GORE DUALMESH PLUS BIOMATERIAL
Report
- Report Number
- 2017233-2019-00006
- Event Type
- Injury
- Date Received
- January 4, 2019
- Report Date
- January 7, 2021
- Manufacturer
- W.L. GORE & ASSOCIATES
- Product Code
- FTL
- UDI-DI
- 00733132601134
- PMA / PMN Number
- K063435
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- 003
Narratives
UPDATED RESULT CODE. CONCLUSION CODE REMAINS UNCHANGED.
ADDED MEDICAL HISTORY. CONCLUSION CODE REMAINS UNCHANGED. ADDED MEDICAL RECORD INFORMATION. ADDITIONAL DETAILS REGARDING THE PATIENT'S CLINICAL COURSE WERE ASCERTAINED FROM A REVIEW OF MEDICAL RECORDS AND ARE AS FOLLOWS: OPERATIVE RECORDS DATED (B)(6) 2001 INDICATE THE PATIENT UNDERWENT SUPRACERVICAL ABDOMINAL HYSTERECTOMY AND APPENDECTOMY. THERE IS NO MENTION OF A GORE DEVICE IN THE RECORDS. OPERATIVE RECORDS DATED (B)(6) 2003 INDICATE THE PATIENT UNDERWENT FLEXIBLE SIGMOIDOSCOPY WITH BIOPSIES. THERE IS NO MENTION OF A GORE DEVICE IN THE RECORDS. OPERATIVE RECORDS DATED (B)(6) 2003 INDICATE THE PATIENT UNDERWENT COLONOSCOPY WITH SNARE POLYPECTOMY AND BIOPSY. THERE IS NO MENTION OF A GORE DEVICE IN THE RECORDS. OPERATIVE RECORDS DATED (B)(6) 2004 INDICATE THE PATIENT UNDERWENT LAPAROSCOPIC INCISIONAL HERNIORRHAPHY WITH DUAL-MESH PLACER. THE PATIENT ¿HAD A LARGE FASCIAL DEFECT PROBABLY 10 CENTIMETERS IN DIAMETER. THIS CONTAINED OMENTUM, PREPERITONEAL FAT AND SOME SMALL BOWEL. A LARGE PIECE OF DUAL-MESH WAS PLACED AND ANCHORED AT THE LATERAL AND SUPERIOR CORNERS AND THEN USED A SPIRAL TACKER TO SECURE THE REST OF THE MESH.¿ OPERATIVE RECORDS DATED 2/26/2004 STATE: ¿THROUGH A COMBINATION OF BLUNT, SHARP AND HARMONIC SCALPEL DISSECTION, THE HERNIA CONTENTS WERE BROUGHT SAFELY OUT OF THE FASCIAL DEFECT. CARE WAS TAKEN NOT TO INJURE AND SMALL INTESTINES. ONCE ALL THE HERNIA CONTENTS WERE REDUCED, A PIECE OF DUAL-MESH WAS MEASURED TO FIT ADEQUATELY OVER THE HERNIA DEFECT. 0-PDS SUTURES WERE PLACED AT THE TWO SUPERIOR CORNERS AND THE LATERAL MIDWAY EDGES.¿ THE RECORDS DATED (B)(6) 2004 CONTINUE: ¿AN INCISION WAS MADE THROUGH THE HERNIA DEFECT IN THE SKIN AND THE MESH WAS PLACED WITHIN THE ABDOMINAL CAVITY. THIS DEFECT WAS SUTURED CLOSED WITH A 3-0 NYLON SUTURE. THE MESH WAS THEN UNRAVELED AND USING A NEEDLE PASSER, THE SUTURES WERE BROUGHT OUT THROUGH THE SKIN THROUGH SEPARATE STAB INCISIONS AND THEN TIED. WE PLACED AN ADDITIONAL 0-PDS SUTURE THROUGH THE SUPERIOR MIDDLE ASPECT OF THE MESH FREEING THIS OUT THROUGH THE FASCIA WITH THE NEEDLE PASSER.¿ OPERATIVE RECORDS DATED (B)(6) 2004 STATE: ¿THE SPIRAL TACKER WAS THEN USED TO SECURE THE MESH CIRCUMFERENTIALLY. EXCESS MESH INFERIORLY WAS CUT OFF AND BROUGHT OUT THROUGH THE PORT SITE. THE MESH HAD NICE COVERAGE OVER THE FASCIAL DEFECT. THE PORTS WERE REMOVED AND WERE HEMOSTATIC. ALL SKIN INCISIONS WERE CLOSED WITH A RUNNING 4-0 MONOCRYL SUBCUTICULAR STITCH.¿ THE RECORDS CONFIRM A GORE DUALMESH® CORDUROY ANTIMICROBIAL (1DLMCP06/01627903) WAS USED DURING THE PROCEDURE. OPERATIVE NOTED DATED (B)(6) 2005 INDICATES THE PATIENT UNDERWENT COLONOSCOPY TO THE CECUM WITH MULTIPLE RANDOM BIOPSIES AND PHOTOGRAPHS. THERE IS NO MENTION OF A GORE DEVICE IN THE RECORDS. RECORDS BETWEEN (B)(6) 2005 AND (B)(6) 2009 WERE NOT PROVIDED. OPERATIVE NOTES DATED (B)(6) 2009 INDICATE THE PATIENT UNDERWENT LAPAROSCOPIC CHOLECYSTECTOMY. THERE IS NO MENTION OF A GORE DEVICE IN THE RECORDS. DISCHARGE SUMMARY NOTES FOR HOSPITAL ADMISSION (B)(6) 2011 TO (B)(6) 2011 INDICATE THE PATIENT WAS ADMITTED FOR PELVIC MASS. THE PATIENT ¿IS A 43 Y.O. G4P3 CAUCASIAN FEMALE WHO INITIALLY PRESENTED IN FAMILY PRACTICE WITH RUQ PRESSURE AND DISCOMFORT. A RUQ ULTRASOUND WAS OBTAINED WITH THE INCIDENTAL FINDING OF A LARGE 15 CM CYSTIC MASS IN THE RLQ, WHICH WAS FURTHER EVALUATED WITH PELVIC ULTRASOUND. THIS APPEARS TO ARISE FROM THE RIGHT ADNEXA. OTHER THAN THE RIGHT SIDED PAIN, THE PATIENT INDICATES THAT SHE HAS BEEN ASYMPTOMATIC. SHE HAS HAD A PREVIOUS SUPRACERVICAL HYSTERECTOMY FOR BENIGN DISEASE.¿ OPERATIVE RECORDS DATED (B)(6) 2011 INDICATE THE PATIENT UNDERWENT EXPLORATORY LAPAROTOMY WITH BILATERAL SALPINGO-OOPHORECTOMY, TRACHELECTOMY AND EXTENSIVE LYSIS OF ADHESIONS. THE PATIENT ¿IS A 43-YEAR-OLD FEMALE WITH A PAST SURGICAL HISTORY REMARKABLE FOR MESH REPAIR OF A VENTRAL HERNIA. SHE WAS UNDERGOING PELVIC EXPLORATION BY DANA M. BENDEN, MD, AND INTRAOPERATIVE CONSULTATION WAS REQUESTED FOR MANAGEMENT OF SMALL BOWEL ADHESIONS INVOLVING THE PREVIOUSLY-PLACED MESH.¿ OPERATIVE FINDINGS DATED (B)(6) 2011 STATE: THE PATIENT ¿WAS NOTED TO HAVE A HISTORY OF PREVIOUS SUPRACERVICAL HYSTERECTOMY, PREVIOUS LAPAROSCOPIC CHOLECYSTECTOMY AND PREVIOUS LAPAROSCOPIC PLACEMENT OF A MESH DUE TO A VENTRAL HERNIA. THE PATIENT WAS NOTED TO HAVE EXTENSION OF ADHESIONS OF THE OMENTUM TO THE ANTERIOR SURFACE OF THE ABDOMINAL WALL AND MESH THAT WAS IN THE LOWER PORTION OF THE ABDOMEN.¿ OPERATIVE RECORDS DATED (B)(6) 2011 CONTINUE: ¿THERE WERE ADHESIONS TO THE SMALL BOWEL AND LARGE BOWEL FROM THE MESH. THERE WERE ALSO ADHESIONS OF THE BOWEL TO THE OVARY AND PELVIC MASS ON THE RIGHT SIDE AND THE LEFT OVARY AND FALLOPIAN TUBE WERE ADHESED WITHIN THE RETROPERITONEUM ON THE LEFT. THE PATIENT'S CERVIX APPEARED VISUALLY NORMAL. IT WAS REMOVED WITHOUT DIFFICULTY. OTHER THAN THE REMAINDER OF THE ADHESIONS OF THE BOWEL, THE REMAINDER OF THE ABDOMEN AND PELVIS WERE WITHOUT EVIDENCE OF MALIGNANCY.¿ RECORDS FOR THE OPERATIVE DATE (B)(6) 2011 STATE: ¿HER UPPER ABDOMEN WAS NORMAL TO VISUAL INSPECTION AND PALPATION. INTRAOPERATIVE CONSULT WAS OBTAINED WITH ERIC F. BREKKE, MD. HE ASSISTED WITH ADHESIOLYSIS OF THE BOWEL FROM THE MESH SURFACE. A VERTICAL MIDLINE INCISION WAS MADE FROM ABOVE THE UMBILICUS TOWARD THE SUPRAPUBIC BONE. THE INCISION WAS CARRIED DOWN SO THE FASCIA WAS IDENTIFIED AND ENTERED IN THE MIDLINE. THE MESH WAS ENCOUNTERED JUST BELOW THE UMBILICUS DOWN TO THE LEVEL OF JUST ABOVE THE SUPRAPUBIC BONE. THERE WERE ADHESIONS TO THE MESH FROM THE OMENTUM AND SMALL BOWEL.¿ THE (B)(6) 2011 OPERATIVE RECORDS CONTINUE: ¿THE ADHESIONS WERE DISSECTED AWAY FROM THE OMENTUM FROM THE MESH SURFACE EXTENSIVELY. APPROXIMATELY 60 MINUTES WERE SPENT ON THIS PORTION OF ADHESIOLYSIS. THE INFERIOR PORTION OF THE MESH ON THE PATIENT'S RIGHT SIDE HAD AN AREA OF 2 LOOPS OF SMALL BOWEL THAT WERE TIGHTLY ADHERENT TO THE MESH SURFACE; THEREFORE, INTRAOPERATIVE CONSULT WITH ERIC F. BREKKE, MD WAS OBTAINED AND HE ASSISTED IN ADHESIOLYSIS AND REMOVAL OF THE BOWEL SURFACE FROM THOSE AREAS.¿ THE OPERATIVE RECORDS DATED (B)(6) 2011 STATE: ¿THE PREVIOUSLY-PLACED MESH, WHICH WAS A GORE-TEX PRODUCT, WAS DIVIDED IN THE MIDLINE ALONG WITH THE FASCIAL INCISION. AT THE INFERIOR EDGE OF THE MESH, THERE WERE SMALL BOWEL ADHESIONS TO THE MESH, PARTICULARLY IN THE RIGHT LOWER ABDOMEN. THE MESH WAS GRASPED WITH LONG ALLIS CLAMPS TO PROVIDE EXPOSURE AND TRACTION.¿ OPERATIVE RECORDS DATED (B)(6) 2011 STATE: ¿THE SMALL BOWEL ADHESIONS TO THE UNDERSURFACE AND TO THE EDGE OF THE MESH WERE DIVIDED BY MEANS OF BLUNT AND SHARP DISSECTION. CARE WAS TAKEN THROUGHOUT TO AVOID ENTEROTOMIES. NONE WAS MADE DURING THE COURSE OF THE DISSECTION. ULTIMATELY, THE SMALL BOWEL ADHESIONS WERE FREED COMPLETELY FROM THE UNDERSURFACE AND INFERIOR CUT EDGE OF THE MESH.¿ RECORDS DATED (B)(6) 2011 STATE: ¿ADDITIONAL ADHESIOLYSIS OF SMALL BOWEL WAS PERFORMED IN ORDER TO FACILITATE THE REMAINDER OF THE DISSECTION. THIS WAS ALSO CARRIED OUT BY MEANS OF BLUNT AND SHARP DISSECTION. AGAIN, NO ENTEROTOMIES WERE MADE. THE PATIENT REMAINED IN THE OPERATING ROOM FOR COMPLETION OF THE PROCEDURE BY DANA M. BENDEN, MD AND HER OPERATIVE TEAM.¿ OPERATIVE RECORDS DATED (B)(6) 2011 STATE: ¿AFTER THE BOWEL WAS COMPLETELY MOBILIZED, IT WAS DISSECTED TO REMOVE ALL ADHESIONS BETWEEN THE SMALL BOWEL SURFACES. THE BOWEL WAS THEN PACKED AWAY WITH MOIST LAPAROTOMY SPONGES. THE SURFACE OF THE RIGHT OVARY PELVIC MASS WAS APPROXIMATELY 20 CM AND WAS COVERED WITH A SURFACE OF ADHESIONS THAT WERE DISSECTED SHARPLY WITH METZENBAUM SCISSORS. THE RETROPERITONEUM WAS IDENTIFIED AND ENTERED SHARPLY WITH A METZENBAUM SCISSORS.¿ RECORDS DATED (B)(6) 2011 STATE: ¿THE INCISION WAS EXTENDED AND THE PSOAS MUSCLE IDENTIFIED. THE ILIAC ARTERY IDENTIFIED AND THE URETER ON THE RIGHT SIDE IDENTIFIED. THE INFUNDIBULOPELVIC LIGAMENT WAS THEN ISOLATED, GRASPED WITH 2 CURVED HEANEY'S, TRANSECTED AND DOUBLY LIGATED WITH 0 VICRYL. THERE WAS GOOD HEMOSTASIS PRESENT. THE REMAINDER OF THE ADHESIONS FROM THE POSTERIOR SURFACE OF THE PERITONEUM WERE THEN DISSECTED SHARPLY WITH METZENBAUM SCISSORS AND THE ADHESIONS TO THE ANTERIOR SURFACE OF THE ABDOMINAL WALL WERE DISSECTED SHARPLY WITH THE METZENBAUM SCISSORS.¿ OPERATIVE RECORDS DATED (B)(6) 2011 STATE: ¿THE SPECIMEN WAS DISSECTED AND SENT TO PATHOLOGY FOR FROZEN SECTION. FROZEN SECTION DID RETURN CONSISTENT WITH A BENIGN CYST. ATTENTION WAS THEN TURNED TO THE LEFT OVARY AND TUBE, WHICH WERE WITHIN THE RETROPERITONEUM. THE SIGMOID COLON WAS ADHERENT OVER THE RETROPERITONEUM ON THE LEFT SIDE. IT WAS, THEREFORE, SHARPLY DISSECTED WITH THE METZENBAUM SCISSORS AND MOBILIZED AWAY FROM THE RETROPERITONEUM. THE RETROPERITONEUM WAS THEN ENTERED SHARPLY WITH THE METZENBAUM SCISSORS.¿ RECORDS DATED (B)(6) 2011 CONTINUE: ¿IT WAS THEN EXTENDED AND THE URETER WAS IDENTIFIED ON THE LEFT SIDE. THE INFUNDIBULOPELVIC LIGAMENT WAS GRASPED WITH 2 CURVED HEANEY'S, TRANSECTED AND SUTURE LIGATED WITH 0 VICRYL. THE OVARY WAS THEN MOBILIZED OUT OF THE RETROPERITONEUM KEEPING THE URETER IN FULL VIEW AT ALL TIMES. IT WAS SHARPLY DISSECTED AWAY FROM THE RETROPERITONEUM AND THE REMAINDER OF ITS ATTACHMENT USING SHARP DISSECTION WITH METZENBAUM SCISSORS. THE SPECIMEN WAS THEN SENT TO PATHOLOGY FOR PERMANENT SECTIONS.¿ OPERATIVE RECORDS DATED (B)(6) 2011 STATE: ¿ATTENTION WAS THEN TURNED TO THE CERVIX. A STANDARD V-CARE MANIPULATOR HAD BEEN PLACED INTO THE VAGINA AND THE CUFF WAS PALPABLE INTRA-ABDOMINALLY. THE PERITONEUM WAS INCISED AND THE BLADDER REFLECTED AWAY FROM THE CERVIX ANTERIORLY. THE CUFF WAS ISOLATED AND 2 BALLANTINE'S WERE PLACED LATERALLY TO DETACH THE REMAINING ATTACHMENTS OF THE UTEROSACRAL LIGAMENT TO THE CERVIX. THEY WERE TRANSECTED AND SUTURE LIGATED WITH 0 VICRYL.¿ THE RECORDS DATED (B)(6) 2011 CONTINUE: ¿THE CUFF WAS THEN INCISED IN A CIRCUMFERENTIAL FASHION AND THE SPECIMEN REMOVED VAGINALLY. DUE TO THE PATIENT'S HABITUS, ATTENTION WAS THEN TURNED VAGINALLY AND THE VAGINAL APEX WAS CLOSED WITH 0 VICRYL IN A RUNNING LOCKED FASHION. THERE WAS GOOD HEMOSTASIS PRESENT. ATTENTION WAS THEN RETURNED ABDOMINALLY. THE ABDOMEN AND PELVIS WERE COPIOUSLY IRRIGATED.¿ OPERATIVE RECORDS DATED (B)(6) 2011 STATE: ¿SHE HAD GOOD HEMOSTASIS WITH THE EXCEPTION OF THE SMALL AMOUNT OF OOZING AT THE ANTERIOR SURFACE OF THE VAGINAL APEX. FLOSEAL WAS PLACED AND THERE WAS GOOD HEMOSTASIS THROUGHOUT. THE ABDOMEN AND PELVIS WERE HEMOSTATIC. ALL INSTRUMENTS AND LAPAROTOMY SPONGES WERE THEN REMOVED FROM THE PATIENT'S ABDOMEN AND PELVIS. THE FASCIAL INCISION WAS CLOSED WITH 0 PROLENE TO REAPPROXIMATE THE FASCIA AND THE MESH SURFACES AFTER SEPRAFILM WAS PLACED INTO THE ABDOMEN. T HE SUBCUTANEOUS SPACE WAS THEN IRRIGATED. THE SUBCUTANEOUS SPACE WAS THEN CLOSED WITH 2-0 VICRYL IN INTERRUPTED FASHION. THE SKIN WAS CLOSED WITH STAPLES.¿ THERE IS NO MENTION OF REMOVAL OF THE GORE DEVICE. OPERATIVE RECORDS DATED (B)(6) 2012 INDICATE THE PATIENT UNDERWENT RIGHT SHOULDER ARTHROSCOPIC SUBACROMIAL DECOMPRESSION. THERE IS NO MENTION OF A GORE DEVICE IN THE RECORDS. DISCHARGE SUMMARY FOR ADMISSION (B)(6) 2013 AND DISCHARGE (B)(6) 2013 FOR PRINCIPAL DIAGNOSIS VENTRAL HERNIA RECURRENT S/P REPAIR WITH MESH. THE PATIENT IS ¿A 45 Y.O. FEMALE WHO WHO [SIC] HAS UNDERGONE MULTIPLE SURGICAL PROCEDURES. IN 2001, THE PATIENT UNDERWENT A SUPRACERVICAL HYSTERECTOMY (AND APPENDECTOMY) FOR DYSFUNCTIONAL UTERINE BLEEDING. IN FEBRUARY, 2004, THE PATIENT UNDERWENT REPAIR OF AN INCARCERATED INCISIONAL HERNIA WITH DUALMESH.¿ THE RECORDS FOR THE HOSPITAL ADMISSION (B)(6) 2013 TO (B)(6) 2013 STATE: ¿IN JANUARY, 2009, SHE UNDERWENT LAPAROSCOPIC CHOLECYSTECTOMY. IN JANUARY, 2011, SHE UNDERWENT EXPLORATORY LAPAROTOMY WITH BILATERAL SALPINGOOOPHORECTOMY AND EXTENSIVE LYSIS OF ADHESIONS. AT THAT TIME, THE PREVIOUSLY PLACED MESH WAS DIVIDED, AND THERE WERE SMALL BOWEL ADHESIONS TAKEN DOWN FROM THE MESH.¿ THE DISCHARGE SUMMARY FOR HOSPITAL ADMISSION (B)(6) 2013 TO (B)(6) 2013 CONTINUE: ¿APPROXIMATELY 6 MONTHS FOLLOWING HER MOST RECENT SURGERY, THE PATIENT BEGAN TO NOTICE A BULGE NEAR THE UMBILICUS. SHE NOTICES THIS MOST WITH CERTAIN ACTIVITIES SUCH AS SHOVELING SNOW OR LIFTING. SHE REPORTS AN OCCASIONAL ASSOCIATED "ACHE" IN THE AREA OF THE UMBILICUS. SHE REPORTS NO ASSOCIATED NAUSEA/VOMITING. IT IS NOTED THAT THE PATIENT IS CURRENTLY IN THE PROCESS OF QUITTING SMOKING AND IS CURRENTLY SMOKING 4 CIGARETTES PER DAY. SHE IS ENCOURAGED TO QUIT SMOKING COMPLETELY PRIOR TO SURGERY TO REPAIR HER HERNIA AND SHE IS MOTIVATED TO DO SO.¿ THE DISCHARGE SUMMARY FOR HOSPITAL ADMISSION (B)(6) 2013 TO (B)(6) 2013 CONTINUE: ¿WAS ADMITTED TO THE HOSPITAL AND TAKEN TO THE OPERATING ROOM FOR A VENTRAL HERNIA REPAIR WITH MESH. SHE TOLERATED THE PROCEDURE WELL WITHOUT COMPLICATIONS. POST OPERATIVELY THE PATIENT WAS TRANSFERRED TO THE FLOOR. HER PAIN WAS INITIALLY CONTROLLED WITH IV PAIN MEDICATIONS. THIS WAS TRANSITIONED TO ORAL PAIN MEDICATIONS WHICH SHE WAS TOLERATING AT THE TIME OF DISCHARGE. THE PATIENT WAS AMBULATING INDEPENDENTLY AS WELL AS PASSING URINE AND FLATUS INDEPENDENTLY AT THE TIME OF DISCHARGE.¿ OPERATIVE RECORDS DATED (B)(6) 2013 INDICATE THE PATIENT UNDERWENT REPAIR OF INCISIONAL HERNIA WITH PHYSIOMESH, 20 X 15 CM. THE PATIENT ¿IS A 45-YEAR-OLD WOMAN WHO HAS HAD MULTIPLE PREVIOUS ABDOMINAL OPERATIONS WHICH INCLUDE AN ABDOMINAL HYSTERECTOMY, A PREVIOUS INCISIONAL HERNIA REPAIR, APPENDECTOMY, EXPLORATORY LAPAROTOMY WITH BILATERAL SALPINGO-OOPHORECTOMY AND EXTENSIVE LYSIS OF ADHESIONS, AND LAPAROSCOPIC CHOLECYSTECTOMY. SHE WAS NOTED TO HAVE AN INCISIONAL HERNIA INVOLVING THE UPPER ASPECT OF HER MIDLINE SCAR.¿ OPERATIVE FINDINGS FROM (B)(6) 2013 STATES: ¿SHE HAD EXTENSIVE ADHESIONS OF THE ABDOMINAL WALL, INCLUDING ADHESIONS TO PREVIOUSLY PLACED MESH IN THE LOWER ABDOMEN. THE MESH IN THE LOWER ABDOMEN WAS NOT ASSOCIATED WITH THE PATIENT'S CURRENT HERNIA AND THE MESH WAS WELL INCORPORATED. THEREFORE, THIS MESH WAS LEFT IN PLACE. THESE ADHESIONS WERE ALL TAKEN DOWN CAREFULLY, WHICH TOOK APPROXIMATELY 1 HOUR. A PIECE OF PHYSIOMESH INTRAPERITONEALLY. WE THEN CLOSED THE FASCIA OVER THE TOP OF THIS WITH A DRAINED SUBFASCIAL AND SUBCU.¿ THE OPERATIVE RECORD DATED (B)(6) 2013 CONTINUES: ¿THE MIDLINE INCISION WAS CREATED THROUGH THE PREVIOUS SCAR. WE THEN CONTINUED OUR DISSECTION DOWN TO ABDOMINAL FASCIA. THERE WAS A HERNIA SAC NOTED JUST SUPRAUMBILICALLY. WE ENTERED THE ABDOMEN SUPERIORLY IN UNDISTURBED TERRITORY. WE THEN CAREFULLY DISSECTED DOWN, OPENING FASCIA THROUGHOUT THE ENTIRE INCISION.¿ THE OPERATIVE RECORDS DATED (B)(6) 2013 STATE: ¿THERE WERE SEVERAL SEPARATE HERNIA DEFECTS ABOUT THE UMBILICUS. THERE WERE UNDERLYING BOWEL AND OMENTUM THAT WE CAREFULLY EXCLUDED FROM THE INCISION. THIS REQUIRED LYSIS OF ADHESIONS, AND CAREFUL DISSECTION SHARPLY TO REMOVE THE UNDERLYING OMENTAL AND SMALL BOWEL ATTACHMENTS FROM THE ANTERIOR ABDOMINAL WALL. AT THE INFERIOR EDGE OF THE INCISION, THERE WAS A PIECE OF DUALMESH WHICH WAS LEFT IN PLACE, AS DESCRIBED ABOVE.¿ THE RECORDS DATED (B)(6) 2013 STATE: ¿HOWEVER, THERE WERE ADHESIONS OF OMENTUM AND SMALL BOWEL TO THE DUALMESH THAT WERE TAKEN DOWN TO FACILITATE EXPOSURE. AFTER OPENING THE ENTIRE INCISION, WE CAREFULLY TOOK DOWN ADDITIONAL SMALL BOWEL AND OMENTAL ADHESIONS FROM THE ANTERIOR ABDOMINAL WALL CIRCUMFERENTIALLY TO ALLOW PLACEMENT OF THE MESH.¿ OPERATIVE RECORDS DATED (B)(6) 2013 CONTINUE: ¿AFTER WE HAD ADEQUATE MARGINS CIRCUMFERENTIALLY, A DECISION WAS MADE FOR REPAIR WITH PHYSIOMESH, THE 15 X 20. TO ALLOW PLACEMENT OF SUTURES, WE DISSECTED THE FASCIA FROM THE OVERLYING SUBCUTANEOUS TISSUE CIRCUMFERENTIALLY WITH ELECTROCAUTERY. THE MESH WAS PLACED AND TACKED IN PLACE CIRCUMFERENTIALLY WITH MATTRESS SUTURES OF 0 PROLENE. SECURING OF THE SUTURES RESULTED IN SATISFACTORY MESH PLACEMENT WITH GOOD COVERAGE OF THE FASCIAL DEFECTS.¿ THE OPERATIVE RECORDS DATED (B)(6) 2013 STATE: ¿WE THEN CLOSED THE ABDOMINAL FASCIA AT THE MIDLINE WITH RUNNING 0 PDS STITCHES. THE FASCIA CLOSED WITHOUT SIGNIFICANT TENSION. PRIOR TO TYING THIS STITCH, WE DID PLACE A DEEP 10-FRENCH JP DRAIN BETWEEN THE MESH AND THE ANTERIOR ABDOMINAL WALL. WE THEN PLACED AN ADDITIONAL JP DRAIN IN THE SUBCUTANEOUS SPACE. THE DRAINS WERE BROUGHT THROUGH SEPARATE STAB INCISIONS ON THE LEFT SIDE OF THE ABDOMEN. AT THIS POINT, WE IRRIGATED THOROUGHLY, AND THEN THE CLOSED SKIN WITH SKIN STAPLES. DRESSINGS WERE PLACED.¿ THERE IS NO MENTION OF REMOVAL OF THE GORE DEVICE. OPERATIVE RECORDS DATED (B)(6) 2014 INDICATE THE PATIENT UNDERWENT LEFT SHOULDER ARTHROSCOPIC SUBACROMIAL DECOMPRESSION AND LEFT SHOULDER ARTHROSCOPIC DISTAL. THERE IS NO MENTION OF A GORE DEVICE IN THE RECORDS. DISCHARGE SUMMARY FOR HOSPITAL ADMISSION (B)(6) 2016 TO (B)(6) 2016 INDICATE PATIENT WAS ADMITTED FOR RECURRENT VENTRAL INCISIONAL HERNIA WITH MESH. THE PATIENT IS ¿A 48 Y.O. FEMALE WHO PRESENTS WITH ABDOMINAL PAIN. SHE HAS IBS PAIN AND CRAMPING AT BASELINE BUT THIS IS DIFFERENT. THE PAIN STARTED 6/11 IN THE MORNING BEFORE GOING TO WISCONSIN DELLS. SHE ATE AT 11:30AM WITHOUT PROBLEM. AROUND 3PM SHE HAD ACHING AND STABBING PAIN. IT INTENSIFIED THROUGH THE EVENING. +NAUSEA, -VOMITING, -DIARRHEA. HAD 3 BMS OVERNIGHT, ALL "NORMAL". CURRENTLY HAS YEAST INFECTION AND PERINEUM IS IRRITATED, SO BMS HAVE HAD SOME BLOOD.¿ THE RECORDS FOR HOSPITAL ADMISSION (B)(6) 2016 TO (B)(6) 2016 CONTINUE: ¿WAS ADMITTED TO THE HOSPITAL FOR A PARTIALLY OBSTRUCTED RECURRENT VENTRAL HERNIA. THE HERNIA WAS REDUCED IN THE TEC WITH EVIDENCE OF CONTRAST PASSAGE THROUGH THE LOOP OF SMALL BOWEL ON DELAYED IMAGES. THE PATIENT WAS ADMITTED FOR OBSERVATION AND DIET ADVANCEMENT, WHICH SHE TOLERATED THIS WELL. THE PATIENT WAS AMBULATING INDEPENDENTLY AS WELL AS PASSING URINE AND FLATUS INDEPENDENTLY AT THE TIME OF DISCHARGE.¿ CT SCAN OF ABDOMEN/PELVIS DATED (B)(6) 2016 STATES: ¿THERE ARE CHANGES RELATED TO VENTRAL HERNIA REPAIR WITH PLACEMENT OF A MESH. THERE IS A LOOP OF HERNIATED INTESTINE WITHIN A PARAUMBILICAL HERNIA WITH EVIDENCE OF LOW-GRADE OBSTRUCTION AS MANIFESTED BY MILD INFLAMMATORY CHANGES OF THE MESENTERIC FAT. MULTIPLE NONDILATED FLUID-FILLED LOOPS OF INTESTINE ARE IDENTIFIED.¿ OPERATIVE RECORDS DATED (B)(6) 2017 INDICATE THE PATIENT UNDERWENT DEBRIDEMENT OF INSERTION ACHILLES TENDON WITH REATTACHMENT, LEFT, EXOSTECTOMY CALCANEUS, LEFT. THERE IS NO MENTION OF A GORE DEVICE IN THE RECORDS. EMERGENCY ROOM RECORDS DATED (B)(6) 2017 INDICATE THE PATIENT WAS TREATED FOR A DIAGNOSIS OF CELLULITIS OF BREAST, POORLY CONTROLLED TYPE 2 DIABETES MELLITUS, AND HYPERGLYCEMIA. 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.
PREVIOUS PATIENT CODES (1695, 2668, 3191: USED FOR "MESH FAILURE") WERE REPORTED BASED ON THE ORIGINAL COMPLAINT AND ARE NO LONGER APPLICABLE PER GORE¿S INVESTIGATION. H10/11: UPDATED FINAL CODES. H10/11: ADDITIONAL CONCLUSION CODE: 4316: APPROPRIATE TERM/CODE NOT AVAILABLE USED FOR "WITHDRAWN COMPLAINT". 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. THIS EVENT WILL BE CLOSED.
H6: UPDATED PATIENT CODES. H6: UPDATED DEVICE CODES. H6: UPDATED CONCLUSION CODES. H6: 4316: APPROPRIATE TERM/CODE NOT AVAILABLE FOR ¿WITHDRAWN COMPLAINT¿. 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. PREVIOUS PATIENT CODES (1695, 2668, 3191: APPROPRIATE TERM/CODE NOT AVAILABLE FOR ¿MESH FAILURE¿) WERE REPORTED BASED ON THE ORIGINAL COMPLAINT AND ARE NO LONGER APPLICABLE AND/OR NOT REPORTABLE PER GORE¿S INVESTIGATION. MEDICAL RECORDS: THE KNOWN MEDICAL RECORDS SPAN (B)(6) 2001 THROUGH (B)(6) 2017 AND NOT ALL RECORDS RECEIVED IN THIS TIME SPAN ARE RELEVANT TO THE GORE® DUALMESH® PLUS BIOMATERIAL. RECORDS FROM (B)(6) 2005 THROUGH (B)(6) 2009 WERE NOT PROVIDED. PATIENT INFORMATION: MEDICAL HISTORY: OBESITY, SMOKING ½ PACK/DAY, HYPERTENSION, DIABETES, SLEEP APNEA, HYPERLIPIDEMIA, IRRITABLE BOWEL SYNDROME, FIBROMYALGIA, TORTICOLLIS-SPASMODIC, ISCHEMIC COLITIS. PRIOR SURGICAL PROCEDURES: ON (B)(6) 2001: SUPRACERVICAL ABDOMINAL HYSTERECTOMY AND APPENDECTOMY. ON (B)(6) 2003: FLEXIBLE SIGMOIDOSCOPY WITH BIOPSIES. ON (B)(6) 2003: COLONOSCOPY WITH SNARE POLYPECTOMY AND BIOPSY. IMPLANT PREOPERATIVE COMPLAINTS: [NONE PROVIDED]. IMPLANT PROCEDURE: LAPAROSCOPIC INCISIONAL HERNIORRHAPHY WITH ¿DUAL-MESH PLACER¿. IMPLANT: GORE® DUALMESH® PLUS BIOMATERIAL (01627903/1DLMCP06) 18 X 24 CM. IMPLANT DATE: (B)(6) 2004. DESCRIPTION OF HERNIA BEING TREATED: [THE PATIENT] ¿HAD A LARGE FASCIAL DEFECT PROBABLY 10 CENTIMETERS IN DIAMETER. THIS CONTAINED OMENTUM, PREPERITONEAL FAT AND SOME SMALL BOWEL.¿ ¿THROUGH A COMBINATION OF BLUNT, SHARP AND HARMONIC SCALPEL DISSECTION, THE HERNIA CONTENTS WERE BROUGHT SAFELY OUT OF THE FASCIAL DEFECT. CARE WAS TAKEN NOT TO INJURE AND SMALL INTESTINES.¿ IMPLANT SIZE AND FIXATION: ¿ONCE ALL THE HERNIA CONTENTS WERE REDUCED, A PIECE OF DUAL-MESH WAS MEASURED TO FIT ADEQUATELY OVER THE HERNIA DEFECT. 0-PDS SUTURES WERE PLACED AT THE TWO SUPERIOR CORNERS AND THE LATERAL MIDWAY EDGES. AN INCISION WAS MADE THROUGH THE HERNIA DEFECT IN THE SKIN AND THE MESH WAS PLACED WITHIN THE ABDOMINAL CAVITY. THIS DEFECT WAS SUTURED CLOSED WITH A 3-0 NYLON SUTURE. THE MESH WAS THEN UNRAVELED AND USING A NEEDLE PASSER, THE SUTURES WERE BROUGHT OUT THROUGH THE SKIN THROUGH SEPARATE STAB INCISIONS AND THEN TIED. WE PLACED AN ADDITIONAL 0-PDS SUTURE THROUGH THE SUPERIOR MIDDLE ASPECT OF THE MESH FREEING THIS OUT THROUGH THE FASCIA WITH THE NEEDLE PASSER. THE SPIRAL TACKER WAS THEN USED TO SECURE THE MESH CIRCUMFERENTIALLY. EXCESS MESH INFERIORLY WAS CUT OFF AND BROUGHT OUT THROUGH THE PORT SITE. THE MESH HAD NICE COVERAGE OVER THE FASCIAL DEFECT. THE PORTS WERE REMOVED AND WERE HEMOSTATIC. ALL SKIN INCISIONS WERE CLOSED WITH A RUNNING 4-0 MONOCRYL SUBCUTICULAR STITCH.¿ NO POST-OPERATIVE RECORDS WERE PROVIDED. RELEVANT MEDICAL INFORMATION: ON (B)(6) 2005: COLONOSCOPY OF THE CECUM WITH BIOPSIES. ON (B)(6) 2009: LAPAROSCOPIC CHOLECYSTECTOMY. THERE IS NO MENTION OF THE GORE DEVICE IN THE (B)(6) 2009 OPERATIVE RECORD. HOSPITALIZATION (B)(6) 2011 FOR ¿PELVIC MASS¿. ON (B)(6) 2011: EXPLORATORY LAPAROTOMY WITH BILATERAL SALPINGO-OOPHORECTOMY, TRACHELECTOMY AND EXTENSIVE LYSIS OF ADHESIONS. [THE PATIENT] ¿IS A 43-YEAR-OLD FEMALE WITH A PAST SURGICAL HISTORY REMARKABLE FOR MESH REPAIR OF A VENTRAL HERNIA. SHE WAS UNDERGOING PELVIC EXPLORATION BY (B)(6), MD, AND INTRAOPERATIVE CONSULTATION WAS REQUESTED FOR MANAGEMENT OF SMALL BOWEL ADHESIONS INVOLVING THE PREVIOUSLY-PLACED MESH.¿ [THE PATIENT] ¿WAS NOTED TO HAVE A HISTORY OF PREVIOUS SUPRACERVICAL HYSTERECTOMY, PREVIOUS LAPAROSCOPIC CHOLECYSTECTOMY AND PREVIOUS LAPAROSCOPIC PLACEMENT OF A MESH DUE TO A VENTRAL HERNIA. THE PATIENT WAS NOTED TO HAVE EXTENSION OF ADHESIONS OF THE OMENTUM TO THE ANTERIOR SURFACE OF THE ABDOMINAL WALL AND MESH THAT WAS IN THE LOWER PORTION OF THE ABDOMEN.¿ ¿THERE WERE ADHESIONS TO THE SMALL BOWEL AND LARGE BOWEL FROM THE MESH. THERE WERE ALSO ADHESIONS OF THE BOWEL TO THE OVARY AND PELVIC MASS ON THE RIGHT SIDE AND THE LEFT OVARY AND FALLOPIAN TUBE WERE ADHESED WITHIN THE RETROPERITONEUM ON THE LEFT. THE PATIENT'S CERVIX APPEARED VISUALLY NORMAL. IT WAS REMOVED WITHOUT DIFFICULTY. OTHER THAN THE REMAINDER OF THE ADHESIONS OF THE BOWEL, THE REMAINDER OF THE ABDOMEN AND PELVIS WERE WITHOUT EVIDENCE OF MALIGNANCY. HER UPPER ABDOMEN WAS NORMAL TO VISUAL INSPECTION AND PALPATION. INTRAOPERATIVE CONSULT WAS OBTAINED WITH (B)(6), MD. HE ASSISTED WITH ADHESIOLYSIS OF THE BOWEL FROM THE MESH SURFACE. A VERTICAL MIDLINE INCISION WAS MADE FROM ABOVE THE UMBILICUS TOWARD THE SUPRAPUBIC BONE. THE INCISION WAS CARRIED DOWN SO THE FASCIA WAS IDENTIFIED AND ENTERED IN THE MIDLINE. THE MESH WAS ENCOUNTERED JUST BELOW THE UMBILICUS DOWN TO THE LEVEL OF JUST ABOVE THE SUPRAPUBIC BONE. THERE WERE ADHESIONS TO THE MESH FROM THE OMENTUM AND SMALL BOWEL. THE ADHESIONS WERE DISSECTED AWAY FROM THE OMENTUM FROM THE MESH SURFACE EXTENSIVELY. APPROXIMATELY 60 MINUTES WERE SPENT ON THIS PORTION OF ADHESIOLYSIS. THE INFERIOR PORTION OF THE MESH ON THE PATIENT'S RIGHT SIDE HAD AN AREA OF 2 LOOPS OF SMALL BOWEL THAT WERE TIGHTLY ADHERENT TO THE MESH SURFACE; THEREFORE, INTRAOPERATIVE CONSULT WITH (B)(6), MD WAS OBTAINED AND HE ASSISTED IN ADHESIOLYSIS AND REMOVAL OF THE BOWEL SURFACE FROM THOSE AREAS.¿ ¿THE PREVIOUSLY-PLACED MESH, WHICH WAS A GORE-TEX PRODUCT, WAS DIVIDED IN THE MIDLINE ALONG WITH THE FASCIAL INCISION. AT THE INFERIOR EDGE OF THE MESH, THERE WERE SMALL BOWEL ADHESIONS TO THE MESH, PARTICULARLY IN THE RIGHT LOWER ABDOMEN. THE MESH WAS GRASPED WITH LONG ALLIS CLAMPS TO PROVIDE EXPOSURE AND TRACTION. THE SMALL BOWEL ADHESIONS TO THE UNDERSURFACE AND TO THE EDGE OF THE MESH WERE DIVIDED BY MEANS OF BLUNT AND SHARP DISSECTION. CARE WAS TAKEN THROUGHOUT TO AVOID ENTEROTOMIES. NONE WAS MADE DURING THE COURSE OF THE DISSECTION. ULTIMATELY, THE SMALL BOWEL ADHESIONS WERE FREED COMPLETELY FROM THE UNDERSURFACE AND INFERIOR CUT EDGE OF THE MESH. ADDITIONAL ADHESIOLYSIS OF SMALL BOWEL WAS PERFORMED IN ORDER TO FACILITATE THE REMAINDER OF THE DISSECTION. THIS WAS ALSO CARRIED OUT BY MEANS OF BLUNT AND SHARP DISSECTION. AGAIN, NO ENTEROTOMIES WERE MADE. THE PATIENT REMAINED IN THE OPERATING ROOM FOR COMPLETION OF THE PROCEDURE BY (B)(6), MD AND HER OPERATIVE TEAM.¿ ¿THE FASCIAL INCISION WAS CLOSED WITH 0 PROLENE TO REAPPROXIMATE THE FASCIA AND THE MESH SURFACES AFTER SEPRAFILM WAS PLACED INTO THE ABDOMEN.¿ DISCHARGE NOTES: [THE PATIENT] ¿IS A 43 Y.O. [YEAR OLD] G4P3 [GRAVIDA 4, PARA 3] CAUCASIAN FEMALE WHO INITIALLY PRESENTED IN FAMILY PRACTICE WITH RUQ [RIGHT UPPER QUADRANT] PRESSURE AND DISCOMFORT. A RUQ ULTRASOUND WAS OBTAINED WITH THE INCIDENTAL FINDING OF A LARGE 15 CM CYSTIC MASS IN THE RLQ [RIGHT LOWER QUADRANT], WHICH WAS FURTHER EVALUATED WITH PELVIC ULTRASOUND. THIS APPEARS TO ARISE FROM THE RIGHT ADNEXA. OTHER THAN THE RIGHT SIDED PAIN, THE PATIENT INDICATES THAT SHE HAS BEEN ASYMPTOMATIC. SHE HAS HAD A PREVIOUS SUPRACERVICAL HYSTERECTOMY FOR BENIGN DISEASE.¿ HOSPITALIZATION (B)(6) 2013. ON (B)(6) 2013: ADMISSION: ¿IN (B)(6) 2009, SHE UNDERWENT LAPAROSCOPIC CHOLECYSTECTOMY. IN (B)(6) 2011, SHE UNDERWENT EXPLORATORY LAPAROTOMY WITH BILATERAL SALPINGOOOPHORECTOMY [SIC] AND EXTENSIVE LYSIS OF ADHESIONS. AT THAT TIME, THE PREVIOUSLY PLACED MESH WAS DIVIDED, AND THERE WERE SMALL BOWEL ADHESIONS TAKEN DOWN FROM THE MESH.¿ ON (B)(6) 2013: REPAIR OF INCISIONAL HERNIA WITH PHYSIOMESH, 20 X 15 CM. [THE PATIENT] ¿IS A 45-YEAR-OLD WOMAN WHO HAS HAD MULTIPLE PREVIOUS ABDOMINAL OPERATIONS WHICH INCLUDE AN ABDOMINAL HYSTERECTOMY, A PREVIOUS INCISIONAL HERNIA REPAIR, APPENDECTOMY, EXPLORATORY LAPAROTOMY WITH BILATERAL SALPINGO-OOPHORECTOMY AND EXTENSIVE LYSIS OF ADHESIONS, AND LAPAROSCOPIC CHOLECYSTECTOMY. SHE WAS NOTED TO HAVE AN INCISIONAL HERNIA INVOLVING THE UPPER ASPECT OF HER MIDLINE SCAR.¿ ¿SHE HAD EXTENSIVE ADHESIONS OF THE ABDOMINAL WALL, INCLUDING ADHESIONS TO PREVIOUSLY PLACED MESH IN THE LOWER ABDOMEN. THE MESH IN THE LOWER ABDOMEN WAS NOT ASSOCIATED WITH THE PATIENT'S CURRENT HERNIA AND THE MESH WAS WELL INCORPORATED. THEREFORE, THIS MESH WAS LEFT IN PLACE. THESE ADHESIONS WERE ALL TAKEN DOWN CAREFULLY, WHICH TOOK APPROXIMATELY 1 HOUR. A PIECE OF PHYSIOMESH INTRAPERITONEALLY.¿ ¿THERE WERE SEVERAL SEPARATE HERNIA DEFECTS ABOUT THE UMBILICUS. THERE WERE UNDERLYING BOWEL AND OMENTUM THAT WE CAREFULLY EXCLUDED FROM THE INCISION. THIS REQUIRED LYSIS OF ADHESIONS, AND CAREFUL DISSECTION SHARPLY TO REMOVE THE UNDERLYING OMENTAL AND SMALL BOWEL ATTACHMENTS FROM THE ANTERIOR ABDOMINAL WALL. AT THE INFERIOR EDGE OF THE INCISION, THERE WAS A PIECE OF DUALMESH WHICH WAS LEFT IN PLACE, AS DESCRIBED ABOVE. HOWEVER, THERE WERE ADHESIONS OF OMENTUM AND SMALL BOWEL TO THE DUALMESH THAT WERE TAKEN DOWN TO FACILITATE EXPOSURE. AFTER OPENING THE ENTIRE INCISION, WE CAREFULLY TOOK DOWN ADDITIONAL SMALL BOWEL AND OMENTAL ADHESIONS FROM THE ANTERIOR ABDOMINAL WALL CIRCUMFERENTIALLY TO ALLOW PLACEMENT OF THE MESH.¿ ON (B)(6) 2013: DISCHARGE SUMMARY: [THE PATIENT] ¿WAS ADMITTED TO THE HOSPITAL AND TAKEN TO THE OPERATING ROOM FOR A VENTRAL HERNIA REPAIR WITH MESH. SHE TOLERATED THE PROCEDURE WELL WITHOUT COMPLICATIONS. POST OPERATIVELY THE PATIENT WAS TRANSFERRED TO THE FLOOR. HER PAIN WAS INITIALLY CONTROLLED WITH IV PAIN MEDICATIONS. THIS WAS TRANSITIONED TO ORAL PAIN MEDICATIONS WHICH SHE WAS TOLERATING AT THE TIME OF DISCHARGE. THE PATIENT WAS AMBULATING INDEPENDENTLY AS WELL AS PASSING URINE AND FLATUS INDEPENDENTLY AT THE TIME OF DISCHARGE.¿ ON (B)(6) 2016: ADMISSION: [THE PATIENT IS] ¿A 48 Y.O. FEMALE WHO PRESENTS WITH ABDOMINAL PAIN. SHE HAS IBS PAIN AND CRAMPING AT BASELINE BUT THIS IS DIFFERENT. THE PAIN STARTED (B)(6) IN THE MORNING BEFORE GOING TO (B)(6). SHE ATE AT 11:30AM WITHOUT PROBLEM. AROUND 3PM SHE HAD ACHING AND STABBING PAIN. IT INTENSIFIED THROUGH THE EVENING. +NAUSEA, -VOMITING, -DIARRHEA. HAD 3 BMS OVERNIGHT, ALL ¿NORMAL¿. CURRENTLY HAS YEAST INFECTION AND PERINEUM IS IRRITATED, SO BMS HAVE HAD SOME BLOOD.¿ ON (B)(6) 2016: CT ABDOMEN/PELVIS: ¿THERE ARE CHANGES RELATED TO VENTRAL HERNIA REPAIR WITH PLACEMENT OF A MESH. THERE IS A LOOP OF HERNIATED INTESTINE WITHIN A PARAUMBILICAL HERNIA WITH EVIDENCE OF LOW-GRADE OBSTRUCTION AS MANIFESTED BY MILD INFLAMMATORY CHANGES OF THE MESENTERIC FAT. MULTIPLE NONDILATED FLUID-FILLED LOOPS OF INTESTINE ARE IDENTIFIED.¿ ON (B)(6) 2016: DISCHARGE SUMMARY: [THE PATIENT] ¿WAS ADMITTED TO THE HOSPITAL FOR A PARTIALLY OBSTRUCTED RECURRENT VENTRAL HERNIA. THE HERNIA WAS REDUCED IN THE TEC [UNKNOWN ACRONYM] WITH EVIDENCE OF CONTRAST PASSAGE THROUGH THE LOOP OF SMALL BOWEL ON DELAYED IMAGES. THE PATIENT WAS ADMITTED FOR OBSERVATION AND DIET ADVANCEMENT, WHICH SHE TOLERATED THIS WELL. THE PATIENT WAS AMBULATING INDEPENDENTLY AS WELL AS PASSING URINE AND FLATUS INDEPENDENTLY AT THE TIME OF DISCHARGE.¿ CONCLUSIONS: IT SHOULD BE NOTED THAT THE GORE® DUALMESH® PLUS 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, 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. REVIEW OF THE MANUFACTURING RECORDS VERIFIED THAT THE LOT MET ALL PRE-RELEASE SPECIFICATIONS. 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: 01627903. 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.
(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) 2004 WHEREBY A GORE DUALMESH® PLUS BIOMATERIAL WAS IMPLANTED. IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT AN ADDITIONAL PROCEDURE WITH NO REPORT OF DEVICE EXPLANT. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: SMALL BOWEL ADHESIONS TO THE MESH, SMALL BOWEL WAS DISSECTED FROM THE ADHESIONS, ADDITIONAL SURGERY, MESH FAILURE. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 9959 | GORE DUALMESH PLUS BIOMATERIAL | MESH, SURGICAL, POLYMERIC | FTL | W.L. GORE & ASSOCIATES | 1DLMCP06 | 01627903 | 00733132601134 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 36 YR | Hospitalization| R |