GORE DUALMESH® PLUS BIOMATERIAL
Report
- Report Number
- 3003910212-2019-00439
- Event Type
- Injury
- Date Received
- October 25, 2019
- Date of Event
- March 26, 2018
- Report Date
- June 3, 2022
- Manufacturer
- W.L. GORE & ASSOCIATES
- Product Code
- FTL
- UDI-DI
- 00733132601103
- PMA / PMN Number
- K063435
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- 003
Narratives
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: [MISSING RECORDS: RECORDS FOR PREVIOUS ABDOMINAL SURGERY WERE NOT PROVIDED.] ON (B)(6) 2016: (B)(6), MD, FELLOW. OPERATIVE REPORT. PRE-OP DIAGNOSIS: MALIGNANT NEOPLASM OF HEAD OF PANCREAS. ABDOMINAL HERNIA. POST-OP DIAGNOSIS: MALIGNANT NEOPLASM OF HEAD OF PANCREAS. ABDOMINAL HERNIA. PROCEDURE(S) PERFORMED: LAPAROSCOPIC INCISIONAL HERNIA REPAIR. LAPAROSCOPIC LYSIS OF ADHESIONS. ANESTHESIA TYPE: GENERAL. FLUID TOTALS: I/O [INTAKE/OUTPUT] THIS SHIFT: 01/08 0600 ¿ 01/08 2259; IN: 1550 (22.1 ML/KG) [IV: 1550]. OUT: 7 (0.1 ML/KG [BLOOD: 7]. NET 1543. WEIGHT 70 KG. ESTIMATED BLOOD LOSS: BLOOD LOSS 7 ML. SPECIMENS TO PATHOLOGY: NO SPECIMENS TO LOG. TEMPORARY IMPLANTS: [BLANK]. PACKING: [BLANK]. PATIENT CONDITION: GOOD. FINDINGS (INCLUDING UNEXPECTED COMPLICATIONS): ABDOMINAL WALL ADHESIONS WITH SMALL INCISIONAL HERNIA. INDICATION: 49 YEAR OLD MALE WITH INCISIONAL HERNIA. THE PATIENT HAD A SYMPTOMATIC HERNIA WHICH DEVELOPED AFTER PREVIOUS ABDOMINAL SURGERY. HE COMPLAINED OF PAIN AND DISFIGUREMENT WITH PHYSICAL ACTIVITY AND REQUESTED REPAIR. HE WAS COUNSELED EXTENSIVELY AS TO THE RISKS, BENEFITS, AND ALTERNATIVES TO SURGICAL REPAIR. WE DISCUSSED EXPECTANT MANAGEMENT. INFORMED CONSENT FOR THIS PROCEDURE WAS OBTAINED. DESCRIPTION OF PROCEDURE: ¿THE PATIENT WAS IDENTIFIED IN THE PREOPERATIVE AREA BY DR. (B)(6). THE PROCEDURE WAS ONCE AGAIN REVIEWED AND INFORMED CONSENT WAS ASSURED FOR INCISIONAL HERNIA REPAIR. HE WAS BROUGHT TO THE OPERATING ROOM, SEDATED AND INTUBATED WITHOUT DIFFICULTY. HIS ABDOMEN WAS THEN PREPPED AND DRAPED IN A STERILE FASHION. AN OFFICIAL TIME OUT WAS PERFORMED WHICH REVEALED THE PATIENT¿S NAME, DATE OF BIRTH, PROCEDURE, INDICATION, ALLERGIES, AND NEED FOR ANTIBIOTICS AND SUBCUTANEOUS HEPARIN. ALL STAFF WERE INDICATED BY NAME. HE RECEIVED 2-G CEFOXITIN FOR SURGICAL PROPHYLAXIS LESS THAN 30 MINUTES PRIOR TO SURGICAL INCISION. A 5 MM LAPAROSCOPE WAS OPTICALLY GUIDED INTO THE PATIENT¿S ABDOMEN IN THE LEFT UPPER QUADRANT USING THE VISIPORT TECHNIQUE. A PNEUMOPERITONEUM OF 12 MMHG CREATED ONCE VERIFICATION OF LOW FLOW EXISTED WITHIN THE CIRCUITRY. UNDER DIRECT VISION, THE REMAINING PORTS WERE PLACED. A 12-MM PORT IN THE LOWER QUADRANT AND A 5-MM PORT IN THE MID RIGHT ABDOMINAL WALL. THE PATIENT WAS SEEN TO HAVE EXTENSIVE ADHESIONS TO THE ABDOMINAL WALL HOWEVER THE BOWEL WAS NOT FIXED WITHIN THE HERNIA. THE PATIENT REQUIRED A DELICATE LYSIS OF ADHESIONS IN THE SUPERIOR ASPECT OF THE PREVIOUS INCISION. THIS WAS DONE USING A SHARP TECHNIQUE AND ELECTROCAUTERY SCISSOR TECHNIQUE. THE BOWEL WAS FREED FROM THE HERNIA SAC. THE PNEUMOPERITONEUM WAS REDUCED AND THE PATIENT¿S FASCIAL DEFECT WAS THEN MARKED OUT ON THE ABDOMINAL WALL. A 4-CM CIRCUMFERENTIAL RADIAL MARGIN WAS DRAWN AROUND THE DEFECT MARGINS. A BARD COMPOSIX CIRCULAR MESH MEASURING 11.4-CM MESH WAS CHOSEN. FOUR 0-ETHIBOND SUTURES WERE PLACED IN THE QUARTILE POSITIONS. THE MESH WAS ROLLED TIGHTLY AND PLACED THROUGH A 12-MM PORT INTO THE PERITONEAL CAVITY. THE MESH WAS UNROLLED AND PLACED INTO POSITION. THE ENDO CLOSE NEEDLE WAS USED TO GRASP THE SUTURES AND PULL THEM EXTRAPERITONEAL AND THE MESH WAS PARACHUTED INTO POSITION. INTRA-ABDOMINAL PRESSURE WAS REDUCED TO 12 MMHG. THE ETHIBOND SUTURES WERE TIED DOWN FOR PERFECT MESH PLACEMENT. A SORBAFIX ABSORBABLE TACKER WAS THEN USED TO TACK THE MESH AT APPROXIMATELY 5 MM INTERVALS ABOUT ITS CIRCUMFERENCE FOR AN EXCELLENT SMOOTH, TAUT REPAIR. A SMALL NUMBER OF TACKS WERE PLACED IN THE INTERIOR OF THE MESH TO DECREASE DEAD SPACE. FINAL INSPECTION REVEALED EXCELLENT HEMOSTASIS. THE PORTS WERE REMOVED AND PNEUMOPERITONEUM RELEASED. THE 12 MM PORT SITE WAS CLOSED USING 0 VICRYL USING A FIGURE OF EIGHT FASHION. THE REMAINDER 5-MM PORT SITES WERE NOT CLOSED. 0.25% MARCAINE WAS USED FOR ANALGESIA. THE SKIN WAS CLOSED WITH 4-0 MONOCRYL AND DERMABOND. DR. (B)(6) WAS PRESENT AND PARTICIPATED IN THE ENTIRE PROCEDURE. THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS EXTUBATED AT THE CONCLUSION OF THE PROCEDURE.¿ ON (B)(6) 2016: (B)(6) CENTER. IMPLANT RECORD. MESH COMPOSIX. MANUFACTURER: DAVOL INC. ON (B)(6) 2018: (B)(6), MD. PATHOLOGY RECORD. FINAL DIAGNOSIS: TERMINAL ILEUM, BIOPSY: SMALL BOWEL MUCOSA WITH NO SPECIFIC PATHOLOGIC CHANGE. INDICATION: ABDOMINAL PAIN. ON (B)(6) 2018: (B)(6), MD, RESIDENT. OPERATIVE REPORT. PRE-OP DIAGNOSIS: ABDOMINAL PAIN, UNSPECIFIED ABDOMINAL LOCATION. MALIGNANT NEOPLASM OF HEAD OF PANCREAS. POST-OP DIAGNOSIS: ABDOMINAL PAIN, UNSPECIFIED ABDOMINAL LOCATION. MALIGNANT NEOPLASM OF HEAD OF PANCREAS. PROCEDURE(S) PERFORMED: LAPAROSCOPY DIAGNOSTIC, COMPLEX LYSIS OF ADHESIONS; EXPLORATORY LAPAROTOMY; BOWEL RESECTION; REMOVAL OF HERNIA MESH, PLACEMENT OF NEW MESH. REPAIR INCISIONAL HERNIA, REDUCIBLE. RESECT SMALL INTESTINE WITH ENTEROSTOMY. ANESTHESIA: GENERAL. FLUID TOTALS: I/O [INTAKE/OUTPUT] THIS SHIFT: 03/16 0600 ¿ 03/16 2259; IN: 1000 (12.3 ML/KG) [IV: 1000]. OUT: 200 (2.5 ML/KG) [URINE: 150; BLOOD 50]. NET: 800. WEIGHT: 81 KG. ESTIMATED BLOOD LOSS: BLOOD LOSS 50 ML. SPECIMENS TO PATHOLOGY: SMALL BOWEL. TEMPORARY IMPLANTS: [BLANK]. PACKING: [BLANK]. PATIENT CONDITION: GOOD. INDICATIONS: ABDOMINAL PAIN. FINDINGS (INCLUDING UNEXPECTED COMPLICATIONS): DIAGNOSTIC LAPAROSCOPY SHOWING ADHESION TO MESH AND PARTIAL BOWEL OBSTRUCTION. LARGE SEGMENT OF SMALL BOWEL INVESTED IN PREVIOUS MESH WITH PARTIAL OBSTRUCTION. LYSIS OF ADHESIONS WITH ENTEROTOMY REQUIRING SMALL BOWEL RESECTION. INDICATION: 51 YEAR OLD MALE WITH INCISIONAL HERNIA. THE PATIENT HAD A SYMPTOMATIC HERNIA WHICH DEVELOPED AFTER PREVIOUS ABDOMINAL SURGERY. HE COMPLAINED OF PAIN AND DISFIGUREMENT WITH PHYSICAL ACTIVITY AND REQUESTED REPAIR. HE WAS COUNSELED EXTENSIVELY AS TO THE RISKS, BENEFITS, AND ALTERNATIVES TO SURGICAL REPAIR. WE DISCUSSED EXPECTANT MANAGEMENT. INFORMED CONSENT FOR THIS PROCEDURE WAS OBTAINED. DESCRIPTION OF PROCEDURE: ¿THE PATIENT WAS IDENTIFIED IN THE PREOPERATIVE AREA BY DR. (B)(6). THE PROCEDURE WAS ONCE AGAIN REVIEWED AND INFORMED CONSENT WAS ASSURED FOR INCISIONAL HERNIA REPAIR. HE WAS BROUGHT TO THE OPERATING ROOM, SEDATED AND INTUBATED WITHOUT DIFFICULTY. HIS ABDOMEN WAS THEN PREPPED AND DRAPED IN A STERILE FASHION. AN OFFICIAL TIME OUT WAS PERFORMED WHICH REVEALED THE PATIENT¿S NAME, DATE OF BIRTH, PROCEDURE, INDICATION, ALLERGIES, AND NEED FOR ANTIBIOTICS AND SUBCUTANEOUS HEPARIN. ALL STAFF WERE INDICATED BY NAME. HE RECEIVED 2-G CEFOXITIN FOR SURGICAL PROPHYLAXIS LESS THAN 30 MINUTES PRIOR TO SURGICAL INCISION. A 5 MM LAPAROSCOPE WAS OPTICALLY GUIDED INTO THE PATIENT¿S ABDOMEN IN THE LEFT UPPER QUADRANT USING THE VISIPORT TECHNIQUE. A PNEUMOPERITONEUM OF 12 MMHG CREATED ONCE VERIFICATION OF LOW FLOW EXISTED WITHIN THE CIRCUITRY. UNDER DIRECT VISION, THE REMAINING PORTS WERE PLACED. A 12-MM PORT IN THE LEFT LOWER QUADRANT AND A 5-MM PORT IN THE MID RIGHT ABDOMINAL WALL. THE PATIENT WAS SEEN TO HAVE EXTENSIVE ADHESIONS OF SMALL BOWEL TO THE MIDLINE MESH. SEVERAL LOOPS OF BOWEL WERE FIXED TO THE MESH WITH EVIDENCE OF PARTIAL OBSTRUCTION. WE SLOWLY PERFORMED ADHESIOLYSIS WITH TEDIOUS AND METICULOUS CARE. SEVERAL LOOPS OF BOWEL WERE EASILY SEPARATED FROM THE MESH BUT AS THESE FELL AWAY, WE COULD SEE FURTHER LOOPS OF BOWEL WERE COMPLETELY ADHERENT TO THE MESH AND WOULD NOT SEPARATE WITHOUT EXTENSIVE DISSECTION. WE CREATED A FULL THICKNESS ENTEROTOMY WHICH WAS RECOGNIZED. SEVERAL OTHER BOWEL LOOPS WERE SIMILARLY DIRECTLY ADHERENT TO THE MESH. AT THIS POINT IS WAS FELT THAT THE BEST COURSE WOULD BE TO REMOVE THE MESH AND PERFORM OPEN REPAIR OF THE HERNIA. WE CREATED AN INCISION ALONG THE LENGTH OF THE PRIOR HERNIA REPAIR. THE INFERIOR ASPECT WAS FREE OF BOWEL INVOLVEMENT AND WE ENTERED THE ABDOMEN SAFELY. WE THEN EXCISED THE MESH FROM THE FREE FASCIAL EDGE. THERE STILL WAS ONE SEGMENT OF SMALL BOWEL THAT WE FIRMLY FIXED TO THE MESH AND WE SLOWLY DISSECTED THIS FREE. DUE TO THE ADHERENCE TO THE MESH, EXCISION REQUIRED ENTEROTOMY. WE THEN EVALUATED THE SMALL BOWEL. THERE WERE THREE SEGMENTS IN WHICH ENTEROTOMY WAS PRESENT ALL MEASURING 30-50 CM FROM EACH OTHER. WE THEREFORE CHOSE TO EXCISE THIS SEGMENT IN TOTAL MEASURING 100 CM. THE SEGMENT OF MESENTERY WAS PREPARED ON EITHER SIDE OF THE ENTEROTOMIES AND A BLUE LOAD GIA STAPLER WAS USED TO TRANSECT THE SMALL BOWEL. THE MESENTERY WAS TAKEN WITH LIGASURE DEVICE. A SIDE-TO-SIDE FUNCTIONAL END-TO-END STAPLED ANASTOMOSIS WAS CREATED USING THE GIA STAPLER WITH A BLUE LOAD AND THE OPENING CLOSED WITH A TA 55 CM STAPLER. THE MESENTERIC DEFECT WAS CLOSED. THE ABDOMEN WAS IRRIGATED UNTIL CLEAR. WE THEN FOCUSED OUR ATTENTION TO THE HERNIA REPAIR. SKIN FLAPS WERE CREATED FOR A DISTANCE OF 8-CM TO THE LATERAL ASPECT OF THE RECTUS MUSCLES FREEING THE FASCIA. THE FASCIAL EDGES APPROXIMATED WITHOUT TENSION. WE FELT THAT CLOSURE OF THE FASCIA WITH ONLAY MESH CLOSURE WOULD BE MOST APPROPRIATE. THE FASCIA WAS CLOSED USING #1 PDS IN FIGURE OF EIGHT FASHION. SUTURES WERE PLACED WITH SNAPS TO ALLOW SAFE PLACEMENT OF A MALLEABLE RETRACTOR. A GORE DUALMESH PLUS 10X15 CM MESH WAS THEN PLACED ABOVE THE FASCIA USING INTERRUPTED 0-PROLENE SUTURE. THE SUTURES WERE PLACED EVERY 4-CM BEGINNING IN THE INFERIOR ASPECT AND TRAVELING CEPHALAD. THE SUTURES WERE SECURED ONCE THE ENTIRE MESH WAS PLACED, WE THEN [SIC] AND TIED LATER. THE MESH WAS 10 X 15 CM. IT WAS SECURED USING #1 PROLENE IN AN INTERMITTENT FIGURE OF EIGHT FASHION. WE THEN IRRIGATED THE SUBCUTANEOUS TISSUE WITH VIGOROUS IRRIGATION OF NEOMYCIN-INFUSED SALINE. GLOVES WERE CHANGED BY THE ENTIRE TEAM. A SINGLE #15 BLAKE DRAIN WAS PLACED ANTERIOR TO THE FASCIA THROUGH A SEPARATE PUNCTURE SITE. THE WOUND WAS CLOSED USING 3-0 VICRYL IN A DEEP DERMAL FASHION AND 4-0 MONOCRYL IN A SUBCUTICULAR FASHION. DERMABOND WAS USED FOR BIO-OCCLUSION OF THE WOUND. DR. GALKA WAS PRESENT AND PARTICIPATED IN THE ENTIRE PROCEDURE. THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS EXTUBATED AT THE CONCLUSION OF THE PROCEDURE.¿ ON (B)(6) 2018: (B)(6) CENTER. IMPLANT RECORD. MESH DUAL PLUS 10CMX15CM ¿ LOG 261213 ¿ IMPLANTED. SERIAL NUMBER: (B)(6). MODEL/CAT NUMBER: 1DLMCP03. MANUFACTURER: WL. GORE AND ASSOCIATES. SIZE: 10 CM X 15 CM X 1 MM. THE RECORDS CONFIRM A GORE® DUALMESH® PLUS BIOMATERIAL (1DLMCP03/14156284) WAS IMPLANTED DURING THE PROCEDURE. ON (B)(6) 2018: (B)(6), MD. PATHOLOGY RECORD. FINAL DIAGNOSIS: SMALL INTESTINE, SEGMENTAL RESECTION: PORTION OF SMALL BOWEL WITH SEROSAL ADHESIONS AND MURAL DEFECTS. TWO LYMPH NODES, NEGATIVE FOR CARCINOMA. INDICATIONS FOR PROCEDURE/CLINICAL HISTORY: ABDOMINAL PAIN, UNSPECIFIED LOCATION; MALIGNANT NEOPLASM OF HEAD OF PANCREAS. GROSS DESCRIPTION: RECEIVED UNFIXED LABELED, ¿PASTOR, (B)(6)¿ AND ¿SMALL BOWEL¿ IS AN UNORIENTED AND DISRUPTED SEGMENT OF SMALL BOWEL (49 CM IN LENGTH AND 3 CM IN DIAMETER) WITH TWO STAPLED ENDS AND ATTACHED MESENTERIC FAT. THE SEROSAL SURFACES ARE PINK-PURPLE AND CONGESTED WITH SCATTERED DENSE FIBROUS ADHESIONS. THERE ARE FIVE TRANSDERMAL DEFECTS RANGING FROM 0.3 X 0.3 CM TO 6.5 X 2.5 CM (EDGE IS INKED YELLOW). THE DEFECTS ARE SURROUNDED BY ADHESIONS. THE MUCOSA IS TAN-PINK WITH UNREMARKABLE FOLDS. SECTIONING REVEALS TWO TAN PINK LYMPH NODE CANDIDATES, EACH 0.3 X 0.3 X 0.2 CM. REPRESENTATIVE SECTIONS ARE SUBMITTED IN FOUR WHITE CASSETTES LABELED 18SSP14728 A1-A4. SUMMARY OF SECTIONS: A1-STAPLED ENDS PERPENDICULAR, TWO PIECES; A2-A3-TRANSDURMAL DEFECTS, A2-TWO PIECES, A3-THREE PIECES; A4-TWO INTACT LYMPH NODE CANDIDATES, TWO PIECES. ON (B)(6) 2018 [ASSIGNED; PATH REPORT AND IMPLANT RECORD INDICATES ON (B)(6) 2018]: (B)(6), MD. OPERATIVE REPORT. ASSISTANT: DR. (B)(6). PREOPERATIVE DIAGNOSIS: INCARCERATED INCISIONAL HERNIA. POSTOPERATIVE DIAGNOSIS: INCARCERATED INCISIONAL HERNIA. OPERATIVE PROCEDURE: VENTRAL HERNIA REPAIR. MESH PROSTHESIS. SMALL-BOWEL RESECTION. ABDOMINAL WALL DEBRIDEMENT AND REMOVAL OF PRIOR MESH. COMPONENT SEPARATION UNILATERAL RIGHT-SIDED FASCIAL CUTANEOUS ADVANCEMENT FLAP. ANESTHESIA: GENERAL. INDICATIONS: THE PATIENT IS APPROXIMATELY 9 DAYS POSTOPERATIVE FROM A PRIOR SMALL BOWEL RESECTION AND VENTRAL HERNIA REPAIR. HE DEMONSTRATED CLINICAL SIGNS OF SMALL-BOWEL OBSTRUCTION AND AN ABDOMINAL CT SCAN WAS OBTAINED, WHICH REVEALED A RECURRENT VENTRAL HERNIA WITH AN INCARCERATED LOOP OF SMALL INTESTINE THAT WAS PARTIALLY OBSTRUCTING. THIS LOOP OF SMALL INTESTINE LIE BENEATH THE GORE-TEX ONLAY MESH AND WAS NOT REDUCIBLE CLINICALLY AND IN CONTACT WITH THE LARGE PORE SIDE OF THE MESH. WE RECOMMENDED A SURGICAL REPAIR, AND WRITTEN INFORMED CONSENT FOR THIS PROCEDURE WAS OBTAINED FOLLOWING A DISCUSSION OF RISKS, BENEFITS, AND ALTERNATIVES. SURGEON¿S NARRATIVE: ¿THE PATIENT WAS ANESTHETIZED IN A SUPINE POSITION, AND HIS ABDOMEN WAS PREPPED AND DRAPED IN THE USUAL STERILE FASHION AND HE UNDERWENT A WHO-COMPLIANT SURGICAL CHECKLIST. THE PATIENT¿S PRIOR MIDLINE INCISION WAS OPENED, REVEALING SOME STRAW-COLORED FLUID AND THE GORE-TEX DUAL MESH TO ONLAY MESH. SEVERAL OF THE PROLENE SUTURES AROUND ITS CIRCUMFERENCE WERE SEEN TO HAVE SOME UNKNOTTED, BUT THAT DID NOT APPEAR TO PLAY ANY ROLE IN THE RECURRENT HERNIATION. ALL OF THE PROLENE SUTURE AND THE MESH WERE EXCISED. UNDERNEATH THE DUAL MESH, THE LOOP OF SMALL INTESTINE COULD BE VISUALIZED. IT WAS MARKEDLY EDEMATOUS AND GELATINOUS AND DENSELY ADHERENT. THIS DID NOT APPEAR TO BE AN ACUTE HERNIATION, BUT PROBABLY PRESENT FOR SEVERAL DAYS. CAREFUL INSPECTION REVEALED THAT ALL OF THE MIDLINE MONOFILAMENT SUTURES WERE IN FACT INTACT AND THE REHERNIATION TOOK PLACE AT AN APPARENT OFF MIDLINE FASCIAL RENT JUST LATERAL TO THE MIDLINE SUTURES. THE BOWEL APPEARED TO BE PINK AND HEALTHY, ALTHOUGH VERY EDEMATOUS AND CLEARLY IRREDUCIBLE. THE MIDLINE SUTURES WERE REMOVED, AND THE HERNIA WAS STILL PRESENT AS THERE WAS APPROXIMATELY 1 CM STRIP OF LEFT-SIDED FASCIA LATERAL TO WHICH THE BOWEL HAD HERNIATED. THIS CONSTRICTING RIGHT WAS THEN INCISED, AND WE COULD EXAMINE THE NECK OF THE SMALL BOWEL, WHICH WAS VERY TIGHT. THE PATIENT UNDERWENT CAREFUL LYSIS OF ADHESIONS AND THE PREVIOUS ANASTOMOSIS AND THE HERNIATED LOOP OF SMALL BOWEL WERE WIDELY MOBILIZED. THE HERNIATED LOOP OF BOWEL WAS APPROXIMATELY 6 OR 7 CM DOWNSTREAM FROM THE PRIOR ANASTOMOSIS. AT NO TIME WERE ANY INADVERTENT ENTEROTOMIES WERE [SIC] PERFORMED. A SINGLE SEROSAL ABRASION WAS PRESENT AT THE NECK OF THE HERNIA ITSELF, APPARENTLY CAUSED BY THE PROCESS OF HERNIATION. THE LOOP OF SMALL INTESTINE WAS SEVERELY INFLAMED, AND THE SEROSAL ABRASION WAS LARGE ENOUGH THAT OVER-SEWING IT WOULD CREATE CONCERNS FOR FURTHER DIMINUTION IN THE SMALL BOWEL LUMEN. A THERE WAS HEALTHY SLIGHTLY DILATED SMALL BOWEL UPSTREAM AND HEALTHY SMALL BOWEL DOWNSTREAM, THE DECISION TO RESENT THE INJURED LOOP OF SMALL INTESTINE AND THE PREVIOUS ANASTOMOSIS WAS MADE. PROXIMAL AND DISTAL INTESTINE WERE TRANSECTED USING ECHELON STAPLER. LIGASURE IMPACT WAS THEN USED TO EXCISE THE MESENTERY. THE PATIENT UNDERWENT A STAPLED FUNCTIONAL END-TO-END ANASTOMOSIS. A FEW MILLIMETERS OF THE PROXIMAL AND DISTAL STAPLE LINE WERE REMOVED WITH ELECTROCAUTERY, AND THEN ECHELON STAPLER WAS USED TO JOIN THE ANTIMESENTERIC WALL. FOLLOWING INTERNAL INSPECTION FOR HEMOSTASIS, THE COMMON CHANNEL WAS CLOSED WITH ANOTHER FIRING OF THE ECHELON STAPLER. THE ANASTOMOSIS WAS INSPECTED CIRCUMFERENTIALLY AND SEEN TO BE AIRTIGHT. A SINGLE 3-0 SILK LEMBERT SUTURE WAS USED AT THE 4 STAPLE POINT. THE MESENTERIC DEFECT WAS THEN CLOSED IN A NON KINKING MANNER USING INTERRUPTED 3-0 SILKS. THE PATIENTS¿ ABDOMEN IS IRRIGATED WITH A LARGE VOLUME OF ANTIBIOTIC SALINE. SURGEONS CHANGED THEIR GLOVES AND CONTAMINATED INSTRUMENTS REMOVED FROM THE FIELD. THE QUALITY OF THE PATIENT¿S FASCIA WAS DIMINISHED BECAUSE OF A LONGSTANDING INFLAMMATION AND BY THE IRREGULAR HERNIATION ON THE LEFT SIDE. THERE WAS A MODEST AMOUNT OF FASCIAL TENSION, WHICH CLEARLY PRECLUDED PRIMARY REPAIR. BECAUSE OF THE INFLAMED SITUATION AND THE PREEXISTING DRAIN AND POSSIBILITY FOR SKIN FLORA, WE OPTED FOR A BIOLOGIC MESH. THIS WAS PLACED IN A RETROFASCIAL POSITION IN CONJUNCTION WITH A UNILATERAL RIGHT-SIDED COMPONENT SEPARATION. TO CONSTRUCT THE MUSCLE FLAP FOR ADVANCEMENT, THE ALREADY SIZEABLE SOFT TISSUE POCKET ON THE RIGHT SIDE WAS ENLARGED USING ELECTROCAUTERY, ULTIMATELY EXTENDING TO THE RIGHT COSTAL MARGIN BEYOND THE ANTERIOR AXILLARY LINE AND DOWN TO THE ANTERIOR SUPERIOR ILIAC SPINE. WE IDENTIFIED THE LATERAL BORDER OF THE RECTUS ABDOMINIS MUSCLE, AND A CM LATERAL TO THAT, A LONG RELEASE OF THE EXTERNAL OBLIQUE WAS PERFORMED USING ELECTROCAUTERY EXTENDING FROM THE COSTAL MARGIN TO 3 OR 4 CM ABOVE THE INGUINAL LIGAMENT. THE RECTUS ABDOMINIS MUSCLE ADVANCED NICELY APPROXIMATELY 5 CM. ADDITIONAL ADVANCEMENT WAS ACHIEVED FROM SOME MINIMAL PIE CRUSTING OF THE ANTERIOR RECTUS SHEATH. SIX HALF SHEETS OF SEPRAFILM WERE INTERLEAVED AROUND THE SMALL INTESTINE. A 10 X 16 CM STRATTICE MESH WAS CHOSEN AS A BIOPROSTHESIS. ITS CORNERS WERE ROUNDED SLIGHTLY. IT WAS THEN INSET USING 0 PDS ON SNAPS CIRCUMFERENTIALLY AT ABOUT 10 TO 15 MM INTERVALS. ONCE ALL THE SUTURES WERE PLACED, THEY WERE CAREFULLY TIED TO DISALLOW ANY ENTRAPMENT OF VISCERA. THEY WERE CAREFULLY PLACED TO ALLOW APPROXIMATION OF THE MIDLINE FASCIA OVER THE STRATTICE MESH. FOLLOWING FURTHER IRRIGATION, THE MIDLINE FASCIA WAS CLOSED WITH #1 PROLENE SUTURES IN A FIGURE-OF-EIGHT FASHION. THESE TOO WERE PLACED ON SNAPS AND TIED DOWN AT THE COMPLETION OF SUTURE PLACEMENT. AN ADDITIONAL 15-FRENCH BLAKE DRAIN WAS PLACED THROUGH A RIGHT-SIDED COUNTER INCISION. THE SUBCUTANEOUS TISSUE WAS REATTACHED TO THE FASCIAL LAYER WITH INTERRUPTED 3-0 MONOCRYL QUILTING SUTURES. 3-0 MONOCRYL WAS USED AS DEEP DERMAL SUTURES. SURGICAL STAPLES WERE THEN PLACED. A DRAIN SUTURE AND STERILE OCCLUSIVE DRESSINGS WERE PLACED. DR. SCHOENIGER WAS PRESENT THROUGHOUT. ESTIMATED BLOOD LOSS: REPORTED AS 100 ML. COUNTS: NEEDLE, PACK, AND INSTRUMENT COUNTS WERE REPORTED TO ME AS CORRECT AT THE END OF THE CASE. DISPOSITION: THE PATIENT WAS EXTUBATED AT ITS CONCLUSION.¿ [MISSING RECORDS: A CT SCAN SHOWING RECURRENT VENTRAL HERNIA WITH AN INCARCERATED LOOP OF SMALL INTESTINE THAT WAS PARTIALLY OBSTRUCTING WAS NOT PROVIDED.] ON (B)(6) 2018: (B)(6) CENTER. IMPLANT RECORD. TISSUE STRATTICE. MANUFACTURER: LIFECELL CORP. ON (B)(6) 2018: (B)(6), MD. PATHOLOGY RECORD. FINAL DIAGNOSIS: HARDWARE, INCISIONAL MESH, EXCISION: FOREIGN MATERIAL, CONSISTENT WITH MESH (GROSS EXAMINATION ONLY). SOFT TISSUE, DEBRIDED FASCIA, EXCISION: DENSE FIBROADIPOSE TISSUE WITH ACUTE AND CHRONIC INFLAMMATION, NECROSIS, AND FOCAL CALCIFICATION. NO MALIGNANCY IDENTIFIED. SMALL BOWEL RESECTION: SMALL BOWEL WITH SIDE-TO-SIDE ANASTOMOSIS, ULCERATION, SUBMUCOSAL EDEMA AND CONGESTION, AND ACUTE SEROSITIS. FRAGMENT OF ADIPOSE TISSUE WITH FIBROSIS AND FAT NECROSIS. NO MALIGNANCY IDENTIFIED. INDICATION: INCISIONAL HERNIA; ANASTOMOSIS WITH SUTURE PROXIMAL. GROSS DESCRIPTION: RECEIVED IN FORMALIN LABELED ¿PASTOR, (B)(6)¿ AND ¿INCISIONAL MESH (FOR GROSS PATH ONLY)¿ IS A 14 X 7.5 X 03 CM FRAGMENT OF TAN STRIATED RUBBERY MAN-MADE GRAFT MATERIAL WITH FOCALLY ADHERENT BLUE SUTURE MATERIAL AND FOCALLY ADHERENT MAROON MEMBRANOUS TISSUE. A GROSS PHOTOGRAPH IS TAKEN. NO SECTIONS ARE SUBMITTED. THIS IS A GROSS ONLY EXAMINATION. RECEIVED IN FORMALIN LABELED ¿PASTOR, TIMOTHY¿ AND ¿DEBRIDED FASCIA (FOR SURG PATH)¿ ARE TWO IRREGULAR FRAGMENTS OF MAROON YELLOW LOBULATED FIBROADIPOSE TISSUE, TOGETHER 5 X 4 X 1.6 CM. NO ORIENTATION IS GIVEN FOR EITHER FRAGMENT. SECTIONING REVEALS MAROON RED TO YELLOW RUBBERY CUT SURFACES. REPRESENTS SECTIONS ARE SUBMITTED IN ONE WHITE CASSETTE LABELED 18SSP16176 B1. SUMMARY OF SECTIONS: B1 ¿ TWO PIECES. RECEIVED IN FORMALIN LABELED ¿PASTOR, TIMOTHY¿ AND ¿SMALL BOWEL RESECTION CONTAINING PREVIOUS ANASTOMOSIS WITH SUTURE PROXIMAL¿ IS A 30 CM LONG BY 3.5 CM DIAMETER SEGMENT OF SMALL BOWEL WITH TWO STAPLED RESECTION MARGINS. NO ORIENTATION IS GIVEN FOR THE SPECIMEN. THE SEROSA IS MAROON TAN, SHAGGY AND ROUGHENED, WITH FOCALLY ADHERENT DENSE YELLOW LOBULATED ADIPOSE TISSUE. SECTIONING REVEALS AN INTACT SIDE-TO-SIDE STAPLED ANASTOMOSIS LOCATED APPROXIMATELY 5 CM FROM THE NEAREST STAPLED SURGICAL RESECTION MARGIN. THE MUCOSA IS MAROON TAN AND FOLDED, AND SLIGHTLY EDEMATOUS. THE WALL AVERAGES 0.2 CM THICK. ALSO RECEIVED IN THE SPECIMEN CONTAINER IS A 8 X 3 X 2 CM FRAGMENT OF DENSE YELLOW-TAN LOBULATED FIBROADIPOSE TISSUE. SECTIONING REVEALS MAROON TAN YELLOW CUT SURFACES. REPRESENTATIVE SECTIONS ARE SUBMITTED IN FIVE WHITE CASSETTES LABELED 18SSP16176 C1 THROUGH C5. SUMMARY OF SECTIONS: C1 ¿ FIRST STAPLED MARGIN, INK AT STAPLE LINE, PERPENDICULAR, ONE PIECE. C2 ¿ ANASTOMOSIS, STAPLES REMOVED, TWO PIECES. C3 ¿ REPRESENTATIVE SECTIONS OF BOWEL PAST ANASTOMOSIS, TWO PIECES. C4 ¿ OPPOSITE STAPLED MARGIN, INK AT STAPLE LINE, PERPENDICULAR, ONE PIECE. C5 ¿ REPRESENTATIVE SECTION, FRAGMENT OF ADIPOSE TISSUE, ONE PIECE. ON (B)(6) 2018: (B)(6) HOSPITAL. [PROVIDER NI]. DISCHARGE SUMMARY. UNDERWENT DIAGNOSTIC LAPAROSCOPY CONVERTED TO OPEN EXPLORATORY LAPAROTOMY, LYSIS OF ADHESIONS, SMALL BOWEL RESECTION, REMOVAL OF MESH, AND PLACEMENT OF NEW MESH WITH DR. (B)(6) ON (B)(6) 2018. YOU TOLERATED THE PROCEDURE WELL. YOUR POST OP COURSE WAS COMPLICATED BY ILEUS. ON (B)(6), YOU RETURNED TO THE OPERATING ROOM WITH DR. (B)(6) FOR A SMALL BOWEL RESECTION OF AN INCARCERATED INFLAMED SMALL BOWEL DISTAL TO THE PRIOR SIDE TO SIDE ANASTOMOSIS. YOUR BOWEL FUNCTION WAS SLOW TO RETURN SO YOUR DIET WAS ADVANCES SLOWLY. YOU HAD A FOLEY CATHETER THAT WAS REMOVED PRIOR TO GOING HOME. YOUR RIGHT SIDED ABDOMINAL DRAIN WAS REMOVED (B)(6), YOUR LEFT ABDOMINAL DRAIN WILL STAY IN UNTIL YOUR FOLLOW UP APPOINTMENT. ON (B)(6) 2018: (B)(6), MD. OFFICE NOTES. MEDICATION: BASAGLAR KWIKPEN, CREON, HUMALOG KWIKPEN. DIAGNOSIS: WOUND INFECTION, STATUS POST REPAIR OF VENTRAL HERNIA. WEIGHT 161 LB 3.2 OZ, BMI 25.3. NEVER SMOKER. HISTORY: ABSCESS OF ABDOMINAL WALL ON (B)(6) 2018-PRESENT; ALCOHOL ABUSE ON (B)(6) 2014-PRESENT; CHRONIC ABDOMINAL PAIN ON (B)(6) 2017-PRESENT; CHRONIC BACK PAIN ON (B)(6) 2016-PRESENT; GASTRIC ULCER ON (B)(6) 2014-PRESENT; HYPERGLYCEMIA ON (B)(6) 2014-PRESENT; PANCREATIC CANCER ON (B)(6) 2014-PRESENT; PANCREATITIS STATUS POST CLASSIC WHIPPLE ON (B)(6) 2014-PRESENT; RADICULAR PAIN OF THORACIC REGION; FLOATING RIB PAIN SYNDROME ON (B)(6) 2016-PRESENT; VENTRAL HERNIA ON (B)(6) 2018-PRESENT. 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.¿ THE GORE® DUALMESH® PLUS 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: 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.¿ 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 RECORDS VERIFIED THAT THE LOT MET ALL PRE-RELEASE SPECIFICATIONS. SECTION C1: NAME: PLUS ANTIMICROBIAL PRODUCT COATING. MANUFACTURER/COMPOUNDER: W. L. GORE & ASSOCIATES, INC. LOT NUMBER: 14156284. 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)(6). (B)(4). 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 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 INCARCERATED INCISIONAL HERNIA REPAIR ON (B)(6) 2018, WHEREBY A GORE DUALMESH PLUS BIOMATERIAL WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2018, AN ADDITIONAL PROCEDURE OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: REMOVAL OF MESH REQUIRING ADDITIONAL SURGERY, ABDOMINAL WALL DEBRIDEMENT. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1033109 | GORE DUALMESH® PLUS BIOMATERIAL | MESH, SURGICAL, POLYMERIC | FTL | W.L. GORE & ASSOCIATES | 1DLMCP03 | 14156284 | 00733132601103 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR | Male | Hospitalization| R |