GORE DUALMESH® PLUS BIOMATERIAL
Report
- Report Number
- 2017233-2019-00781
- Event Type
- Injury
- Date Received
- August 30, 2019
- Date of Event
- October 23, 2018
- Report Date
- April 25, 2022
- Manufacturer
- W.L. GORE & ASSOCIATES
- Product Code
- FTL
- UDI-DI
- 00733132601097
- PMA / PMN Number
- K063435
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- 003
Narratives
B7: ADDED MEDICAL HISTORY. H6: CONCLUSION CODE REMAINS UNCHANGED. H10/11: ADDED MEDICAL RECORD INFORMATION. ADDITIONAL DETAILS REGARDING THE PATIENT'S CLINICAL COURSE WERE ASCERTAINED FROM A REVIEW OF MEDICAL RECORDS AND ARE AS FOLLOWS: ON (B)(6) 2008 (B)(6) HOSPITAL. (B)(6), MD. OPERATIVE REPORT. PREOP DIAGNOSIS: INCISIONAL HERNIA. POSTOP DIAGNOSIS: INCISIONAL HERNIA. OPERATION: REPAIR OF INCISIONAL HERNIA WITH MESH. ANESTHESIA: GENERAL. ANESTHESIOLOGIST: RAY KNOWLAND, CRNA; JOHN M SHIRO, MD. PROCEDURE DESCRIPTION: ¿PATIENT WAS PLACED IN SUPINE POSITION ON THE OPERATING ROOM TABLE. A TIME-OUT WAS COMPLETED PRIOR TO THE PREP. SHE WAS THEN PREPPED AND DRAPED IN THE USUAL STERILE FASHION. IOBAN DRESSING WAS PLACED. A SKIN INCISION WAS THEN MADE OVERLYING HER PREVIOUS PFANNENSTIEL INCISION. DISSECTION WAS CARRIED DOWN THROUGH THE SKIN AND SUBCUTANEOUS TISSUE. JUST TO THE RIGHT OF THE MIDLINE, THERE WAS NOTED TO BE A FASCIAL DEFECT. THE FASCIAL EDGES WERE DISSECTED FREE. THE HERNIA SAC WAS THEN OPENED. THERE WAS NOTED TO BE OMENTAL FAT WITHIN THE HERNIA SAC. THE ABDOMEN WAS THEN FURTHER DISSECTED OFF THE FASCIA. A PIECE OF GORE DUALMESH PLUS WAS THEN OBTAINED WHICH MEASURED 8 CM X 12 CM. THE FASCIAL DEFECT ITSELF WAS NOTED TO MEASURE 4 CM X 5 CM. THE MESH WAS IRRIGATED AND SOAKED IN BACITRACIN/POLYMYXIN IRRIGATION. THE MESH WAS THEN SECURED INTO POSITION WITH #1 ETHIBOND SUTURES IN AN INTERRUPTED FASHION. THE HERNIA SAC LINING WAS THEN TACKED DOWN OVERLYING THE MESH WITH THE USE OF A 3-0 VICRYL SUTURE. IRRIGATION WAS PERFORMED. THROUGH A SEPARATE STAB INCISION, A 10 MM JP [(B)(6)] DRAIN WAS PLACED. DEEP TISSUE WAS THEN REAPPROXIMATED WITH INTERRUPTED 3-0 VICRYL SUTURES. THE SKIN WAS THEN REAPPROXIMATED WITH THE USE OF THE SKIN STAPLER. A STERILE DRESSING WAS APPLIED. PATIENT TOLERATED PROCEDURE WELL AND WAS TRANSFERRED TO RECOVERY ROOM IN STABLE CONDITION.¿ ON (B)(6) 2008 (B)(6) HOSPITAL [ASSIGNED]. PATIENT CASE RECORD/OR LOG/NURSING PLAN OF CARE. IMPLANT RECORD. IMPLANT COMPANY: GORE. IMPLANT TYPE: MESH. QUANTITY: 1. PRODUCT: 8CMX12CMX1MM DUAL MESH PLUS. CATALOG NO: 1DLMCP02. LOT NO: 04498418. THE RECORDS CONFIRM A GORE® DUALMESH® PLUS BIOMATERIAL (1DLMCP02/04498418) WAS IMPLANTED DURING THE PROCEDURE. RECORDS BETWEEN (B)(6) 2008 AND (B)(6) 2018 WERE NOT PROVIDED. ON (B)(6) 2018 (B)(6) HOSPITAL. (B)(6), DO. BRIEF OPERATIVE NOTE. PREOPERATIVE DIAGNOSIS: INCISIONAL HERNIA, WITHOUT OBSTRUCTION OR GANGRENE. POSTOPERATIVE DIAGNOSIS: SAME. PROCEDURE: ROBOTIC INCISIONAL HERNIA REPAIR WITH MESH, EXTENSIVE LYSIS OF ADHESIONS. SURGEON: KRYSTLE LANGE, DO. ASSISTANT: TRACI BLAKE, STFA. ANESTHESIA: GENERAL ANESTHESIA ¿ ET. EXPAREL 20 CC BILATERAL TAP BLOCK. FLUIDS: SEE ANESTHESIA RECORD. ESTIMATED BLOOD LOSS: 30 CC. DRAINS: NONE. FINDINGS: ¿PREVIOUS MESH WAS CURLED AT EDGES AND VERY INCORPORATED IN THE TISSUE, THE NEW DEFECT WAS 2.5 CM IN GREATEST DIAMETER. A 12 CM ROUND SYMBOTEX MESH WAS PLACED AROUND ORIGINAL MESH AND NEW DEFECT. THERE WAS A LARGE AMOUNT OF OMENTUM IN DEFECT.¿ SPECIMEN: NO SPECIMENS IN LOG. URINE OUTPUT: NOT RECORDED. COMPLICATIONS: NONE. DISPOSITION: STABLE TO RECOVERY. ON (B)(6) 2018 (B)(6) HOSPITAL. (B)(6), DO. OPERATIVE NOTE. PREOPERATIVE DIAGNOSIS: INCISIONAL HERNIA, WITHOUT OBSTRUCTION OR GANGRENE. POSTOPERATIVE DIAGNOSIS: SAME. PROCEDURE: ROBOTIC INCISIONAL HERNIA REPAIR WITH MESH, EXTENSIVE LYSIS OF ADHESIONS. ANESTHESIOLOGIST: MARSA L. MITCHELL, MD. ASSISTANT: TRACI BLAKE STFA. ANESTHESIA: GENERAL ANESTHESIA ¿ ET. EXPAREL 20 CC BILATERAL TAP BLOCK. FLUIDS: SEE ANESTHESIA RECORD. ESTIMATED BLOOD LOSS: 30 CC. DRAINS: NONE. FINDINGS: ¿PREVIOUS MESH WAS CURLED AT EDGES AND VERY INCORPORATED IN THE TISSUE, THE NEW DEFECT WAS 2.5 CM IN GREATEST DIAMETER. A 12 CM ROUND SYMBOTEX MESH WAS PLACED AROUND ORIGINAL MESH AND NEW DEFECT. THERE WAS A LARGE AMOUNT OF OMENTUM IN DEFECT. THERE WERE MULTIPLE ADHESIONS THAT REQUIRED OVER AN HOUR TO TAKE DOWN TO EVEN FIND AND GET TO THE HERNIA.¿ URINE OUTPUT: NOT RECORDED. COMPLICATIONS: NONE. DISPOSITION: STABLE TO RECOVERY. INDICATIONS: ¿PATIENT IS A 49-YEAR-OLD FEMALE WHO I SAW IN MY CLINIC FOR A VENTRAL HERNIA. SHE HAD AN OPEN HERNIA REPAIR ABOUT 8 YEARS AGO WHERE MESH WAS USED AND JUST ABOVE THIS THERE WAS A RECURRENT OR NEW HERNIA WITH A LARGE AMOUNT OF OMENTUM INCARCERATED IN HERE. I EXPLAINED THE RISKS/BENEFITS/ALTERNATIVES TO UNDERGOING A ROBOTIC ASSISTED VENTRAL INCISIONAL HERNIA REPAIR WITH MESH AND SHE AGREED TO PROCEED. INFORMED CONSENT WAS OBTAINED.¿ DESCRIPTION OF PROCEDURE: ¿AFTER OBTAINING INFORMED CONSENT THE PATIENT WAS IDENTIFIED AND TAKEN TO THE OPERATING ROOM AND POSITIONED IN THE SUPINE POSITION. GENERAL ENDOTRACHEAL ANESTHESIA WAS INDUCED BY THE ANESTHESIA TEAM WITHOUT COMPLICATION. A TIME OUT IS PERFORMED WITH RECONFIRMATION OF THE PATIENT¿S IDENTITY AND PROPOSED PROCEDURE. SAFETY MEASURES ARE REVIEWED. IT IS CONFIRMED THAT THE PATIENT HAS RECEIVED PERIOPERATIVE ANTIBIOTICS. A FOLEY CATHETER WAS PLACED. THE ABDOMEN WAS PREPPED AND DRAPED IN THE USUAL STERILE FASHION. A LEFT UPPER QUADRANT SKIN INCISION WAS MADE AND AN ATTEMPT AT ESTABLISHING PNEUMOPERITONEUM WAS DONE USING A VERESS NEEDLE. FOR WHATEVER REASON HIGH PRESSURES WERE OBTAINED AND SO AN OPTIVIEW TECHNIQUE WAS USED TO ENTER THE LEFT MID ABDOMEN AND PNEUMOPERITONEUM WAS THEN ESTABLISHED. THE LAPAROSCOPE WAS INSERTED AND WE LOOKED AROUND WHERE THE VERESS NEEDLE WAS PLACED AND THERE WAS NO INJURY NOTED ANYWHERE. TWO ADDITIONAL ROBOTIC TROCARS WITH CONTROL CENTERS ARE PLACED IN THE LATERAL ABDOMEN CEPHALAD AND CAUDAL TO THIS TROCAR. EXPAREL, 10 ML WAS INJECTED BILATERALLY FOR A TAP BLOCK. THE ROBOT IS NOW DOCKED AND INSTRUMENTS ARE INSERTED BY THE SURGICAL ASSISTANT; FENESTRATED BIPOLAR, MONOPOLAR SCISSORS. THERE WERE MULTIPLE ADHESIONS AND THE OMENTUM WAS DRAPED OVER THE ANTERIOR ABDOMINAL WALL, AND THEREFORE, IT TOOK ABOUT AN HOUR TO TAKE DOWN ALL THE ADHESIONS TO EVEN GET TO THE HERNIA IN THE LOWER RIGHT ABDOMEN BELOW THE UMBILICUS. IN THE LOWER MIDLINE THE PREVIOUS MESH WAS FOUND. IT HAD SHRUNK SUBSTANTIALLY AND HAD CURLED EDGES, BUT IT WAS VERY WELL INCORPORATED. AT THIS TIME THE OMENTUM WAS REDUCED FROM THE HERNIA AND THERE WAS A LARGE AMOUNT INCARCERATED WHICH TOOK QUITE A BIT OF TIME TO REDUCE. THE HERNIA DEFECT WAS AT THE LARGEST SIZE 2.5 CM AND WAS RIGHT NEXT TO THE PREVIOUS MESH. ON EVALUATING IF THIS COULD BE PRIMARILY CLOSED I FELT THAT THERE WOULD BE TOO MUCH TENSION AND THEREFORE, IT WAS DECIDED TO NOT CLOSE THIS. I DID TRIM OFF SOME OF THE ROUGH ENDS OF THE PREVIOUS MESH, BUT LEFT THAT IN PLACE AS IT WAS BRIDGING A HERNIA AND WAS WELL INCORPORATED IN THE TISSUE. MEASURING THE NEW DEFECT AND THE SPAN OF THE OLD MESH, THIS WAS ABOUT 5 CM IN LENGTH AND THEREFORE I CHOSE A 15 CM ROUND SYMBOTEX MESH TO OBTAIN GOOD COVERAGE OVER THE PRIOR MESH AND NEW DEFECT. THERE WERE A COUPLE OF SMALL FASCIAL DEFECTS AROUND THIS OTHER HERNIA AS WELL THAT WOULD BE COVERED WITH THIS NEW MESH. THE MESH WAS SUTURED IN PLACE WITH 2-0 STATIFIX SUTURE CIRCUMFERENTIALLY. THE OMENTUM WAS THEN TACKED TO THE MESH WITH 3-0 VICRYL TO PROTECT THE BOWEL FROM THE MESH. FINAL INSPECTION IS COMPLETED AND THE TROCARS ARE REMOVED. TROCAR SITES ARE CLOSED WITH 4-0 MONOCRYL SUTURE. STERILE DRESSINGS ARE APPLIED. MARCAINE 0.5% WAS INJECTED INTO THE INCISIONS FOR LOCAL ANESTHESIA. THE PATIENT WAS EXTUBATED AND TRANSFERRED TO RECOVERY IN STABLE CONDITION. SPONGE, NEEDLE AND INSTRUMENT COUNTS ARE CORRECT. THE PATIENT SUSTAINED NO COMPLICATIONS OR IMMEDIATE SEQUELAE AS A RESULT OF ANESTHESIA AND/OR OPERATIVE PROCEDURE.¿ THERE IS NO MENTION OF GORE DEVICE REMOVAL IN THE RECORDS. ON (B)(6) 2018 (B)(6) HOSPITAL. (B)(6), APRN; (B)(6), DO. DISCHARGE SUMMARY. ADMISSION DATE: (B)(6)2018. DISCHARGE DATE: (B)(6) 2018. PRIMARY DISCHARGE DIAGNOSIS: INCISIONAL HERNIA WITHOUT OBSTRUCTION OR GANGRENE. DISCHARGE DISPOSITION: HOME OR SELF-CARE. HISTORY OF PRESENT ILLNESS: 49-YEAR-OLD FEMALE HERE FOR EVALUATION AND TREATMENT OF ABDOMINAL WALL HERNIA. STATES SHE FELT IT A COUPLE OF WEEKS AGO, HAS SOME DISCOMFORT, THINKS SHE HAD THIS REPAIRED AT SOME POINT AND THAT IS RECURRENT. DR. (B)(6) DID AN OPEN HERNIA REPAIR WITH MESH ABOUT 8 YEARS AGO ACCORDING TO HER. HAS HAD 3 C-[CESAREAN] SECTIONS AND A LOW MIDLINE INCISION FROM HYSTERECTOMY. SHE CAN¿T PUSH IT BACK IN AT ALL. HOSPITAL COURSE: PATIENT HAD THE ABOVE STATE SURGERY AND TOLERATED THE PROCEDURE WELL. POSTOPERATIVELY, SHE HAD DIFFICULTIES WITH URINE RETENTION AND HAD A FOLEY CATHETER PLACED FOR MANAGEMENT OF THIS. ON THE DAY OF DISCHARGE, THE CATHETER WAS REMOVED AND THE PATIENT WAS ABLE TO VOID SPONTANEOUSLY WITHOUT DIFFICULTY. ONCE SHE WAS TOLERATING A GENERAL DIET WITHOUT NAUSEA OR VOMITING AND HER PAIN WAS WELL CONTROLLED WITH ORAL PAIN MEDICATION, SHE WAS DISCHARGED HOME. OPERATIVE PROCEDURES PERFORMED: ROBOTIC INCISIONAL HERNIA REPAIR WITH MESH, EXTENSIVE LYSIS OF ADHESIONS. ACTIVITY ORDERS: UP AS TOLERATED, DO NOT LIFT GREATER THAN 15 POUNDS FOR 4 WEEKS, AFTER 2 WEEKS YOU MAY DO ANY AEROBIC MOVEMENT; WALK, BIKE, DANCE, OR SWIM, DO NOT DO ANY WEIGHT TRAINING FOR 6 WEEKS AFTER SURGERY. DO NOT DO ANYTHING STRENUOUS UNTIL OKAYED BY YOUR DOCTOR. AVOID ALL TOBACCO PRODUCTS INCLUDING SECOND HAND SMOKE. TAKE STOOL SOFTENERS DAILY IF TAKING NARCOTICS. WITH CONSTIPATION MAY INCREASE TO TWICE A DAILY STOOL SOFTENERS. IF NO BOWEL MOVEMENT IN 3 DAYS, TRY SUPPOSITORY. A POTENTIAL RELATIONSHIP, IF ANY, BETWEEN THE ALLEGED INJURIES OR COMPLICATIONS AND THE GORE DEVICE HAS NOT BEEN ESTABLISHED AT THIS TIME BASED ON AVAILABLE INFORMATION. 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.
B7: ADDED MEDICAL HISTORY. H6: UPDATED RESULTS CODE 1 FOR MANUFACTURING EVALUATION. CONCLUSION CODE REMAINS UNCHANGED. H10/11: ADDED MEDICAL RECORD INFORMATION. ADDITIONAL DETAILS REGARDING THE PATIENT'S CLINICAL COURSE WERE ASCERTAINED FROM A REVIEW OF MEDICAL RECORDS AND ARE AS FOLLOWS: (B)(6) 2004: (B)(6) HOSPITAL. (B)(6) . OPERATIVE REPORT. PREVIOUS CESAREAN SECTION X 2. OPERATION: REPEAT LOW TRANSVERSE CESAREAN SECTION. POMEROY TUBAL LIGATION. (B)(6) 2008: (B)(6) . RADIOLOGY-CT ABDOMEN/PELVIS. SUMMARY: LOWER ABDOMINAL WALL VENTRAL HERNIA CONTAINING ONLY FAT. (B)(6) 2008: (B)(6) HOSPITAL. (B)(6) . HISTORY AND PHYSICAL. ABNORMAL UTERINE BLEEDING. PELVIC PAIN. NOTED TO HAVE VENTRAL ABDOMINAL WALL HERNIA. DOES NOT APPEAR TO HAVE ANY INCARCERATION. CT SCAN CONSISTENT WITH THAT FINDING. ULTRASOUND SHOWED SMALL POLYP AND SOME INTRAUTERINE FLUID CONSISTENT WITH BLEEDING. PAST MEDICAL HISTORY: OBESITY. (B)(6) 2008: [FACILITY NI]. MK, [NI]. OFFICE NOTES. PHYSICAL EXAM: 185 LB. ABDOMEN SOFT. HAS FASCIAL DEFECT PRESENT IN RIGHT LOWER QUADRANT, EASILY REDUCIBLE. WELL-HEALED PFANNENSTIEL INCISION, OTHERWISE SOFT. TENDER AT INCISIONAL HERNIA SITE. ASSESSMENT: INCISIONAL HERNIA. PLAN: DISCUSSED PROCEEDING WITH SURGERY FOR REPAIR OF INCISIONAL HERNIA, DOING MIDLINE INCISION, PLACING MESH INTO HERNIA, WILL HAVE DRAINING PERIOD. WILL BE IN HOSPITAL FOR COUPLE OF DAYS FOLLOWING SURGERY FOR PAIN CONTROL. (B)(6) 2008: [FACILITY NI]. MK, [NI]. HISTORY AND PHYSICAL. COMPLAINTS OF RIGHT LOWER QUADRANT ABDOMINAL PAIN HAS HAD FOR SOME TIME. UNDERWENT DILATATION AND CURETTAGE ON 15TH AND HAD CT PRIOR TO THAT WHICH DEMONSTRATED INCISIONAL HERNIA. PRESENTS FOR DISCUSSION OF REPAIR OF THIS INCISIONAL HERNIA WITH MESH. PAST MEDICAL HISTORY: DENIES. SOCIAL HISTORY: SMOKES ABOUT PACK A DAY FOR EIGHTEEN YEARS. [MISSING PAGES]. (B)(6) 2008: (B)(6) HOSPITAL. (B)(6) . HISTORY & PHYSICAL. COMPLAINTS OF ABDOMINAL PAIN. CT SCAN DEMONSTRATED INCISIONAL HERNIA. IMPRESSION: INCISIONAL HERNIA. PLAN: PROCEEDING TO OPERATING ROOM FOR REPAIR OF INCISIONAL HERNIA WITH MESH. (B)(6) 2008: (B)(6) HOSPITAL. (B)(6) . OPERATIVE PROCEDURES. REPAIR OF INCISIONAL HERNIA WITH MESH. FINDINGS: HERNIA SIZE DEFECT 4 CM X 5 CM. DUAL GORE MESH 8 X 12 CM PLACED. (B)(6) 2008: (B)(6) . NURSE¿S NOTE. ABDOMINAL BINDER. (B)(6) 2008: (B)(6) HOSPITAL. (B)(6) . DISCHARGE SUMMARY. ADMITTING/FINAL DIAGNOSIS: INCISIONAL HERNIA. OPERATIONS: REPAIR OF INCISIONAL HERNIA WITH MESH. POSTOPERATIVELY RECOVERED WELL WITH ADEQUATE PAIN CONTROL. (B)(6) 2008: (B)(6) . DISCHARGE INSTRUCTIONS. NO HEAVY LIFTING OR STRAINING. (B)(6) 2008: [FACILITY NI]. (B)(6) , [NI]. OFFICE NOTES. FOLLOWUP AFTER INCISIONAL HERNIA REPAIR. HAS NOT HAD A STOOL SINCE DISCHARGE. TAKING COLACE. JP DRAIN DRAINING 20, 20, 25 CC FOR PAST 3 DAYS. INCISION SITE HEALING WELL. DRAIN DRAINING TOO MUCH AT THIS TIME FOR REMOVAL. SEE BACK ON 6/2. I TOLD HER I WANTED HER TO HAVE STOOL BY SATURDAY MORNING. (B)(6) 2008: [FACILITY NI]. (B)(6) , [ILLEGIBLE]. OFFICE NOTES. REMOVAL OF STAPLES AND DRAIN. (B)(6) 2008: [FACILITY NI]. (B)(6) , [NI]. OFFICE NOTES. FOLLOWUP AFTER INCISIONAL HERNIA REPAIR WITH MESH. PHYSICAL EXAM: INCISION SITE HEALING WELL. LITTLE BIT OF REACTION AROUND STAPLES. DRAIN NOTED TO HAVE 10 CC TO 5 CC OUT AT TIME. DRAIN REMOVED WITHOUT ANY PROBLEMS. SEE PATIENT BACK IN ABOUT 2 WEEKS. (B)(6) 2008: [FACILITY NI]. (B)(6) , [NI]. OFFICE NOTES. INCISION WELL-HEALED. NO EVIDENCE OF ANY INFECTION OR INFLAMMATION. FOLLOWUP AS NEEDED. (B)(6) 2008: [FACILITY NI]. (B)(6) , [NI]. OFFICE NOTES. PAIN IN HERNIA SITE AREA. SORENESS ON RIGHT LOWER ASPECT FOR ABOUT PAST COUPLE WEEKS. PHYSICAL EXAM: INCISION SITE HEALING VERY WELL. DO NOT FEEL ANY EVIDENCE OF FASCIAL DEFECT AT INCISION OR AROUND HERNIA REPAIR. PLAN: DO NOT FEEL ANY EVIDENCE OF RECURRENT HERNIA. OFFERED FOLLOWUP CT SCAN OR SUGGESTED MONITORING. SHE WOULD LIKE TO MONITOR AREA. SEE BACK IN MONTH OR TWO. (B)(6) 2009: (B)(6) HEALTH SYSTEM. (B)(6) . EMERGENCY ROOM VISIT. COMPLAINING OF ABDOMINAL PAIN FOR THREE DAYS WITH NAUSEA AND DIARRHEA. CAT SCAN NEGATIVE. DISCHARGE DIAGNOSIS OF ABDOMINAL PAIN AND DIARRHEA. (B)(6) 2009: (B)(6) HEALTH SYSTEM. (B)(6) . RADIOLOGY-CT ABDOMEN/PELVIS. HISTORY: CONSTIPATION, TOOK LAXATIVE NOW HAS DIARRHEA AND NAUSEA. CONCLUSION: NO ACUTE INTRAABDOMINAL AND INTRAPELVIC PROCESS. (B)(6) 2010: (B)(6) HOSPITAL. (B)(6) . HISTORY AND PHYSICAL. ABNORMAL UTERINE BLEEDING. PAST MEDICAL HISTORY: THREE C-SECTIONS 1999, 2003, 2004. (B)(6) 2010: (B)(6) HOSPITAL. (B)(6) . HISTORY AND PHYSICAL. EVALUATION OF MENORRHAGIA AND ABNORMAL BLEEDING. PLAN FOR ABDOMINAL HYSTERECTOMY. DUE TO PREVIOUS HERNIA REPAIR, PLAN TO HAVE DR. KELLER FROM GENERAL SURGERY TO ASSIST IN ORDER TO OPTIMIZE CARE OF PREVIOUS INCISIONAL HERNIA REPAIR. (B)(6) 2010: (B)(6) HOSPITAL. (B)(6) . PROGRESS NOTES. PLANS FOR SURGERY AND POSSIBLE DIVISION OF MESH, EXPLAINED CONCERNS OF POSSIBLE RECURRENCE OF HERNIA, DISCUSSED CONCERNS OF POSSIBLE INFECTION OF MESH. (B)(6) 2010: (B)(6) HOSPITAL. PREANESTHESIA EVALUATION. PULMONARY HISTORY: SMOKER QUIT 1 YEAR. WEIGHT: 200 LBS. ASA: 2. (B)(6) 2010: (B)(6) HOSPITAL. (B)(6) . OPERATIVE REPORT. PREOPERATIVE DIAGNOSIS: MENORRHAGIA. ABNORMAL UTERINE BLEEDING. POSTOPERATIVE DIAGNOSIS: MENORRHAGIA. ABNORMAL UTERINE BLEEDING. OPERATION: TOTAL ABDOMINAL HYSTERECTOMY. ASSISTANT: MARY E. KELLER, MD. ANESTHESIA: GENERAL. FLUIDS: 1750 CC LR. URINE OUTPUT: 250 CC VIA FOLEY CATH. ESTIMATED BLOOD LOSS: 300 CC. SPECIMEN: UTERUS AND CERVIX. COMPLICATIONS: NONE. OPERATIVE FINDINGS: AN 8 TO 10 WEEK SIZE UTERUS, NORMAL OVARIES AND TUBES BILATERALLY, OMENTAL ADHESIONS TO THE ANTERIOR ABDOMINAL WALL, NOTABLE MESH IN THE FASCIA ON THE RIGHT SIDE. OPERATIVE NOTE INDICATIONS: THE PATIENT IS A 41-YEAR OLD G3, P3, WHO HAS HAD 3 C-SECTIONS IN THE PAST. IN ADDITION, SHE HAS HAD AN INCISIONAL HERNIA REPAIR WITH MESH. SHE PRESENTED FOR EVALUATION OF MENORRHAGIA AND ABNORMAL BLEEDING. SHE HAD FAILED TREATMENT WITH ORAL CONTRACEPTIVE PILLS. DUE TO MULTIPLE C-SECTIONS, SHE WAS NOT A GOOD CANDIDATE FOR ABLATION. SHE DECLINED THE MIRENA IUD AND OPTED FOR A HYSTERECTOMY. THE PLAN WAS FOR ABDOMINAL HYSTERECTOMY AND TO KEEP THE OVARIES AS LONG AS THEY APPEARED NORMAL. DUE TO HER PREVIOUS HERNIA REPAIR, THE PLAN WAS TO HAVE DR. KELLER FROM GENERAL SURGERY TO ASSIST WITH THE CASE, IN ORDER TO OPTIMIZE THE CARE OF THAT PERVIOUS INCISIONAL HERNIA SITE. THE SURGICAL RISKS WERE REVIEWED, INCLUDING BUT NOT LIMITED TO BLEEDING, INFECTION, DAMAGE TO SURROUNDING ORGANS, THE RISK OF RECURRENCE OF INCISIONAL HERNIA, THE RISK OF INFECTION WITHIN THE MESH THAT IS IN PLACE. ALL OF HER QUESTIONS WERE ANSWERED. VERBAL AND WRITTEN CONSENT WERE OBTAINED. PROCEDURE DESCRIPTION: ¿AFTER THE INFORMED CONSENT WAS GIVEN AND THE APPROPRIATE CONSENTS WERE SIGNED, THE PATIENT WAS TAKEN TO THE OPERATING ROOM WHERE SHE WAS ADMINISTERED GENERAL ANESTHESIA. ONCE AN APPROPRIATE LEVEL WAS OBTAINED, THE PATIENT WAS PREPPED AND DRAPED IN THE USUAL STERILE FASHION IN THE SUPINE POSITION. A FOLEY CATHETER WAS PLACED UNDER STERILE TECHNIQUE. THE PATIENT RECEIVED CIPRO AND FLAGYL FOR PREOPERATIVE ANTIBIOTIC PROPHYLAXIS. SCD BOOTS WERE IN PLACE FOR DVT PROPHYLAXIS. A MIDLINE SKIN INCISION WAS MADE WITH A SCALPEL AND EXTENDED SHARPLY DOWN TO THE FASCIA. THE FASCIA WAS ENTERED SUPERIORLY NEAR THE UMBILICUS. AT THIS POINT, THE ROUND LIGAMENTS WERE IDENTIFIED, SUTURE LIGATED AND THEN TRANSECTED. THE UTEROVESICAL PERITONEUM WAS TENTED AND INCISED SHARPLY WAS TENTED AND INCISED SHARPLY BILATERALLY. THERE WERE SOME THICK ADHESIONS AND THOSE WERE TAKEN DOWN SHARPLY WITH THE METZENBAUM SCISSORS, ALONG WITH THE BOVIE CAUTERY. ONCE THE AREA WAS FREED UP WELL, IT WAS GENTLY PUSHED DOWN WITH A SPONGE STICK AND PUSHED WELL OFF THE LOWER UTERINE SEGMENT AND CERVIX, WITH NO EVIDENCE OF ANY INJURY TO THE BLADDER. THE URETERS WERE IDENTIFIED BILATERALLY AND NOTED TO BE DEEP IN THE PELVIS, FAR AWAY FROM THE ANTICIPATED PEDICLE SITES. THE UTERO-OVARIAN LIGAMENTS WERE THEN CLAMPED BILATERALLY WITH CURVED HEANEY CLAMPS AFTER MAKING A PERITONEAL WINDOW IN THE BROAD LIGAMENT BILATERALLY. THOSE PEDICLES WERE TRANSECTED AND SUTURE LIGATED WITH 0 VICRYL SUTURE X 2 AND GOOD HEMOSTASIS WAS NOTED. THE UTERINE ARTERIES WERE THEN SKELETONIZED AND CLAMPED WITH CURVED HEANEY CLAMPS, TRANSECTED AND SUTURE LIGATED WITH 0 VICRYL SUTURE AND GOOD HEMOSTASIS WAS NOTED BILATERALLY. THE CARDINAL LIGAMENTS WERE TAKEN DOWN IN 2 BITES WITH STRAIGHT HEANEY CLAMPS BILATERALLY. THE LIGAMENTS WERE SUTURE LIGATED WITH 0 VICRYL SUTURE IN HEANEY STITCH FASHION. GOOD HEMOSTASIS WAS NOTED. THE UTEROSACRAL LIGAMENTS WERE CLAMPED WITH STRAIGHT HEANEY CLAMPS AND THE UTERUS AND CERVIX WERE AMPUTATED. THE CORNER OF THE VAGINA WERE SUTURE LIGATED WITH 0 VICRYL SUTURE IN A HEANEY STITCH FASHION. THE CUFF WAS CLOSED WITH 0 VICRYL SUTURE IN A RUNNING LOCKING FASHION AND GOOD CLOSURE AND GOOD HEMOSTASIS WAS NOTED. THERE WAS A SMALL BLEEDER ON THE RIGHT VAGINAL CORNER AND IT WAS CLAMPED WITH AN ALLIS CLAMP AND SUTURE LIGATED WITH 0 VICRYL SUTURE AND GOOD HEMOSTASIS WAS ACHIEVED. AT THIS POINT, THE ABDOMEN WAS IRRIGATED WITH COPIOUS AMOUNTS OF SALINE AND GOOD HEMOSTASIS WAS NOTED AT THE CUFF. THE UTEROSACRAL LIGAMENTS WERE THEN PLICATED TOGETHER DURING THE CLOSURE OF THE CUFF. THE UTEROSACRAL LIGAMENTS WERE THEN PLICATED TOGETHER DURING THE CLOSURE OF THE CUFF. AT THIS POINT, INSTRUMENTS AND SPONGES WERE REMOVED AND COUNTS WERE CORRECT. THE TUBES AND OVARIES WERE NORMAL IN APPEARANCE AND THE UTERO-OVARIAN LIGAMENTS WERE DRY, AS WELL AS THE REST OF THE PEDICLES. AT THIS POINT, DR. KELLER WENT AHEAD AND CLOSED THE FASCIA DUE TO THE PRIOR MESH BEING IN PLACE. DURING THE ENTRANCE INTO THE ABDOMEN, THERE WAS A SMALL PORTION OF THE MESH THAT WAS REMOVED AND EXCISED WITH THE MAYO SCISSORS DUE TO THE FACT THAT IT WAS BALLED UP AND OVERLAPPED ON ITSELF. AT THIS POINT, THE FASCIA WAS CLOSED BY DR. KELLER, INCORPORATING THE PERITONEUM, THE MUSCLE AND THE FASCIA WITH INTERRUPTED 0 ETHIBOND SUTURES AND THOSE WERE TIED DOWN SUCCESSIVELY, NOTING GOOD CLOSURE AND GOOD HEMOSTASIS. AT THIS POINT, THE SUBCUTANEOUS TISSUE WAS LAVAGED WITH WARM SALINE, FLUID WAS SUCTIONED OUT AND HEMOSTASIS WAS ACHIEVED WITH BOVIE CAUTERY. THE SUBCUTANEOUS TISSUE WAS REAPPROXIMATED WITH INTERRUPTED 3-0 VICRYL SUTURES AND GOOD APPROXIMATION WAS NOTED. THE SKIN INCISION WAS CLOSED WITH STAPLES. A STERILE PRESSURE BANDAGE WAS APPLIED. THE PATIENT WAS THEN EXTUBATED AND TAKEN TO THE RECOVERY ROOM IN STABLE CONDITION AFTER TOLERATING THE PROCEDURE.¿ (B)(6) 2010: [MISSING RECORDS: A PATHOLOGY REPORT DETAILING ANALYSIS OF THE DEVICE REMOVED DURING THE (B)(6) 2010 PROCEDURE WAS NOT PROVIDED.] (B)(6) 2010: (B)(6) HOSPITAL. (B)(6) . DISCHARGE SUMMARY. FINAL DIAGNOSIS: MENORRHAGIA, ABNORMAL UTERINE BLEEDING. UNDERWENT SURGERY WITHOUT DIFFICULTY. DISCHARGED HOME. WILL FOLLOWUP IN OFFICE IN 4 DAYS. (B)(6) 2010: (B)(6) HOSPITAL. (B)(6) . HISTORY AND PHYSICAL. POSTOPERATIVE WOUND CELLULITIS. RETURNED TO OFFICE WEEK AFTER SURGERY. MIDLINE SKIN INCISION, DUE TO FACT WE WERE TRYING TO AVOID PREVIOUS INCISIONAL HERNIA REPAIR. NOTED A LITTLE BIT OF REDNESS AROUND WOUND. TOOK OUT EVERY OTHER STAPLE, WOUND APPEARED INTACT. SMALL AMOUNT OF ERYTHEMA ON RIGHT SIDE OF WOUND. RETURNS TWO DAYS LATER AND STATES REDNESS INCREASED. STARTING TO HAVE DISCOMFORT AROUND WOUND, STATED SHE HAD SOME DRAINAGE AT HOME. REST OF STAPLES WERE REMOVED AND WOUND REMAINED INTACT. PRESSURE PLACED AROUND INCISION AREA, NO EVIDENCE OF DRAINAGE OR WEEPING AT ANY SITES. NOTED INCREASE IN ERYTHEMA ON RIGHT SIDE AND IT CROSSED OVER ON TO LEFT SUGGESTIVE OF WOUND CELLULITIS. BECAUSE PATIENT HAD PREVIOUS HERNIA REPAIR AND HAD MESH OVER HERNIA REPAIR, WE HAD DR. (B)(6) ASSIST WITH HYSTERECTOMY. DUE TO CONCERN WITH THE MESH IN PLACE IN THE FASCIA AND ONSET OF WOUND CELLULITIS, I CALLED HER BY PHONE. SHE AGREED WITH KEEPING WOUND CLOSED. RECOMMENDED IV ANTIBIOTICS, REEVALUATED IN THE MORNING. AMIT TO HOSPITAL, CHECK CBC, FOLLOW TEMP CURVE, START IV ANTIBIOTICS . (B)(6) 2010: (B)(6) HOSPITAL. (B)(6) . DISCHARGE SUMMARY. FINAL DIAGNOSIS: POSTOP WOUND CELLULITIS. ERYTHEMA DECREASED MUCH FURTHER. DISCHARGE HOME, FOLLOW UP WITH DR. (B)(6) . HOME ON LEVAQUIN. (B)(6) 2010: (B)(6) . OFFICE NOTES. FOLLOW-UP OF CELLULITIS OF ANTERIOR ABDOMINAL WALL AFTER HYSTERECTOMY. STILL ON ANTIBIOTICS. NO FURTHER DRAINAGE. ABDOMEN: MIDLINE INCISION HEALING WELL, ERYTHEMA IMPROVED. (B)(6) 2010: (B)(6) . OFFICE NOTES. FOLLOW-UP OF HYSTERECTOMY WITH CELLULITIS. NO EVIDENCE OF INFECTION, FOLLOW UP ONE MONTH. (B)(6) 2010: (B)(6) . RADIOLOGY-CT ABDOMEN/PELVIS. IMPRESSION: PROBABLE HEMORRHAGIC CYST LEFT ADNEXA AS DESCRIBED WITH SMALL RIGHT OVARIAN CYST. STRANDING OF THE SUBCUTANEOUS FAT PROBABLY POSTOPERATIVE. SURGICAL MESH ALONG ANTERIOR ABDOMINAL WALL TO RIGHT OF MIDLINE. NO DISCRETE ENHANCING FLUID COLLECTION SUGGEST ABSCESS NO DRAINABLE FLUID COLLECTION. (B)(6) 2010: (B)(6) . OFFICE NOTES. FOLLOW-UP OF CELLULITIS. HAVING PAIN ON HER LEFT AND NOTED BY CT SCAN TO HAVE CYST ON LEFT OVARY. TOBACCO USE: CIGARETTES 1 PACK DAILY 18 YEARS. IMPRESSION: POSTOP CELLULITIS. FOLLOW UP AS NEEDED. (B)(6) 2018: (B)(6) . DISCHARGE SUMMARY. GASTROESOPHAGEAL REFLUX DISEASE. (B)(6) 2018: (B)(6) . EMERGENCY ROOM VISIT. CHEST PAIN. MOST LIKELY CHEST PAIN IS MUSCULOSKELETAL PAIN SECONDARY FROM COUGHING. (B)(6) 2018: [FACILITY NI]. (B)(6) . RADIOLOGY- CT ABDOMEN/PELVIS. INDICATIONS: RIGHT LOWER QUADRANT PAIN FOR 1 MONTH, AREA OF PREVIOUS HERNIA. ABDOMINAL WALL: JUST ABOVE SURGICAL SITE, THERE IS RIGHT PARAMIDLINE UMBILICAL HERNIA MEASURING 2 CM IN DIAMETER CONTAINING LARGE AMOUNT OF OMENTAL FAT AND SMALL VESSELS. NO EVIDENCE FOR BOWEL HERNIATION . (B)(6) 2018: [FACILITY NI]. [PROVIDED NI]. ANESTHESIA RECORD. ASA STATUS 3. (B)(6) 2018: (B)(6) . IMPLANT RECORD. IMPLANT: MESH SYMBOTEX SYM15. IMPLANT: MESH PHASIX 15CM CIR. (B)(6) 2018: [FACILITY NI]. (B)(6) . HISTORY AND PHYSICAL. UNDERWENT VENTRAL INCISIONAL HERNIA REPAIR WITH MESH. HAVING SIGNIFICANT ABDOMINAL PAIN AFTER, ADMITTED FOR OBSERVATION. PAST SURGICAL HISTORY: 12/1999 C-SECTION,(B)(6) 2003 CESAREAN SECTION. (B)(6) 2018: [FACILITY NI]. (B)(6) . RADIOLOGY-CT ABDOMEN/PELVIS. INDICATIONS: HERNIA SURGERY 3 WEEKS AGO, NOW PALPABLE MASS AND PAIN IN AREA OF INCISION. ABDOMINAL WALL. FLUID COLLECTION IN PREVIOUS AREA OF HERNIA SAC. MEASURES 7 8 CM IN LENGTH AND 4.8 CM IN AP DIMENSION. RIGHT OF MIDLINE. MINIMAL STRANDING AROUND THIS ARE IN THE SUBCUTANEOUS FAT IS SEEN. MESH IN AREA OF HERNIA REPAIR IS SEEN. MINIMAL STRANDING IN MESENTERIC FAT AT LEVEL OF SUBCUTANEOUS FLUID COLLECTION. CONCLUSION: FLUID COLLECTION IN AREA OF PREVIOUS HERNIA SAC COULD REPRESENT POSTOP FLUID COLLECTION. ABSCESS CANNOT BE EXCLUDED. (B)(6) 2018: (B)(6) . RADIOLOGY-BIOPSY CT GUIDED. INDICATIONS: CT GUIDED ASPIRATION ABDOMINAL SEROMA STATUS POST VENTRAL HERNIA REPAIR. FINDINGS: THERE IS A FLUID COLLECTION WITHIN THE ANTERIOR ABDOMINAL WALL SUBCUTANEOUS TISSUES AND CAPSULATED WITHIN SOFT TISSUE ATTENUATION GRAHAM. NEEDLE POSITION WITHIN THE FLUID COLLECTION. MAXIMAL ASPIRATION PERFORMED YIELDING SANGUINOUS OTHERWISE UNREMARKABLE FLUID. MAXIMAL ASPIRATION RESULTED IN COLLAPSE OF THE FLUID COLLECTION CAVITY. (B)(6) 2018: (B)(6) . RADIOLOGY-BIOPSY CT GUIDED. INDICATIONS: CT GUIDED ABDOMINAL WALL SEROMA/HEMATOMA. USING CT GUIDANCE NEEDLE WAS ADVANCED IN TO THE RIGHT DEEP SUBCUTANEOUS ANTERIOR ABDOMINAL WALL FLUID COLLECTION. SUBSEQUENTLY 65 CC OF SEROUS SANGUINOUS FLUID WAS MAXIMALLY ASPIRATED FROM THE COLLECTION WITH CT GUIDANCE. (B)(6) 2019: (B)(6) . RADIOLOGY-CT GUIDED ABDOMINAL WALL FLUID COLLECTION ASPIRATION. INDICATIONS: CT GUIDED ABDOMINAL SEROMA ASPIRATION. NEEDLE PLACED INTO SUBCUTANEOUS FLUID COLLECTION IN ANTERIOR ABDOMINAL WALL. 10 CC OF CLEAR YELLOW FLUID OBTAINED. (B)(6) 2019: (B)(6) . RADIOLOGY-BIOPSY CT GUIDED. INDICATIONS: ABDOMINAL WALL SEROMA, SCLEROTHERAPY. 15 CC SEROUS FLUID REMOVED. SUCCESSFUL CT ¿GUIDED SEROMA CAVITY ASPIRATION WITH ETHANOL ABLATION. (B)(6) 2019: [MISSING RECORDS: OPERATIVE REPORT FOR ¿MESH REMOVAL AND ABDOMINAL WALL SEROMA EXCISION¿ WAS NOT PROVIDED.] (B)(6) 2019: (B)(6) HEALTH SYSTEM LABORATORIES. (B)(6) , [NI]. PATHOLOGY REPORT. SPEC#: 19S:8543. REQ#: (B)(4). DIAGNOSIS: A: ABDOMINAL WALL SEROMA, EXCISION: SEROMA. B: EXPLANTED MESH, REMOVAL: MESH WITH ATTACHED FRAGMENTS OF BENIGN FIBROVASCULAR AND ADIPOSE TISSUE. FALSE NEGATIVE AND FALSE POSITIVE DIAGNOSES OF SURGICAL SPECIMENS MAY OCCUR. CONSIDERATION SHOULD BE GIVEN TO CLINICAL, RADIOLOGIC, AND LABORATORY FINDINGS. DISCORDANCE MAY BE AN INDICATION FOR FURTHER REVIEW OR EVALUATION PRIOR TO MAKING THERAPEUTIC DECISIONS. CLINICAL HISTORY: ABDOMINAL WALL SEROMA, INITIAL ENCOUNTER. TISSUE SPECIMEN. A: ABDOMINAL WALL SEROMA. B: EXPLANTED MESH. MICROSCOPIC DESCRIPTION. A: SECTIONS REVEAL BENIGN FIBROVASCULAR AND ADIPOSE TISSUE WITH A CYSTIC SPACE LINE BY FIBROUS TISSUE AND SOME FOREIGN BODY GIANT CELL REACTION. ATYPIA AND MALIGNANCY ARE NOT IDENTIFIED. B: SECTIONS REVEAL BENIGN FIBROVASCUALR AND ADIPOSE TISSUE. SIGNIFICANT ACUTE AND CHRONIC INFLAMMATION ARE NOT IDENTIFIED. GROSS DESCRIPTION. A: THE SPECIMEN IS RECEIVED IN FORMALIN LABELED WITH THE PATIENT¿S NAME, DATE OF BIRTH, AND ¿ABDOMINAL WALL SEROMA¿. THE SPECIMEN CONSISTS OF AN 8.5 X 5.1 X 2.3 CM TAN-YELLOW, LOBULATED UNORIENTED FRAGMENT OF SOFT TISSUE. THE OUTER SURFACE THE SPECIMEN IS INKED BLACK. THE SPECIMEN IS SERIALLY SECTIONED TO REVEAL A 2.5 X 2.5 X 0.3 CM ABSCESS CAVITY THAT IS FILLED WITH A TAN-YELLOW FRIABLE MATERIAL. THE REMAINING CUT SURFACE IS TAN-YELLOW LOBULATED AND UNREMARKABLE. REPRESENTATIVE SECTIONS OF THE ABSCESS CAVITY ARE SUBMITTED IN CASSETTES A1-A5. B. THE SPECIMEN IS RECEIVED IN FORMALIN LABELED WITH THE PATIENT¿S NAME, DATE OF BIRTH, AND ¿OLD MESH¿. THE SPECIMEN CONSISTS OF A 9.4 X 6.1 X 2.1 CM FRAGMENT OF TAN PINK MESH LIKE MATERIAL WITH GREEN SUTURES. ADHERENT TO THE MESH MATERIAL IS A TAN-PINK TO TAN YELLOW SOFT TISSUE. REPRESENTATIVE FRAGMENTS OF THE SOFT TISSUE ARE SUBMITTED IN CASSETTE B1. DICTATED BY: NMD. A POTENTIAL RELATIONSHIP, IF ANY, BETWEEN THE ALLEGED INJURIES OR COMPLICATIONS AND THE GORE DEVICE HAS NOT BEEN ESTABLISHED AT THIS TIME BASED ON AVAILABLE INFORMATION. IT SHOULD BE NOTED THAT THE INSTRUCTIONS FOR GORE® DUALMESH® PLUS BIOMATERIAL 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 HEALTH EFFECT. H6: UPDATED INVESTIGATION FINDING . H6: UPDATED INVESTIGATION CONCLUSIONS . H6: HEALTH EFFECT IMPACT CODE: F26: NO HEALTH CONSEQUENCES OR IMPACT. H6: MEDICAL DEVICE COMPONENT: G04088: MEMBRANE. THE INVESTIGATION HAS BEEN COMPLETED. BASED UPON THE TOTALITY OF THE INFORMATION RECEIVED OVER THE COURSE OF THE INVESTIGATION AND REPORTED BY GORE IN THE PREVIOUSLY SUBMITTED MEDICAL RECORD NARRATIVES THE FOLLOWING CONCLUSIONS HAVE BEEN REACHED. AS PREVIOUSLY REPORTED, ALL PERTINENT MEDICAL RECORDS REQUESTED MAY NOT HAVE BEEN RECEIVED. THROUGH GORE'S INVESTIGATION AND BASED ON THE AVAILABLE INFORMATION 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 NO PROBLEM DETECTED. PREVIOUS PATIENT CODES WERE REPORTED BASED ON THE ORIGINAL COMPLAINT AND ARE NO LONGER APPLICABLE AND/OR NOT REPORTABLE PER GORE¿S INVESTIGATION. 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. THE INSTRUCTIONS FOR USE FURTHER WARN: ¿AS WITH ANY IMPLANTABLE SURGICAL DEVICE, STRICT ASEPTIC TECHNIQUES SHOULD BE FOLLOWED. IF AN INFECTION DEVELOPS, IT SHOULD BE TREATED AGGRESSIVELY. AN UNRESOLVED INFECTION MAY REQUIRE REMOVAL OF THE MATERIAL.¿ PROCEDURE AND SPECIFIC PATIENT FACTORS MAY CONTRIBUTE TO OR CAUSE INFECTION, LEADING TO CONTAMINATION, EXPOSURE, LACK OF INCORPORATION AND/OR SEEDING OF DEVICE. PROCEDURE RELATED FACTORS MAY INCLUDE ADHERENCE TO CLINICAL GUIDELINES ON INFECTION RISK MANAGEMENT, CONTAMINATION OF DEVICE PRIOR TO OR DURING IMPLANT, AND POST-OPERATIVE PERSISTENT/SYMPTOMATIC SEROMA AND WOUND MANAGEMENT. PATIENT RISK FACTORS MAY INCLUDE DIABETES, SMOKING, AGE, MALNUTRITION, IMMUNOSUPPRESSIVE THERAPY, POST-OPERATIVE INSTRUCTION NONCOMPLIANCE, AND HYGIENE. THE INSTRUCTIONS FOR USE FURTHER WARN: ¿WHEN USING THIS DEVICE AS A PERMANENT IMPLANT AND EXPOSURE OCCURS, TREAT TO AVOID CONTAMINATION, OR DEVICE REMOVAL MAY BE NECESSARY.¿ MEDICAL RECORDS THAT INDICATE MESH EXPOSURE MAY REFLECT ABDOMINAL WALL WOUND DEHISCENCE AS A FUNCTION OF A PATIENT¿S POOR TISSUE QUALITY OR LOSS OF ANCHORAGE OF FIXATION OR MAY BE RELATED TO INDIVIDUAL PATIENT COMORBIDITIES, AND TECHNICAL AND/OR PROCEDURAL ASPECTS OF THE REPAIR. THESE FACTORS INCLUDE, BUT ARE NOT LIMITED TO, FIXATION TYPE, SUTURE TECHNIQUE, TYPE OF AND TENSION ON THE INCISION, AND WOUND CLASSIFICATION AT TIME OF PROCEDURE. POST-OPERATIVE FACTORS SUCH AS THE DEVELOPMENT OF A POST-OPERATIVE INFECTION, AN INCISION AND DRAINAGE PROCEDURE, OR WOUND PACKING COULD RESULT IN MESH EXPOSURE. ADDITIONALLY, PATIENT COMORBIDITIES THAT COULD INFLUENCE WOUND DEHISCENCE LEADING TO MESH EXPOSURE INCLUDE, BUT ARE NOT LIMITED TO, SMOKING AND OBESITY. THE INSTRUCTIONS FOR USE FURTHER STATE: ¿CUTTING GORE® DUALMESH® BIOMATERIAL TO THE PROPER SIZE IS ESSENTIAL. USE SHARP SURGICAL INSTRUMENTS TO TRIM THE MESH. IF GORE® DUALMESH® BIOMATERIAL IS CUT TOO SMALL, EXCESSIVE TENSION MAY BE PLACED ON THE SUTURE LINE, WHICH MAY RESULT IN RECURRENCE OF THE ORIGINAL, OR DEVELOPMENT OF AN ADJACENT, TISSUE DEFECT.¿ THE INSTRUCTIONS FOR USE FURTHER INCLUDES A PRECAUTION WHICH STATES, ¿ENSURE THE SIZE OF THE DEVICE IS ADEQUATE FOR THE INTENDED REPAIR.¿ INDIVIDUAL MEDICAL DECISIONS, IF INCONSISTENT AND/OR NON-CONFORMING TO THE DEVICE MANUFACTURER¿S RECOMMENDATIONS, IFU, OR RECOGNIZED BEST PRACTICES, MAY RESULT IN OR CONTRIBUTE TO AN ADVERSE EVENT. 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. THE DEVICE WAS NOT ABLE TO BE RETURNED TO GORE FOR EVALUATION; THEREFORE, A DIRECT PRODUCT ANALYSIS COULD NOT BE CONDUCTED. REVIEW OF THE MANUFACTURING AND STERILIZATION RECORDS VERIFIED THAT THE LOT MET ALL PRE-RELEASE SPECIFICATIONS. NAME: PLUS ANTIMICROBIAL PRODUCT COATING . MANUFACTURER/COMPOUNDER: W. L. GORE & ASSOCIATES, INC. LOT NUMBER: 04498418. 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). THE INITIAL REPORTER'S COMPLETE ADDRESS IS (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 INCISIONAL HERNIA REPAIR ON (B)(6) 2008 WHEREBY A GORE® DUALMESH® PLUS BIOMATERIAL WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2018, AN ADDITIONAL REVISION PROCEDURE OCCURRED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: MESH WAS CURLED AT THE EDGES, MESH FAILURE REQUIRING REVISION SURGERY. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 745318 | GORE DUALMESH® PLUS BIOMATERIAL | MESH, SURGICAL, POLYMERIC | FTL | W.L. GORE & ASSOCIATES | 1DLMCP02 | 04498418 | 00733132601097 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 49 YR | Female | Hospitalization| R |