UNKNOWN
Report
- Report Number
- 3003910212-2019-00189
- Event Type
- Injury
- Date Received
- July 2, 2019
- Date of Event
- November 4, 2010
- Report Date
- September 22, 2021
- Manufacturer
- W.L. GORE & ASSOCIATES
- Product Code
- OWT
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- 003
Narratives
PREVIOUS PATIENT CODES (1994, 3191: APPROPRIATE TERM/CODE BEING USED FOR ¿PROTRUSION OF MESH INTO THE UMBILICUS¿) WERE REPORTED BASED ON THE ORIGINAL COMPLAINT AND ARE NO LONGER APPLICABLE PER GORE¿S INVESTIGATION. 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. THEREFORE, THIS EVENT IS BEING CODED AS NO CLINICAL SIGNS, SYMPTOMS OR CONDITIONS, NO HEALTH CONSEQUENCES OR IMPACT AND WILL BE CLOSED AS FALSE CLAIM AND NO PROBLEM DETECTED. MEDICAL RECORDS: THE KNOWN MEDICAL RECORDS SPAN (B)(6) 2010 THROUGH (B)(6) 2010 AND NOT ALL RECORDS RECEIVED IN THIS TIME SPAN ARE RELEVANT TO THE UNKNOWN GORE DEVICE. PATIENT INFORMATION: MEDICAL HISTORY: DIVERTICULOSIS; DIVERTICULITIS; SEROMA REQUIRING DRAINING; OBESITY; (B)(6) 2010: 265.5 LBS.; (B)(6) 2010: 271 LBS. SURGICAL PROCEDURES: (B)(6): OPEN SIGMOID COLECTOMY FOR DIVERTICULOSIS AND DIVERTICULITIS. (B)(6) 2010: SIGMOIDOSCOPY, FUNCTIONAL DIAGNOSTIC WITHOUT COLLECTION OF SPECIMEN. LAPAROSCOPIC SURGICAL REPAIR OF VENTRAL HERNIA, REDUCIBLE. IMPLANT: GORE® DUALMESH® BIOMATERIAL. IMPLANT PREOPERATIVE COMPLAINTS: (B)(6) 2010: INDICATION: ¿THE PATIENT IS A 32-YEAR-OLD HISPANIC MALE WHO UNDERWENT AN OPEN SIGMOID COLECTOMY FOR DIVERTICULOSIS AND SEVERAL BOUTS OF DIVERTICULITIS WITH ONE COMPLICATED BY THE DIVERTICULITIS. HE HAD AN ELECTIVE SIGMOID COLECTOMY AT THE TIME AND HE RECOVERED FROM THIS UNEVENTFULLY, HOWEVER, IN OUTPATIENT SETTING DID DEVELOP A SEROMA OF THE WOUND WHICH REQUIRED DRAINAGE THROUGH THE SUPERIOR PORTION OF HIS MIDLINE WOUND. IT WAS DRAINED AND PACKED AND EVENTUALLY HEALED WITHOUT ANY COMPLICATIONS. THIS WAS ORIGINALLY DONE BACK IN (B)(6) 2009. THE PATIENT PRESENTED TO THE CLINIC TOWARD THE END OF FEBRUARY COMPLAINING THAT HE HAD FOUND A NEW BULGE IN HIS ABDOMINAL WALL AROUND HIS UMBILICUS. ON EXAMINATION, HE WAS FOUND TO HAVE AN UMBILICAL HERNIA.¿ IMPLANT PROCEDURE: SIGMOIDOSCOPY, FUNCTIONAL DIAGNOSTIC WITHOUT COLLECTION OF SPECIMEN. LAPAROSCOPIC SURGICAL REPAIR OF VENTRAL HERNIA, REDUCIBLE. [IMPLANT: GORE® DUALMESH® BIOMATERIAL. PRODUCT ID NOT AVAILABLE]. IMPLANT DATE: (B)(6 2010: FINDINGS: ¿TWO SMALL VENTRAL HERNIAS, ONE AROUND THE UMBILICUS THAT WAS APPROXIMATELY 3 X 5CM. ONE IN THE LEFT LOWER QUADRANT THAT WAS ABOUT 1 X 1CM AND SUBXIPHOID 2.2CM DEFECT. THE SWISS-CHEESE DEFECTS WERE COVERED UP WITH A PIECE OF GORE-TEX DUAL MESH WHICH WAS 24 X 12CM IN DIAMETER. IT COVERED ALL THE DEFECTS WELL WITH SEVERAL CENTIMETERS OF OVERLAP. DESCRIPTION OF HERNIA BEING TREATED: ¿TWO SMALL VENTRAL HERNIAS, ONE AROUND THE UMBILICUS THAT WAS APPROXIMATELY 3 X 5CM. ONE IN THE LEFT LOWER QUADRANT THAT WAS ABOUT 1 X 1CM AND SUBXIPHOID 2.2CM DEFECT.¿ ¿MARCAINE WAS USED TO INFILTRATE THE SKIN IN THE LEFT UPPER QUADRANT. A SMALL BLADE WAS USED TO MAKE AN INCISION WHERE A 5MM OPTIVIEW TROCAR WAS INSERTED INTO THE ABDOMEN. PNEUMOPERITONEUM WAS ACHIEVED. UNDER DIRECT VISUALIZATION, I PLACED ANOTHER 5MM PORT IN EACH OF THE FOUR QUADRANTS. THERE WERE SOME MIDLINE ADHESIONS WHICH WERE TAKEN DOWN WITH A COMBINATION OF SHARP DISSECTION AND A HARMONIC SCALPEL. NO BOWEL WAS INCORPORATED OR UP INTO THE HERNIA AND THERE WAS NO BOWEL STUCK TO THE ABDOMINAL WALL. THESE FLIMSY ADHESIONS WERE TAKEN DOWN WITHOUT MUCH COMPLICATION OF TROUBLE. ONCE THE ADHESIONS WERE FULLY TAKEN DOWN, I COULD VISUALIZE THIS DEFECT. AT FIRST IT SEEMED LIKE THIS WAS A SINGLE DEFECT. IT WAS RATHER SMALL AND WOULD BE COVERED BY A SIMPLE 10CM PIECE OF MESH. HOWEVER, SUPERIORLY TOWARD THE XIPHOID, HE DID HAVE ANOTHER VENTRAL HERNIA DEFECT AND WITH A 1CM BRIDGE OF TISSUE. THIS WAS ABOUT 2CM AND THE LOWER ONE WAS ABOUT 3CM, SO THIS ALL TOGETHER WAS ABOUT 6CM IN LENGTH. HE HAD ONE JUST OFF THE LEFT LOWER QUADRANT THAT WAS APPROXIMATELY 1 X 1CM. THESE DEFECTS WERE NOT EASILY FELT ON THE ANTERIOR ABDOMINAL WALL HOWEVER, FROM THE INSIDE IT WAS CLEARLY A VENTRAL HERNIA DEFECT.¿ IMPLANT SIZE AND FIXATION: ¿THE SWISS-CHEESE DEFECTS WERE COVERED UP WITH A PIECE OF GORE-TEX DUAL MESH WHICH WAS 24 X 12CM IN DIAMETER. IT COVERED ALL THE DEFECTS WELL WITH SEVERAL CENTIMETERS OF OVERLAP.¿ ¿WE TOOK THE PIECE OF MESH THAT WAS 10 X 19CM GORE-TEX DUAL MESH, THAT WOULD EASILY COVER ALL THESE DEFECTS AFTER MEASUREMENT ON THE ABDOMINAL WALL WITH SEVERAL CENTIMETERS OF FASCIAL OVERLAP ON THE SIDES. WE MARKED THE ABDOMINAL WALL, DESUFFLATED THE ABDOMEN AND PLACED 2-0 GORE-TEX SUTURES INTO THE MESH AT FOUR POINTS WITH RELATION TO THE EXTERNAL MARKINGS. THIS MESH WAS THEN INSERTED THROUGH THE 5MM INCISION SITE BY PULLING IT THROUGH A TROCAR, PLACING IT INSIDE THE ABDOMEN AND LAID DOWN FLAT. CARTER-THOMPSON WAS PLACED THROUGH EACH ONE OF THE FOUR 12 O¿CLOCK, 3 O¿CLOCK, 6 O¿CLOCK AND 9 O¿CLOCK POSITIONS IN ORDER TO PULL THESE SUTURES UP THROUGH THE ABDOMINAL WALL AND THESE TRANSFASCIAL FIXATION SUTURES WERE THEN TIED DOWN. THIS PARACHUTED THE MESH UP WELL WITH THE ABDOMEN COMPLETELY DESUFFLATED. WE INSUFFLATED THE ABDOMEN TO ABOUT 9 MMHG AND LOOKED AT THE MESH, WHICH WAS LYING WELL AND COVERING THE DEFECTS. WE PLACED #2-0 PROLENE SUTURES WITH A KIESS NEEDLE THROUGH FOUR OTHER AREAS BETWEEN EACH ONE OF THESE OTHER FIXATION SUTURES UNDER DIRECT VISUALIZATION IN ORDER TO SECURE BETWEEN EACH ONE OF THESE FIXATION SUTURES TO BETTER APPROXIMATE THE MESH TO THE FASCIA. THEN USING ABSORBATACK, PLACED TWO TACKS BETWEEN EACH ONE OF THESE SUTURES AND MADE SURE THAT THE MESH WAS WELL SECURED TO THE FASCIA. WE WOUND UP PLACING APPROXIMATELY SIX 2-0 PROLENE SUTURES IN DIFFERENT POSITIONS IN ORDER TO INSURE (SIC) THAT THE MESH WAS WELL TACKED TO THE ABDOMINAL FASCIA, A TOTAL OF FOUR 2-0 GORE-TEX SUTURES. SEVERAL TACKS WERE USED ALL THE WAY AROUND THE MESH CIRCUMFERENTIALLY IN ORDER TO TACK IT DOWN. THE ABDOMEN WAS THEN DESUFFLATED COMPLETELY AND PNEUMOPERITONEUM WAS REMOVED. THE TROCAR INCISIONS WERE CLOSED WITH 4-0 MONOCRYL AND DERMABOND AND EACH OF THE STAB INCISIONS WITH TRANSFASCIAL SUTURES WHICH WERE COVERED WITH DERMABOND AS WELL.¿ NO POST-OPERATIVE RECORDS WERE PROVIDED. OF NOTE: THE PRODUCT USED IN THE ABOVE OUTLINED OPERATIVE PROCEDURE IS CAPTURED AS ¿GORE-TEX DUAL MESH¿. LOT/SERIAL AND ITEM NUMBERS WERE NOT PROVIDED. THE TWO DIMENSIONS OUTLINED IN THE OPERATIVE REPORT, 24CM X 12CM AND 10CM X 19CM DON'T CORRELATE WITH DUALMESH OR ANY OTHER GORE PRODUCT. HOWEVER, IT IS NOT CLEAR IF THE SURGEON TRIMMED A GORE PRODUCT AND THEN REFERENCED THOSE MEASUREMENTS. RELEVANT MEDICAL INFORMATION: (B)(6) 2010: ¿S/P [STATUS POST] VENTRAL HERNIA REPAIR WITH MESH. C/O [COMPLAINS OF] RECURRENT BULGE AT SUPERIOR INCISION. NORMAL BM [BOWEL MOVEMENT], NO N/V [NAUSEA/VOMITING]. EXAM: 2X3 CM AROUND RIGHT SUPERIOR INCISION HERNIA, REDDISH, NO PAIN ON PALPATION. ASSESSMENT: RECURRENT INCISIONAL HERNIA.¿ (B)(6) 2010: CT ABDOMEN/PELVIS: ¿UNDERGONE PRIOR MIDLINE VENTRAL HERNIA REPAIR INVOLVING ANTERIOR-INFERIOR ABDOMINAL WALL. SUPERIOR TO MESH, IS RESIDUAL OR RECURRENT HERNIA WITH FAT, 11.0 X 2.7 X 4.0 CM HERNIA CONTAINING MESENTERIC FAT WITH NO BOWEL LOOPS WITHIN HERNIA SAC. SUPERIOR TO HERNIA, IS SECOND HERNIA LEFT PARAMEDIAN ANTERIOR ABDOMINAL WALL 2.8 X 1.1 X 1.8 CM, NO SURROUNDING OR INTERNAL INFLAMMATION WITH WIDE MOUTH IDENTIFIED. AT LEVEL OF MID MESH, PROTRUSION OF MESH INTO UMBILICUS REGION COMPATIBLE WITH DIASTASIS RECTI. NO INTRAABDOMINAL CONTENTS SEEN OUTSIDE CONFINES OF MESH IN THIS LOCATION. MIDLINE ANTERIOR ABDOMINAL WALL SCAR PRESENT IN REGION OF HERNIA AND MESH.¿ (B)(6) 2010: ¿NO ABD [ABDOMINAL] PAIN, + [POSITIVE] ABD SWELLING/BULGE AT HERNIA, NO FOCAL DEFICITS. EXAM: ABDOMEN SOFT, NONDISTENDED. IMPRESSION: INCISIONAL/VENTRAL HERNIA. PLAN: ROBOTICALLY ASSISTED LAP VHR [VENTRAL HERNIA REPAIR] WITH MESH.¿ CONCLUSION: IT SHOULD BE NOTED THAT THE GORE® DUALMESH® BIOMATERIAL INSTRUCTIONS FOR USE INCLUDE 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, COMPROMISED DEVICE BIOCOMPATIBILITY, CONTAMINATION WHICH MAY LEAD TO PATIENT HARMS, DEVICE DAMAGE, DYSPHAGIA, EROSION OR EXTRUSION AND RELATED HARMS, EXPOSURE OR PROTRUSION AND RELATED HARMS, FEVER, FISTULA, GERD RECURRENCE, DEFECT RECURRENCE AND RELATED HARMS, ILEUS, INCREASED PROCEDURE TIME AND RELATED HARMS, IRRITATION OR INFLAMMATION, INFECTION, MESH MIGRATION, MESH CONTRACTION, PAIN, PARESTHESIA, PERFORATION, REVISION / RE-INTERVENTION, SEROMA OR HEMATOMA AND RELATED HARMS, TISSUE ISCHEMIA, WOUND COMPLICATIONS AND WOUND DEHISCENCE AND ADDITIONAL INTERVENTION INCLUDING SURGERY. 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, STATUS OF THE DEVICE IS UNABLE TO BE CONFIRMED AND THEREFORE NOT AVAILABLE FOR EVALUATION. THE DEVICE WAS NOT ABLE TO BE RETURNED TO GORE FOR EVALUATION; THEREFORE, A DIRECT PRODUCT ANALYSIS COULD NOT BE CONDUCTED. AFTER MULTIPLE REQUESTS, SPECIFIC LOT NUMBER INFORMATION WAS NOT PROVIDED FOR THIS DEVICE, BUT PRODUCT TYPE HAS BEEN CONFIRMED. REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE PERFORMED AS A VALID LOT NUMBER WAS NOT PROVIDED. 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: CODES 4118/3221 - PRODUCT IDENTIFICATION RECORDS FOR THE ALLEGED GORE DEVICE WAS NOT PROVIDED. THEREFORE, A REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE PERFORMED. H6: CONCLUSION CODE REMAINS UNCHANGED. ADDITIONAL DETAILS REGARDING THE PATIENT'S CLINICAL COURSE WERE ASCERTAINED FROM A REVIEW OF MEDICAL RECORDS AND ARE AS FOLLOWS: (B)(6) 2010: OPERATIVE REPORT. PRE/POSTOP DX: DIVERTICULOSIS OF THE COLON. UNSPECIFIED VENTRAL HERNIA, NO OBSTRUCTION OR GANGRENE. FUNCTIONAL DIGESTIVE DISEASE, OTHER CONSTIPATION UNSPECIFIED. PROCEDURE: SIGMOIDOSCOPY, FUNCTIONAL DIAGNOSTIC WITHOUT COLLECTION OF SPECIMEN. LAPAROSCOPIC SURGICAL REPAIR OF VENTRAL HERNIA, REDUCIBLE. ANESTHESIA: GENERAL, ENDOTRACHEAL. FLUIDS: 1200CC CRYSTALLOID. URINE OUTPUT: 200CC. COMPLICATIONS: NONE. FINDINGS: ¿TWO SMALL VENTRAL HERNIAS, ONE AROUND THE UMBILICUS THAT WAS APPROXIMATELY 3 X 5CM. ONE IN THE LEFT LOWER QUADRANT THAT WAS ABOUT 1 X 1CM AND SUBXIPHOID 2.2CM DEFECT. THE SWISS-CHEESE DEFECTS WERE COVERED UP WITH A PIECE OF GORE-TEX DUAL MESH WHICH WAS 24 X 12CM IN DIAMETER. IT COVERED ALL THE DEFECTS WELL WITH SEVERAL CENTIMETERS OF OVERLAP. INDICATIONS: THE PATIENT IS A 32-YEAR-OLD HISPANIC MALE WHO UNDERWENT AN OPEN SIGMOID COLECTOMY FOR DIVERTICULOSIS AND SEVERAL BOUTS OF DIVERTICULITIS WITH ONE COMPLICATED BY THE DIVERTICULITIS. HE HAD AN ELECTIVE SIGMOID COLECTOMY AT THE TIME AND HE RECOVERED FROM THIS UNEVENTFULLY, HOWEVER, IN OUTPATIENT SETTING DID DEVELOP A SEROMA OF THE WOUND WHICH REQUIRED DRAINAGE THROUGH THE SUPERIOR PORTION OF HIS MIDLINE WOUND. IT WAS DRAINED AND PACKED AND EVENTUALLY HEALED WITHOUT ANY COMPLICATIONS. THIS WAS ORIGINALLY DONE BACK IN (B)(6) 2009. THE PATIENT PRESENTED TO THE CLINIC TOWARD THE END OF FEBRUARY COMPLAINING THAT HE HAD FOUND A NEW BULGE IN HIS ABDOMINAL WALL AROUND HIS UMBILICUS. ON EXAMINATION, HE WAS FOUND TO HAVE AN UMBILICAL HERNIA. AT THAT TIME, HE WAS SET UP FOR LAPAROSCOPIC VENTRAL HERNIA REPAIR. OPERATIVE FORM WAS COMPLETED AND OBTAINED. THE PATIENT WAS TAKEN TO THE OPERATING ROOM AND PLACED IN SUPINE POSITION UNDER GENERAL ENDOTRACHEAL ANESTHESIA. HE WAS FULLY PREPPED AND DRAPED IN A STERILE FASHION. HE WAS PLACED IN REVERSE TRENDELENBURG POSITION. MARCAINE WAS USED TO INFILTRATE THE SKIN IN THE LEFT UPPER QUADRANT. A SMALL BLADE WAS USED TO MAKE AN INCISION WHERE A 5MM OPTIVIEW TROCAR WAS INSERTED INTO THE ABDOMEN. PNEUMOPERITONEUM WAS ACHIEVED. UNDER DIRECT VISUALIZATION, I PLACED ANOTHER 5MM PORT IN EACH OF THE FOUR QUADRANTS. THERE WERE SOME MIDLINE ADHESIONS WHICH WERE TAKEN DOWN WITH A COMBINATION OF SHARP DISSECTION AND A HARMONIC SCALPEL. NO BOWEL WAS INCORPORATED OR UP INTO THE HERNIA AND THERE WAS NO BOWEL STUCK TO THE ABDOMINAL WALL. THESE FLIMSY ADHESIONS WERE TAKEN DOWN WITHOUT MUCH COMPLICATION OF TROUBLE. ONCE THE ADHESIONS WERE FULLY TAKEN DOWN, I COULD VISUALIZE THIS DEFECT. AT FIRST IT SEEMED LIKE THIS WAS A SINGLE DEFECT. IT WAS RATHER SMALL AND WOULD BE COVERED BY A SIMPLE 10CM PIECE OF MESH. HOWEVER, SUPERIORLY TOWARD THE XIPHOID, HE DID HAVE ANOTHER VENTRAL HERNIA DEFECT AND WITH A 1CM BRIDGE OF TISSUE. THIS WAS ABOUT 2CM AND THE LOWER ONE WAS ABOUT 3CM, SO THIS ALL TOGETHER WAS ABOUT 6CM IN LENGTH. HE HAD ONE JUST OFF THE LEFT LOWER QUADRANT THAT WAS APPROXIMATELY 1 X 1CM. THESE DEFECTS WERE NOT EASILY FELT ON THE ANTERIOR ABDOMINAL WALL HOWEVER, FROM THE INSIDE IT WAS CLEARLY A VENTRAL HERNIA DEFECT. WE TOOK THE PIECE OF MESH THAT WAS 10 X 19CM GORE-TEX DUAL MESH, THAT WOULD EASILY COVER ALL THESE DEFECTS AFTER MEASUREMENT ON THE ABDOMINAL WALL WITH SEVERAL CENTIMETERS OF FASCIAL OVERLAP ON THE SIDES. WE MARKED THE ABDOMINAL WALL, DESUFFLATED THE ABDOMEN AND PLACED 2-0 GORE-TEX SUTURES INTO THE MESH AT FOUR POINTS WITH RELATION TO THE EXTERNAL MARKINGS. THIS MESH WAS THEN INSERTED THROUGH THE 5MM INCISION SITE BY PULLING IT THROUGH A TROCAR, PLACING IT INSIDE THE ABDOMEN AND LAID DOWN FLAT. CARTER-THOMPSON WAS PLACED THROUGH EACH ONE OF THE FOUR 12 O'CLOCK, 3 O'CLOCK, 6 O'CLOCK AND 9 O'CLOCK POSITIONS IN ORDER TO PULL THESE SUTURES UP THROUGH THE ABDOMINAL WALL AND THESE TRANSFACIAL FIXATION SUTURES WERE THEN TIED DOWN. THIS PARACHUTED THE MESH UP WELL WITH THE ABDOMEN COMPLETELY DESUFFLATED. WE INSUFFLATED THE ABDOMEN TO ABOUT 9 MMHG AND LOOKED AT THE MESH, WHICH WAS LYING WELL AND COVERING THE DEFECTS. WE PLACED #2-0 PROLENE SUTURES WITH A KIESS NEEDLE THROUGH FOUR OTHER AREAS BETWEEN EACH ONE OF THESE OTHER FIXATION SUTURES UNDER DIRECT VISUALIZATION IN ORDER TO SECURE BETWEEN EACH ONE OF THESE FIXATION SUTURES TO BETTER APPROXIMATE THE MESH TO THE FASCIA. THEN USING ABSORBATACK, PLACED TWO TACKS BETWEEN EACH ONE OF THESE SUTURES AND MADE SURE THAT THE MESH WAS WELL SECURED TO THE FASCIA. WE WOUND UP PLACING APPROXIMATELY SIX 2-0 PROLENE SUTURES IN DIFFERENT POSITIONS IN ORDER TO INSURE THAT THE MESH WAS WELL TACKED TO THE ABDOMINAL FASCIA, A TOTAL OF FOUR 2-0 GORE-TEX SUTURES. SEVERAL TACKS WERE USED ALL THE WAY AROUND THE MESH CIRCUMFERENTIALLY IN ORDER TO TACK IT DOWN. THE ABDOMEN WAS THEN DESUFFLATED COMPLETELY AND PNEUMOPERITONEUM WAS REMOVED. THE TROCAR INCISIONS WERE CLOSED WITH 4-0 MONOCRYL AND DERMABOND AND EACH OF THE STAB INCISIONS WITH TRANSFACIAL SUTURES WHICH WERE COVERED WITH DERMABOND AS WELL. WITH THIS PORTION OF THE PROCEDURE COMPLETE, WE THEN BROUGHT IN A COLONOSCOPE. UNDER DIRECT VISUALIZATION, WE INSERTED THE COLONOSCOPE PAST THE PREVIOUS SIGMOID RESECTION UNTIL WE IDENTIFIED THE COLORECTAL ANASTOMOSIS. THIS WAS WIDE OPEN AND INTACT. THERE WAS A STAPLE SEEN THAT CLEARLY IDENTIFIED WHERE THE ANASTOMOSIS WAS. THERE WAS NO ULCERATION OF THE MUCOSA. THERE WAS NO DIVERTICULOSIS SEEN AT ALL IN PREVIOUS SIGMOID COLECTOMY. THE SCOPE WAS DRAWN UP TO THE SPLENIC FLEXURE. THE REST OF THE COLON APPEARED NORMAL. THERE WERE NO COMPLICATIONS DURING THIS PORTION OF THE PROCEDURE. THE COLON WAS DESUFFLATED AND THE SCOPE WAS REMOVED. THE PATIENT TOLERATED THIS PROCEDURE WELL. THERE WERE NO COMPLICATIONS. HE WAS EXTUBATED AT THE END OF THE CASE AND RETURNED TO THE RECOVERY ROOM IN GOOD CONDITION.¿ PRODUCT IDENTIFICATION RECORDS FOR THE ALLEGED ¿GORE-TEX MESH¿ WERE NOT PROVIDED. (B)(6) 2010: OFFICE NOTES. WT 265.5. CC: ABD PAIN. S/P VENTRAL HERNIA REPAIR WITH MESH. C/O RECURRENT BULGE AT SUPERIOR INCISION. NORMAL BM, NO N/V. EXAM: 2X3 CM AROUND RIGHT SUPERIOR INCISION HERNIA, REDDISH, NO PAIN ON PALPATION. ASSESSMENT: RECURRENT INCISIONAL HERNIA. PLAN: CT ABDOMEN/PELVIS TO SEE OLD MESH AND HERNIA SITE. (B)(6) 2010: RADIOLOGY ¿ CT ABDOMEN/PELVIS WITH CONTRAST. INDICATION: ABDOMINAL PAIN, SORENESS AROUND HERNIA REPAIR AREA. HX HERNIA REPAIR (B)(6) 2010. DISCUSSION: UNDERGONE PRIOR MIDLINE VENTRAL HERNIA REPAIR INVOLVING ANTERIOR-INFERIOR ABDOMINAL WALL. SUPERIOR TO MESH, IS RESIDUAL OR RECURRENT HERNIA WITH FAT, 11.0 X 2.7 X 4.0 CM HERNIA CONTAINING MESENTERIC FAT WITH NO BOWEL LOOPS WITHIN HERNIA SAC. SUPERIOR TO HERNIA, IS SECOND HERNIA LEFT PARAMEDIAN ANTERIOR ABDOMINAL WALL 2.8 X 1.1 X 1.8 CM, NO SURROUNDING OR INTERNAL INFLAMMATION WITH WIDE MOUTH IDENTIFIED. AT LEVEL OF MID MESH, PROTRUSION OF MESH INTO UMBILICUS REGION COMPATIBLE WITH DIASTASIS RECTI. NO INTRAABDOMINAL CONTENTS SEEN OUTSIDE CONFINES OF MESH IN THIS LOCATION. MIDLINE ANTERIOR ABDOMINAL WALL SCAR PRESENT IN REGION OF HERNIA AND MESH. IMPRESSION: S/P MIDLINE VENTRAL MID TO INFERIOR ABDOMINAL WALL HERNIA REPAIR WITH SURGICAL MESH IN PLACE WITH PROTRUSION OF MESH ANTERIORLY LIKELY FROM UNDERLYING DIASTASIS RECTI. NO DISTINCT HERNIATION THROUGH MESH ITSELF. SUPERIOR TO MESH, ALONG MIDLINE, IS VENTRAL ABDOMINAL WALL HERNIA. IMMEDIATELY SUPERIOR TO THIS HERNIA, IN LEFT PARAMEDIAN AREA, THERE IS ANOTHER SMALL HERNIA. THESE HERNIAS CONTAIN FAT AND ARE WIDE-MOUTHED WITH NO CT EVIDENCE OF INCARCERATION OR STRANGULATION. (B)(6) 2010: HISTORY AND PHYSICAL. CC: RECURRENT VENTRAL HERNIA. PSH: EX LAP FOR DIVERTICULITIS WITH SUBSEQUENT INCISIONAL HERNIA S/P LAP REPAIR WITH NEW VENTRAL HERNIA. ROS: NO ABD PAIN, + ABD SWELLING/BULGE AT HERNIA, NO FOCAL DEFICITS. EXAM: ABDOMEN SOFT, NONDISTENDED. IMPRESSION: INCISIONAL/VENTRAL HERNIA. PLAN: ROBOTICALLY ASSISTED LAP VHR WITH MESH. THERE IS NO MENTION OF GORE DEVICE REMOVAL IN THE RECORDS. 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 ALTHOUGH THE BRAND NAME AND LOT# OF A GORE DEVICE HAS NOT BEEN PROVIDED, THE INSTRUCTIONS FOR USE FOR THE VAST MAJORITY OF GORE¿S EPTFE PATCH PRODUCTS THAT ARE INDICATED FOR THE RECONSTRUCTION OF SOFT TISSUE DEFICIENCIES INCLUDE THE FOLLOWING WARNINGS AMONG OTHERS: ¿POSSIBLE 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. 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.
(B)(4). PRODUCT IDENTIFICATION RECORDS FOR THE ALLEGED GORE DEVICE WAS NOT PROVIDED. THEREFORE, A REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE PERFORMED. THE INITIAL REPORTER'S COMPLETE ADDRESS IS (B)(6). IT SHOULD BE NOTED THAT ALTHOUGH THE BRAND NAME AND LOT# OF A GORE DEVICE HAS NOT BEEN PROVIDED, THE INSTRUCTIONS FOR USE FOR THE VAST MAJORITY OF GORE¿S EPTFE PATCH PRODUCTS THAT ARE INDICATED FOR THE RECONSTRUCTION OF SOFT TISSUE DEFICIENCIES INCLUDE THE FOLLOWING WARNINGS AMONG OTHERS: ¿POSSIBLE 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 VENTRAL HERNIA REPAIR ON (B)(6) 2010 WHEREBY AN UNKNOWN GORE DEVICE WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2010, A SCAN SHOWED A PROTRUSION OF MESH INTO THE UMBILICUS. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: PROTRUSION OF MESH INTO THE UMBILICUS, PAIN, ADDITIONAL SURGERY. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 546977 | UNKNOWN | OWT | W.L. GORE & ASSOCIATES | UKN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 33 YR | Hospitalization| R |