GORE DUALMESH BIOMATERIAL
Report
- Report Number
- 3003910212-2019-00140
- Event Type
- Injury
- Date Received
- May 3, 2019
- Date of Event
- February 8, 2011
- Report Date
- September 13, 2021
- Manufacturer
- W.L. GORE & ASSOCIATES
- Product Code
- FTL
- UDI-DI
- 00733132600991
- PMA / PMN Number
- K992189
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- 003
Narratives
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: (B)(6) 2010: (B)(6). HISTORY AND PHYSICAL. VENTRAL HERNIA FOR SEVERAL YEARS, PRODUCES MILD BUT SIGNIFICANT DISCOMFORT. LOOSE STOOLS FOR SEVERAL WEEKS. ONLY PREVIOUS SURGERY WAS HYSTERECTOMY THROUGH PFANNENSTIEL INCISION. NO OTHER MEDICAL PROBLEMS. SOCIAL HISTORY: EMPLOYED AS A MULTIMEDIA TECHNICIAN AT KROGER, 1 DRINK PER WEEK, NO PRESENT OR PAST TOBACCO USE. SURGICAL HISTORY: COMPLETE ABDOMINAL HYSTERECTOMY 1990. PLAN: TO OR WITH DR. WU FOR OPEN VENTRAL HERNIA REPAIR WITH MESH. (B)(6) 2010- (B)(6) 2010: (B)(6). MEDICATION ADMINISTRATION. INSULIN ASPART. (B)(6) 2010: (B)(6). PROGRESS NOTES. SOME MILD ABDOMINAL PAIN AND NAUSEA OVERNIGHT WITH NGT [NASOGASTRIC TUBE] IN AND ICE CHIPS. NEGATIVE FLATUS, NEGATIVE BOWEL MOVEMENT. WEIGHT (B)(6) 2010 228 LB. EXAMINATION: ABDOMEN; SOFT, MINIMALLY TENDER TO PALPATION CENTRALLY, NONDISTENDED, BOWEL SOUNDS NORMOACTIVE, NO REBOUND OR GUARDING, INCISION MIDLINE CLEAN/DRY/INTACT. DOING WELL OVERALL, WILL ENCOURAGE AMBULATION, CONSIDER DISCONTINUE NASOGASTRIC TUBE AND DIET OF CLEARS TO SEE IF TOLERATES, AWAIT BOWEL FUNCTION. (B)(6) 2010: (B)(6). LAB. WBC 15.1 (5.0-10.0) H. (B)(6) 2010: (B)(6). LAB. WBC 9.7. (B)(6) 2010: (B)(6). LAB. WBC 8.9. WEIGHT 227 LB 1.2 OZ. (B)(6) 2010: (B)(6). PROGRESS NOTE. HAD A BOWEL MOVEMENT TODAY, NO ABDOMINAL PAIN. EXAMINATION: ABDOMEN; STAPLES CLEAN. IMPRESSION: UNCONTROLLED HYPERTENSION. HYPERGLYCEMIA LIKELY FROM INTRAVENOUS FLUIDS CONTAINING D5 [DEXTROSE]. OBESITY. LEUKOCYTOSIS; RESOLVED. (B)(6) 2010: (B)(6). DISCHARGE SUMMARY. ADMISSION DIAGNOSIS: VENTRAL HERNIA. DISCHARGE DIAGNOSIS: STATUS POST OPEN VENTRAL HERNIA REPAIR WITH MESH. HEMOVAC DRAIN ABOVE THE FASCIAL CLOSURE. HOSPITAL COURSE: NO SIGNIFICANT MEDICAL HISTORY, NOTICED STOMACH ENLARGING WITH A PROTRUDING BULGE IN CENTER OF ABDOMEN THREE TO FOUR YEARS AGO. DOES NOT EXPERIENCE PAIN AT REST, HAS DULL ACHE AFTER STANDING FOR SEVERAL HOURS AND WITH HEAVY LIFTING. DID NOT HAVE NAUSEA OR VOMITING, ENDORSED FEELING FULL QUICKER WITH EATING OVER PAST FEW MONTHS. ALSO NOTICED BOWEL MOVEMENTS MORE LOOSE IN PAST YEAR, EXPERIENCES FECAL URGENCY. ON EXAMINATION, ABDOMEN WAS SOFT, DISTENDED, LARGE PROTUBERANT MASS CENTRALLY, NOT EASILY REDUCIBLE, NONTENDER TO PALPATION. BOWEL SOUNDS PRESENT ALL FOUR QUADRANTS. ALSO HAD 2+ PITTING EDEMA BILATERAL EXTREMITIES UP TO KNEES. HAD OPEN VENTRAL HERNIA REPAIR WITH MESH, NO COMPLICATIONS, TWO HEMOVAC DRAINS PLACED ABOVE THE FASCIAL CLOSURES. DID WELL POSTOPERATIVE, PAIN WELL CONTROLLED, DID HAVE ELEVATED BLOOD PRESSURE CONSISTENTLY, STARTED ON HER ORAL MEDICATIONS. DIET ADVANCED SLOWLY FROM LIQUIDS TO REGULAR DIET. WAS SENT HOME ON POSTOPERATIVE DAY #5 WHEN TOLERATING REGULAR DIET. DRAINS STILL HAD SEROSANGUINEOUS DRAINAGE, SENT HOME WITH TWO DRAINS AFTER DRAIN TEACHING. TO DRAIN THREE TIMES EVERY DAY AND MONITOR OUTPUT. ENCOURAGE AMBULATION AND INCENTIVE SPIROMETRY. REPEAT BMP IN TWO WEEKS TO ASSESS THE CREATININE AND GLUCOSE AS WAS STARTED ON LISINOPRIL AND ALSO CHECK FOR DIABETES. DISCHARGE CONDITION: DOING WELL, DENIED ABDOMINAL PAIN, NAUSEA, VOMITING. TOLERATING REGULAR DIET, BOWEL MOVEMENTS WERE BASELINE, FLATUS PRESENT. BOWEL SOUNDS NORMAL, NO TENDERNESS, STAPLES INTACT, TWO DRAINS WITH SEROSANGUINEOUS DRAINAGE. NO LIFTING WEIGHT OVER 10 POUNDS FOR SIX WEEKS. SHOWER. (B)(6) 2011: (B)(6). HISTORY AND PHYSICAL. STATUS POST REPAIR OF LARGE VENTRAL HERNIA CONTAINING HER SMALL BOWEL AND RIGHT COLON WITH DUAL MESH 07/26/10 WITH A HISTORY OF STAPH INFECTION IN HER INCISION. SURGEONS HAVE BEEN FOLLOWING WHAT WAS INITIALLY DESCRIBED AS A GRAPEFRUIT SIZED COLLECTION OF FLUID NEAR INCISION. WE HAVE BEEN ASKED TO DRAIN THIS COLLECTION FOR ANALYSIS. AT THE SURGICAL SIDE THERE IS A 9.3 X 5.4 CM FLUID COLLECTION SEEN IN THE MIDLINE OF THE ANTERIOR ABDOMINAL WALL. THE FLUID COLLECTION IS ENCLOSED BY MESH. THIS MAY REPRESENT A POST-OPERATIVE SEROMA. AN INFECTIOUS PROCESS OR ABSCESS CANNOT TOTALLY BE RULED OUT, THOUGH THERE IS NO AIR SEEN WITHIN THE FLUID COLLECTION. THERE IS INDURATION OF THE SUBCUTANEOUS FAT ADJACENT TO THE FLUID COLLECTION. THERE IS A 7.7 MM NODULE NOTED IN THE RIGHT MIDDLE LOBE, TOO SMALL TO CHARACTERIZE. PAST MEDICAL HISTORY: STAPH AUREUS INFECTION IN HERNIA WOUND. DIABETES MELLITUS. PAST SURGICAL HISTORY: GANGLION CYST ON RIGHT WRIST 1974, 1984. MEDICATION: METFORMIN. EXAMINATION: WEIGHT 213 LB. ABDOMEN; BOWEL SOUND PRESENT, TENDERNESS AT INCISIONAL SITE, LARGE FLUID COLLECTION MIDLINE. IMPRESSION: POST-OPERATIVE SEROMA ABDOMEN; STATUS POST REPAIR VENTRAL HERNIA; HISTORY STAPH AUREUS INCISIONAL INFECTION; DIABETES MELLITUS. ASA 3. RECOMMENDATION: CT GUIDED DRAINAGE OF FLUID COLLECTION AT ABDOMINAL INCISION. (B)(6) 2011: (B)(6). CULTURE. SPECIMEN: ABDOMINAL SEROMA. GRAM STAIN: 2+ WHITE BLOOD CELLS; 1+ RED BLOOD CELLS; 2+ GRAM POSITIVE COCCUS. CULTURE: HEAVY GROWTH OF STAPHYLOCOCCUS AUREUS. (B)(6) 2011: (B)(6). HISTORY AND PHYSICAL. STATUS POST INCISIONAL HERNIA REPAIR (B)(6) 2010; POST-OPERATIVE COURSE UNREMARKABLE; IN (B)(6) 2011 DEVELOPED SPONTANEOUS DRAINAGE FROM THE INCISION WHICH WAS PURULENT; CT REVEALED LARGE FLUID COLLECTION WHICH WAS ASPIRATED AND THE CULTURE GREW HEAVY GROWTH OF STAPH; CONTINUED TO HAVE PURULENT DRAINAGE, DENIES FEVER, ADMITS TO SWEATS. EXAMINATION: ABDOMEN; SOFT, BOWEL SOUNDS NORMAL, NO DISTENTION, NO TENDERNESS, NO RIGIDITY, NO REBOUND, NO GUARDING. ASSESSMENT/PLAN: MESH INFECTION POST-OPERATIVELY. ABSCESS INVOLVING MESH VISUALIZED ON CT. PLAN EXPLORATORY LAPAROTOMY WITH REMOVAL OF THE MESH; POSSIBLE BIOLOGICAL MESH PLACEMENT DEPENDING ON THE INTRA-OPERATIVE FINDINGS. BY MOUTH BACTRIM PRESCRIPTION GIVEN. (B)(6) 2011: (B)(6). ANESTHESIA RECORD. ASA III. WEIGHT 215 LB 8 OZ. (B)(6) 2011: (B)(6). LAB. WBC 10.0. 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® 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.¿ THE GORE® DUALMESH® BIOMATERIAL INSTRUCTIONS FOR USE ALSO STATES: ¿STRICT ASEPTIC TECHNIQUES SHOULD BE FOLLOWED. IF AN INFECTION DEVELOPS, IT SHOULD BE TREATED AGGRESSIVELY. AN UNRESOLVED INFECTION MAY REQUIRE REMOVAL OF THE MATERIAL.¿ 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: HEALTH EFFECT ¿ CLINICAL CODE. H6: UPDATED INVESTIGATION FINDING. H6: UPDATED INVESTIGATION CONCLUSION. H6: HEALTH EFFECT IMPACT CODE: (B)(4): NO HEALTH CONSEQUENCES OR IMPACT. H6: MEDICAL DEVICE COMPONENT: G04088: MEMBRANE . PREVIOUS PATIENT CODES (B)(6): OTHER USED FOR ¿WOUND VAC¿) WERE REPORTED BASED ON THE ORIGINAL COMPLAINT AND ARE NO LONGER APPLICABLE PER GORE¿S INVESTIGATION. THE INVESTIGATION HAS BEEN COMPLETED. 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 NO PROBLEM DETECTED. MEDICAL RECORDS: THE KNOWN MEDICAL RECORDS SPAN (B)(6) 2011 AND NOT ALL RECORDS RECEIVED IN THIS TIME SPAN ARE RELEVANT TO THE GORE® DUALMESH® BIOMATERIAL. PATIENT INFORMATION: MEDICAL HISTORY: OBESITY, (B)(6) 2010: 231 LBS., BMI 46.66, (B)(6) 2011: 213 LBS., BMI 43, (B)(6) 2011: 215 LBS., BMI 43.4, HYPERTENSION, DIABETES, (B)(6) 2011: METFORMIN. SURGICAL PROCEDURES: 1990: TOTAL ABDOMINAL HYSTERECTOMY. (B)(6) 2010: OPEN VENTRAL HERNIA REPAIR WITH MESH. IMPLANT GORE® DUALMESH® BIOMATERIAL. (B)(6) 2011: EXPLORATORY LAPAROTOMY, REMOVAL OF INFECTED MESH, DRAINAGE OF INTRA-ABDOMINAL ABSCESS, APPLICATION OF WOUND VAC. IMPLANT PREOPERATIVE COMPLAINTS: (B)(6) 2010: ¿2-YEAR HISTORY OF ABDOMINAL WALL HERNIA, PROGRESSIVELY INCREASING IN SIZE; NOW CAUSING INTERMITTENT DISCOMFORT.¿ ¿PRIOR HISTORY OF TOTAL ABDOMINAL HYSTERECTOMY VIA PFANNENSTIEL INCISION BUT OTHERWISE NO INCISION IN THE AREA OF THE HERNIA.¿ ¿OBESE WITH SOCCER BALL SIZED HERNIA BULGE EPIGASTRIUM AND LEFT UPPER QUADRANT, NONREDUCIBLE, NO OVERLYING SKIN CHANGES, NONTENDER.¿ ¿CT ABDOMEN/PELVIS: LARGE VENTRAL ABDOMINAL HERNIA 7.3 CM DEFECT WITH HERNIATION OF MESENTERIC FAT AND SMALL AND LARGE BOWEL. ALSO, 4.8 CM UMBILICAL HERNIA DEFECT WITH HERNIATION OF FAT. RECOMMEND OPEN REPAIR.¿ (B)(6) 2010: ¿VENTRAL HERNIA FOR SEVERAL YEARS, PRODUCES MILD BUT SIGNIFICANT DISCOMFORT.¿ IMPLANT PROCEDURE: OPEN VENTRAL HERNIA REPAIR WITH MESH. [IMPLANT: GORE® DUALMESH® BIOMATERIAL, 1DLMC06/7110864, 18CM X 24CM X 1MM THICK]. IMPLANT DATE: (B)(6) 2010 [HOSPITALIZED (B)(6) 2010]. DESCRIPTION OF HERNIA BEING TREATED: ¿THEN WE MADE AN APPROXIMATELY 12 CM VERTICAL MIDLINE INCISION EXTENDING FROM THE UMBILICUS UP TO SUBXIPHOID. THIS WAS MADE WITH A SCALPEL AND THEN TAKEN DOWN WITH ELECTROCAUTERY TO SUBCUTANEOUS TISSUE. A FEW CM DOWN THE HERNIA SAC WAS ENCOUNTERED. THE SAC WAS CAREFULLY DISSECTED AWAY FROM THE SUBCUTANEOUS TISSUE WITH ELECTROCAUTERY AND EVENTUALLY ENTERED. THERE WAS A VERY LARGE AMOUNT OF SMALL BOWEL AND LARGE BOWEL WITHIN THE SAC, NOTABLY THE ASCENDING COLON, CECUM AND SMALL BOWEL WAS WITHIN SAC. THE SAC WAS CAREFULLY INCISED AROUND THE CIRCUMFERENCE OF THE FASCIAL DEFECT WHICH MEASURED APPROXIMATELY 6 X 6 CM. THE SAC WAS COMPLETELY EXCISED AND HANDED OFF THE FIELD. THERE WAS (SIC) NUMEROUS ADHESIVE BANDS GOING ACROSS THE COLON AND SMALL BOWEL WHICH WERE INCISED. THESE ADHESIONS APPEARED TO BE BETWEEN THE MESENTERY AND OMENTUM. ONCE ALL THE ADHESIONS BETWEEN THE BOWEL AND HERNIA SAC AND FASCIAL DEFECT WERE LIGATED, THE BOWEL CONTENTS WERE ABLE TO BE REDUCED INTO THE ABDOMEN THROUGH THE HERNIA DEFECT. ON FINAL PALPATION AROUND THE CIRCUMFERY OF THE DEFECT WE DID NOTICE THAT THERE WAS AN ADDITIONAL, APPROXIMATELY 2 X 2 CM DEFECT NEAR THE UMBILICUS. WE THEREFORE ELECTED TO CONNECT THESE TWO DEFECTS BY INCISING THE FASCIA. THERE WAS AN ADDITIONAL HERNIA SAC WITH SOME INCARCERATED OMENTUM WITHIN THE UMBILICAL HERNIA. THIS SAC WAS ALSO EXCISED WITH ELECTROCAUTERY. THERE WAS A SMALL, WHAT APPEARED TO BE A NODE INSIDE OF THIS SAC WHICH WAS HANDED OFF TO PATHOLOGY. THE HERNIA SAC WAS THUS COMPLETELY EXCISED AROUND THE ENTIRE PERIPHERY OF THE FASCIA. THE RESULTING DEFECT MEASURED APPROXIMATELY 12 X 12 CM. ALL ADHESIONS WITHIN THE PERITONEUM WERE ALSO LYSED TO PROVIDE ADEQUATE SEATING FOR A MESH.¿ IMPLANT SIZE AND FIXATION: ¿WE THEN SELECTED DUALMESH OF 20 X 25 CM AND CUT IT DOWN TO A 16 X 16 CM SIZE. THEN USING PROLENE SUTURE, WE TACKED THE MESH IN AN UNDERLAY FASHION WITH 2 CM OVERLAP AROUND THE CIRCUMFERENCE USING HORIZONTAL MATTRESS STITCHES. THE STITCHES WERE PLACED APPROXIMATELY 1 CM APART AND PROVIDED EXCELLENT APPOSITION OF THE MESH IN UNDERLAY FASHION TO THE FASCIA. THE MESH LAID FLAT WITH A SMALL AMOUNT OF LAXITY. THE SUTURES WERE ALL PLACED SEQUENTIALLY AND THEN ALL TIED. THE WOUND CAVITY WAS THEN THOROUGHLY IRRIGATED. TWO BLAKE DRAINS WERE PLACED TO EXIT THROUGH SEPARATE STAB INCISIONS INFERIOR TO THE REPAIR. THEN THE SKIN WAS REAPPROXIMATED USING SUBDERMAL STITCHES WITH 4-0 VICRYL. SKIN WAS CLOSED WITH STAPLES.¿ ¿ POST-OPERATIVE PERIOD: [ONE WEEK] . (B)(6) 2010: PATHOLOGY. ¿GROSS DESCRIPTION: RECEIVED IN FORMALIN IN A CONTAINER LABELED ¿(B)(6)¿, IS A SACCULAR SEGMENT OF TAN-PINK, RUBBERY MEMBRANOUS TISSUE AND ATTACHED ADIPOSE TISSUE, MEASURING 21 X 16 X 1 CM IN MAXIMUM DIMENSIONS. THE SPECIMEN IS THOROUGHLY SAMPLED AND REPRESENTATIVE SECTIONS ARE SUBMITTED IN ONE BLOCK. PRE/POSTOPERATIVE DIAGNOSIS: VENTRAL HERNIA.¿ (B)(6) 2010: ¿SOME MILD ABDOMINAL PAIN AND NAUSEA OVERNIGHT WITH NGT [NASOGASTRIC TUBE] IN AND ICE CHIPS. NEGATIVE FLATUS, NEGATIVE BOWEL MOVEMENT.¿ (B)(6) 2010: ¿UNCONTROLLED HYPERTENSION. HYPERGLYCEMIA LIKELY FROM INTRAVENOUS FLUIDS CONTAINING D5 [DEXTROSE]. OBESITY. LEUKOCYTOSIS; RESOLVED.¿ (B)(6) 2010: DISCHARGE SUMMARY: ¿HAD OPEN VENTRAL HERNIA REPAIR WITH MESH, NO COMPLICATIONS, TWO HEMOVAC DRAINS PLACED ABOVE THE FASCIAL CLOSURES. DID WELL POSTOPERATIVE, PAIN WELL CONTROLLED, DID HAVE ELEVATED BLOOD PRESSURE CONSISTENTLY, STARTED ON HER ORAL MEDICATIONS. DIET ADVANCED SLOWLY FROM LIQUIDS TO REGULAR DIET. WAS SENT HOME ON POSTOPERATIVE DAY #5 WHEN TOLERATING REGULAR DIET. DRAINS STILL HAD SEROSANGUINEOUS [SIC] DRAINAGE, SENT HOME WITH TWO DRAINS AFTER DRAIN TEACHING. TO DRAIN THREE TIMES EVERY DAY AND MONITOR OUTPUT. ENCOURAGE AMBULATION AND INCENTIVE SPIROMETRY. REPEAT BMP IN TWO WEEKS TO ASSESS THE CREATININE AND GLUCOSE AS WAS STARTED ON LISINOPRIL AND ALSO CHECK FOR DIABETES.¿ RELEVANT MEDICAL INFORMATION: (B)(6) 2010: ¿HAS 2 DRAINS IN, EACH WITH ABOUT 80-90 CC SEROUS OUTPUT DAILY STILL.¿ ¿ABDOMEN SOFT, INCISION HEALING, SOME INDURATION ON LEFT ABDOMINAL WALL WHERE PREVIOUS HERNIA CAVITY WAS, NO ERYTHEMA. JPS SEROSANGUINOUS; LEFT JP DISCONTINUED; EVERY OTHER STAPLE REMOVED.¿ (B)(6) 2010: ¿INCISION CLEAN/DRY/INTACT. POSTOP 2 WEEKS. WEANING OFF NARCOTICS, BOWEL MOVEMENTS FORMED, TOLERATING DIET. JP REMOVED; STAPLES REMOVED.¿ (B)(6) 2010: ¿ABDOMEN SOFT, INCISION HEALING, SOME INDURATION ON LEFT ABDOMINAL WALL WHERE PREVIOUS HERNIA CAVITY WAS, PALPABLE GRAPEFRUIT SIZED SEROMA WITH VERY MINIMAL PINKNESS OF SKIN.¿ (B)(6) 2010: ¿ABDOMEN SOFT, INCISION HEALING, SOME INDURATION ON LEFT ABDOMINAL WALL WHERE PREVIOUS HERNIA CAVITY WAS, PREVIOUSLY PALPABLE GRAPEFRUIT SIZED SEROMA NOW FIRM. NO PALPABLE HERNIA.¿ ¿NO EVIDENCE OF INFECTION.¿ (B)(6) 2011: ¿UNEVENTFUL POSTOP COURSE. DOING WELL UNTIL BEGINNING OF JANUARY; DEVELOPED SPONTANEOUS OPENING OF INCISION W/ DRAINAGE OF LARGE AMOUNT OF SEROSANGUINOUS FLUID. REPORTS LOW GRADE FEVER AT THAT TIME. SEEN AT UVMC AND ADMITTED, EVALUATED BY SURGEON (B)(6). CT SCAN PERFORMED (NOT AVAILABLE TO ME). STATES SHE WAS TREATED WITH IV ANTIBIOTICS, TOLD SHE HAD A STAPH INFECTION, DISCHARGED HOME FOR FURTHER FOLLOW UP WITH ME. REPORTS DRAINAGE HAS SIGNIFICANTLY DECREASED SINCE THAT TIME. DENIES FEVER/CHILLS.¿ ¿ABDOMEN MORBIDLY OBESE, INCISION WELL HEALED EXCEPT IN MIDPORTION THERE IS A SMALL SUPERFICIAL AREA OF 5MM OF GRANULATION¿THE AREA WAS PROBED WITH A COTTON TIPPED APPLICATOR AND DID NOT SEEM TO TRACK DEEPLY. NO ERYTHEMA, NO ACTIVE DRAINAGE, NO OBVIOUS HERNIA OR PALPABLE MASS/FLUID COLLECTION BUT EXAM COMPROMISED SECONDARY TO BODY HABITUS.¿ ¿IMPRESSION: POSSIBLE SUPERFICIAL INFECTION VERSUS DEEP/MESH INFECTION.¿ (B)(6) 2011: CT ABDOMEN/PELVIS: ¿STATUS POST VENTRAL HERNIA REPAIR. AT SURGICAL SITE, THERE IS A 9.3 X 5.4 CM FLUID COLLECTION SEEN IN THE MIDLINE OF THE ANTERIOR ABDOMINAL WALL. THE FLUID COLLECTION IS ENCLOSED BY MESH. THIS MAY REPRESENT POSTOPERATIVE SEROMA. AN INFECTIOUS PROCESS OR ABSCESS CANNOT TOTALLY BE RULED OUT, THOUGH THERE IS NO AIR SEEN WITHIN THE FLUID COLLECTION.¿ (B)(6) 2011: CT GUIDED SEROMA DRAINAGE OF ABDOMINAL WALL. ¿APPROXIMATELY 100 CC OF SEROUS FLUID WAS REMOVED. FLUID SENT FOR CULTURE AND SENSITIVITY.¿ (B)(6) 2011: ABDOMINAL SEROMA CULTURE. ¿HEAVY GROWTH OF STAPHYLOCOCCUS AUREUS.¿ (B)(6) 2011: ¿POST-OPERATIVE SEROMA ABDOMEN; STATUS POST REPAIR VENTRAL HERNIA; HISTORY STAPH AUREUS INCISIONAL INFECTION.¿ EXPLANT PREOPERATIVE COMPLAINTS: (B)(6) 2011: ¿STATUS POST VENTRAL HERNIA REPAIR WITH MESH. MESH INFECTION POSTOP. ABSCESS INVOLVING THE MESH VISUALIZED ON CT SCAN. PLAN EXPLORATORY LAP WITH REMOVAL OF MESH; POSSIBLE BIOLOGICAL MESH PLACEMENT DEPENDING ON THE INTRAOPERATIVE FINDINGS.¿ (B)(6) 2011: ¿STATUS POST INCISIONAL HERNIA REPAIR 07/2010; POST-OPERATIVE COURSE UNREMARKABLE; IN (B)(6) 2011 DEVELOPED SPONTANEOUS DRAINAGE FROM THE INCISION WHICH WAS PURULENT; CT REVEALED LARGE FLUID COLLECTION WHICH WAS ASPIRATED AND THE CULTURE GREW HEAVY GROWTH OF STAPH; CONTINUED TO HAVE PURULENT DRAINAGE, DENIES FEVER, ADMITS TO SWEATS.¿ EXPLANT PROCEDURE: EXPLORATORY LAPAROTOMY, REMOVAL OF INFECTED MESH, DRAINAGE OF INTRA-ABDOMINAL ABSCESS, APPLICATION OF WOUND VAC. EXPLANT DATE: (B)(6) 2011 [HOSPITALIZED (B)(6) 2011]: ¿THE MESH WAS EASILY IDENTIFIED, AND THERE WAS PURULENT FLUID OVER THE MESH. WE THEN FOUND THE EDGES OF THE MESH AND REMOVED THE INTERRUPTED PROLENE SUTURES HOLDING IN PLACE. THERE WAS LARGE AMOUNT OF PURULENT FLUID THEN BENEATH THE MESH. THIS WAS EVACUATED AND SPECIMEN TAKEN FOR CULTURE. ONCE THE MESH HAD BEEN REMOVED IN ITS ENTIRETY, THE AREA WAS INSPECTED AND THE TISSUE AND FASCIA WERE NOTED TO BE QUITE FRIABLE. THERE WAS NO RIND OVERLYING THE BOWEL. ALL THE BOWEL APPEARED TO BE HEALTHY. AT THIS POINT, DECISION WAS MADE TO PLACE THE WOUND VAC. THE ABDOMEN WAS THOROUGHLY IRRIGATED. THERE WAS ADAPTIC PLACED OVER THE INFLAMMATORY RIND AND THEN THE WOUND VAC WAS PLACED.¿ (B)(6) 2011: PATHOLOGY: ¿SOFT TISSUES, CONSISTING OF FIBROMUSCULAR TISSUES; MIXED INFLAMMATION WITH GIANT CELL FOREIGN BODY REACTION; GRANULATION TISSUE; RECENT AND OLD HEMORRHAGE.¿ (B)(6) 2011: WOUND CULTURE: ¿MODERATE GROWTH OF STAPHYLOCOCCUS AUREUS.¿ (B)(6) 2011: DISCHARGE SUMMARY: ¿ADMITTED FOR PLAN ON EX LAP WITH REMOVAL OF INFECTED MESH WITH APPLICATION OF VACSPONGE SYSTEM. TOLERATED SURGERY WITH NO COMPLICATIONS AND READY FOR DISCHARGE POST OP DAY #3 WITH HOME HEALTH CARE FOR VAC MANAGEMENT AND WOUND CARE.¿ CONCLUSION: 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 GORE® DUALMESH® BIOMATERIAL INSTRUCTIONS FOR USE FURTHER WARNS: ¿STRICT ASEPTIC TECHNIQUES SHOULD BE FOLLOWED. IF AN INFECTION DEVELOPS, IT SHOULD BE TREATED AGGRESSIVELY. AN UNRESOLVED INFECTION MAY REQUIRE REMOVAL OF THE MATERIAL.¿ 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.¿ 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 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.¿ 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 MY 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. 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 RESULTS CODE. CONCLUSION CODE REMAINS UNCHANGED.
ADDITIONAL DETAILS REGARDING THE PATIENT'S CLINICAL COURSE WERE ASCERTAINED FROM A REVIEW OF MEDICAL RECORDS AND ARE AS FOLLOWS: RECORDS PRIOR TO 7/26/2010, INCLUDING RECORDS FOR HYSTERECTOMY, WERE NOT PROVIDED. (B)(6) 2010: (B)(6). OPERATIVE REPORT. PRE/POSTOP DIAGNOSIS: VENTRAL HERNIA. OPERATION: OPEN VENTRAL HERNIA REPAIR WITH MESH. DRAINS: 2 HEMOVAC DRAINS PLACED ABOVE THE FASCIAL CLOSURE. SPECIMENS: NONE. INDICATIONS: ¿HAS HAD A VENTRAL HERNIA FOR SEVERAL YEARS. THIS STARTED OUT SMALL AND HAS SLOWLY PROGRESSED IN SIZE TO A VERY CONSIDERABLE SIZE AT THIS POINT. THE HERNIA GIVES THE PATIENT A MODERATE AMOUNT OF DISCOMFORT. SHE WOULD LIKE TO HAVE IT REPAIRED. NOTE THE ONLY PAST SURGICAL HISTORY IS A HYSTERECTOMY THAT IS THROUGH A PFANNENSTIEL INCISION. THE RISKS, BENEFITS AND ALTERNATIVES OF THE PROCEDURE WERE EXPLAINED TO THE PATIENT AND SHE CONSENTED TO PROCEED.¿ DETAILS OF PROCEDURE: ¿BROUGHT TO THE OPERATING ROOM AND PLACED IN THE SUPINE POSITION. MEFOXIN WAS INFUSED FOR PROPHYLACTIC ANTIBIOTICS AND ANESTHESIA INTUBATED THE PATIENT AND INITIATED GENERAL ANESTHESIA. OF NOTE, THE PATIENT WAS HYPERTENSIVE ON ENTRANCE TO THE OR WITH A SYSTOLIC BLOOD PRESSURE OF 240, THIS IMPROVED MARKEDLY AFTER 10 MG OF HYDRALAZINE. THE PATIENT¿S ABDOMEN WAS THEN PREPPED AND DRAPED IN THE USUAL STERILE FASHION. FOLEY CATHETER WAS INSERTED WITH A MODERATE AMOUNT OF DIFFICULTY. THEN WE MADE AN APPROXIMATELY 12 CM VERTICAL MIDLINE INCISION EXTENDING FROM THE UMBILICUS UP TO SUBXIPHOID. THIS WAS MADE WITH A SCALPEL AND THEN TAKEN DOWN WITH ELECTROCAUTERY TO SUBCUTANEOUS TISSUE. A FEW CM DOWN THE HERNIA SAC WAS ENCOUNTERED. THE SAC WAS CAREFULLY DISSECTED AWAY FROM THE SUBCUTANEOUS TISSUE WITH ELECTROCAUTERY AND EVENTUALLY ENTERED. THERE WAS A VERY LARGE AMOUNT OF SMALL BOWEL AND LARGE BOWEL WITHIN THE SAC, NOTABLY THE ASCENDING COLON, CECUM AND SMALL BOWEL WAS WITHIN SAC. THE SAC WAS CAREFULLY INCISED AROUND THE CIRCUMFERENCE OF THE FASCIAL DEFECT WHICH MEASURED APPROXIMATELY 6 X 6 CM. THE SAC WAS COMPLETELY EXCISED AND HANDED OFF THE FIELD. THERE WAS NUMEROUS ADHESIVE BANDS GOING ACROSS THE COLON AND SMALL BOWEL WHICH WERE INCISED. THESE ADHESIONS APPEARED TO BE BETWEEN THE MESENTERY AND OMENTUM. ONCE ALL THE ADHESIONS BETWEEN THE BOWEL AND HERNIA SAC AND FASCIAL DEFECT WERE LIGATED, THE BOWEL CONTENTS WERE ABLE TO BE REDUCED INTO THE ABDOMEN THROUGH THE HERNIA DEFECT. ON FINAL PALPATION AROUND THE CIRCUMFERY OF THE DEFECT WE DID NOTICE THAT THERE WAS AN ADDITIONAL, APPROXIMATELY 2 X 2 CM DEFECT NEAR THE UMBILICUS. WE THEREFORE ELECTED TO CONNECT THESE TWO DEFECTS BY INCISING THE FASCIA. THERE WAS AN ADDITIONAL HERNIA SAC WITH SOME INCARCERATED OMENTUM WITHIN THE UMBILICAL HERNIA. THIS SAC WAS ALSO EXCISED WITH ELECTROCAUTERY. THERE WAS A SMALL, WHAT APPEARED TO BE A NODE INSIDE OF THIS SAC WHICH WAS HANDED OFF TO PATHOLOGY. THE HERNIA SAC WAS THUS COMPLETELY EXCISED AROUND THE ENTIRE PERIPHERY OF THE FASCIA. THE RESULTING DEFECT MEASURED APPROXIMATELY 12 X 12 CM. ALL ADHESIONS WITHIN THE PERITONEUM WERE ALSO LYSED TO PROVIDE ADEQUATE SEATING FOR A MESH. WE THEN SELECTED DUALMESH OF 20 X 25 CM AND CUT IT DOWN TO A 16 X 16 CM SIZE. THEN USING PROLENE SUTURE, WE TACKED THE MESH IN AN UNDERLAY FASHION WITH 2 CM OVERLAP AROUND THE CIRCUMFERENCE USING HORIZONTAL MATTRESS STITCHES. THE STITCHES WERE PLACED APPROXIMATELY 1 CM APART AND PROVIDED EXCELLENT APPOSITION OF THE MESH IN UNDERLAY FASHION TO THE FASCIA. THE MESH LAID FLAT WITH A SMALL AMOUNT OF LAXITY. THE SUTURES WERE ALL PLACED SEQUENTIALLY AND THEN ALL TIED. THE WOUND CAVITY WAS THEN THOROUGHLY IRRIGATED. TWO BLAKE DRAINS WERE PLACED TO EXIT THROUGH SEPARATE STAB INCISIONS INFERIOR TO THE REPAIR. THEN THE SKIN WAS REAPPROXIMATED USING SUBDERMAL STITCHES WITH 4-0 VICRYL. SKIN WAS CLOSED WITH STAPLES. A STERILE DRESSING WAS THEN APPLIED. THE PATIENT TOLERATED THE PROCEDURE WELL. ALL SPONGE, NEEDLE AND INSTRUMENT COUNTS WERE CORRECT AT THE END OF THE CASE. DR. WU WAS PRESENT, SCRUBBED AND PARTICIPATING THROUGHOUT THE ENTIRE CASE.¿ ??/??/??: (B)(6) HOSPITAL. IMPLANT RECORD. IMPLANT NAME: MESH DUAL 18 X 24 X 1 MM GORE 1DLMC06-LOG50518. MODEL/CAT #: 1DLMC06. LOT #: 7110864. MANUFACTURER: W.L. GORE & ASSOCIATES INC. STATUS: IMPLANTED. NUMBER USED: 1. AREA: ABDOMEN. THE RECORDS CONFIRM A GORE® DUALMESH® BIOMATERIAL (1DLMC06/7110864) WAS IMPLANTED DURING THE PROCEDURE. (B)(6) 2011: (B)(6). RADIOLOGY-CT GUIDED SEROMA DRAINAGE OF ABDOMINAL WALL. INDICATION: S/P REPAIR OF LARGE VENTRAL HERNIA CONTAINING ALL HER SMALL BOWEL AND R COLON WITH DUAL MESH® (B)(6) 2010 WITH A HX OF STAPH INFECTION IN HER INCISION. SURGEONS HAVE BEEN FOLLOWING WHAT WAS INITIALLY DESCRIBED AS GRAPEFRUIT SIZED COLLECTION OF FLUID NEAR HER INCISION. WE HAVE BEEN ASKED TO DRAIN THIS COLLECTION FOR ANALYSIS. PROTOCOL: PLACED IN SUPINE POSITION ON CT TABLE. SKIN SUPERFICIAL TO THE FLUID COLLECTION WAS IDENTIFIED AND CLEANSED USING STERILE TECHNIQUE. NEXT, A 5 F DRAINAGE CATHETER WAS PERCUTANEOUSLY PLACED INTO THE COLLECTION USING STANDARD SALDINGER TECHNIQUE. CATHETER POSITIONING WAS VERIFIED WITH CT GUIDANCE. AS MUCH FLUID WAS ASPIRATED AS POSSIBLE. A POST-PROCEDURAL CT SCAN WAS UNREMARKABLE WITH REMOVAL OF ALL THE FLUID. TOLERATED PROCEDURE WELL WITH NO IMMEDIATE COMPLICATIONS. RECEIVED 2.0 MG OF VERSED AND 100 UG OF FENTANYL IV FOR SEDATION AND PAIN CONTROL. IMPRESSION: SUCCESSFUL CT GUIDED INTRA-ABDOMINAL FLUID DRAINAGE AS DESCRIBED ABOVE. APPROXIMATELY 100 CC OF SEROUS FLUID WAS REMOVED. FLUID SENT FOR CULTURE AND SENSITIVITY. [MISSING RECORDS: A CULTURE REPORT DETAILING ANALYSIS OF THE FLUID REMOVED DURING THE (B)(6) 2011 PROCEDURE WAS NOT PROVIDED.] (B)(6) 2011: (B)(6). OPERATIVE REPORT. PRE/POSTOP DIAGNOSIS: INFECTED MESH. OPERATION: EXPLORATORY LAPAROTOMY, REMOVAL OF INFECTED MESH, DRAINAGE OF INTRA-ABDOMINAL ABSCESS, APPLICATION OF WOUND VAC. DRAINS: VAC TWICE LEFT IN PLACED [SIC]. SPECIMEN: CULTURE. INDICATION: SPONTANEOUS PURULENT DRAINAGE FROM MIDLINE INCISION. CT SCAN DEMONSTRATED FLUID COLLECTION ABOVE THE MESH. PROCEDURE: ¿AFTER INFORMED CONSENT WAS OBTAINED, PATIENT WAS BROUGHT TO OPERATING ROOM AND PLACED TO THE OPERATING TABLE IN SUPINE POSITION. MONITORS WERE BEGUN. PATIENT WAS SEDATED AND INTUBATED. ABDOMEN WAS PREPPED AND DRAPED IN USUAL STERILE FASHION. A TIME-OUT WAS PERFORMED AND CORRECT PATIENT AND PROCEDURE WERE IDENTIFIED. ANTIBIOTICS WERE ADMINISTERED PREOPERATIVELY. ANESTHESIA WAS PLACED PRIOR TO INDUCTION. AN UPPER MIDLINE INCISION WAS CREATED WITH 10-BLADE THROUGH THE PREVIOUS INCISION AND OVERLYING THE DRAINAGE TRACT. THE SUBCUTANEOUS TISSUE WAS DISSECTED WITH BOVIE ELECTROCAUTERY. THE MESH WAS EASILY IDENTIFIED, AND THERE WAS PURULENT FLUID OVER THE MESH. WE THEN FOUND THE EDGES OF THE MESH AND REMOVED THE INTERRUPTED PROLENE SUTURES HOLDING IN PLACE. THERE WAS LARGE AMOUNT OF PURULENT FLUID THEN BENEATH THE MESH. THIS WAS EVACUATED AND SPECIMEN TAKEN FOR CULTURE. ONCE THE MESH HAD BEEN REMOVED IN ITS ENTIRETY, THE AREA WAS INSPECTED AND THE TISSUE AND FASCIA WERE NOTED TO BE QUITE FRIABLE. THERE WAS NO RIND OVERLYING THE BOWEL. ALL THE BOWEL APPEARED TO BE HEALTHY. AT THIS POINT, DECISION WAS MADE TO PLACE THE WOUND VAC. THE ABDOMEN WAS THOROUGHLY IRRIGATED. THERE WAS ADAPTIC PLACED OVER THE INFLAMMATORY RIND AND THEN THE WOUND VAC WAS PLACED. THE PATIENT WAS THEN AWOKEN AND TRANSFERRED TO PACU IN STABLE CONDITION. ALL SPONGE, INSTRUMENT, AND NEEDLE COUNTS WERE VERIFIED AS CORRECT AT THE END OF THE PROCEDURE.¿ THERE IS NO INFORMATION DETAILING THE ETIOLOGY OF THE INFECTION. [MISSING RECORDS: RECORDS FOR THE CT SCAN SHOWING ¿FLUID COLLECTION ABOVE THE MESH¿ WAS NOT PROVIDED.] [MISSING RECORDS: A CULTURE REPORT DETAILING ANALYSIS OF THE FLUID REMOVED DURING THE (B)(6) 2011 PROCEDURE WAS NOT PROVIDED.] (B)(6) 2011: (B)(6). DISCHARGE SUMMARY. DISCHARGE DX: S/P REMOVAL OLD MESH GRAFT. HOSPITAL COURSE: ADMITTED FOR PLAN ON EX LAP WITH REMOVAL OF INFECTED MESH WITH APPLICATION OF VAC SPONGE SYSTEM. TOLERATED SURGERY WITH NO COMPLICATIONS AND READY FOR DISCHARGE POST OP DAY #3 WITH HOME HEALTH CARE FOR VAC MANAGEMENT AND WOUND CARE. EXAM: ABD; OBESE, APPROPRIATE TENDERNESS AROUND SITE. MIDLINE WOUND/INCISION WITH WOUND VAC IN PLACE, GOOD SEAL, + BS. DISCHARGE MEDS: CONTINUE METFORMIN (GLUCOPHAGE). ACTIVITY: AS TOLERATED. 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® 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.¿ THE GORE® DUALMESH® BIOMATERIAL INSTRUCTIONS FOR USE ALSO STATES: ¿STRICT ASEPTIC TECHNIQUES SHOULD BE FOLLOWED. IF AN INFECTION DEVELOPS, IT SHOULD BE TREATED AGGRESSIVELY. AN UNRESOLVED INFECTION MAY REQUIRE REMOVAL OF THE MATERIAL.¿ 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: 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) 2010: (B)(6) CENTER. (B)(6) MD. OFFICE NOTES. 2-YEAR HISTORY OF ABDOMINAL WALL HERNIA, PROGRESSIVELY INCREASING IN SIZE; NOW CAUSING INTERMITTENT DISCOMFORT. SOME NAUSEA, NO EMESIS. LOOSE STOOLS. NO PRIOR COLONOSCOPY. PRIOR HISTORY OF TOTAL ABDOMINAL HYSTERECTOMY VIA PFANNENSTIEL INCISION BUT OTHERWISE NO INCISION IN THE AREA OF THE HERNIA. SOCIAL HISTORY: TOBACCO USE NEVER; ALCOHOL USE 2X/MONTH. REVIEW OF SYSTEMS: POSITIVE FOR COUGH AND SHORTNESS OF BREATH, POSITIVE FOR NAUSEA/ABDOMINAL PAIN. ABDOMINAL EXAM: SOFT, BOWEL SOUNDS NORMAL, NO DISTENTION, MASS, SPLENOMEGALY, HEPATOMEGALY, TENDERNESS, REBOUND, GUARDING, OR HERNIA. OBESE WITH SOCCER BALL SIZED HERNIA BULGE EPIGASTRIUM AND LEFT UPPER QUADRANT, NONREDUCIBLE, NO OVERLYING SKIN CHANGES, NONTENDER. DIAGNOSTIC STUDIES: CT ABDOMEN/PELVIS AT DMI¿LARGE VENTRAL ABDOMINAL HERNIA 7.3 CM DEFECT WITH HERNIATION OF MESENTERIC FAT AND SMALL AND LARGE BOWEL. ALSO, 4.8 CM UMBILICAL HERNIA DEFECT WITH HERNIATION OF FAT. IMPRESSION/PLAN: LARGE VENTRAL HERNIA AND UMBILICAL HERNIA WITH HERNIATION OF BOWEL, INCARCERATED BUT NON-OBSTRUCTING AND NOT STRANGULATED. RECOMMEND OPEN REPAIR OF VENTRAL AND UMBILICAL HERNIA WITH MESH. PROCEDURE EXPLAINED IN DETAIL, INCLUDING RISKS, BENEFITS, ALTERNATIVES AND COMPLICATIONS. UNDERSTANDS, AGREES TO PROCEED. PRE-OP BOWEL PREP. LETTER TO DR. JONES. WT 231 LBS., BMI 46.66. (B)(6) 2010: [FACILITY NI]. (B)(6) MD. PATHOLOGY REPORT. ACCESSION #: S10-6020. SPECIMEN(S) RECEIVED: HERNIA SAC. FINAL PATHOLOGIC DIAGNOSIS: HERNIA SAC, EXCISION: FIBROADIPOSE TISSUE WITH DENSE AREAS OF FIBROSIS CONSISTENT WITH HERNIA SAC. MICROSCOPIC DESCRIPTION: SECTIONS EXAMINED. GROSS DESCRIPTION: RECEIVED IN FORMALIN IN A CONTAINER LABELED ¿RUSSEL, (B)(6) SAC¿, IS A SACCULAR SEGMENT OF TAN-PINK, RUBBERY MEMBRANOUS TISSUE AND ATTACHED ADIPOSE TISSUE, MEASURING 21 X 16 X 1 CM IN MAXIMUM DIMENSIONS. THE SPECIMEN IS THOROUGHLY SAMPLED AND REPRESENTATIVE SECTIONS ARE SUBMITTED IN ONE BLOCK. PRE/POSTOPERATIVE DIAGNOSIS: VENTRAL HERNIA. (B)(6) 2010: (B)(6) CENTER. (B)(6) MD. OFFICE NOTES. STATUS POST REPAIR OF LARGE VENTRAL HERNIA CONTAINING HER SMALL BOWEL AND RIGHT COLON WITH DUAL MESH (B)(6) 2010. HAS 2 DRAINS IN, EACH WITH ABOUT 80-90 CC SEROUS OUTPUT DAILY STILL. NO FEVER/CHILLS. TOLERATING ORAL, NO N/V, BOWEL MOVEMENTS, PAIN CONTROLLED. EXAM: ABDOMEN SOFT, INCISION HEALING, SOME INDURATION ON LEFT ABDOMINAL WALL WHERE PREVIOUS HERNIA CAVITY WAS, NO ERYTHEMA. JPS SEROSANGUINOUS; LEFT JP DISCONTINUED; EVERY OTHER STAPLE REMOVED. IMPRESSION/PLAN: FOLLOW UP 1 WEEK FOR REMOVAL OF STAPLES AND DRAIN. CONTINUE NO HEAVY LIFTING. (B)(6) 2010: (B)(6) CENTER. (B)(6) DO. OFFICE NOTES. INCISION CLEAN/DRY/INTACT. POSTOP 2 WEEKS. WEANING OFF NARCOTICS, BOWEL MOVEMENTS FORMED, TOLERATING DIET. JP REMOVED; STAPLES REMOVED. FOLLOW UP 2 WEEKS. (B)(6) 2010: (B)(6) CENTER. (B)(6) MD. OFFICE NOTES. HAD 2 DRAINS IN, BOTH NOW OUT, STAPLES REMOVED. NO FEVER/CHILLS. TOLERATING ORAL, NO NAUSEA/VOMITING, POSITIVE BOWEL MOVEMENTS, PAIN CONTROLLED. EXAM: ABDOMEN SOFT, INCISION HEALING, SOME INDURATION ON LEFT ABDOMINAL WALL WHERE PREVIOUS HERNIA CAVITY WAS, PALPABLE GRAPEFRUIT SIZED SEROMA WITH VERY MINIMAL PINKNESS OF SKIN. IMPRESSION/PLAN: FOLLOW UP 3 WEEKS. COUNSELED TO MONITOR FOR SIGNS/SYMPTOMS OF INFECTION. MONITOR SEROMA, NO ASPIRATION UNLESS CONTINUES TO ENLARGE. CONTINUE NO HEAVY LIFTING. (B)(6) 2010: (B)(6) CENTER. (B)(6) , MD. OFFICE NOTES. NO FEVER/CHILLS. TOLERATING ORAL, NO NAUSEA/VOMITING, POSITIVE BOWEL MOVEMENTS, PAIN CONTROLLED. SEROMA POSTOP SITE; FOLLOWING. EXAM: ABDOMEN SOFT, INCISION HEALING, SOME INDURATION ON LEFT ABDOMINAL WALL WHERE PREVIOUS HERNIA CAVITY WAS, PREVIOUSLY PALPABLE GRAPEFRUIT SIZED SEROMA NOW FIRM. NO PALPABLE HERNIA. IMPRESSION/PLAN: OBSERVATION OF ABDOMINAL WALL CHANGES, SHOULD RESOLVE WITH TIME. NO EVIDENCE OF INFECTION. RETURN TO WORK (B)(6) 2010. FOLLOW UP AS NEEDED. DIAGNOSIS: VENTRAL HERNIA. (B)(6) 2011: [MISSING RECORDS: RECORDS FROM UVMC INCLUDING RECORDS FOR ER VISIT, ADMISSION AND CT SCAN FOLLOWING ¿SPONTANEOUS OPENING OF INCISION¿ WERE NOT PROVIDED.] (B)(6) 2011: (B)(6) CENTER. (B)(6) MD. OFFICE NOTES. UNEVENTFUL POSTOP COURSE. DOING WELL UNTIL BEGINNING OF JANUARY; DEVELOPED SPONTANEOUS OPENING OF INCISION W/ DRAINAGE OF LARGE AMOUNT OF SEROSANGUINOUS FLUID. REPORTS LOW GRADE FEVER AT THAT TIME. SEEN AT UVMC AND ADMITTED, EVALUATED BY SURGEON DR. LOWERY. CT SCAN PERFORMED (NOT AVAILABLE TO ME). STATES SHE WAS TREATED WITH IV ANTIBIOTICS, TOLD SHE HAD A STAPH INFECTION, DISCHARGED HOME FOR FURTHER FOLLOW UP WITH ME. REPORTS DRAINAGE HAS SIGNIFICANTLY DECREASED SINCE THAT TIME. DENIES FEVER/CHILLS. TOLERATING ORAL. REGULAR BOWEL MOVEMENTS. EXAM: ABDOMEN MORBIDLY OBESE, INCISION WELL HEALED EXCEPT IN MIDPORTION THERE IS A SMALL SUPERFICIAL AREA OF 5MM OF GRANULATION¿THE AREA WAS PROBED WITH A COTTON TIPPED APPLICATOR AND DID NOT SEEM TO TRACK DEEPLY. NO ERYTHEMA, NO ACTIVE DRAINAGE, NO OBVIOUS HERNIA OR PALPABLE MASS/FLUID COLLECTION BUT EXAM COMPROMISED SECONDARY TO BODY HABITUS. IMPRESSION/PLAN: POSSIBLE SUPERFICIAL INFECTION VERSUS DEEP/MESH INFECTION. OBTAIN CT RESULTS/NOTES, REPEAT CT FURTHER RECOMMENDATIONS PENDING THOSE RESULTS. IF SUSPICIOUS FOR MESH INFECTION, MESH WILL NEED TO BE REMOVED. DIAGNOSES: ACUTE ABDOMINAL PAIN-RULE OUT ABSCESS; STATUS POST HERNIA REPAIR, ABDOMINAL WALL ABSCESS AT SITE OF SURGICAL WOUND. (B)(6) 2011: (B)(6) CENTER. (B)(6) . RADIOLOGY CT ABDOMEN/PELVIS W/ CONTRAST. INDICATION: ACUTE ABDOMINAL PAIN, STATUS POST VENTRAL HERNIA REPAIR. FINDINGS: FLUID COLLECTION SEEN IN MIDLINE OF ANTERIOR ABDOMINAL WALL; APPEARS TO BE CONFINED BY SURGICAL MESH. NO AIR SEEN WITHIN FLUID COLLECTION. IMPRESSION: STATUS POST VENTRAL HERNIA REPAIR. AT SURGICAL SITE, THERE IS A 9.3 X 5.4 CM FLUID COLLECTION SEEN IN THE MIDLINE OF THE ANTERIOR ABDOMINAL WALL. THE FLUID COLLECTION IS ENCLOSED BY MESH. THIS MAY REPRESENT POSTOPERATIVE SEROMA. AN INFECTIOUS PROCESS OR ABSCESS CANNOT TOTALLY BE RULED OUT, THOUGH THERE IS NO AIR SEEN WITHIN THE FLUID COLLECTION. THERE IS INDURATION OF THE SUBCUTANEOUS FAT ADJACENT TO THE FLUID COLLECTIONS. THERE IS A 7.7 MM NODULE NOTED IN THE RIGHT MIDDLE LOBE; TOO SMALL TO CHARACTERIZE. CT SCAN OF CHEST SHOULD BE CONSIDERED. (B)(6) 2011:(B)(6) CENTER. (B)(6) DO. OFFICE NOTES. STATUS POST OPEN INCISIONAL HERNIA REPAIR (B)(6) 2010. POSTOP COURSE UNREMARKABLE. RECENTLY IN (B)(6) 2011, DEVELOPED SPONTANEOUS DRAINAGE FROM INCISION WHICH WAS PURULENT. A CT SCAN REVEALED A LARGE FLUID COLLECTION WHICH WAS ASPIRATED AND CULTURE GREW HEAVY GROWTH STAPH. CONTINUED TO HAVE PURULENT DRAINAGE. DENIES FEVER, ADMITS SWEATS. SKIN: POSITIVE FOR WOUND (MIDLINE INCISION WITH LURULENT [SIC] DRAINAGE FROM A SINUS TRACT). ABDOMINAL EXAM: SOFT, BOWEL SOUNDS NORMAL, NO DISTENTION, TENDERNESS, REBOUND, OR GUARDING. IMPRESSION/PLAN: STATUS POST VENTRAL HERNIA REPAIR WITH MESH. MESH INFECTION POSTOP. ABSCESS INVOLVING THE MESH VISUALIZED ON CT SCAN. PLAN EXPLORATORY LAP WITH REMOVAL OF MESH; POSSIBLE BIOLOGICAL MESH PLACEMENT DEPENDING ON THE INTRAOPERATIVE FINDINGS. SURGERY, RISKS DISCUSSED. ORAL BACTRIM SCRIPT GIVEN. WOUND, SURGICAL, INFECTED. ABSCESS OF ABDOMINAL CAVITY. (B)(6) 2011:[FACILITY NI]. (B)(6) MD. PATHOLOGY REPORT. ACCESSION #: S11-1304. SPECIMEN(S): ABDOMINAL MESH. FINAL PATHOLOGIC DIAGNOSIS: SOFT TISSUES, CONSISTING OF FIBROMUSCULAR TISSUES; MIXED INFLAMMATION WITH GIANT CELL FOREIGN BODY REACTION; GRANULATION TISSUE; RECENT AND OLD HEMORRHAGE. ABDOMINAL MESH (GROSS EXAMINATION ONLY). MICROSCOPIC DESCRIPTION: RECEIVED IN FORMALIN IN A CONTAINER LABELED ¿(B)(6) ABDOMINAL MESH¿, IS A SYNTHETIC FABRIC WITH SOME SUTURES ATTACHED. THERE IS A SMALL AMOUNT OF SOFT TISSUE ATTACHED AS WELL. SOME OF THIS MATERIAL IS PROCESSED IN ONE BLOCK. PRE/POSTOPERATIVE DIAGNOSIS: MESH INFECTION. (B)(6) 2011:[FACILITY NI]. MICROBIOLOGY. CULTURE, WOUND. SPECIMEN DESCRIPTION: WOUND ABDOMINAL INCISION. SPECIAL REQUESTS: SPEC A, SWABS, SURGICAL. GRAM STAIN: 2+ RED BLOOD CELLS, 3+ WHITE BLOOD CELLS, 2+ GRAM POSITIVE COCCUS. CULTURE: MODERATE GROWTH OF STAPHYLOCOCCUS AUREUS. (B)(6) 2011: [FACILITY NI]. MICROBIOLOGY. CULTURE, WOUND. SPECIMEN DESCRIPTION: WOUND ABDOMINAL ABSCESS. SPECIAL REQUESTS: SPEC B, SWABS, SURGICAL. GRAM STAIN: 2+ RED BLOOD CELLS, 2+ WHITE BLOOD CELLS, 2+ GRAM POSITIVE COCCUS. CULTURE: MODERATE GROWTH OF STAPHYLOCOCCUS AUREUS. (B)(6) 2011:(B)(6) CENTER. (B)(6) DO. OFFICE NOTES. STATUS POST REMOVAL INFECTED MESH. WOUND VAC CHANGED TODAY. GRANULATION TISSUE PRESENT, WOUND HEALING WELL BY SECONDARY INTENTION. CONTINUE WOUND VAC. OFF WORK UNTIL WOUND VAC DISCONTINUED. FOLLOW UP 3 WEEKS. WILL NEED FOLLOW UP CT SCAN CHEST 3-6 MONTHS TO FOLLOW UP SMALL NODULES SEEN ON THE ONE DONE PER OP BECAUSE SOME NODULES SEEN WHEN HAD ABDOMINAL FLUID COLLECTION ASPIRATED. (B)(6) 2011: (B)(6) CENTER. (B)(6) , DO. OFFICE NOTES. STATUS POST REMOVAL INFECTED MESH. WOUND HEALING WELL. CONTINUE VAC DRESSING. FOLLOW UP 2 WEEKS. PLAN LAPAROSCOPIC INCISIONAL HERNIA REPAIR APPROX. NEXT 4 MONTHS. IMPRESSION: NONHEALING SURGICAL WOUND. (B)(6) 2011:(B)(6) CENTER. (B)(6) DO. OFFICE NOTES. ABDOMINAL WOUND HEALING WELL. DISCONTINUE VAC. WET TO DRY DAILY. FOLLOW UP 3 WEEKS. WILL NEED LAP RECURRENT HERNIA REPAIR. IMPRESSION: NONHEALING SURGICAL WOUND. (B)(6) 2011:(B)(6) CENTER. (B)(6) DO. OFFICE NOTES. MIDLINE ABDOMINAL WOUND HEALING WELL. CHANGE TO AQUA CELL DAILY, MAY SHOWER, TOLERATING DIET, WEAN OFF NARCOTICS. PLANNING LAP REPAIR RECURRENT INCISIONAL HERNIA SOMETIME AROUND JULY. FOLLOW UP 4 WEEKS. IMPRESSION: INCISIONAL HERNIA, NONHEALING SURGICAL WOUND. (B)(6) 2011:(B)(6) CENTER. (B)(6) DO. OFFICE NOTES. PLAN LAP REPAIR RECURRENT HERNIA ONCE WOUND COMPLETELY HEALED. FOLLOW UP 3 WEEKS. IMPRESSION: NONHEALING SURGICAL WOUND, INCISIONAL HERNIA. (B)(6) 2011:(B)(6) CENTER. (B)(6) DO. OFFICE NOTES. INCISION HEALED WELL EXCEPT FOR A SMALL ESCAR [SIC] IN CENTER OF INCISION. WILL NEED A LAP REPAIR WITH MESH IN THE NEXT 4 WEEKS. DRY DRESSING. NO HEAVY LIFTING. 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® 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.¿ THE GORE® DUALMESH® BIOMATERIAL INSTRUCTIONS FOR USE ALSO STATES: ¿STRICT ASEPTIC TECHNIQUES SHOULD BE FOLLOWED. IF AN INFECTION DEVELOPS, IT SHOULD BE TREATED AGGRESSIVELY. AN UNRESOLVED INFECTION MAY REQUIRE REMOVAL OF THE MATERIAL.¿ 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.
IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT VENTRAL HERNIA REPAIR ON (B)(6) 2010, WHEREBY A GORE® DUALMESH® BIOMATERIAL WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2011, AN ADDITIONAL PROCEDURE OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: MESH INFECTION, REMOVAL, DRAINAGE OF ABSCESS, WOUND VAC, ADDITIONAL PROCEDURES. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.
(B)(4). THE INITIAL REPORTER'S COMPLETE ADDRESS IS (B)(4). IT SHOULD BE NOTED THAT THE GORE® DUALMESH® 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.¿ THE GORE® DUALMESH® BIOMATERIAL INSTRUCTIONS FOR USE ALSO STATES: ¿STRICT ASEPTIC TECHNIQUES SHOULD BE FOLLOWED. IF AN INFECTION DEVELOPS, IT SHOULD BE TREATED AGGRESSIVELY. AN UNRESOLVED INFECTION MAY REQUIRE REMOVAL OF THE MATERIAL.¿
IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT VENTRAL HERNIA REPAIR ON (B)(6) 2010, WHEREBY A GORE® DUALMESH® BIOMATERIAL WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2011, AN ADDITIONAL PROCEDURE OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: MESH INFECTION, REMOVAL, DRAINAGE OF ABSCESS, WOUND VAC, ADDITIONAL PROCEDURES. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 371968 | GORE DUALMESH BIOMATERIAL | MESH, SURGICAL, POLYMERIC | FTL | W.L. GORE & ASSOCIATES | 1DLMC06 | 7110864 | 00733132600991 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR | Hospitalization| R |