GORE-TEX® SOFT TISSUE PATCH
Report
- Report Number
- 2017233-2014-00251
- Event Type
- Injury
- Date Received
- May 15, 2014
- Date of Event
- June 11, 2012
- Report Date
- October 23, 2015
- Manufacturer
- W.L. GORE & ASSOCIATES
- Product Code
- FTL
- PMA / PMN Number
- K963619
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
INITIAL REPORTER ADDRESS - (B)(6). GORE HAS REQUESTED ADDITIONAL INFORMATION FROM THE REPORTER.
(B)(4). ADDITIONAL DETAILS REGARDING THE PATIENT¿S CLINICAL COURSE WERE ASCERTAINED FROM A REVIEW OF MEDICAL RECORDS AND ARE AS FOLLOWS: RECORDS DATED (B)(6) 2000 INDICATE THE PATIENT WAS SEEN FOR POSTOPERATIVE FOLLOW UP. THE RECORDS STATE THE PATIENT ¿¿IS STATUS POST VAGINAL HYSTERECTOMY WITH AN ANTERIOR/POSTERIOR REPAIR AND PLACEMENT OF A CORTEX [SIC] PUBOVAGINAL SLING ON (B)(6) 2000 WITHOUT COMPLICATION.¿ ¿SHE HAS NO COMPLAINTS OTHER THAN VERY SCANT AMOUNT OF VAGINAL DISCHARGE WHICH SHE HAS BEEN TREATING USING SITZ BATHS AND A PERI BOTTLE.¿ ¿DENIES ANY PROBLEMS WITH URINARY INCONTINENCE.¿ EXAM NOTES STATE: ¿SUBRAPUBIC WOUNDS ARE WELL HEALED. THE VAGINAL MUCOSA IS HEALING WELL WITHOUT SIGNS OF INFECTION.¿ RECORDS DATED (B)(6) 2000 INDICATE THE PATIENT WAS SEEN FOR POSTOPERATIVE FOLLOW UP AND ¿POSTOPERATIVELY SHE HAS DONE VERY WELL. SHE IS CURRENTLY FEELING GREAT¿¿ ¿SHE IS VERY PLEASED WITH THE OUTCOME OF HER VAGINAL SURGERY. SHE STATES THAT SHE NO LONGER NEEDS TO WEAR PADS FOR PROTECTION. SHE DENIES ANY LEAKAGE OF URINE WITH THE EXCEPTION OF SCANT LEAKAGE WHEN HER BLADDER IS VERY FULL.¿ EXAM NOTES STATE: ¿PELVIC EXAMINATION REVEALS WELL HEALED SUPRAPUBIC WOUNDS. VAGINAL EXAMINATION DEMONSTRATES EXCELLENT VAGINAL SUPPORT WITH A WELL HEALED VAGINAL EPITHELIUM AND NO CLINICAL SIGNS OF INFECTION.¿ RECORDS DATED (B)(6) 2005 INDICATE THE PATIENT WAS SEEN FOR AN UNCOMPLICATED URINARY TRACT INFECTION. THE RECORDS INDICATE: ¿NO ABDOMINAL PAIN, DYSURIA, NO BACK OR FLANK PAIN, FREQUENCY, URGENCY, NO UNUSUAL VAGINAL DISCHARGE.¿ RECORDS DATED (B)(6) 2011 INDICATE: ¿SHE HAS A LOT OF DISCOMFORT IN HER ABDOMEN WHEN SHE SITS.¿ ¿SHE HAS A LOWER PELVIC PRESSURE INCREASED URINARY FREQUENCY AND INCONTINENCE.¿ ¿SHE HAD A CT SCAN DONE OF HER ABDOMEN ABOUT A YEAR AGO FOR EVALUATION OF ABDOMINAL DISCOMFORT. IT WAS NORMAL.¿ ASSESSMENT NOTES STATE: ¿ABDOMINAL DISCOMFORT.¿ ¿MORBID OBESITY. DIABETES. HYPERTENSION. STATUS POST HYSTERECTOMY. HEAD PAIN. URINARY TRACT INFECTION.¿ RECORDS DATED (B)(6) 2012 INDICATE: ¿I SAW HER COUPLE WEEKS AGO AND AT THAT TIME SHE HAD A URINARY TRACT INFECTION. SHE WAS TREATED WITH A ONE-WEEK COURSE OF SEPTRA DS AND HAS HAD SOME IMPROVEMENT IN HER DYSURIA, BUT HER URINE STILL SMELLS VERY FOUL AND SHE HAS SOME URINARY INCONTINENCE WHICH IS CHRONIC.¿ ¿AT THE TIME OF OUR LAST VISIT, SHE HAD NOT BEEN TAKING ANY OF HER MEDICINES FOR DIABETES INCLUDING HER INSULIN.¿ IMPRESSION NOTES STATE: ¿UTI. ORAL THRUSH. DIABETES OUT OF CONTROL.¿ RECORDS DATED (B)(6) 2012 STATE: ¿SHE CONTINUES TO HAVE SOME INCREASED URINARY URGENCY. SHE¿S NOTED SOME BLOOD ON THE PAD SHE WEARS. I TREATED HER FOR URINARY TRACT INFECTION WITH 2 COURSES OF ANTIBIOTICS. SHE HAD A COURSE OF SEPTRA DOUBLE STRENGTH THIS COURSE OF CIPRO. HER URINE CULTURE GREW MIXED GRAM-POSITIVE ORGANISMS. SHE¿S NOT BEEN TAKING HER INSULIN¿SHE HAS URINARY INCONTINENCE¿¿ IMPRESSION NOTES STATE: ¿INCREASED URINARY FREQUENCY. POSSIBLE VAGINAL BLEEDING. DIABETES, UNCONTROLLED.¿ PLAN NOTES STATE: ¿SHE¿S HAVING URINARY URGENCY PARTLY BECAUSE SHE IS NOT ON HER INSULIN.¿ RECORDS DATED (B)(6) 2012 STATE THE PATIENT WAS SEEN FOR URINARY INCONTINENCE AND VAGINAL BLEEDING. THE RECORDS STATE: ¿¿IN THE LAST SEVERAL MONTHS, SHE HAS HAD VAGINAL BLEEDING.¿ ¿SHE INITIALLY THOUGHT THAT THIS WAS FROM HER BLADDER, AS SHE WAS RECENTLY TREATED FOR A URINARY TRACT INFECTION. HOWEVER, THAT INFECTION HAS SINCE CLEARED AND SHE CONTINUES TO HAVE BLEEDING.¿ ¿PATIENT ALSO PRESENTS FOR EVALUATION SECONDARY TO URINARY INCONTINENCE SYMPTOMS.¿ ¿THE PATIENT ALSO COMPLAINS OF FECAL INCONTINENCE SYMPTOMS. SHE HAS NOTED THESE SYMPTOMS FOR AT LEAST 3 YEARS. SHE NOTES FECAL URGENCY AT ALL TIMES.¿ MEDICAL HISTORY IS NOTED AS HYPERTENSION, GERD, LOW BACK PAIN, TYPE 2 DIABETES, MIGRAINE HEADACHES, PAROXYSMAL SUPRAVENTRICULAR TACHYCARDIA, DEPRESSION, VAGINAL HYSTERECTOMY, ¿BLADDER REPAIR,¿ TONSILS, CYSTOSCOPY WITH BLADDER INSTILLATIONS (YOUNG ADULTHOOD), TUBAL LIGATION, CHOLECYSTECTOMY, VENTRAL HERNIA REPAIR, AND ULNAR NERVE TRANSPOSITION. EXAM NOTES FROM (B)(6) 2012 INDICATE: ¿EXTERNAL FEMALE GENITALIA IS NOTABLE FOR ERYTHEMA INVOLVING THE VULVA AS WELL AS THE CRURAL FOLDS CONSISTENT WITH A PAD RASH. THE VAGINA APPEARS ATROPHIC. CAREFUL SPECULUM EXAMINATION IS PERFORMED. THERE IS AN AREA AT THE MIDLINE OF THE ANTERIOR VAGINAL WALL APPROXIMATELY 5 CM PROXIMAL TO THE URETHRAL MEATUS WITH EVIDENCE OF FOREIGN BODY. THERE IS GRANULATION TISSUE SURROUNDING THIS AREA OF EXPOSED FOREIGN BODY. THE AREA OF GRAFT MATERIAL VISIBLE IS APPROXIMATELY 7 MM IN GREATEST DIMENSION. IT DOES NOT APPEAR LIKE POLYPROPYLENE MESH. IT APPEARS MORE CONSISTENT WITH A BIOLOGIC GRAFT. PELVIC ORGAN PROLAPSE QUANTIFICATION EXAM SHOWS AA -2, BA -2, C -7, AP 0, BP 0.¿ ASSESSMENT AND PLAN NOTES FROM (B)(6) 2012 STATE: ¿THE SOURCE OF HER VAGINAL BLEEDING APPEARS TO BE AN EXPOSED GRAFT MATERIAL IN THE ANTERIOR VAGINAL WALL WITH SURROUNDING GRANULATION TISSUE. SHE IS ALSO HAVING URINARY INCONTINENCE SYMPTOMS, WHICH ARE CONSISTENT WITH URGE INCONTINENCE. ALSO LONGSTANDING FECAL INCONTINENCE SYMPTOMS ASSOCIATED WITH CHRONIC DIARRHEA. A RECTOCELE IS NOTED ON POP-Q EXAM.¿ RECORDS DATED (B)(6) 2012 INDICATE THE PATIENT WAS SEEN FOR FOLLOW UP SECONDARY TO VAGINAL BLEEDING AND URINARY INCONTINENCE SYMPTOMS. THE RECORDS STATE: ¿PATIENT CONTINUES TO HAVE VAGINAL BLEEDING. SHE WAS FOUND TO HAVE EVIDENCE OF GRAFT MATERIAL IN HER VAGINA AT HER INITIAL VISIT WITH ME. SHE HAS BEEN UNABLE TO HAVE INTERCOURSE BECAUSE OF HER BLEEDING AS WELL AS PAIN. PATIENT STATES THAT HER URINARY INCONTINENCE SYMPTOMS ARE UNCHANGED.¿ ASSESSMENT AND PLAN NOTES STATE: ¿PATIENT WITH VAGINAL BLEEDING AND EVIDENCE OF GRAFT MATERIAL IN THE VAGINA. PATIENT HAS PREVIOUSLY UNDERGONE A PUBOVAGINAL SLING WITH GORE-TEX MESH, AS WELL AS GORE-TEX SUTURE USED.¿ ¿SHE HAS URINARY INCONTINENCE, WHICH APPEARS TO BE PRIMARILY URGE INCONTINENCE BASED ON MULTICHANNEL URODYNAMIC TESTING TODAY. NO EVIDENCE OF FOREIGN BODY OR OTHER SIGNIFICANT FINDING ON CYSTOURETHROSCOPY. ASYMPTOMATIC RECTOCELE. LONGSTANDING FECAL INCONTINENCE, FOR WHICH THE PATIENT HAS YET TO SCHEDULE EVALUATION BY GI.¿ OPERATIVE RECORDS DATED (B)(6) 2012 INDICATE THE PATIENT UNDERWENT EXCISION OF PUBOVAGINAL SLING AND CYSTOSCOPY FOR DIAGNOSES OF ¿VAGINAL BLEEDING, HISTORY OF A PUBOVAGINAL SLING WITH A GORE-TEX GRAFT, EXPOSED GRAFT WITHIN THE VAGINA.¿ THE RECORDS STATE: ¿FINDINGS:¿APPROXIMATELY 1 CM AREA OF EXPOSED GORE-TEX MATERIAL AT THE MIDLINE OF THE ANTERIOR VAGINAL WALL APPROXIMATELY 5 CM PROXIMAL TO THE URETHRAL MEATUS.¿ ¿¿WITH GENTLE TRACTION, THE ENTIRE SLING WAS REMOVED.¿ ¿THE GRAFT AS WELL AS THE SUTURE MATERIAL WERE SENT IN TOTAL TO PATHOLOGY. THE GRAFT WAS NOTED TO BE FOLDED OVER ON ITSELF. HOWEVER, WHEN IT WAS FLATTENED, THE LENGTH OF THE GRAFT WAS APPROXIMATELY 5 CM AND THE WIDTH OF THE GRAFT WAS APPROXIMATELY 2 CM. THE SURROUNDING GRANULATION TISSUE WAS EXCISED AND SENT WITH THE EXCISED GRAFT.¿ ¿THE PATIENT TOLERATED THE PROCEDURE WELL.¿ A PATHOLOGY REPORT DATED (B)(6) 2012 REGARDING SPECIMENS COLLECTED (B)(6) 2012 INDICATE: ¿DIAGNOSIS: VAGINAL BIOPSY AND PUBOVAGINAL SLING REMOVAL: - GRANULATION TISSUE WITH ABUNDANT ACUTE AND CHRONIC INFLAMMATION. ¿ PUBOVAGINAL SLING (GROSS ONLY).¿ ¿RECEIVED IN FORMALIN¿IS A 3.5 X 1.5 X 0.2 CM PLASTIC PUBOVAGINAL SLING WITH ATTACHED 3 CM IN LENGTH STRINGS AT THE EDGE AND TWO PINK-RED SOFT TISSUE FRAGMENTS MEASURING 1 X 0.2 X 0.2 CM AND 0.3 X 0.2 X 0.2 CM.¿ RECORDS DATED (B)(6) 2012 INDICATE THE PATIENT WAS SEEN FOR POSTOPERATIVE FOLLOW UP, AND ¿PATIENT REPORTS THAT SHE IS DOING VERY WELL. HAS ONLY HAD 1 EPISODE OF INCONTINENCE SINCE SURGERY¿¿ ¿HAS NOTED VULVAR ITCHING AND BURNING SINCE LAST WEEKEND. GRADUALLY GETTING WORSE. TOOK CIPRO RECENTLY FOR UTI¿¿ ASSESSMENT AND PLAN NOTES STATE: ¿DOING WELL. INCISION HEALING WELL. SYMPTOMS AND EXAMINATION CONSISTENT WITH YEAST. WILL TREAT WITH DIFLUCAN¿¿ IT SHOULD BE NOTED THAT THE GORE-TEX® SOFT TISSUE PATCH INSTRUCTIONS FOR USE MENTIONS THE FOLLOWING WARNING, AMONG OTHERS: ¿WHEN USING THIS DEVICE AS A PERMANENT IMPLANT EXPOSURE OCCURS, TREAT TO AVOID CONTAMINATION OR DEVICE REMOVAL MAY BE NECESSARY." ¿POSSIBLE ADVERSE REACTIONS WITH THE USE OF ANY TISSUE DEFICIENCY PROSTHESIS MAY INCLUDE, BUT ARE NOT LIMITED TO, CONTAMINATION, INFECTION, INFLAMMATION, ADHESION, FISTULA FORMATION, SEROMA FORMATION, HEMATOMA, AND RECURRENCE.¿
CONCLUSION CODE REMAINS THE SAME. INVESTIGATION IS IN PROGRESS. ADDITIONAL DETAILS REGARDING THE PATIENT¿S CLINICAL COURSE WERE ASCERTAINED FROM A REVIEW OF MEDICAL RECORDS AND ARE AS FOLLOWS: OPERATIVE REPORT (B)(6) 2000: GORE-TEX USED IN PUBOVAGINAL SLING. OPERATIVE REPORT DATED (B)(6) 2012 INDICATES: "VAGINAL BLEEDING." "EXPOSED GRAFT WITHIN THE VAGINA." "FINDINGS:...APPROXIMATELY 1 CM AREA OF EXPOSED GORE-TEX GRAFT MATERIAL AT THE MIDLINE OF THE ANTERIOR VAGINAL WALL APPROXIMATELY 5 CM PROXIMAL TO THE URETHRAL MEATUS." "WITH GENITAL TRACTION, THE ENTIRE SLING WAS REMOVED."
(B)(4). ACCORDING TO INFORMATION RECEIVED FROM COMPLAINANT, DEVICE SERIAL NUMBER "(B)(4)" AND PART NUMBER 1415020010 WAS IMPLANTED ON (B)(6) 2000. GORE SERIAL NUMBERS DO NOT CONTAIN A HYPHEN. IN ADDITION, OUR RECORDS INDICATE THAT DEVICE SERIAL NUMBER "(B)(4)" WAS MANUFACTURED ON 9/10/2007, AFTER THE IMPLANT DATE, AND CORRESPONDS WITH PART NUMBER 132603402A, NOT PART NUMBER 1415020010 AS INDICATED BY THE COMPLAINANT'S INFORMATION. ALTHOUGH PART NUMBER 1415020010 CORRESPONDS WITH A GORE DEVICE, WE CANNOT CONFIRM THE SERIAL NUMBER IMPLANTED ON (B)(6) 2000 OR CONDUCT A REVIEW OF THE DEVICE HISTORY RECORDS WITHOUT FURTHER INFORMATION.
IT WAS REPORTED TO GORE THAT A PATIENT ALLEGES TO HAVE EXPERIENCED RECURRENCE, CHRONIC PAIN, EROSION, INFECTIONS, INCONTINENCE, DYSPAREUNIA, AND INFLAMMATION AFTER HAVING BEEN IMPLANTED WITH A GORE-TEX PRODUCT. IT WAS ALSO REPORTED THAT THE PATIENT UNDERWENT AN ADDITIONAL PROCEDURE APPROXIMATELY 12 YEARS LATER. ADDITIONAL EVENT SPECIFIC INFORMATION HAS NOT BEEN PROVIDED.
THIS REPORT IS BEING SUBMITTED AS A FOLLOW UP REPORT 2017233-2014-00251.
THIS REPORT IS BEING SUBMITTED AS FOLLOW UP REPORT #2 FOR 2017233-2014-00251.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 290945 | GORE-TEX® SOFT TISSUE PATCH | MESH, SURGICAL, POLYMERIC | FTL | W.L. GORE & ASSOCIATES | 5348195 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR | Required Intervention |