Office notes. Weight (b)(6) pounds, (b)(6) ounces. Has been doing well. Exam: stoma pink, parastomal hernia. Ct scan 5/13 reviewed; parastomal hernia with bowel. Impression: no evidence of recurrence on ct abdomen 5/13. Plan: patient is considering having the parastomal hernia recurrence repaired again by dr. (b)(6). (b)(6) 2013: (b)(6) medical office. (b)(6), md. Email to (b)(6). Your hemoglobin a1c test was borderline high at 5. 8 and in the pre-diabetes range. The a1c test is your average blood sugar (glucose) over the past 2 to 3 months. Please note the following ranges: 4. 8-5. 6 normal, 5. 7-6. 4 borderline high (pre-diabetes), greater than 6. 5 diabetes. (b)(6) 2013: kaiser permanente-anaheim kraemer med office. Jose luis hernandez, pa. Office notes. History of enlarged asymptomatic peristomal hernia. Will be admitted (b)(6) 2013 for laparoscopic ventral hernia repair. Weight (b)(6)pounds, bmi 30. 28. Exam: abdomen soft, bowel sounds are normal. He exhibits no distension. There is no tenderness, no rebound and no guarding. Patent urostomy. Non tender perisotmal hernia. Impression: peristomal hernia. Plan: laparoscopic ventral hernia repair with mesh possible open. Risks and benefits discussed with patient. To include but not limited to bleeding, infection, injury to surrounding structures or organs and anesthesia, the opportunity to have all questions answered was given to patient. Prior to signing the consent. (b)(6) 2013: (b)(6) laboratory. Lab. White blood cell 12. 8 h (4. 0-11. 0). (b)(6) 2013: (b)(6). Jl paragas. Anesthesia record. Weight (b)(6) pounds. Asa 2. (b)(6) 2013: (b)(6) medical center. (b)(6), md. Indication: ¿pt with a parastomal hernia. ¿ implant procedure: laparoscopic parastomal hernia repair with mesh. [implant: gore-tex® soft-tissue patch, 1415020010/11158564, 20 x 15 cm] implant date: november 18, 2013 (hospitalization (b)(6), 2013) (b)(6) 2013: (b)(6) medical center. (b)(6), md. Operative report. Assistant: (b)(6), md. Preoperative diagnosis: recurrent parastomal hernia at urostomy site. Postoperative diagnosis: same. Complications: none. Anesthesia: general. Findings: ¿recurrence at superior side of the urostomy with loops of intestine in the hernia. ¿ procedure: ¿after general anesthesia, the patient was prepped and draped in the usual sterile fashion. A foley catheter was placed with balloon up in the urostomy. Ioban wrap was applied. An initial skin incision was made at the left lateral area. Hasson technique was used to insert the trocar. Three additional trocars were placed. Extensive adhesion was noted midline and at the site of the urostomy. Adhesiolysis was done. It was noted the patient had recurrent hernia at superior aspect of the urostomy. The previously placed mesh was in pace, but the fascial/muscle layer had split wide creating the hernia. A loop of intestine was noted in the hernia and was reduced. A ticron suture was used to close the fascial defect primarily. Further dissection was carried out to clear space for mesh placement. A small 1-2mm enterotomy was note [sic] at right lower quadrant and was repaired with vicryl sutures primarily. There was no visible contamination at all. Irrigation was applied. The mesentery was noted to be shortened and bulky making a sugarbaker [sic] repair anatomically difficult. A 16x14 cm eptfe mesh with slit cut of 8 cm from from [sic] midpoint on the 14cm side was used to cover the urostomy area. Combination of tacker and sutures was used to anchor the mesh to the abdominal wall. After the mesh was secured, it was decided to use one additional eptfe mesh as a sling to hold the distal intraabdominal end of the urostomy to the anterior abdominal wall. The mesh was tied to anterior abd wall and tacker was used to provided additional support. Irrigation was applied and hemostasis was examined and achieved. A jp drain was inserted to rlq. The hasson trocar site was closed in two layers and all trocar sites were closed w stapler. The patient was awakened, extubated and went to recovery room in stable condition. ¿ (b)(6) 2013: (b)(6) medical. Implant log. Implant: patch surg 20 x 15cm soft confrim trim strong gore-tex thk 1mm sterile hernia repair, w l gore. Model/cat number: 1415020010. Lot number: 11158564. The records confirm a gore-tex® soft-tissue patch (1415020010/11158564) was implanted during the procedure. Relevant medical information: (b)(6) 2013: (b)(6) medical center. (b)(6), md; (b)(6), md. Discharge summary. Admission date: (b)(6) 2013. Diagnosis: peristomal hernia. Course of hospital stay: admitted for post-operative pain control. Patient improved and was discharged on post-operative day 4. On day of discharge patient was ambulating well, tolerating diet, and pain controlled. Condition of wound: incision is clean, dry and intact. Disposition: home. Instructions/follow up: okay to shower tomorrow evening; no soaking/bathing; pat incisional areas dry when wet. Okay to resume normal diet. No heavy (greater to or equal to 10 pounds) lifting for 6-8 weeks. Follow up in nurse surgery clinic in 1 week for post-operative visit and staple removal. (b)(6) 2013: kaiser permanente-anaheim kraemer med office. Nurse notes. Here for post surgery follow up. Eating regular meals. Having regular bowel movements. Ambulating without difficulty. Occasional incisional discomfort with certain activities. Pain controlled with medications. Incision closed/dry and intake with staples without any signs of infection. No ecchymosis surrounding incisions. Incision area cleansed with chloraprep, all staples removed without difficulty. Steri-strips applied to incision. Abdomen soft. Instructed not to lift over 10 pounds for 4 weeks from date of surgery. No abdominal exercise/sports/physical education for 4 weeks from date of surgery and to report any signs of symptoms of infection. The patient indicates understanding of these issues and agrees with plan. Verbal and written aftercare instructions given. (b)(6) 2013: (b)(6) medical offices. (b)(6), md. Office notes. Weight (b)(6) pounds. Presents today for fever to 101 x 5 days. Was low grade status post laparoscopic hernia repair. Did have elevated white blood cell while in hospital. Discharged on 5 day course of augmentin. Fever started after finishing course. Has had slight chills. Exam: abdomen soft, bowel sounds are normal. Exhibits no distension and no mass. No hepatosplenomegaly, no tenderness, no rebound and guarding. Incision site without erythema, induration, warmth. Impression/plan: fever; check labs. (b)(6) 2013: (b)(6) laboratory. Lab. White blood cell 17. 0 h (4. 0-11. 0). (b)(6) 2013: (b)(6) medical offices. (b)(6), md. Office notes. Present for follow up on fever. No fever since last appointment. Decrease intake; 5 pounds weight loss since 3 days ago. Impression/plan: leukocytosis, malaise and fatigue. Repeat complete blood count and additional workup for leukocytosis. (b)(6) 2013: kfh irvine laboratory. Lab. White blood cell 17. 3 h (4. 0-11. 0). (b)(6) 2013: (b)(6) med offices. (b)(6), md. Office notes. Follow up leukocytosis. Positive igm; levels not too high. Exam: abdominal soft, bowel sounds normal. No tenderness. Impression: possible myelodysplasia; with leukocytosis of unclear etiology. Plan: bone marrow biopsy. (b)(6) 2014: kfh irvine laboratory. Lab. White blood cell 11. 7 h (4. 0-11. 0). (b)(6) 2014: kaiser permanente-anaheim kraemer med office. Radiology- ct chest, abdomen, pelvis with contrast. Indication: rule out metastasis or lymph nodes to be down within 3 weeks. Comparison: ct abdomen and pelvis (b)(6) 2013 and ct chest (b)(6) 2012. Impression: mild/moderate bilateral hydronephrosis which is new since the previous exam. Ureters are dilated to the right lower quadrant ileal pouch. The dilated loops of bowel within the right lower quadrant is thought to likely represent the neobladder. Superficial to this, between the neobladder and abdominal wall is increased density. This has the appearance of surgical mesh and should be correlate for interval surgery and uncertain if this may be the underlying etiology for the new hydronephrosis. No evidence of metastatic disease.
 
Event Description
It was reported to gore that the patient underwent laparoscopic parastomal hernia repair on (b)(6) 2013 whereby a gore-tex® soft tissue patch was implanted. The complaint alleges that on (b)(6) 2014, an additional procedure occurred whereby the gore device was explanted. It was reported the patient alleges the following injuries: removal of gore mesh due to failed mesh and pain, recurrent hernia repaired with new mesh. 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, INC.
1505 n. fourth street
flagstaff AZ 86004
Manufacturer (Section G)
MPD APC B/P
p.o. box 1408
elkton MD 21922 1408
Manufacturer Contact
jorja nackard
1505 n. fourth street
flagstaff, AZ 86004
9285263030
MDR Report Key13158113
MDR Text Key283673171
Report Number3003910212-2022-01320
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
Source Type Other
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 01/04/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/04/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date01/31/2018
Device Model Number1415020010
Device Catalogue Number1415020010
Was Device Available for Evaluation? No
Date Manufacturer Received01/04/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured02/20/2013
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: 01/04/2022 Patient Sequence Number: 1
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