GORE DUALMESH PLUS BIOMATERIAL
Report
- Report Number
- 3003910212-2019-00004
- Event Type
- Injury
- Date Received
- January 4, 2019
- Date of Event
- October 26, 2012
- Report Date
- January 5, 2021
- Manufacturer
- W.L. GORE & ASSOCIATES
- Product Code
- FTL
- UDI-DI
- 00733132601110
- PMA / PMN Number
- K063435
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- 003
Narratives
UPDATED RESULTS CODE. CONCLUSIONS CODE REMAINS UNCHANGED.
H6: CONCLUSION CODE REMAINS UNCHANGED. THIS CLAIM WAS WITHDRAWN ON 4/10/20, AND THE ALLEGED PRODUCT COMPLAINT IS NO LONGER BEING PURSUED AT THIS TIME. THE INVESTIGATION WILL BE COMPLETED WITH THE AVAILABLE INFORMATION. CONCLUSION CODE REMAINS UNCHANGED UNTIL THE INVESTIGATION IS COMPLETE. W.L. GORE & ASSOCIATES, INC. (GORE) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY GORE, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. BLANK FIELDS PRESENT ON THIS REPORT INCLUDE REQUIRED FIELDS AND FIELDS DETERMINED TO BE NOT APPLICABLE. BLANK REQUIRED FIELDS INDICATE THAT THE INFORMATION WAS NOT PROVIDED, WAS DEEMED UNAVAILABLE OR WAS NOT APPLICABLE. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, GORE, OR ITS ASSOCIATES THAT THE DEVICE, GORE OR ITS ASSOCIATES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY "DEFECTS" OR HAS "MALFUNCTIONED". THESE WORDS ARE INCLUDED IN THE REPORT AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA, TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REPORTING PURSUANT TO PART 803. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT.
ADDITIONAL DETAILS REGARDING THE PATIENT'S CLINICAL COURSE WERE ASCERTAINED FROM A REVIEW OF MEDICAL RECORDS AND ARE AS FOLLOWS: RECORDS PRIOR TO (B)(6) 2012, INCLUDING RECORDS FOR THE ALLEGED 7/12/2010 GORE® DUALMESH® PLUS BIOMATERIAL IMPLANT PROCEDURE AND PRIOR ABDOMINAL PROCEDURES, WERE NOT PROVIDED. ADDITIONALLY, RECORDS DETAILING THE PATIENT¿S POSTOPERATIVE COURSE AFTER (B)(6) 2010 AND PRIOR TO (B)(6) 2012 WERE NOT PROVIDED. RECORDS DATED (B)(6) 2012 STATE THE PATIENT WAS SEEN FOR FOLLOW UP. ¿HAS GAINED 20 POUNDS IN THE PAST 6 MONTHS.¿ ABDOMINAL EXAM NOTES STATE: ¿NORMAL BOWEL SOUNDS, SOFT, HAS A 10CM DIAMETER VENTRAL HERNIA. NO SUPRAPUBIC TENDERNESS. NO PALPABLE HEPATOSPLENOMEGALY.¿ ASSESSMENT/PLAN NOTES STATE: ¿VENTRAL HERNIA - PLEASE CONSULT GEN SURGERY FOR ANOTHER OPINION ¿ [PATIENT] REPORTS THE HERNIA IS CAUSING DISCOMFORT AND SHE WOULD LIKE SURGERY FOR THIS.¿ RECORDS DATED (B)(6) 2012 STATE THE PATIENT PRESENTED ¿FOR EVALUATION OF AN EPIGASTRIC VENTRAL HERNIA. PREVIOUSLY SEEN IN (B)(6) 2011, BUT [SURGERIES] PRIMARILY IN THE LOWER ABDOMEN AND THOUGHT NOT RELATED TO THE HERNIA. RETURNS NOW FOR REASSESSMENT. HERNIA HAS GOTTEN BIGGER AND FEELS LIKE "SOMEONE HAS PUNCHED YOU IN THE SAME SPOT OVER AND OVER". ALSO WITH SOME NAUSEA. WOULD LIKE TO HAVE IT FIXED.¿ ABDOMINAL EXAM NOTES STATE: ¿REDUCIBLE MEDIUM SI[Z]ED VENTRAL HERNIA ABOVE AND TO THE RIGHT OF THE UMBILICUS. ALSO WITH UMBILICAL HERNIA.¿ RECORDS DATED (B)(6) 2012 STATE THE PATIENT WAS SEEN ¿¿.WITH AN ENLARGING, PAINFUL/CONSTANT SORENESS SUPRAUMBILICAL HERNIA THAT IS ASSOCIATED WITH INTERMITTENT NAUSEA. SHE HAS NOT HAD ANY HOSPITALIZATIONS R/T [SIC] THE HERNIA. SHE IS HERE TODAY FOR [HER] PRE-OP.¿ ABDOMINAL EXAM NOTES FROM THE VISIT STATE: ¿NONDISTENDED, SOFT, NON-TENDER. NO MASSES, NORMOACTIVE BOWEL SOUNDS, NO BRUITS. LOW MIDLINE SCAR. PORT SITE SCARS. 2-3 CM VERTICAL SCAR MIDLINE ABOVE UMBILICUS. SOFT, ROUND, REDUCIBLE TANGERINE SIZED SUPRAUMBILICAL BULGE [WITH]~4 CM DEFECT (WAS DIFFICULT TO ID ACTUAL DEFECT SIZE) TO THE LEFT OF MIDLINE. TINY, SOFT UMBILICAL HERNIA.¿ OPERATIVE RECORDS DATED (B)(6) 2012 STATE THE PATIENT UNDERWENT LAPAROSCOPIC INCISIONAL HERNIA REPAIR WITH MESH. ¿THE PATIENT IS A 55-YEAR-OLD FEMALE WITH AN ENLARGING AND PAINFUL SUPRAUMBILICAL HERNIA THAT IS ASSOCIATED WITH INTERMITTENT NAUSEA. SHE HAS NOT HAD ANY HOSPITALIZATIONS RELATED TO THIS HERNIA AND ELECTED TO HAVE IT REPAIRED.¿ FINDINGS FROM THE PROCEDURE STATE: ¿6 X 6 CM INCISIONAL HERNIA AND ONE 3 X 3 CM INCISIONAL HERNIA.¿ THE (B)(6) 2012 OPERATIVE REPORT STATES: ¿THE ABDOMINAL CAVITY WAS EXAMINED FOR SIGNS OF TRAUMA ASSOCIATED WITH THE INSUFFLATION AND THERE WERE NONE. THERE WERE COPIOUS AMOUNTS OF ADHESIONS. NEXT A 10 MM TROCAR WAS PLACED IN THE PATIENT'S LEFT LATERAL POSITION UNDER DIRECT VISUALIZATION. THEN USING A COMBINATION OF ELECTROCAUTERY AND SHARP DISSECTION, ALL ADHESIONS WERE TAKEN DOWN FROM THE ABDOMINAL WALL AND PREVIOUS GORTEX [SIC] MESH. THE ABDOMINAL DEFECT WAS IDENTIFIED AND IT WAS COMPLETELY REDUCED. THIS WAS MEASURED AT 6 X 6 CM. IT WAS CEPHALAD TO PRIOR HERNIA REPAIR. NEXT DURING THE PROCEDURES OF LYSIS OF ADHESIONS, A 3 X 3 CM DEFECT IN THE LEFT LOWER QUADRANT WAS ALSO SEEN. THIS WAS ALSO REDUCED. FIRST INCISION WAS TURNED TO THE 3 X 3 CM DEFECT. THIS WAS CLOSED PRIMARILY USING THE CARTER-THOMASON WITH 2-0 ETHIBOND AND WAS CLOSED PRIMARILY UNDER NO TENSION.¿ THE (B)(6) 2012 OPERATIVE REPORT STATES: ¿NEXT ATTENTION WAS TURNED TO THE LARGER 6 X 6 CM ABDOMINAL DEFECT. AN ECHO 15 X 20 CM MESH WAS PLACED INTO THE ABDOMINAL CAVITY. USING THE ECHO MESH PLACEMENT SYSTEM THE MESH WAS SECURED INTO PLACE WITH AT LEAST 4 CM OF OVERLAP OF THE DEFECT ON ALL SIDES. THEN USING THE SECURE STRAP, THE MESH WAS SUTURED INTO PLACE . THE ECHO MESH PLACEMENT SYSTEM WAS THEN REMOVED FROM THE ABDOMINAL CAVITY. THE ABDOMINAL CAVITY WAS INSPECTED FOR ANY SIGNS OF ANY ISSUES FROM TRAUMA. THERE WERE NONE AND THE MESH APPEARED TO BE IN GOOD POSITION. NEXT ALL PORTS WERE REMOVED UNDER DIRECT VISUALIZATION. JUST BEFORE THAT THE 10 MM PORT FASCIA WAS CLOSED USING THE CARTER-THOMASON WITH 2-0 ETHIBOND SUTURE. THE PATIENT'S ABDOMEN WAS DESUFFLATED. SHE WAS EXTUBATED WITHOUT DIFFICULTY. JUST BEFORE THAT HER INCISIONS WERE CLOSED WITH 4-0 MONOCRYL AND THE INCISIONS WERE DRESSED WITH DERMABOND.¿ THERE WAS NO MENTION OF GORE DEVICE REMOVAL IN THE RECORDS. X-RAY RESULTS DATED (B)(6) 2012 STATE: ¿SINGLE VIEW THE ABDOMEN SHOWS GASEOUS DISTENTION OF STACKED SMALL BOWEL LOOPS IN THE RIGHT HEMIABDOMEN MEASURING UP TO 4.8 CM IN DIAMETER. CLIPS, PRESUMABLY RELATED TO HERNIA REPAIR AND CHOLECYSTECTOMY ARE NOTED. THERE IS NO SUPINE EVIDENCE FOR FREE AIR. THE VISUALIZED BONES OF THE SPINE AND PELVIS ARE UNREMARKABLE. IMPRESSION: MILDLY DISTENDED LOOPS OF SMALL BOWEL, CORRELATE FOR SMALL BOWEL OBSTRUCTION.¿ DISCHARGE SUMMARY RECORDS DATED (B)(6) 2012 STATE: ¿56 [FEMALE] WAS ADMITTED AFTER A LAPAROSCOPIC INCISIONAL HERNIA REPAIR WITH MESH. TOLERATED THE PROCEDURE WELL WITH NO COMPLICATIONS. POST OP HAD AN UNEVENTFUL HOSPITAL COURSE.¿ RECORDS DATED (B)(6) 2012 STATE THE PATIENT WAS SEEN FOR FOLLOW UP. ¿55 YEAR OLD FEMALE REPORTS LEFT SIDE HURTS AND IT FEELS LIKE SOMETHING IS PUSHING IN THERE. FOR THE LAST 2 WEEKS. WHEN SHE STANDS OR SITS DOWN. NOT WHEN SHE¿S LYING DOWN OR STANDING UP. DOES NOT FEEL LIKE A HERNIA.¿ ¿[PATIENT] IS [STATUS POST] LAPAROSCOPIC INCISIONAL HERNIA REPAIR WITH MESH LAST MONTH. DOING WELL. SHE SEES THE SURGEONS TOMORROW.¿ ASSESSMENT/PLAN NOTES STATE: ¿[LEFT] ABDOMINAL PAIN NEAR LAPROSCOPIC SCAR. [STATUS POST] LAPAROSCOPIC INCISIONAL HERNIA REPAIR WITH MESH (B)(6) 2012. ABDOMINAL EXAM IS REASSURING. [PATIENT] IS AFEBRILE. SUSPECT RELATED TO HEALING FROM SURGERY.¿ RECORDS DATED (B)(6) 2012 STATE THE PATIENT WAS SEEN FOR FOLLOW UP. ¿55 [YEAR/OLD] WHITE FEMALE [STATUS POST] LAP VENTRAL HERNIA (B)(6) 2012. RETURNS NOW FOR HER SCHEDULED POSTOP VISIT.¿ ¿SOME BACK PAIN, OTHERWISE DOING OK.¿ ¿TROCAR SITES HEALING. + SEROMA BUT NOT RECURRENCE.¿ PERTINENT RECORDS BETWEEN (B)(6) 2012 AND (B)(6) 2015 WERE NOT PROVIDED. RECORDS DATED (B)(6) 2015 STATE: ¿SHE HAS A [HISTORY OF] DEVELOPING HERNIAS. SHE JUST NOTICED ¿A NEW HERNIA ON HER LEFT SIDE OF HER BELLY¿ THAT SHE BELIEVES IS ANOTHER HERNIA.¿ PERTINENT RECORDS BETWEEN (B)(6) 2015 AND (B)(6) 2017 WERE NOT PROVIDED. RECORDS DATED (B)(6) 2017 INDICATE A CT OF THE ABDOMEN AND PELVIS WAS PERFORMED FOR ¿DIARRHEA X 3 WEEKS.¿ ¿FINDINGS CONSISTENT WITH PRIOR CHOLECYSTECTOMY.¿ ¿FINDINGS CONSISTENT WITH HISTORY OF VENTRAL ABDOMINAL HERNIA. LARGE LEFT LATERAL VENTRAL BOWEL FILLED HERNIA WITHOUT EVIDENCE OF OBSTRUCTION. LAXITY OF THE INTRA-ABDOMINAL WALL.¿ ¿IMPRESSION: LARGE LEFT LATERAL VENTRAL BOWEL FILLED HERNIA WITHOUT EVIDENCE OF OBSTRUCTION.¿ RECORDS DATED (B)(6) 2018 STATE: ¿SHE REPORTS WORSENING/GROWING OF LEFT ABDOMINAL VENTRAL HERNIA OVER THE LAST YEAR. DENIES SIGNS/SYMPTOMS OF STRANGULATION.¿ RECORDS DATED (B)(6) 2018 STATE: ¿61-YEAR-OLD WHITE FEMALE PRESENTS WITH AN ABDOMINAL WALL HERNIA. SHE IS WELL-KNOWN TO OUR SERVICE HAVING UNDERGONE LAPAROSCOPIC CHOLECYSTECTOMY IN 2010. LAPAROSCOPIC REPAIR OF AN EPIGASTRIC HERNIA WAS PERFORMED SEVERAL MONTHS LATER. SHE DEVELOPED A RECURRENCE AND ANOTHER LAPAROSCOPIC REPAIR WAS PERFORMED OF THE EPIGASTRIC HERNIA. AT THAT TIME AND ATTEMPTED LAPAROSCOPIC PRIMARY CLOSURE OF A LEFT LOWER QUADRANT ABDOMINAL WALL HERNIA WAS ALSO PERFORMED. I CANNOT DISCERN FROM THE OPERATIVE REPORT WHETHER OR NOT AN ATTEMPT WAS MADE TO COVER THIS REPAIR WITH MESH. SHE HAS DEVELOPED A SMALL RECURRENCE OF HER EPIGASTRIC HERNIA AND AN ENLARGING, UNCOMFORTABLE PROTRUSION IN THE LEFT LOWER QUADRANT. SHE HAD PREVIOUSLY UNDERGONE GYNECOLOGIC SURGERY WITH A LOWER MIDLINE SCAR EXTENDING ABOVE THE UMBILICUS. SHE DENIES CARDIORESPIRATORY DISEASE AND DOES NOT SMOKE.¿ THE (B)(6) 2018 RECORDS STATE: ¿THERE IS A LOW MIDLINE SCAR EXTENDING ABOVE THE UMBILICUS. A MODEST PROTRUSION IS PRESENT IN THE EPIGASTRIUM . AN ORANGE-SIZED PROTRUSION IS PRESENT IN THE LEFT LOWER QUADRANT WITH A SEVERAL CENTIMETER DEFECT PALPABLE. CT SCAN HAD BEEN PERFORMED FOR ENTERITIS RECENTLY AND THE HERNIA IS WELL DEMONSTRATED LATERAL TO PREVIOUSLY PLACED MESH MATERIAL IN THE LEFT LOWER QUADRANT.¿ ¿ASSESSMENT: RECURRENT LEFT LOWER QUADRANT ABDOMINAL WALL HERNIA, POSSIBLE PORT SITE RISPERDAL [SIC] AND HERNIA.¿ ¿PLAN: GIVEN THE EXTENSIVE NATURE OF HER ABDOMINAL SURGERY WITH 2 PREVIOUSLY PLACED MESHES, WE WILL PLAN DIRECT OPEN REPAIR OF THIS HERNIA WITH ¿SANDWICH-TYPE¿ MESH REPAIR.¿ OPERATIVE RECORDS DATED 8/6/2018 STATE THE PATIENT UNDERWENT ¿OPEN LATERAL VENTRAL HERNIA REPAIR WITH MESH AND LYSIS OF ADHESIONS X30 MINUTES.¿ POST-OPERATIVE DIAGNOSIS STATES: ¿LEFT LATERAL VENTRAL HERNIA, RECURRENT.¿ FINDINGS FROM THE PROCEDURE STATE: ¿LEFT LATERAL VENTRAL HERNIA RECURRENT LATERAL TO PRIOR MESH REPAIR. EVIDENCE OF PRIOR LAPAROSCOPIC LATERAL VENTRAL HERNIA REPAIR WITH MESH AND METAL TACKS. MODERATE ADHESIONS BETWEEN SMALL BOWEL AND ANTERIOR ABDOMINAL WALL.¿ INDICATIONS FOR THE (B)(6) 2018 PROCEDURE STATE: ¿THIS PATIENT IS A 61-YEAR-OLD FEMALE WHO PRESENTED TO OUR CLINIC WITH COMPLAINTS OF A LEFT LOWER QUADRANT ABDOMINAL WALL HERNIA. SHE WAS KNOWN TO OUR SERVICE FROM HAVING UNDERGONE A LAPAROSCOPIC CHOLECYSTECTOMY IN 2010, WITH LAPAROSCOPIC REPAIR OF AN EPIGASTRIC HERNIA SOME MONTHS AFTER THAT. HER LAPAROSCOPIC EPIGASTRIC HERNIA REPAIR RECURRED AND SHE UNDERWENT A SECOND LAPAROSCOPIC REPAIR SOMETIME AFTER THAT, AND DURING THAT THE SECOND OPERATION A PRIMARY CLOSURE OF THE LEFT LOWER QUADRANT ABDOMINAL WALL HERNIA WAS PERFORMED. IT IS BELIEVED THAT THIS WAS PERFORMED LAPAROSCOPICALLY AND WITH MESH. SINCE THAT TIME, SHE HAS DEVELOPED AN UNCOMFORTABLE BULGE IN HER LEFT LOWER QUADRANT AND WISHED TO HAVE IT REPAIRED.¿ THE (B)(6) 2018 OPERATIVE REPORT STATES: ¿A NUMBER 10 SCALPEL WAS USED TO INCISE THE SKIN AND DISSECTION WAS CARRIED OUT WITH ELECTROCAUTERY UNTIL THE HERNIA SAC AND FASCIA WERE ENCOUNTERED. THIS SAC WAS CLEARED OF OVERLYING ADHERENT TISSUE AND THE FASCIA WAS SIMILARLY CLEANED. THE HERNIA SAC WAS OPENED AND INSPECTION OF THE ABDOMINAL CONTENTS REVEALED MODERATE ADHESIONS BETWEEN THE SMALL BOWEL AND THE ANTERIOR ABDOMINAL WALL. THE HERNIA DEFECT WAS LATERAL TO THE PRIOR LAPAROSCOPIC REPAIR WITH MESH AND METAL TACKS.¿ THE (B)(6) 2018 OPERATIVE REPORT CONTINUES: ¿WE SHARPLY LYSED THE ADHESIONS TO ALLOW SPACE FOR OUR 8 CM VENTRALEX MESH. A TOTAL OF 4 DOUBLE-ARMED PROLENE SUTURES WERE PLACED IN THE SUPERIOR, INFERIOR AND LATERAL ASPECTS OF THE CIRCULAR MESH. EACH NEEDLE WAS THEN BROUGHT INTO THE FASCIAL DEFECT THROUGH THE PERITONEUM AND A LARGE BITE OF FASCIA WAS TAKEN WITH EACH NEEDLE AND THEN THE 2 ARMS OF EACH SUTURE WERE TIED TO ONE ANOTHER AFTER PLACING THE MESH IN THE DEFECT, SECURING THE MESH IN 4 SPOTS. THE SUBCUTANEOUS SPACE WAS THEN REAPPROXIMATED WITH FOUR 3-0 VICRYL SIMPLE INTERRUPTED SUTURES TO OBLITERATE THE DEAD SPACE. THE SKIN WAS REAPPROXIMATED WITH 4-0 MONOCRYL IN A SUBCUTICULAR RUNNING FASHION AND DERMABOND SKIN GLUE WAS APPLIED OVER THE CLOSED INCISION.¿ THE RECORDS INDICATE A BARD VENTRALEX MESH (NON-GORE DEVICE) WAS IMPLANTED DURING THE PROCEDURE. THERE WAS NO MENTION OF THE GORE DEVICE IN THE RECORDS AND NO MENTION OF DEVICE REMOVAL. DISCHARGE SUMMARY RECORDS DATED (B)(6) 2018 STATE: ¿[THE PATIENT] IS A PLEASANT 61 [YEAR OLD] [FEMALE] WITH HISTORY OF LAPAROSCOPIC CHOLECYSTECTOMY IN 2010. LAPAROSCOPIC REPAIR OF AN EPIGASTRIC HERNIA WAS PERFORMED SEVERAL MONTHS LATER. SHE HAS DEVELOPED A SMALL RECURRENCE OF HER EPIGASTRIC HERNIA AND AN ENLARGING, UNCOMFORTABLE PROTRUSION IN THE LEFT LOWER QUADRANT. ON 8/6/18 SHE UNDERWENT UNEVENTFUL REPAIR OF HER HERNIA AND HER POSTOPERATIVE COURSE HAS BEEN UNEVENTFUL.¿ A PATHOLOGY REPORT DATED (B)(6) 2018 REGARDING A SPECIMEN COLLECTED (B)(6) 2018 STATES: ¿SPECIMEN RECEIVED: LEFT HERNIA SAC.¿ ¿GROSS DESCRIPTION: THE SPECIMEN IS RECEIVED IN FORMALIN LABELED¿¿L. HERNIA SAC.¿ THE SPECIMEN CONSISTS OF 8.5 X 5.5 CM MEMBRANOUS TISSUE WITH AN AVERAGE THICKNESS OF 0.2 CM. THE CUT SURFACES ARE UNREMARKABLE THROUGHOUT. NO INDURATED OR IRREGULAR AREAS ARE PRESENT. MICROSCOPIC EXAM/DIAGNOSIS: LEFT HERNIA SAC, HERNIA REPAIR: -FIBROMEMBRANOUS TISSUE, CONSISTENT WITH HERNIA SAC.¿ A POTENTIAL RELATIONSHIP, IF ANY, BETWEEN THE ALLEGED INJURIES OR COMPLICATIONS AND THE GORE DEVICE IS UNCLEAR FROM THE PROVIDED INFORMATION AT THIS TIME. IT SHOULD BE NOTED THAT THE GORE DUALMESH® PLUS BIOMATERIAL INSTRUCTIONS FOR USE INCLUDES WARNINGS AND ADDRESSES THE FOLLOWING ADVERSE REACTIONS AMONG OTHERS: ¿POSSIBLE ADVERSE REACTIONS WITH THE USE OF ANY TISSUE DEFICIENCY PROSTHESIS MAY INCLUDE, BUT ARE NOT LIMITED TO, CONTAMINATION, INFECTION, INFLAMMATION, ADHESION, FISTULA FORMATION, SEROMA FORMATION, HEMATOMA, AND RECURRENCE.¿ W.L. GORE & ASSOCIATES, INC. (GORE) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY GORE, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. BLANK FIELDS PRESENT ON THIS REPORT INCLUDE REQUIRED FIELDS AND FIELDS DETERMINED TO BE NOT APPLICABLE. BLANK REQUIRED FIELDS INDICATE THAT THE INFORMATION WAS NOT PROVIDED, WAS DEEMED UNAVAILABLE OR WAS NOT APPLICABLE. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, GORE, OR ITS ASSOCIATES THAT THE DEVICE, GORE OR ITS ASSOCIATES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY "DEFECTS" OR HAS "MALFUNCTIONED". THESE WORDS ARE INCLUDED IN THE REPORT AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA, TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REPORTING PURSUANT TO PART 803. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT.
H6: UPDATED PATIENT CODES. H6: UPDATED DEVICE CODE. H6: UPDATED CONCLUSION CODES. PREVIOUS PATIENT CODES (1994; 3191: APPROPRIATE TERM/CODE NOT AVAILABLE FOR ¿MESH FAILURE¿) WERE REPORTED BASED ON THE ORIGINAL COMPLAINT AND ARE NO LONGER APPLICABLE PER GORE¿S INVESTIGATION. THIS CLAIM WAS WITHDRAWN, AND THE ALLEGED PRODUCT COMPLAINT IS NO LONGER BEING PURSUED AT THIS TIME. NO FURTHER INVESTIGATION IS REQUIRED AT THIS TIME. BASED UPON GORE¿S INVESTIGATION THERE IS NO AVAILABLE INFORMATION THAT REASONABLY SUGGESTS THAT A GORE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO DEATH, SERIOUS INJURY OR REPORTABLE MALFUNCTION, AND IS NO LONGER CONSIDERED REPORTABLE. THE FOLLOWING INFORMATION WAS DETERMINED FROM THE MEDICAL RECORDS. MEDICAL RECORDS: THE KNOWN MEDICAL RECORDS SPAN (B)(6) 2012 THROUGH (B)(6) 2018 AND NOT ALL RECORDS RECEIVED IN THIS TIME SPAN ARE RELEVANT TO THE GORE® DUALMESH® PLUS BIOMATERIAL. MEDICAL RECORDS FROM (B)(6) 2012 THROUGH (B)(6) 2017 AND WERE NOT PROVIDED. PATIENT INFORMATION: MEDICAL HISTORY: GASTROESOPHAGEAL REFLUX DISEASE [GERD], CHRONIC LOW BACK PAIN, OBESITY. PRIOR SURGICAL PROCEDURES: IN 1972: APPENDECTOMY, IN 2003: HYSTERECTOMY, IN 2010: LAPAROSCOPIC CHOLECYSTECTOMY. IMPLANT PREOPERATIVE COMPLAINTS: [NO RECORDS PROVIDED]. IMPLANT PROCEDURE: [NO RECORDS PROVIDED]. IMPLANT DATE: (B)(6) 2010 [NO RECORDS PROVIDED]. RELEVANT MEDICAL INFORMATION: ON (B)(6) 2012: ¿HAS GAINED 20 POUNDS IN THE PAST 6 MONTHS.¿ ¿NORMAL BOWEL SOUNDS, SOFT, HAS A 10CM DIAMETER VENTRAL HERNIA.¿ ¿VENTRAL HERNIA - PLEASE CONSULT GEN SURGERY FOR ANOTHER OPINION ¿ [PATIENT] REPORTS THE HERNIA IS CAUSING DISCOMFORT AND SHE WOULD LIKE SURGERY FOR THIS.¿ ON (B)(6) 2012: ¿ FOR EVALUATION OF AN EPIGASTRIC VENTRAL HERNIA. PREVIOUSLY SEEN IN (B)(6) 2011, BUT [SURGERIES] PRIMARILY IN THE LOWER ABDOMEN AND THOUGHT NOT RELATED TO THE HERNIA. RETURNS NOW FOR REASSESSMENT. HERNIA HAS GOTTEN BIGGER AND FEELS LIKE ¿SOMEONE HAS PUNCHED YOU IN THE SAME SPOT OVER AND OVER.¿ ALSO WITH SOME NAUSEA. WOULD LIKE TO HAVE IT FIXED.¿ EXAM: ¿REDUCIBLE MEDIUM SI[Z]ED VENTRAL HERNIA ABOVE AND TO THE RIGHT OF THE UMBILICUS. ALSO WITH UMBILICAL HERNIA.¿ ON (B)(6) 2012: ¿WITH AN ENLARGING, PAINFUL/CONSTANT SORENESS SUPRAUMBILICAL HERNIA THAT IS ASSOCIATED WITH INTERMITTENT NAUSEA. SHE HAS NOT HAD ANY HOSPITALIZATIONS R/T [SIC] THE HERNIA. SHE IS HERE TODAY FOR [HER] PRE-OP.¿ EXAM: ¿NONDISTENDED, SOFT, NON-TENDER. NO MASSES, NORMOACTIVE BOWEL SOUNDS, NO BRUITS. LOW MIDLINE SCAR. PORT SITE SCARS. 2-3 CM VERTICAL SCAR MIDLINE ABOVE UMBILICUS. SOFT, ROUND, REDUCIBLE TANGERINE SIZED SUPRAUMBILICAL BULGE [WITH]~4 CM DEFECT (WAS DIFFICULT TO ID ACTUAL DEFECT SIZE) TO THE LEFT OF MIDLINE. TINY, SOFT UMBILICAL HERNIA.¿ ON (B)(6) 2012 [HOSPITALIZATION (B)(6) 2012] INCISIONAL HERNIA REPAIR WITH MESH. ¿THE ABDOMINAL CAVITY WAS EXAMINED FOR SIGNS OF TRAUMA ASSOCIATED WITH THE INSUFFLATION AND THERE WERE NONE. THERE WERE COPIOUS AMOUNTS OF ADHESIONS. NEXT A 10 MM TROCAR WAS PLACED IN THE PATIENT'S LEFT LATERAL POSITION UNDER DIRECT VISUALIZATION. THEN USING A COMBINATION OF ELECTROCAUTERY AND SHARP DISSECTION, ALL ADHESIONS WERE TAKEN DOWN FROM THE ABDOMINAL WALL AND PREVIOUS GORTEX [SIC] MESH. THE ABDOMINAL DEFECT WAS IDENTIFIED AND IT WAS COMPLETELY REDUCED. THIS WAS MEASURED AT 6 X 6 CM. IT WAS CEPHALAD TO PRIOR HERNIA REPAIR. NEXT DURING THE PROCEDURES OF LYSIS OF ADHESIONS, A 3 X 3 CM DEFECT IN THE LEFT LOWER QUADRANT WAS ALSO SEEN. THIS WAS ALSO REDUCED. FIRST INCISION WAS TURNED TO THE 3 X 3 CM DEFECT. THIS WAS CLOSED PRIMARILY USING THE CARTER-THOMASON WITH 2-0 ETHIBOND AND WAS CLOSED PRIMARILY UNDER NO TENSION.¿ ¿NEXT ATTENTION WAS TURNED TO THE LARGER 6 X 6 CM ABDOMINAL DEFECT. AN ECHO 15 X 20 CM MESH WAS PLACED INTO THE ABDOMINAL CAVITY. USING THE ECHO MESH PLACEMENT SYSTEM THE MESH WAS SECURED INTO PLACE WITH AT LEAST 4 CM OF OVERLAP OF THE DEFECT ON ALL SIDES. THEN USING THE SECURE STRAP, THE MESH WAS SUTURED INTO PLACE. THE ECHO MESH PLACEMENT SYSTEM WAS THEN REMOVED FROM THE ABDOMINAL CAVITY. THE ABDOMINAL CAVITY WAS INSPECTED FOR ANY SIGNS OF ANY ISSUES FROM TRAUMA. THERE WERE NONE AND THE MESH APPEARED TO BE IN GOOD POSITION.¿ THERE WAS NO MENTION OF GORE DEVICE REMOVAL IN THE RECORDS. ON (B)(6) 2012: ¿REPORTS LEFT SIDE HURTS AND IT FEELS LIKE SOMETHING IS PUSHING IN THERE. FOR THE LAST 2 WEEKS. WHEN SHE STANDS OR SITS DOWN. NOT WHEN SHE¿S LYING DOWN OR STANDING UP. DOES NOT FEEL LIKE A HERNIA.¿ ¿[PATIENT] IS [STATUS POST] LAPAROSCOPIC INCISIONAL HERNIA REPAIR WITH MESH LAST MONTH. DOING WELL. SHE SEES THE SURGEONS TOMORROW.¿ ASSESSMENT/PLAN NOTES STATE: ¿[LEFT] ABDOMINAL PAIN NEAR LAPAROSCOPIC SCAR. [STATUS POST] LAPAROSCOPIC INCISIONAL HERNIA REPAIR WITH MESH (B)(6) 2012. ABDOMINAL EXAM IS REASSURING. [PATIENT] IS AFEBRILE. SUSPECT RELATED TO HEALING FROM SURGERY.¿ ON (B)(6) 2012: ¿SOME BACK PAIN, OTHERWISE DOING OK.¿ ¿+ SEROMA BUT NOT RECURRENCE.¿ ON (B)(6) 2015: ¿SHE HAS A [HISTORY OF] DEVELOPING HERNIAS. SHE JUST NOTICED ¿A NEW HERNIA ON HER LEFT SIDE OF HER BELLY¿ THAT SHE BELIEVES IS ANOTHER HERNIA.¿ ON (B)(6) 2017: CT ABDOMEN: ¿IMPRESSION: LARGE LEFT LATERAL VENTRAL BOWEL FILLED HERNIA WITHOUT EVIDENCE OF OBSTRUCTION.¿ ON (B)(6) 2018: ¿SHE REPORTS WORSENING/GROWING OF LEFT ABDOMINAL VENTRAL HERNIA OVER THE LAST YEAR. DENIES SIGNS/SYMPTOMS OF STRANGULATION.¿ ON (B)(6) 2018: "PRESENTS WITH AN ABDOMINAL WALL HERNIA. SHE IS WELL-KNOWN TO OUR SERVICE HAVING UNDERGONE LAPAROSCOPIC CHOLECYSTECTOMY IN 2010. LAPAROSCOPIC REPAIR OF AN EPIGASTRIC HERNIA WAS PERFORMED SEVERAL MONTHS LATER. SHE DEVELOPED A RECURRENCE AND ANOTHER LAPAROSCOPIC REPAIR WAS PERFORMED OF THE EPIGASTRIC HERNIA. AT THAT TIME AND ATTEMPTED LAPAROSCOPIC PRIMARY CLOSURE OF A LEFT LOWER QUADRANT ABDOMINAL WALL HERNIA WAS ALSO PERFORMED. I CANNOT DISCERN FROM THE OPERATIVE REPORT WHETHER OR NOT AN ATTEMPT WAS MADE TO COVER THIS REPAIR WITH MESH. SHE HAS DEVELOPED A SMALL RECURRENCE OF HER EPIGASTRIC HERNIA AND AN ENLARGING, UNCOMFORTABLE PROTRUSION IN THE LEFT LOWER QUADRANT.¿ ON (B)(6) 2018: ¿OPEN LATERAL VENTRAL HERNIA REPAIR WITH MESH AND LYSIS OF ADHESIONS X30 MINUTES.¿ ¿A NUMBER 10 SCALPEL WAS USED TO INCISE THE SKIN AND DISSECTION WAS CARRIED OUT WITH ELECTROCAUTERY UNTIL THE HERNIA SAC AND FASCIA WERE ENCOUNTERED. THIS SAC WAS CLEARED OF OVERLYING ADHERENT TISSUE AND THE FASCIA WAS SIMILARLY CLEANED. THE HERNIA SAC WAS OPENED AND INSPECTION OF THE ABDOMINAL CONTENTS REVEALED MODERATE ADHESIONS BETWEEN THE SMALL BOWEL AND THE ANTERIOR ABDOMINAL WALL. THE HERNIA DEFECT WAS LATERAL TO THE PRIOR LAPAROSCOPIC REPAIR WITH MESH AND METAL TACKS.¿ ¿WE SHARPLY LYSED THE ADHESIONS TO ALLOW SPACE FOR OUR 8 CM VENTRALEX MESH. A TOTAL OF 4 DOUBLE-ARMED PROLENE SUTURES WERE PLACED IN THE SUPERIOR, INFERIOR AND LATERAL ASPECTS OF THE CIRCULAR MESH. EACH NEEDLE WAS THEN BROUGHT INTO THE FASCIAL DEFECT THROUGH THE PERITONEUM AND A LARGE BITE OF FASCIA WAS TAKEN WITH EACH NEEDLE AND THEN THE 2 ARMS OF EACH SUTURE WERE TIED TO ONE ANOTHER AFTER PLACING THE MESH IN THE DEFECT, SECURING THE MESH IN 4 SPOTS. THE SUBCUTANEOUS SPACE WAS THEN REAPPROXIMATED WITH FOUR 3-0 VICRYL SIMPLE INTERRUPTED SUTURES TO OBLITERATE THE DEAD SPACE. THE SKIN WAS REAPPROXIMATED WITH 4-0 MONOCRYL IN A SUBCUTICULAR RUNNING FASHION AND DERMABOND SKIN GLUE WAS APPLIED OVER THE CLOSED INCISION.¿ THE RECORDS INDICATE A BARD VENTRALEX MESH (NON-GORE DEVICE) WAS IMPLANTED DURING THE PROCEDURE. THERE WAS NO MENTION OF THE GORE DEVICE IN THE RECORDS AND NO MENTION OF DEVICE REMOVAL. CONCLUSION: IT SHOULD BE NOTED THAT THE GORE® DUALMESH® PLUS BIOMATERIAL INSTRUCTIONS FOR USE INCLUDES WARNINGS AND ADDRESSES THE FOLLOWING ADVERSE REACTIONS AMONG OTHERS: ¿POSSIBLE ADVERSE REACTIONS WITH THE USE OF ANY TISSUE DEFICIENCY PROSTHESIS MAY INCLUDE, BUT ARE NOT LIMITED TO, CONTAMINATION, INFECTION, INFLAMMATION, ADHESION, FISTULA FORMATION, SEROMA FORMATION, HEMATOMA, AND RECURRENCE.¿ AS WITH ANY SURGICAL PROCEDURE, THERE ARE ALWAYS RISKS OF COMPLICATIONS FOR SURGICAL REPAIR OF HERNIAS AND SOFT TISSUE DEFICIENCIES, WITH OR WITHOUT MESH. THESE MAY INCLUDE BUT ARE NOT LIMITED TO, ADHESIONS AND RELATED HARMS, BLEEDING, BOWEL OBSTRUCTION, DYSPHAGIA, EROSION OR EXTRUSION AND RELATED HARMS, EXPOSURE OR PROTRUSION AND RELATED HARMS, FEVER, FISTULA, GERD RECURRENCE, RECURRENCE, ILEUS, INCREASED PROCEDURE TIME AND RELATED HARMS, IRRITATION OR INFLAMMATION, INFECTION, PAIN, PARESTHESIA, PERFORATION, REVISION / RE-INTERVENTION, SEROMA OR HEMATOMA AND RELATED HARMS, WOUND COMPLICATIONS AND WOUND DEHISCENCE. MANY OF THE POTENTIAL COMPLICATIONS ARE ASSOCIATED WITH THE PATIENT¿S UNDERLYING DISEASE PROGRESSION, CO-MORBIDITIES, ADDITIONAL MEDICAL HISTORY AND/OR OTHER SURGICAL PROCEDURES. THE ABOVE INHERENT RISKS ARE TYPICALLY DETAILED IN STANDARD INFORMED CONSENT DOCUMENTS. BASED UPON THE INFORMATION RECEIVED, THE DEVICE REMAINS IN THE PATIENT AND WAS NOT AVAILABLE FOR EVALUATION. AFTER MULTIPLE REQUESTS, PRODUCT IDENTIFICATION INFORMATION WAS NOT PROVIDED FOR THIS DEVICE AND THUS IT COULD NOT BE CONFIRMED TO BE A GORE HERNIA DEVICE. REVIEW OF THE MANUFACTURING AND STERILIZATION RECORDS COULD NOT BE PERFORMED AS A VALID LOT NUMBER WAS NOT PROVIDED. IN AN ABUNDANCE OF CAUTION FOR PRODUCT SURVEILLANCE TRACKING AND TRENDING PURPOSES ONLY, THIS EVENT HAS BEEN ANALYZED, CODED AND REPORTED AS NECESSARY ASSUMING IT IS A GORE HERNIA DEVICE. ALL AVAILABLE INFORMATION HAS BEEN PLACED ON FILE FOR USE IN PRODUCT SURVEILLANCE TRACKING, TRENDING AND FOLLOW-UP. SECTION C1: NAME: PLUS ANTIMICROBIAL PRODUCT COATING. MANUFACTURER/COMPOUNDER: W. L. GORE & ASSOCIATES, INC. LOT NUMBER: 06454216. ADDITIONAL MANUFACTURER NARRATIVE: THE PLUS ANTIMICROBIAL PRODUCT COATING CONTAINS SILVER CARBONATE [APPROXIMATELY 800 MICROGRAMS PER CUBIC CENTIMETER OF PRODUCT (G/CM3)], AND CHLORHEXIDINE DIACETATE [APPROXIMATELY 1600 MICROGRAMS PER CUBIC CENTIMETER OF PRODUCT (G/CM3)]. W.L. GORE & ASSOCIATES, INC. (GORE) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY GORE, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. BLANK FIELDS PRESENT ON THIS REPORT INCLUDE REQUIRED FIELDS AND FIELDS DETERMINED TO BE NOT APPLICABLE. BLANK REQUIRED FIELDS INDICATE THAT THE INFORMATION WAS NOT PROVIDED, WAS DEEMED UNAVAILABLE OR WAS NOT APPLICABLE. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, GORE, OR ITS ASSOCIATES THAT THE DEVICE, GORE OR ITS ASSOCIATES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY "DEFECTS" OR HAS "MALFUNCTIONED". THESE WORDS ARE INCLUDED IN THE REPORT AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA, TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REPORTING PURSUANT TO PART 803. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT.
ADDED MEDICAL HISTORY. (B)(4). (B)(6). IT SHOULD BE NOTED THAT THE GORE DUALMESH® PLUS BIOMATERIAL INSTRUCTIONS FOR USE INCLUDES WARNINGS AND ADDRESSES THE FOLLOWING ADVERSE REACTIONS AMONG OTHERS: ¿POSSIBLE ADVERSE REACTIONS WITH THE USE OF ANY TISSUE DEFICIENCY PROSTHESIS MAY INCLUDE, BUT ARE NOT LIMITED TO, CONTAMINATION, INFECTION, INFLAMMATION, ADHESION, FISTULA FORMATION, SEROMA FORMATION, HEMATOMA, AND RECURRENCE.¿
IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT OPEN VENTRAL HERNIA REPAIR ON (B)(6) 2010 WHEREBY A GORE DUALMESH® PLUS BIOMATERIAL WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2012, AN ADDITIONAL PROCEDURE OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: ADDITIONAL SURGERY, MESH REMOVAL, MESH FAILURE, AND PAIN. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 11585 | GORE DUALMESH PLUS BIOMATERIAL | MESH, SURGICAL, POLYMERIC | FTL | W.L. GORE & ASSOCIATES | 1DLMCP04 | 06454216 | 00733132601110 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 55 YR | Hospitalization| R |