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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); Obstruction/Occlusion (2422)
Event Date 05/05/2019
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: on (b)(6) 2014: (b)(6) center. (b)(6), md. Operative report: clinical history: (b)(6) has large volume superficial bladder cancer at the dome of his bladder, as well as a one small focus along the right lateral wall. Total volume of tumor at the dome was about 5 cm. The imaging does not indicate that this appears to be muscle invasive. The risks and benefits of a cystoscopy with a tur [transurethral resection] were discussed. Of note, he also did have necrotic-appearing prostatic fossa, likely secondary to prior green light laser and so a turp to clean up his channel was also discussed. Preoperative and postoperative diagnosis: bladder cancer. Necrotic prostatic urethra. Operation preformed: cystoscopy, bilateral retrograde pyelograms, bipolar turp, turbt large. Assistant: none. Anesthesia: lma [laryngeal mask airway]. Complications: none. Specimens: none. Findings: ¿necrotic prostate with urothelium sculpted down using the bipolar resectoscope to at least a normal-appearing fossa. In addition to that, the lesion at the dome of the bladder was resected using the button, given the concern for perforation. ¿ drains: 22 (b)(6) urethral catheter. Complications: none. Disposition: recovery room in stable condition. Follow-up plan: see him back in the office in about 6-8 weeks. Operation: ¿the patient was brought to the operating room, identified by myself. Intubated in the supine position, then placed in the lithotomy position. Prepped and draped in standard sterile fashion. Surgical time-out was performed. Cystoscope was inserted via the urethra. Urethra immediately revealed a normal-appearing urethra, but we got to the prostatic fossa and there was sort of necrotic debris, consistent with a prior ktp [potassium titanyl phosphate] laser. There was no evidence of any malignancy here. I entered into the bladder and then looked at the dome and saw up at the dome there was a 3-4 cm tumor along the right side of the dome, we do another small scattered foci along the right lateral bladder wall. Of note, he received obturator block prior to surgery. I then removed the cystoscope and inserted a resectoscope. Using the bipolar coagulation, i initially attempted to resect up at this site, but found that could not easily re set up at the dome. Therefore, i switched over to bipolar and performed a resection using the button instead of the loop. We cauterized this and vaporized the tissue until it was roughly a flat area. There is no other evidence of bleeding, although frankly i did not get as good of a look as i would like, given the absolute size of him and his prostate and bladder. In addition to resecting the bladder, particularly about a 5-cm area of that up at the dome and lateral wall, i then turned my attention and performed a bipolar resection of the prostate, until i whittled this down to fairly normal-appearing prosthetic scar consistent with prior turp. There were no formal turp chips that were sent off because most of the debris was just necrotic. Of note, his psa is undetectable, so i do not think it is prostate cancer. At this point, i then performed a bilateral retrograde pyelogram, which showed no evidence of any filling defects in either of the upper urinary tracts. A fresh 22-(b)(6), 30 ml catheter was inserted. We will do mitomycin-c in the recovery room. Plan is to see him back in a few weeks to review pathology and schedule him for re-scoping. ¿ on (b)(6) 2014: (b)(6) center. (b)(6), md. Operative report: clinical history:(b)(6) has a history of superficial bladder cancer status post and initial resection 6 weeks ago. He also has an enlarged prostate with a history of green light laser with a fair amount of necrotic tissue, identified at the last cystoscopy. He presents today for restaging tur [transurethral resection] as well as potential re-resection of the prostate based upon volume of necrotic tissue that is remaining. Preoperative and postoperative diagnosis: bladder cancer. Benign prostatic hyperplasia. Procedure: cystoscopy, transurethral resection of bladder tumor [turbt] (large, greater than 5 cm respected area) turp [transurethral resection of prostate], installation of mitomycin-c into the bladder. Assistant: yu kuan lin, md. Anesthesia: general endotracheal. Fluid: 1000 ml of crystalloid. Estimated blood loss: minimal. Complications: none. Drains: a 22 (b)(6) urethral catheter with 30 ml in the balloon. Followup [sic] plan: the patient will have mitomycin-c for an hour and then catheter removed tomorrow morning. See me back in 6 weeks for followup [sic]. Disposition: recovery room in stable condition. Operation: ¿the patient was brought to the operating room, identified by myself. Anesthesia was induced. He was placed in lithotomy position. Prepped and draped in standard sterile fashion. Surgical time-out was performed. The films were reviewed. Digital rectal examination was initially performed, which noted a 2+ prostate. There was no focal nodularity or suspicious lesions to suggest overt presence of cancer. After inserting the cystoscope via the urethra into the bladder. I identified some necrotic debris remaining in the prosthetic fossa, albeit improved from before. Upon entering into the bladder as we looked up to the dome, we did see recurrent cancer located up in that area as well as multiple areas that were sort of a weak [sic] thing. Some of these areas look less suspicious for malignancy, but were still having a steady amount of oozing perhaps due to his history of the radiation for prostate cancer. In any case, i removed the cystoscope and inserted a resectoscope. Prior to doing that i did obtain a urinary study. Because this was located, all the way it was quite hard to reach and therefore i elected to use a cotton coags function on the bipolar that actually performed the resection. All visible tumor were [sic] resected using the cut and then we coagulated this entire area around it. Total volume of coagulation and cauterization was well over 5 cm all like a dome. At this point everything seemed quite clean up at all [sic]. Therefore, i then pulled back to the prostatic fossa and switched off my button for a loop and i took some resection to the prostate until we got down to more flat less necrotic appearing tissue. Overall, this did look much better than where it did before [sic]. This was cauterized as well. Hemostasis was good. A 22 (b)(6) catheter was inserted. Urine was clear. It was capped with mitomycin-c instilled for the next hour period there were no complications or issues. On (b)(6) 2015: (b)(6) center. Inpatient hospitalization. (b)(6) 2015: (b)(6) center. (b)(6), md. Operative report: preoperative and postoperative diagnosis: superficial recurrent bladder cancer, radiation cystitis with severe and intractable urinary frequency, urgency and urge incontinence. Operation performed: radical cystoprostatectomy with ileal conduit and limited pelvic lymph node dissection. Assistant: dr. (b)(6) and consulting surgeon, dr. (b)(6). Complications: none. Blood loss: 1600 ml. Specimen: bladder, prostate, seminal vesicles, distal ureters, obturator and external iliac lymph nodes. Findings: ¿no evidence of extravesical extension of tumor. ¿ indications: ¿this (b)(6) male status post brachytherapy for prostate cancer who presents with severe bladder symptoms as well as recurrence of superficial bladder cancer. The patient's recurrent prostatic urethral strictures have made his lower urinary tract symptoms intolerable and recurrent and he desires radical cystectomy for treatment of all issues. ¿ operation: the patient was brought to the operating room and appropriately identified. He was placed on the table, prepped, and draped in the usual sterile fashion. And appropriate timeout was performed. A foley catheter was placed. We made a midline incision between the rectus muscle and dissected down, identifying the urachus and ligating it entering the abdomen. We developed the space of retzius best we could. It was clear there was a lot of radiation reaction down around the prostate. We started fairly high in the abdomen and mobilizing the cecum and terminal ileum by incising the posterior peritoneum and packing these into the upper quadrants. The right ureter was identified as it coursed through the retroperitoneum. We encircled it with a vessel loop, dissected it free down to the level of the bladder and at this point took the ligasure across the medial umbilical ligament and the superior vesical artery. This gave us access to develop a little more of the space of retzius lateral to the bladder. With the right ureter, clamped and divided, the distal stump was oversewn and the frozen section was sent of the proximal stump which was negative for tumor. We turned our attention next to the left side. We developed the space of retzius lateral to the bladder again, mobilized the left colon off the pelvic sidewall and identified the left ureter. We traced the left ureter down to its insertion into the bladder. At this point, the superior vesical artery and the medial umbilical ligaments were divided with the ligasure and the ureter was clamped and divided. We next addressed the anterior surface of the bladder. This was sharply taken down of the public symphysis and the endopelvic fascia was identified bilaterally. The endopelvic fascia was opened with moderate difficulty given the amount of radiation that had been applied in this area. The dorsal vein complex was ligated with an 0 vicryl and a back-bleeding stitch was placed at the level of bladder neck. We then incised the peritoneum between the rectum and the bladder and developed the prerectal fat plane. This was extremely difficult given the patient¿s prior radiation. All of this dissection was done sharply with a pair of scissors with significant difficulty staying out of the rectum. We felt that we had safely done so. The lateral pedicles of the bladder were taken down with a vascular stapler down to the level of the prostate base. The remainder of the dissection was done sharply with a pair of scissors and multiple vascular clips. We then divided the dorsal vein complex as well as the anterior urethra. The foley catheter was brought through into the incision and used to place the prostate on anterior traction. With a pair of metzenbaum scissors, we very carefully divided the posterior wall of the urethra as well as the rectourethralis muscle. The remaining apical attachments were taken down sharply, again taking great care to stay out of the rectum. With the specimen lifted free, we obtained good hemostasis and asked colorectal surgery to enter the operative field to examine the recum. They felt that there was no rectal injury and i concurred. The pelvis was washed out and we proceeded with our bilateral pelvic lymph node dissection. Given the fact that there is no muscle invasive disease we kept the node dissection limited to common iliac lymph nodes down to the femoral canal. A split and roll was performed down the external iliac artery and the lymphatic tissue was stripped out lateral to the genitofemoral nerve. The obturator fossa was cleared in a similar manner taking care not to damage the obturator nerve. This was the node of cloquet which was resected with the packet. This same dissection was performed on either side of the pelvis. We next proceeded with our urinary diversion. We had already swung the left ureter over to the right side through a retrosigmoid tunnel. An appropriate length of small bowel was selected 15 cm proximal to the ileocecal valve. This was taken down between 2 tires of the gia stapler. The mesentery taken down with the ligasure. We performed a side-to-side stapled reanastomosis using a 75 mm stapler and closed the end of the anastomosis with a 90 mm linear stapler. 3-0 silks were used to buttress the crotch of the anastomosis as well as to close the mesenteric defect. The conduit was then opened at its distal end and washed out. We oversewed the proximal staple line with a 3-0 vicryl to keep it separate from the lumen of the conduit. Bilateral bricker style anastomosis was performed. The ureter were spatulated and sewn in over 7-(b)(6) stents with 4-0 monocryl in an interrupted fashion. The stents were affixed within the conduit using 3-0 chromic. We selected a point previously marked by the wound ostomy nurse. Skin and subcuticular fat was taken out down to the level of fascia which was opened in a cruciate fashion. The rectus muscle belly was spread parallel to the line of the fibers. The underlying peritoneum was divided with cautery. A babcock clamp was placed through the defect, grasped the distal end of the conduit and brought it through. It was quite a stretch given the patient¿s body habitus, but we were able to get it to the skin. Very little length was present for an eversion of the conduit but we placed our brooking stitches in 4 quadrants, so we were able to get a small amount of the stoma. The stoma was then finished using 3-0 chromics. A stomal catheter was placed through it and the stents were affixed to the skin. We placed the french blake drain through a separate stab incision in the left lower quadrant. The abdomen was then washed out, the bowel was run and we proceeded to close. Closure was accomplished with #1 pds. We brought the fat together with some subcuticular stitches and the skin was then closed with staples. Sterile dressings and a stoma appliance bag were applied. The patient tolerated the procedure well. There were no complications. I was present and actively participated throughout. ¿ indications: ¿this is a (b)(6) male patient with a superficial bladder cancer and urge incontinence who has undergone by dr. (b)(6) elective radical cystoprostatectomy with ileal conduit and a limited pelvic node dissection. Dr. (b)(6) is requesting my assistance in the aspect of to rule out any rectal injuries because his dissection rectum when he was removed from the bladder and the prostate was very difficult. After arrival in the operating room, the patient had already undergone a midline incision and the pelvic was fully exposed. The sigmoid colon appeared soft. The distal rectum had several areas where there was scar and thickened tissue present. All the area for exam [sic], no serosal tears or full thickness injury of the rectum were identified. In the anterior portion of the rectum, the posterior membrane of the prostate was present for approximately 2 x 2 cm. There was an area of significant bleeding on the rectum, which was suture ligated using a 2-0 silk suture in a figure of eight fashion. No other injuries were identified. The instrument, sponge and needle counts were correct at the end of the procedure. I was present and scrubbed for my portion of the procedure. Dr. (b)(6) continued with his procedure. ¿ on (b)(6) 2015: (b)(6) center. (b)(6), md. Operative report: preoperative diagnosis: this is an intraoperative consultation for assessment of the rectum to rule out rectal injury. Findings: ¿thickened rectum, portion of the posterior membrane of the prostate was found on the rectum, no areas of injuries or serosal tears were identified, a small area of bleeding was suture ligated. Drains were left by dr. (b)(6). On (b)(6) 2015: (b)(6) center. (b)(6), md. X-ray abdomen: clinical history: cystectomy with ileal conduit. Evaluate ureteral stent position. Findings: ¿abdomen: ap [anterior posterior] supine abdominal radiograph demonstrates surgical drain in the pelvis and multiple clips, compatible with a history of cystectomy. Bilateral nephroureteral stents with tips projecting over the right lower quadrant. And additional catheter projects over the right lower quadrant in the expected position of the ileal conduit. The proximal loop on the left stent is slightly uncurled. The right stent is slightly inferiorly positioned in the position of lower pole of the right kidney as seen on prior ct. No acute osseous sis abnormality. ¿ on (b)(6) 2015: (b)(6) center. (b)(6), md and (b)(6), md. Discharge summary: physical exam: ostomy appliance with 2 ureteral stents in place. Instructions: keep your incision clean and dry. No heavy lifting (>10 lbs. ) or other strenuous activity until cleared in clinic. Follow-up with (b)(6), md (b)(6). On (b)(6) 2015. (b)(6) 2015: (b)(6) center. (b)(6), md. Ct abdomen and pelvis with and without contrast: clinical history: bladder cancer. Impression: ¿ status post radical cystoprostatectomy. Thickening of distal 2 cm of the right ureter which may be on a postoperative inflammatory basis. No definite upper or lower tract urothelial lesions. No findings to suggest metastatic disease within chest, abdomen, or pelvis. Stable 2 cm cystic lesion within the uncinate process of the pancreas, unchanged from abdominal mri of (b)(6) 2014. ¿ on (b)(6) 2015: (b)(6) center. Inpatient hospitalization. On (b)(6) 2015: (b)(6) center. (b)(6), md. History and physical: chief complaint: ¿transfer from j. C. Blair hospital for small-bowel obstruction. History of present illness: mr. (b)(6) is a pleasant (b)(6) male with history of prostate cancer treated with brachytherapy in 2009. He then was subsequently found to have superficial bladder cancer after an episode of gross hematuria in 2012. He did have recurrence of this disease once [sic] that was again resected. Unfortunately, mr. (b)(6) then developed radiation cystitis from his brachytherapy and had debilitating symptoms of urgency, frequency and urge incontinence. Ultimately, it was decided he would benefit from having his bladder removed. He underwent a cystectomy with ileal conduit creation and bilateral pelvic lymph node dissection on(b)(6) 2015 by dr. (b)(6). Pathology from this showed pto no mo [sic] disease with margins negative. Following surgery, he has had no signs of disease recurrence. He has had several episodes of abdominal discomfort that were attributed more to constipation rather than any signs of bowel obstruction as there is no dilated bowel on any ct imaging. However, the patient now presented with severe onset of abdominal pain starting yesterday around 4:00 p. M. He describes the pain as sharp and coming in cyclical waves, never getting any better than a 5/10, but when exacerbated is 10/10 pain and ¿feels like labor pains. ¿ around 3:00 a. M. This morning, he did have an episode of nausea with emesis of brown bilious material with food particles within it. No blood was noted. He has passed minimal flatus during this episode of pain. His last normal bowel movement was approximately 4 days ago with some small bowel movements 2 days ago after taking colace. The patient then presented to (b)(6) hospital after calling ems for transport. Upon arrival at j. C. Blair, a full set of labs was performed which showed a stable creatinine of 1. 3 with a baseline of 1. 2. Electrolytes were normal. White blood cell count was normal at 3. 8. Liver enzymes were also within normal limits. He had a lactate of 1. 4 and albumin of 4. 1. Ct imaging with iv contrast demonstrated evidence of a small-bowel obstruction with a transposition point in the right lower quadrant he was then arranged for transfer to our emergency room. Upon arrival, he was hemodynamically stable and afebrile. A new set of labs was requested. Imaging was discussed with radiology, who agrees with the above findings. He was admitted to the urology service for management of his small bowel obstruction. Physical exam: abdomen is distended and tender to palpation across his mid-abdomen and tympanic on exam. His abdomen is compressible but firmer than normal. He is nonperitoneal. His ileal conduit was in the right lower quadrant, is pink and viable, producing clear, yellow urine. Imaging: review of the outside ct scan of the abdomen and pelvis with iv contrast, both independently and with radiology, confirms a distended stomach and small bowel down to the level of the right lower quadrant where there is a transition point present near the bowel anastomosis but not involving the bowel anastomosis. There is stool present throughout the colon. Additionally, there is a parastomal hernia with what appears to be omental fat and some simple fluid. Assessment: mr. (b)(6) is a (b)(6) male with a history of gleason six prostate cancer status post brachytherapy as well as superficial recurrent bladder cancer who ultimately developed radiation cystitis and underwent a cystectomy with ileal conduit creation. He now has evidence of a small-bowel obstruction, likely a partial bowel obstruction, but a complete obstruction cannot be ruled out. Plan: the patient will be admitted to the urology service, floor status under the care of dr. Ross (b)(6), the urology attending on-call. He will be kept n. P. O. [nothing by mouth], no exceptions, and placed on maintenance iv fluids. 3. An ng tube will be placed to decompress his stomach and small bowel. Kub [kidney, ureter, and bladder] imaging will be obtained to confirm proper placement within the stomach. ¿ on (b)(6) 2015: (b)(6) center. (b)(6), md. Radiology: portable x-ray abdomen1 view. Findings: ¿single ap [anterior posterior] supine view of the abdomen. Nasogastric tube is not visualized. Air-filled stomach. There are multiple loops of air-filled dilated small bowel distal up to 3. 8 cm. Air in the nondistended large bowel. Surgical clips in the pelvis. Impression: nasogastric tube is not visualized on this abdominal radiograph. Consider repositioning and/or chest x-ray to locate the nasogastric tube. Multiple loops of air-filled small bowel some pathologically distended, concerning for small bowel obstruction. ¿ (b)(6) 2015: (b)(6) center. (b)(6), md. Radiology: x-ray small bowel follow through: clinical history: small bowel follow through. Sbo [small bowel obstruction] prev. Identified, now s/p [status post] ngt [nasogastric tube], clinically improved with flatus. S/p cystectomy and ileal conduit in 2015. Findings: ¿scout abdominal radiography demonstrates nasogastric tube tip in the stomach. Nonobstructed bowel gas pattern with mild colonic stool burden. No evidence of pneumatosis or pneumoperitoneum. Surgical clips overlie the pelvis. Clear lung bases. Degenerative changes in the spine. There is filling of the stomach with free flow contrast into the small bowel to the terminal ileum into the large bowel, the small bowel transit time of 150 minutes, which is normal. Normal mucosal pattern of jejunum and ileum. There are no strictures, large filling defects, or diverticula of the small bowel. No sinus or fistulous tracts identified. The terminal ileum is well-visualized and is normal. No excuse aphthous ulcers, wall irregularity, strictures, or fistulous tracts. Impression: no findings of obstruction. ¿ on (b)(6) 2015: (b)(6) center. Radiology: portable x-ray abdomen1 view: findings: ¿nasogastric tube tip in the gastric cardia with side port above the ge junction. Limited evaluation scattered bowel gas pattern given patients body habitus. Mild stool burden in the distal transverse and descending colon. No evidence of pneumatosis or pneumoperitoneum. Surgical clips overlie the pelvis. Impression: nasogastric tube tip in the gastric cardia with side port above the ge junction. Limited evaluation scattered bowel gas pattern given the patient's body habitus. However may represent mild ileus versus partial smell bowel obstruction. ¿ on (b)(6) 2015: (b)(6) center. (b)(6), md. Discharge summary: discharge diagnosis: ¿small bowel obstruction. Brief hospital course: the patient was admitted to the urology service under the care of (b)(6) on (b)(6) 2015. Ng tube was placed for decompression of his gi system. A small bowel follow through was subsequently performed which showed no evidence of obstruction, likely suggesting resolved small bowel obstruction and ultimately ng tube was then removed. The patient was then advanced and he was able to tolerate well with passage of flatus and having bowel movements. The patient was deemed stable for discharge on (b)(6) 2015. By the time of discharge he was afebrile, hemodynamically stable, tolerating a regular diet, passing flatus, having bowel movements, ambulating independently. Plan for him is to see us back in clinic in four weeks to discuss potentially elective correction of any intraabdominal adhesions, possible revision of the endocentric and anastomosis. ¿ on (b)(6) 2016: (b)(6) center. (b)(6), md. Ultrasound renal complete. Clinical history: history recurrent superficial bladder cancer and radiation cystitis post brachytherapy and cystoprostatectomy. Comparison: multiple prior studies the most recent renal ultrasound dated (b)(6) 2015. Bladder: the bladder is surgically absent. Right kidney: the right kidney is normal in size, shape, and echogenicity. Renal cortical thickness is maintained. No evidence of hydronephrosis. There is no perinephric fluid. Right kidney: 11. 2 x 4. 6 x 6. 2 cm. Left kidney: the left kidney is normal in size, shape, and echogenicity. Renal cortical thickness is maintained. No evidence of hydronephrosis. There is no perinephric fluid. Left kidney: 10. 8 x 4. 1 x 5. 6 cm. Impression: unremarkable renal ultrasound with no evidence of hydronephrosis. On (b)(6) 2016: (b)(6) center. Inpatient hospitalization. On (b)(6) 2016: (b)(6) center. (b)(6), md. Urology history and physical: chief complaint¿ small-bowel obstruction¿. History of present illness: ¿(b)(6) [sic] was recently evaluated at (b)(6) for a 1-day history of acute intermittent, sharp abdominal pain, nausea with emesis and abdominal distention. An ng tube was placed and the patient reported some symptomatic relief with return of bilius output. A noncontrast abdominopelvic ct scan was performed, which identified ¿distended fluid-filled small-bowel loops with mid mesenteric edema with possible distal small-bowel obstruction. Right lower quadrant ilea loop conduit ostomy with parastomal hernia. ¿ the patient was transferred to hershey medical center as a direct admit for continued evaluation and management. He reports feeling better than he did prior to hospital evaluation and a kub was performed, which identified a satisfactory position of his ng tube. Physical examination: abdomen: soft, mildly distended, mildly tender, tympanic. Your ostomy appears pink, healthy and viable with yellow urine in appliance bag. Imaging studies: a noncontrast abdominopelvic ct scan was performed at the referring hospital on (b)(6) 2015 [sic], which identified ¿distended fluid-filled small bowel loops with mild mesenteric edema and possible distal small-bowel obstruction. Right lower quadrant ileal loop conduit ostomy with parastomal hernia. Diverticulosis of the colon with no evidence of acute diverticulitis. Plan: admit to the urology services. Ng tube to low intermittent suction. N. P. O. With no exceptions and maintenance iv fluids. On (b)(6) 2016: (b)(6) center. (b)(6), md. Radiology: x-ray abdomen: clinical history: ng tube placement. Findings: ¿limited x-ray of the abdomen was obtained. A nasogastric tube is identified with the tip just at the ge junction and should be advanced. Some fecal material identified within the colon. There are several small bowel loops that are mildly prominent some that may have mild wall thickening. Impression: nasogastric tube identified with the tip near the ge junction and should be advanced. Mild ileus. ¿ on (b)(6) 2016: (b)(6) center. (b)(6), md. Discharge summary: discharge diagnosis: small bowel obstruction. Hospital course: ¿the patient was admitted to the hospital on (b)(6) 2016 with a small bowel obstruction. The patient had an ng tube placed, kept to low intermittent suction. The patient was controlled as appropriate. On (b)(6) 2016, the patient already began to have some great improvement with regards to his abdominal discomfort. His ng tube was placed to clamp trials that revealed that he had very low residual. His ng tube was discontinued. The patient began to pass regular flatus and on (b)(6) 2016, he was advanced to a diet of sips of clears. On (b)(6) 2016, the patient began to have bowel movements and continued to have regular flatus. He was advanced to a clear liquid diet which he was able to tolerate quite well. On (b)(6) 2016, the patient advanced to a regular diet which he tolerated well. He continued to pass regular flatus with no complaints of abdominal pain. The patient was deemed stable for discharge from the hospital on (b)(6) 2016, sent home on the appropriate follow up and discharge instructions. On (b)(6) 2016: (b)(6) center. (b)(6), md. Ct abdomen and pelvis [a/p] without contrast. Clinical history: (b)(6) with hx cystectomy with ileal conduit for bladder ca [cancer] and radiation cystitis recent sbo [small bowel obstruction], parastomal hernia, intermittent ab pain. Comparison: multiple priors, most recent ct dated (b)(6) 2015. Findings: evaluation of the solid organs is limited due to lack of intravenous contrast. Abdomen, liver gallbladder & bile ducts: normal. Pancreas: stable 1. 3 x 2. 0 cm cyst in the uncinate process. No pancreatic ductal dilation or distal pancreatic atrophy. Kidneys, collecting system and ureters: postsurgical changes of urinary diversion with ostomy in the right lower quadrant of the abdomen. No hydronephrosis or hydroureter. Thickening of distal 2 cm of the left ureter which may be on a postoperative or inflammatory basis is grossly unchanged. Bowel and mesentery: postsurgical changes of urinary diversion with ostomy in the lower quadrant. No bowel obstruction. Scattered diverticula without diverticulitis. Bladder: status post radical cystoprostatectomy. Impression: status post radical cystoprostatectomy. Thickening of distal 2 cm of the left ureter, grossly unchanged. No findings to suggest metastatic disease within abdomen or pelvis. Stable cystic lesion within the uncinate process of the pancreas. On (b)(6) 2016: (b)(6) center. (b)(6), pa-c. History and physical [h&p]: preoperative information: procedure: hernia parastomal repair laparoscopic. Date: (b)(6) 2016. Medical history: copd, chronic sob [shortness of breath] with exertion. Obstructive sleep apnea. Gerd, obesity: bmi 35. Cigarette smoker? former smoker, quict >1 yr. Alcohol: denies. Addendum (b)(6) 2016: 9/1/16: former smoker, ¿quit 40 years ago. Smoked 10-15 years >2 packs per day. ¿ on (b)(6) 2016: (b)(6) center. (b)(6), pa-c. H&p addendum: ¿surgery cancelled d/t [due to] significant anemia requiring multiple transfusions over the past 3 months. Pt [patient] to undergo w/u [work up] at osh for source of anemia. ¿ on (b)(6) 2016: (b)(6) center. Inpatient hospitalization.
 
Event Description
It was reported to gore that the patient underwent laparoscopic parastomal hernia repair on (b)(6) 2016 whereby a gore-tex® soft tissue patch was implanted. The complaint alleges that on (b)(6) 2019 and (b)(6) 2021, additional procedures occurred whereby the gore device was explanted. It was reported the patient alleges the following injuries: surgery to remove mesh, mesh eroding into bowel, open draining wound, inflammation, bowel resection, bowel perforation, adhesions to small intestine, adhesions to bowel, adhesions, hernia recurrence, severe and chronic pain/discomfort, small bowel obstruction. 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 Key13152462
MDR Text Key287832975
Report Number3003910212-2022-01319
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,Followup
Report Date 03/11/2022
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 Date01/31/2020
Device Model Number1415020010
Device Catalogue Number1415020010
Was Device Available for Evaluation? No
Date Manufacturer Received03/10/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/02/2015
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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