GORE DUALMESH® BIOMATERIAL
Report
- Report Number
- 3003910212-2019-00239
- Event Type
- Injury
- Date Received
- August 15, 2019
- Date of Event
- June 16, 2015
- Report Date
- May 16, 2022
- Manufacturer
- W.L. GORE & ASSOCIATES
- Product Code
- FTL
- UDI-DI
- 00733132600991
- PMA / PMN Number
- K992189
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- 003
Narratives
ADDITIONAL DETAILS REGARDING THE PATIENT'S CLINICAL COURSE WERE ASCERTAINED FROM A REVIEW OF MEDICAL RECORDS AND ARE AS FOLLOWS: (B)(6) 2009: (B)(6) . [ILLEGIBLE SIGNATURE]. HISTORY AND PHYSICAL. EXPLORATORY LAP FOR PRESUMED SMALL BOWEL OBSTRUCTION, BUT FOUND TO HAVE HERNIA, WHICH WAS REPAIRED, NOW ENLARGING RECURRENT HERNIA. PAST MEDICAL HISTORY: DIABETES TYPE II. SINCE 2005 WITH INCREASED PAIN, INTERMITTENT NAUSEA AND VOMITING. PAST SURGICAL HISTORY: HYSTERECTOMY WITH BILATERAL SALPINGO OOPHORECTOMY, EXPLORATORY LAPAROTOMY, LAPAROSCOPIC CHOLECYSTECTOMY, HERNIA REPAIR 1991. SOCIAL HISTORY: NO TOBACCO, ALCOHOL, OR DRUGS. (B)(6) 2009: MCG HEALTH, INC. [NOT SIGNED.] OFFICE NOTES. CHIEF COMPLAINT: VENTRAL HERNIA. WEIGHT 79.4 KG. (B)(6) 2009: (B)(6) , MD. LETTER TO DR. (B)(6) , MD. ¿I HAD THE PLEASURE TODAY OF SEEING MAMIE WILLIAMS. I APPRECIATE VERY MUCH YOUR CONFIDENCE FOR ALLOWING ME TO SEE THIS PLEASANT LADY WITH YOU. AS YOU KNOW, SHE HAS UNDERGONE PREVIOUS HYSTERECTOMY, EXPLORATORY LAPAROTOMY AND LAPAROSCOPIC CHOLECYSTECTOMY. SHE HAS DEVELOPED RECURRENT INCISIONAL HERNIA UNDER HER MIDLINE INCISION AND A CT SCAN WHICH SHE COORDINATED THERE IN GREENWOOD DOCUMENTS WELL THAT SHE HAS SEVERAL DEFECTS, ONE OF WHICH ALLOWS BOWEL TO RESIDE IN HER SUBCUTANEOUS SPACE TO THE RIGHT OF HER MIDLINE. ON EXAM THIS IS A PALPABLE AND NONREDUCIBLE HERNIA WHICH IS MILDLY TENDER FROM PRESSURE. SHE DOES OCCASIONALLY HAVE SOME MILD OBSTRUCTIVE SYMPTOMS, AND BELIEVES THE BULGE AND THE SYMPTOMS ARE BECOMING MORE PROMINENT IN RECENT MONTHS. SHE HAS NO FRANK EVIDENCE OF BOWEL OBSTRUCTION AT THIS POINT. I HAD A GOOD DISCUSSION WITH THE PATIENT AND HER FAMILY TODAY REGARDING HERNIA REPAIR. WE DISCUSSED THE PROS AND CONS OF VARIOUS APPROACHES. SHE HAS DECIDED TO PROCEED WITH A LAPAROSCOPIC REPAIR. WE MAY CONVERT TO AN OPEN PROCEDURE IF THE BOWEL INCARCERATION IS TOO DIFFICULT TO SAFELY DEAL WITH LAPAROSCOPICALLY. SHE WILL BE SCHEDULED FOR THIS IN THE NEXT FEW WEEKS. I WILL KEEP YOU POSTED ON HER PROGRESS, AND I APPRECIATE VERY MUCH THE CONFIDENCE IN ALLOWING ME TO SEE THIS PATIENT WITH YOU. PLEASE FEEL FREE TO CONTACT ME AT YOUR CONVENIENCE IF WE SHOULD DISCUSS THIS FURTHER IN ANY WAY IN THE MEAN TIME.¿ (B)(6) 2009: (B)(6) , MD. OPERATIVE REPORT. PREOPERATIVE DIAGNOSIS: RECURRENT INCARCERATED INCISIONAL HERNIA. POSTOPERATIVE DIAGNOSES: RECURRENT INCARCERATED INCISIONAL HERNIA. MULTIPLE DEFECTS WITH INCARCERATED OMENTUM. CO-MORBIDITIES: OBESITY. DIABETES MELLITUS. DEPRESSION. PROCEDURES PERFORMED: LAPAROSCOPIC REPAIR OF RECURRENT INCARCERATED INCISIONAL HERNIA. RESIDENT SURGEON: MALAY SHAH, MD. SPECIMENS: NONE. DRAINS, IMPLANTS AND STENTS: A 24 X 18 CM PIECE GORE-TEX DUAL MESH. COMPLICATIONS: NONE. INDICATION FOR PROCEDURE: MS. WILLIAMS IS AN AFRICAN-AMERICAN FEMALE WITH A SYMPTOMATIC RECURRENT INCISIONAL HERNIA WHO DESIRES ELECTIVE REPAIR. DESCRIPTION OF PROCEDURE: ¿AFTER AN INFORMED CONSENT HAD BEEN OBTAINED, THE PATIENT WAS BROUGHT TO THE OPERATING ROOM AND PLACED SUPINE ON THE OPERATING ROOM TABLE. AFTER INDUCTION OF GENERAL ANESTHESIA AND THE ADMINISTRATION OF PREOPERATIVE ANTIBIOTICS WAS COMPLETED, THE PATIENT¿S ABDOMEN WAS PREPPED AND DRAPED STERILELY. A LEFT UPPER QUADRANT VERESS NEEDLE WAS PLACED IN THE USUAL MANNER AND ABDOMINAL INSUFFLATION WAS ACHIEVED TO 15 MMHG. ONCE THIS WAS ACCOMPLISHED, A 12 MM TROCAR WAS PLACED IN THE RIGHT UPPER QUADRANT UNDER CAMERA GUIDANCE. WE INSPECTED THE ABDOMEN AND FOUND NO EVIDENCE OF IATROGENIC INJURY SECONDARY TO VERESS NEEDLE PLACEMENT. TWO ADDITIONAL RIGHT SIDED 5 MM TROCARS WERE PLACED UNDER CAMERA GUIDANCE AS WELL AS TWO LEFT SIDED TROCARS. THERE WAS A LARGE AMOUNT OF OMENTAL ADHESIONS TO THE ANTERIOR ABDOMINAL WALL. WE ALSO NOTED THAT THE LEFT LATERAL SEGMENT OF THE LIVER WAS STUCK TO THE ANTERIOR ABDOMINAL WALL. SHARP DISSECTION AS WELL AS A MINIMAL AMOUNT OF ELECTROCAUTERY WAS USED TO DISSECT THE LATERAL SEGMENT OF THE LIVER FROM THE ANTERIOR ABDOMINAL WALL. ONCE THIS WAS DONE, WE NOTED A VERY SMALL BILE LEAK FROM THE LIVER EDGE. WE PLACED CLIPS TO ACHIEVE CONTROL OF BILE LEAKAGE DRAINAGE. WE NEXT BEGAN METICULOUS LYSIS OF ADHESIONS USING SHARP DISSECTION WITH MINIMUM AMOUNTS OF ELECTROCAUTERY TO OBTAIN HEMOSTASIS. GREATER THAN THREE HOURS WERE SPENT TAKING DOWN NUMEROUS OMENTAL ADHESIONS TO THE ABDOMINAL WALL. THE ANTERIOR ABDOMINAL WALL RESEMBLED SWISS CHEESE WITH RESPECT TO THE NUMBER OF SMALL AND LARGE DEFECTS. EACH OF THESE DEFECTS CONTAINED OMENTUM THAT WERE EACH SYSTEMICALLY REDUCED. THERE WAS NO EVIDENCE OF BOWEL WITHIN THESE HERNIAS. THE LARGEST WAS IN THE RIGHT LOWER QUADRANT. ONCE ALL ADHESIONS WERE TAKEN DOWN, WE CONFIRMED NO EVIDENCE OF BOWEL INJURY. NEXT, WE MEASURED THE DEFECT SIZE WITH APPROPRIATE SURROUNDING MARGINS. A 24 X 18 CM PIECE OF GORE-TEX DUAL MESH WAS CHOSEN. THE MESH WAS PREPARED ON THE BACK TABLE PLACING FOUR GORE SUTURES ON THE INFERIOR, SUPERIOR, AND LATERAL ASPECT OF THE MESH. THE MESH WAS SUBSEQUENTLY PLACED WITHIN THE ABDOMEN. ONCE THE MESH WAS UNROLLED AND ORIENTED PROPERLY, THE PREVIOUSLY PLACED GORE SUTURES WERE BROUGHT OUT IN A TRANSFASCIAL MANNER IN THEIR RESPECTIVE ORIENTATION USING GORE SUTURE PASSING DEVICE. THE MESH WAS INSPECTED AND FOUND TO BE UNDER THE APPROPRIATE AMOUNT OF TENSION. WE NEXT SECURED THE MESH CIRCUMFERENTIALLY AROUND THE DEFECTS USING A PROTACK DEVICE. THE STAPLES WERE THEN PLACED IN 1 CM INTERVALS CIRCUMFERENTIALLY. AT THIS POINT, WE PLACED FOUR ADDITIONAL GORE SUTURES IN A TRANSFASCIAL MANNER TO SECURE THE MESH TO ANTERIOR ABDOMINAL WALL. ONCE THIS WAS COMPLETED, THE MESH WAS INSPECTED AND FOUND TO BE IN GOOD POSITION. EACH OF TROCARS WERE REMOVED AND ABDOMINAL INSUFFLATION WAS RELEASED. THE SKIN AT THE TROCAR SITES WERE CLOSED USING 4-0 MONOCRYL SUBCUTICULAR SUTURES. THE WOUNDS WERE DRESSED, STERI-STRIPS AND BURN GAUZE WERE PLACED ON THE ABDOMEN. ABDOMINAL BINDER WAS PLACED. THE PATIENT TOLERATED THE PROCEDURE WELL, WAS EXTUBATED, AND TRANSFERRED TO POST ANESTHESIA CARE UNIT IN STABLE CONDITION.¿ (B)(6) 2009: MCG HEALTH, INC. IMPLANT RECORD. PROCEDURE: LAPAROSCOPIC HERNIA REPAIR, VENTRAL. LYSIS OF ADHESIONS. IMPLANT: MESH DUAL 18 CM X 24 CM X 1 MM. SIZE: 18 X 24. SITE: ABDOMINAL WALL. EXPIRATION DATE: 05/27/2013. MANUFACTURER: W.L. GORE AND ASSOCIATES. MODEL: 1DLMC06. LOT #: 06960133. THE RECORDS CONFIRM A GORE® DUALMESH® BIOMATERIAL (1DLMC06/05960133) WAS IMPLANTED DURING THE PROCEDURE. (B)(6) 2009: MCG HEALTH, INC. [ILLEGIBLE SIGNATURE]. PROGRESS NOTES. POST OP NOTE. ABDOMEN SOFT, NONTENDER, MILDLY DISTENDED, ABDOMINAL BINDER IN PLACE. INCISION CLEAN, DRY, AND INTACT. NOTHING BY MOUTH. PAIN CONTROL WITH MORPHINE. (B)(6) 2009: MCG HEALTH, INC. [ILLEGIBLE SIGNATURE]. PROGRESS NOTES. POST OP DAY 1. NO FLATUS, NO BOWEL MOVEMENT. PAIN CONTROLLED. ALLOW CLEAR LIQUID UNTIL FLATUS. (B)(6) 2009: MCG HEALTH, INC. [ILLEGIBLE SIGNATURE]. PROGRESS NOTES. PAIN CONTROLLED. NO FLATUS, NO BOWEL MOVEMENT. DECREASED URINE OUTPUT. PLAN: IV FLUIDS AT 100 CC/HR. (B)(6) 2009: MEDICAL COLLEGE OF GEORGIA. [ILLEGIBLE SIGNATURE]. PROGRESS NOTES. CONFUSED OVERNIGHT; LIKELY RELATED TO ANESTHESIA. ABDOMEN SOFT. PASSING FLATUS. (B)(6) 2009: MEDICAL COLLEGE OF GEORGIA. [ILLEGIBLE SIGNATURE]. PROGRESS NOTES. STATUS POST VENTRAL HERNIA REPAIR POST-OPERATIVE DAY 5. POSITIVE FLATUS, POSITIVE BOWEL MOVEMENT. NUTRITION, ADVANCE TO DIABETIC DIET. (B)(6) 2009: MCG HEALTH, INC. [AUTHOR NI]. DISCHARGE SUMMARY [ASSIGNED]. HOSPITAL COURSE: UNDERWENT LAPAROSCOPIC VENTRAL HERNIA REPAIR, TOLERATED PROCEDURE WELL. IMMEDIATELY POSTOPERATIVELY, THE PATIENT HAD DECREASED URINE OUTPUT, WHICH WAS RESPONSIVE TO FLUID BOLUSES AND 250 CC OF ALBUMIN. SINCE THAT TIME HAD ADEQUATE URINE OUTPUT. UNDERWENT PHYSICAL THERAPY TO REGAIN BASELINE STATUS. PASSING GAS ON DAY THREE, ADVANCED DIET TO CLEAR, THEN REGULAR. STABLE AT DISCHARGE WITHOUT LEUKOCYTOSIS. DIAGNOSES: VENTRAL HERNIA. DIABETES MELLITUS, TYPE 2. DEPRESSION. PRINCIPAL [NO FURTHER PAGES]. (B)(6) 2009: MCG HEALTH, INC. [ILLEGIBLE SIGNATURE]. DISCHARGE INSTRUCTIONS. DIAGNOSIS: VENTRAL HERNIA. PROCEDURE: LAPAROSCOPIC VENTRAL HERNIA REPAIR. CALL IF TEMPERATURE, INCREASED ABDOMINAL PAIN, SEVERE NAUSEA AND VOMITING. PHYSICAL ACTIVITY: NO STRENUOUS ACTIVITY 4 WEEKS. FOLLOW UP WITH SURGERY, DR. MELLINGER IN TWO WEEKS. (B)(6) 2015: A HEALTH AUGUSTA UNIVERSITY. RAY KING, MD. OPERATIVE REPORT. PREOPERATIVE DIAGNOSES: CHRONIC ABDOMINAL WOUND INFECTION. POST-OPERATIVE DIAGNOSES: SAME AS PRE-OPERATIVE DIAGNOSES. COMORBIDITIES: HYPERTENSION, DIABETES MELLITUS. INDICATION FOR PROCEDURE: CHRONIC CENTRAL HERNIA MESH INFECTION. PROCEDURE PERFORMED: EXPLORATORY LAPAROSCOPY, LAPAROSCOPIC EXTENSIVE LYSIS OF ADHESIONS >2 HOURS, LAPAROSCOPIC ASSISTED SMALL BOWEL RESECTION, LAPAROSCOPIC EXCISION OF INFECTED MESH. DESCRIPTION OF PROCEDURES: ¿AFTER INFORMED CONSENT WAS OBTAINED, PATIENT WAS TAKEN DOWN TO THE OR AND PLACED ON THE TABLE IN SUPINE POSITION. AFTER APPROPRIATE TIMEOUT PERFORMED AND PREOPERATIVE ANTIBIOTICS GIVEN, PATIENT WAS PLACED UNDER GENERAL ENDOTRACHEAL ANESTHESIA. A 5 MM INCISION WAS MADE IN THE LUQ [LEFT UPPER QUADRANT] AND A VERESS NEEDLE INSERTED AND THE ABDOMEN WAS INSUFFLATED TO 18 MMHG AND REPLACED WITH 5 MM PORT. 2 ADDITIONAL 12 MM AND 5 MM PORTS WERE PLACED ALONG THE LEFT FLANK. IMMEDIATELY ENCOUNTERED DENSE OMENTAL ADHESIONS TO THE INFECTED MESH. EXTENSIVE LYSIS OF ADHESIONS AS PERFORMED FOR GREATER THAN 2 HOURS. WE ALSO ENCOUNTERED A LOOP OF SMALL BOWEL THAT WAS INCARCERATED INTO THE PREVIOUS HERNIA SAC/HEMATOMA WITH MULTIPLE SPIRAL TITANIUM TACKS ERODING THROUGH THE BOWEL. THE SMALL BOWEL WAS SHARPLY DISSECTED AWAY FROM THE MESH AND SURROUNDING OMENTUM. MULTIPLE SEROSAL INJURIES WERE NOTED ALONG INCARCERATED SEGMENTS OF THE SMALL BOWEL. A 3-0 VICRYL MARKING SUTURE WAS PLACED AT THE MIDPOINT OF THE INJURED BOWEL. THE DUOMESH APPEARED TO BE BUNCHED UP AND ENTRAPPED IN THE HEMATOMA SAC. THE MESH WAS EXCISED ALONG WITH SURROUNDING TITANIUM SPIRAL TACKS. NEXT A 10 CM SUPRAUMBILICAL MIDLINE LAPAROTOMY INCISION WAS MADE THROUGH THE FASCIA GIVEN THE LARGE AMOUNT OF SCARRED MESH AND MORE MESH MATERIAL WAS IDENTIFIED AND EXTRACTED. OLD HEMATOMA MATERIAL WAS ALSO EXTRACTED. THE EXCISED MESH WAS THEN NEXT EXTRACTED THROUGH THE MINI-LAPAROTOMY INCISION. THE MARKED SEGMENT OF SMALL BOWEL WAS ALSO EXTERIORIZED. THE SEGMENT WAS DIVIDED PROXIMALLY AND DISTALLY WITH TAN 60 MM ENDOGIA STAPLER AND THE MESENTERY LIGATED AND DIVIDED WITH THE HARMONIC ULTRASONIC SHEAR. ONCE GOOD MESENTERIC ALIGNMENT WAS ACHIEVED, TWO ENTEROTOMIES WERE MADE AT THE DIVIDED ENDS AND A SIDE-BY-SIDE FUNCTIONAL ANASTOMOSIS WAS MADE USING ADDITIONAL LOAD OF THE 60 TAN ENDOGIA STAPLER. THE COMMON ENTEROTOMY WAS CLOSED WITH 2 LAYERS OF 3- PDS IN RUNNING FASHION AND THE MESENTERY DEFECT APPROXIMATED WITH 2-0 SILK. EXCELLENT ANASTOMOTIC PATENCY WAS PALPATED AND BOWEL RETURNED TO THE ABDOMEN. THE ABDOMEN WAS IRRIGATED WITH 3L OF WARM SALINE. THE FASCIAL DEFECT WAS CLOSED SECURED TO THE LLQ [LEFT LOWER QUADRANT] WITH 3-0 NYLON. THE ABDOMEN RE-INSUFFLATED AND THE 2 12 MM PORT SITES WERE CLSOED [SIC] WITH #1 PDS WITH THE CARTER-THOMPSON SUTURE PASSER. 30 ML OF BUPIVICAINE [SIC] WAS USED TO PERFORM A LEFT SIDED TAP NERVE BLOCK UNDER DIRECT LAPAROSCOPIC VISUALIZATION. LIQUEFIED SEPRAFILM WAS ALSO INJECTED INTO THE ABDOMINAL CAVITY. ALL PORTS WERE REMOVED AND FASCIAL DEFECTS CLOSED. SKIN WOUNDS WERE CLSOED [CLOSED] WITH 4-0 MONOCRYL AND DRESSED WITH SS AND TEGADERM. PATIENT TOLERATED THE PROCEDURE WELL, EXTUBATED, AND TAKEN TO THE PACU IN STABLE CONDITION.¿ FINDINGS: LARGE PIECE OF CHRONICALLY INFECTED DUOMESH WITH LOOP OF SMALL BOWEL FISTULIZING TO THE WOUND WITH PENETRATING TACKS. DRESSING APPLIED: ADHESIVE BANDAGE. ESTIMATED BLOOD LOSS: 50 ML. SPECIMEN: SENT TO PATHOLOGY. COMPLICATIONS: NONE. [MISSING RECORDS: A PATHOLOGY REPORT AND CULTURE REPORT DETAILING ANALYSIS OF THE DEVICE AND SPECIMENS REMOVED DURING THE (B)(6) 2015 PROCEDURE WAS NOT PROVIDED.] IT SHOULD BE NOTED THAT THE GORE® DUALMESH® 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.¿ 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 INVESTIGATION CONCLUSION: D15: CAUSE NOT ESTABLISHED. H6: HEALTH EFFECT IMPACT CODE: F1903: DEVICE EXPLANTATION . H6: MEDICAL DEVICE COMPONENT: G04088: MEMBRANE. THE INVESTIGATION HAS BEEN COMPLETED. IN THE ABSENCE OF ADDITIONAL INFORMATION OR MEDICAL RECORDS FROM THE COMPLAINANT, THIS EVENT FILE WILL BE CLOSED WITH THE INFORMATION PROVIDED. PREVIOUS PATIENT CODES (1930, 1695, 2068, 3191: APPROPRIATE TERM/CODE NOT AVAILABLE FOR "MESH CONTRACTED ("BUNCHED UP)"; "ENTWINED WITH AND ERODED INTO THE BOWEL, BECOMING CHRONICALLY INFECTED"; "MESH SIGNIFICANTLY SCARRED"; "SEPTIC SHOCK POST-OPERATIVELY"] WERE REPORTED BASED ON THE ORIGINAL COMPLAINT AND ARE NO LONGER APPLICABLE AND/OR NOT REPORTABLE PER GORE¿S INVESTIGATION. MEDICAL RECORDS: THE KNOWN MEDICAL RECORDS SPAN (B)(6) 2009 THROUGH (B)(6) 2015 AND NOT ALL RECORDS RECEIVED IN THIS TIME SPAN ARE RELEVANT TO THE GORE® DUALMESH® BIOMATERIAL. MEDICAL RECORDS FROM (B)(6) 2009 THROUGH (B)(6) 2015 WERE NOT PROVIDED. PATIENT INFORMATION: MEDICAL HISTORY: OBESITY (B)(6) 2009: 175 LBS., BMI 32.7. TYPE II DIABETES MELLITUS. SURGICAL PROCEDURES: UNKNOWN DATE: HYSTERECTOMY WITH BILATERAL SALPINGO OOPHORECTOMY. UNKNOWN DATE: EXPLORATORY LAPAROTOMY ¿FOR PRESUMED SMALL BOWEL OBSTRUCTION.¿ UNKNOWN DATE: LAPAROSCOPIC CHOLECYSTECTOMY. 1991: HERNIA REPAIR. (B)(6) 2009: LAPAROSCOPIC REPAIR OF RECURRENT INCARCERATED INCISIONAL HERNIA. IMPLANT: GORE® DUALMESH® BIOMATERIAL. (B)(6) 2015: EXPLORATORY LAPAROSCOPY, LAPAROSCOPIC EXTENSIVE LYSIS OF ADHESIONS, LAPAROSCOPIC ASSISTED SMALL BOWEL RESECTION, LAPAROSCOPIC EXCISION OF INFECTED MESH. IMPLANT PREOPERATIVE COMPLAINTS: (B)(6) 2009: HISTORY AND PHYSICAL. ¿EXPLORATORY LAP FOR PRESUMED SMALL BOWEL OBSTRUCTION, BUT FOUND TO HAVE HERNIA, WHICH WAS REPAIRED, NOW ENLARGING RECURRENT HERNIA.¿ ¿SINCE 2005 WITH INCREASED PAIN, INTERMITTENT NAUSEA AND VOMITING.¿ (B)(6) 2009: OFFICE NOTES. ¿CHIEF COMPLAINT: VENTRAL HERNIA.¿ (B)(6) 2009: ¿... SHE HAS UNDERGONE PREVIOUS HYSTERECTOMY, EXPLORATORY LAPAROTOMY AND LAPAROSCOPIC CHOLECYSTECTOMY. SHE HAS DEVELOPED RECURRENT INCISIONAL HERNIA UNDER HER MIDLINE INCISION AND A CT SCAN WHICH SHE COORDINATED DOCUMENTS WELL THAT SHE HAS SEVERAL DEFECTS, ONE OF WHICH ALLOWS BOWEL TO RESIDE IN HER SUBCUTANEOUS SPACE TO THE RIGHT OF HER MIDLINE. ON EXAM THIS IS A PALPABLE AND NONREDUCIBLE HERNIA WHICH IS MILDLY TENDER FROM PRESSURE. SHE DOES OCCASIONALLY HAVE SOME MILD OBSTRUCTIVE SYMPTOMS, AND BELIEVES THE BULGE AND THE SYMPTOMS ARE BECOMING MORE PROMINENT IN RECENT MONTHS. SHE HAS NO FRANK EVIDENCE OF BOWEL OBSTRUCTION AT THIS POINT. I HAD A GOOD DISCUSSION WITH THE PATIENT AND HER FAMILY TODAY REGARDING HERNIA REPAIR. WE DISCUSSED THE PROS AND CONS OF VARIOUS APPROACHES. SHE HAS DECIDED TO PROCEED WITH A LAPAROSCOPIC REPAIR. WE MAY CONVERT TO AN OPEN PROCEDURE IF THE BOWEL INCARCERATION IS TOO DIFFICULT TO SAFELY DEAL WITH LAPAROSCOPICALLY. SHE WILL BE SCHEDULED FOR THIS IN THE NEXT FEW WEEKS.¿ IMPLANT PROCEDURE: LAPAROSCOPIC REPAIR OF RECURRENT INCARCERATED INCISIONAL HERNIA. [IMPLANT: GORE® DUALMESH® BIOMATERIAL 1DLMC06/05960133, 18CM X 24CM X 1MM THICK] IMPLANT DATE: (B)(6) 2009 [HOSPITALIZATION DATES: (B)(6) 2009] WOUND CLASSIFICATION: NOT PROVIDED. DESCRIPTION OF HERNIA BEING TREATED: ¿A LEFT UPPER QUADRANT VERESS NEEDLE WAS PLACED IN THE USUAL MANNER AND ABDOMINAL INSUFFLATION WAS ACHIEVED TO 15 MMHG. ONCE THIS WAS ACCOMPLISHED, A 12 MM TROCAR WAS PLACED IN THE RIGHT UPPER QUADRANT UNDER CAMERA GUIDANCE. WE INSPECTED THE ABDOMEN AND FOUND NO EVIDENCE OF IATROGENIC INJURY SECONDARY TO VERESS NEEDLE PLACEMENT. TWO ADDITIONAL RIGHT SIDED 5 MM TROCARS WERE PLACED UNDER CAMERA GUIDANCE AS WELL AS TWO LEFT SIDED TROCARS. THERE WAS A LARGE AMOUNT OF OMENTAL ADHESIONS TO THE ANTERIOR ABDOMINAL WALL. WE ALSO NOTED THAT THE LEFT LATERAL SEGMENT OF THE LIVER WAS STUCK TO THE ANTERIOR ABDOMINAL WALL. SHARP DISSECTION AS WELL AS A MINIMAL AMOUNT OF ELECTROCAUTERY WAS USED TO DISSECT THE LATERAL SEGMENT OF THE LIVER FROM THE ANTERIOR ABDOMINAL WALL. ONCE THIS WAS DONE, WE NOTED A VERY SMALL BILE LEAK FROM THE LIVER EDGE. WE PLACED CLIPS TO ACHIEVE CONTROL OF BILE LEAKAGE DRAINAGE. WE NEXT BEGAN METICULOUS LYSIS OF ADHESIONS USING SHARP DISSECTION WITH MINIMUM AMOUNTS OF ELECTROCAUTERY TO OBTAIN HEMOSTASIS. GREATER THAN THREE HOURS WERE SPENT TAKING DOWN NUMEROUS OMENTAL ADHESIONS TO THE ABDOMINAL WALL. THE ANTERIOR ABDOMINAL WALL RESEMBLED SWISS CHEESE WITH RESPECT TO THE NUMBER OF SMALL AND LARGE DEFECTS. EACH OF THESE DEFECTS CONTAINED OMENTUM THAT WERE EACH SYSTEMICALLY REDUCED. THERE WAS NO EVIDENCE OF BOWEL WITHIN THESE HERNIAS. THE LARGEST WAS IN THE RIGHT LOWER QUADRANT. ONCE ALL ADHESIONS WERE TAKEN DOWN, WE CONFIRMED NO EVIDENCE OF BOWEL INJURY.¿ IMPLANT SIZE AND FIXATION: ¿NEXT, WE MEASURED THE DEFECT SIZE WITH APPROPRIATE SURROUNDING MARGINS. A 24 X 18 CM PIECE OF GORE-TEX DUAL MESH WAS CHOSEN. THE MESH WAS PREPARED ON THE BACK TABLE PLACING FOUR GORE SUTURES ON THE INFERIOR, SUPERIOR, AND LATERAL ASPECT OF THE MESH. THE MESH WAS SUBSEQUENTLY PLACED WITHIN THE ABDOMEN. ONCE THE MESH WAS UNROLLED AND ORIENTED PROPERLY, THE PREVIOUSLY PLACED GORE SUTURES WERE BROUGHT OUT IN A TRANSFASCIAL MANNER IN THEIR RESPECTIVE ORIENTATION USING GORE SUTURE PASSING DEVICE. THE MESH WAS INSPECTED AND FOUND TO BE UNDER THE APPROPRIATE AMOUNT OF TENSION. WE NEXT SECURED THE MESH CIRCUMFERENTIALLY AROUND THE DEFECTS USING A PROTACK DEVICE. THE STAPLES WERE THEN PLACED IN 1 CM INTERVALS CIRCUMFERENTIALLY. AT THIS POINT, WE PLACED FOUR ADDITIONAL GORE SUTURES IN A TRANSFASCIAL MANNER TO SECURE THE MESH TO ANTERIOR ABDOMINAL WALL. ONCE THIS WAS COMPLETED, THE MESH WAS INSPECTED AND FOUND TO BE IN GOOD POSITION. EACH OF TROCARS WERE REMOVED AND ABDOMINAL INSUFFLATION WAS RELEASED. THE SKIN AT THE TROCAR SITES WERE CLOSED USING 4-0 MONOCRYL SUBCUTICULAR SUTURES.¿ (B)(6) 2009: DISCHARGE INSTRUCTIONS: ¿NO STRENUOUS ACTIVITY 4 WEEKS. FOLLOW UP WITH SURGERY, DR. M. IN TWO WEEKS.¿ EXPLANT PREOPERATIVE COMPLAINTS: (B)(6) 2015: PREOPERATIVE DIAGNOSES: ¿CHRONIC ABDOMINAL WOUND INFECTION.¿ EXPLANT PROCEDURE: EXPLORATORY LAPAROSCOPY, LAPAROSCOPIC EXTENSIVE LYSIS OF ADHESIONS >2 HOURS, LAPAROSCOPIC ASSISTED SMALL BOWEL RESECTION, LAPAROSCOPIC EXCISION OF INFECTED MESH. EXPLANT DATE: (B)(6) 2015 [HOSPITALIZATION DATES: (B)(6) 2015 THROUGH (B)(6) 2015]. WOUND CLASSIFICATION: NOT PROVIDED. FINDINGS: ¿LARGE PIECE OF CHRONICALLY INFECTED DUOMESH WITH LOOP OF SMALL BOWEL FISTULIZING TO THE WOUND WITH PENETRATING TACKS.¿ ¿SENT TO PATHOLOGY.¿ PROCEDURE: ¿A 5 MM INCISION WAS MADE IN THE LUQ [LEFT UPPER QUADRANT] AND A VERESS NEEDLE INSERTED AND THE ABDOMEN WAS INSUFFLATED TO 18 MMHG AND REPLACED WITH 5 MM PORT. 2 ADDITIONAL 12 MM AND 5 MM PORTS WERE PLACED ALONG THE LEFT FLANK. IMMEDIATELY ENCOUNTERED DENSE OMENTAL ADHESIONS TO THE INFECTED MESH. EXTENSIVE LYSIS OF ADHESIONS AS PERFORMED FOR GREATER THAN 2 HOURS. WE ALSO ENCOUNTERED A LOOP OF SMALL BOWEL THAT WAS INCARCERATED INTO THE PREVIOUS HERNIA SAC/HEMATOMA WITH MULTIPLE SPIRAL TITANIUM TACKS ERODING THROUGH THE BOWEL. THE SMALL BOWEL WAS SHARPLY DISSECTED AWAY FROM THE MESH AND SURROUNDING OMENTUM. MULTIPLE SEROSAL INJURIES WERE NOTED ALONG INCARCERATED SEGMENTS OF THE SMALL BOWEL. A 3-0 VICRYL MARKING SUTURE WAS PLACED AT THE MIDPOINT OF THE INJURED BOWEL. THE DUOMESH APPEARED TO BE BUNCHED UP AND ENTRAPPED IN THE HEMATOMA SAC. THE MESH WAS EXCISED ALONG WITH SURROUNDING TITANIUM SPIRAL TACKS. NEXT A 10 CM SUPRAUMBILICAL MIDLINE LAPAROTOMY INCISION WAS MADE THROUGH THE FASCIA GIVEN THE LARGE AMOUNT OF SCARRED MESH AND MORE MESH MATERIAL WAS IDENTIFIED AND EXTRACTED. OLD HEMATOMA MATERIAL WAS ALSO EXTRACTED. THE EXCISED MESH WAS THEN NEXT EXTRACTED THROUGH THE MINI-LAPAROTOMY INCISION. THE MARKED SEGMENT OF SMALL BOWEL WAS ALSO EXTERIORIZED. THE SEGMENT WAS DIVIDED PROXIMALLY AND DISTALLY WITH TAN 60 MM ENDOGIA STAPLER AND THE MESENTERY LIGATED AND DIVIDED WITH THE HARMONIC ULTRASONIC SHEAR. ONCE GOOD MESENTERIC ALIGNMENT WAS ACHIEVED, TWO ENTEROTOMIES WERE MADE AT THE DIVIDED ENDS AND A SIDE-BY-SIDE FUNCTIONAL ANASTOMOSIS WAS MADE USING ADDITIONAL LOAD OF THE 60 TAN ENDOGIA STAPLER. THE COMMON ENTEROTOMY WAS CLOSED WITH 2 LAYERS OF 3- PDS IN RUNNING FASHION AND THE MESENTERY DEFECT APPROXIMATED WITH 2-0 SILK. EXCELLENT ANASTOMOTIC PATENCY WAS PALPATED AND BOWEL RETURNED TO THE ABDOMEN. THE ABDOMEN WAS IRRIGATED WITH 3L OF WARM SALINE. THE FASCIAL DEFECT WAS CLOSED SECURED TO THE LLQ [LEFT LOWER QUADRANT] WITH 3-0 NYLON. THE ABDOMEN RE-INSUFFLATED AND THE 2 12 MM PORT SITES WERE CLOSED [SIC] WITH #1 PDS WITH THE CARTER-THOMPSON SUTURE PASSER. 30 ML OF BUPIVICAINE [SIC] WAS USED TO PERFORM A LEFT SIDED TAP NERVE BLOCK UNDER DIRECT LAPAROSCOPIC VISUALIZATION. LIQUEFIED SEPRAFILM WAS ALSO INJECTED INTO THE ABDOMINAL CAVITY. ALL PORTS WERE REMOVED AND FASCIAL DEFECTS CLOSED. SKIN WOUNDS WERE CLOSED [CLOSED] WITH 4-0 MONOCRYL AND DRESSED WITH SS AND TEGADERM.¿ PATHOLOGY REPORT FOR SPECIMENS REMOVED DURING THE (B)(6) 2015 PROCEDURE WAS NOT PROVIDED. (B)(6) 2015: ¿PREOPERATIVE DIAGNOSIS. ¿SEPTIC SHOCK.¿ (B)(6) 2015: INDICATION. ¿NEED FOR HEMODYNAMIC MONITORING.: (B)(6) 2015: PROCEDURE PERFORMED. ¿PLACEMENT OF RIGHT RADIAL ARTERIAL LINE.¿ CONCLUSION: IT SHOULD BE NOTED THAT THE GORE® DUALMESH® BIOMATERIAL INSTRUCTIONS FOR USE INCLUDE WARNINGS AND ADDRESSES THE FOLLOWING ADVERSE REACTIONS AMONG OTHERS: ¿POSSIBLE ADVERSE REACTIONS WITH THE USE OF ANY TISSUE DEFICIENCY PROSTHESIS MAY INCLUDE, BUT ARE NOT LIMITED TO, CONTAMINATION, INFECTION, INFLAMMATION, ADHESION, FISTULA FORMATION, SEROMA FORMATION, HEMATOMA, AND RECURRENCE.¿ 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. MEDICAL RECORDS THAT INDICATE MESH ¿MOVEMENT¿ OR THAT THE DEVICE LOST ANCHORAGE MAY BE A FUNCTION OF A PATIENT¿S POOR TISSUE QUALITY LEADING TO FASCIAL DEHISCENCE OR LOSS OF ANCHORAGE OF FIXATION, OR MAY BE RELATED TO THE HERNIA TYPE, INDIVIDUAL PATIENT COMORBIDITIES, AND TECHNICAL AND PROCEDURAL ASPECTS OF THE REPAIR. THESE FACTORS INCLUDE BUT ARE NOT LIMITED TO, FIXATION TYPE, MESH SHAPE/SIZING USED, AND DEFECT CLOSURE DECISIONS. 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 SHRINKAGE, 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. THERE IS INSUFFICIENT INFORMATION AVAILABLE FOR GORE TO REASONABLY DRAW CONCLUSIONS RELATED TO ASPECTS OF THE EVENT, THEREFORE CONCLUSION CODE "D15: CAUSE NOT ESTABLISHED" IS BEING USED. INSUFFICIENT INFORMATION MAY INCLUDE LIMITED OR MISSING RELEVANT MEDICAL RECORDS, INVOLVEMENT OF MULTIPLE IMPLANTED DEVICES (INCLUDING NON-GORE DEVICES) IN THE FIELD OF TREATMENT, PATIENT NON-COMPLIANCE, AND/OR A GENERAL LACK OF AVAILABLE DETAIL OR SPECIFICITY RELATED TO AN ADVERSE EVENT AND/OR DEVICE. 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: HEALTH EFFECT ¿ CLINICAL CODE. H6: UPDATED INVESTIGATION FINDING. H6: UPDATED INVESTIGATION CONCLUSION. H6: HEALTH EFFECT IMPACT CODE: F1903: DEVICE EXPLANTATION . H6: MEDICAL DEVICE COMPONENT: G04088: MEMBRANE. THE INVESTIGATION HAS BEEN COMPLETED. IN THE ABSENCE OF ADDITIONAL INFORMATION OR MEDICAL RECORDS FROM THE COMPLAINANT, THIS EVENT FILE WILL BE CLOSED WITH THE INFORMATION PROVIDED. PREVIOUS PATIENT CODES (1930, 1695, 2068, 3191: APPROPRIATE TERM/CODE NOT AVAILABLE FOR "MESH CONTRACTED ("BUNCHED UP)"; "ENTWINED WITH AND ERODED INTO THE BOWEL, BECOMING CHRONICALLY INFECTED"; "MESH SIGNIFICANTLY SCARRED"; "SEPTIC SHOCK POST-OPERATIVELY"] WERE REPORTED BASED ON THE ORIGINAL COMPLAINT AND ARE NO LONGER APPLICABLE AND/OR NOT REPORTABLE PER GORE¿S INVESTIGATION. MEDICAL RECORDS: ¿ THE KNOWN MEDICAL RECORDS SPAN (B)(6) 2009 THROUGH (B)(6) 2015 AND NOT ALL RECORDS RECEIVED IN THIS TIME SPAN ARE RELEVANT TO THE GORE® DUALMESH® BIOMATERIAL. ¿ MEDICAL RECORDS FROM (B)(6) 2009 THROUGH (B)(6) 2015 WERE NOT PROVIDED. PATIENT INFORMATION: MEDICAL HISTORY: ¿ OBESITY - (B)(6) 2009: 175 LBS., BMI 32.7 ¿ TYPE II DIABETES MELLITUS SURGICAL PROCEDURES: ¿ UNKNOWN DATE: HYSTERECTOMY WITH BILATERAL SALPINGO OOPHORECTOMY ¿ UNKNOWN DATE: EXPLORATORY LAPAROTOMY ¿FOR PRESUMED SMALL BOWEL OBSTRUCTION¿ ¿ UNKNOWN DATE: LAPAROSCOPIC CHOLECYSTECTOMY ¿ 1991: HERNIA REPAIR ¿ (B)(6) 2009: LAPAROSCOPIC REPAIR OF RECURRENT INCARCERATED INCISIONAL HERNIA. IMPLANT: GORE® DUALMESH® BIOMATERIAL. ¿ (B)(6) 2015: EXPLORATORY LAPAROSCOPY, LAPAROSCOPIC EXTENSIVE LYSIS OF ADHESIONS, LAPAROSCOPIC ASSISTED SMALL BOWEL RESECTION, LAPAROSCOPIC EXCISION OF INFECTED MESH IMPLANT PREOPERATIVE COMPLAINTS: ¿ (B)(6) 2009: HISTORY AND PHYSICAL. ¿EXPLORATORY LAP FOR PRESUMED SMALL BOWEL OBSTRUCTION, BUT FOUND TO HAVE HERNIA, WHICH WAS REPAIRED, NOW ENLARGING RECURRENT HERNIA.¿ ¿SINCE 2005 WITH INCREASED PAIN, INTERMITTENT NAUSEA AND VOMITING.¿ ¿ (B)(6) 2009: OFFICE NOTES. ¿CHIEF COMPLAINT: VENTRAL HERNIA.¿ ¿ (B)(6) 2009: ¿... SHE HAS UNDERGONE PREVIOUS HYSTERECTOMY, EXPLORATORY LAPAROTOMY AND LAPAROSCOPIC CHOLECYSTECTOMY. SHE HAS DEVELOPED RECURRENT INCISIONAL HERNIA UNDER HER MIDLINE INCISION AND A CT SCAN WHICH SHE COORDINATED DOCUMENTS WELL THAT SHE HAS SEVERAL DEFECTS, ONE OF WHICH ALLOWS BOWEL TO RESIDE IN HER SUBCUTANEOUS SPACE TO THE RIGHT OF HER MIDLINE. ON EXAM THIS IS A PALPABLE AND NONREDUCIBLE HERNIA WHICH IS MILDLY TENDER FROM PRESSURE. SHE DOES OCCASIONALLY HAVE SOME MILD OBSTRUCTIVE SYMPTOMS, AND BELIEVES THE BULGE AND THE SYMPTOMS ARE BECOMING MORE PROMINENT IN RECENT MONTHS. SHE HAS NO FRANK EVIDENCE OF BOWEL OBSTRUCTION AT THIS POINT. I HAD A GOOD DISCUSSION WITH THE PATIENT AND HER FAMILY TODAY REGARDING HERNIA REPAIR. WE DISCUSSED THE PROS AND CONS OF VARIOUS APPROACHES. SHE HAS DECIDED TO PROCEED WITH A LAPAROSCOPIC REPAIR. WE MAY CONVERT TO AN OPEN PROCEDURE IF THE BOWEL INCARCERATION IS TOO DIFFICULT TO SAFELY DEAL WITH LAPAROSCOPICALLY. SHE WILL BE SCHEDULED FOR THIS IN THE NEXT FEW WEEKS.¿ IMPLANT PROCEDURE: LAPAROSCOPIC REPAIR OF RECURRENT INCARCERATED INCISIONAL HERNIA. [IMPLANT: GORE® DUALMESH® BIOMATERIAL 1DLMC06/05960133, 18CM X 24CM X 1MM THICK] IMPLANT DATE: (B)(6) 2009 [HOSPITALIZATION DATES:(B)(6) 2009] ¿ WOUND CLASSIFICATION: NOT PROVIDED. ¿ DESCRIPTION OF HERNIA BEING TREATED: ¿A LEFT UPPER QUADRANT VERESS NEEDLE WAS PLACED IN THE USUAL MANNER AND ABDOMINAL INSUFFLATION WAS ACHIEVED TO 15 MMHG. ONCE THIS WAS ACCOMPLISHED, A 12 MM TROCAR WAS PLACED IN THE RIGHT UPPER QUADRANT UNDER CAMERA GUIDANCE. WE INSPECTED THE ABDOMEN AND FOUND NO EVIDENCE OF IATROGENIC INJURY SECONDARY TO VERESS NEEDLE PLACEMENT. TWO ADDITIONAL RIGHT SIDED 5 MM TROCARS WERE PLACED UNDER CAMERA GUIDANCE AS WELL AS TWO LEFT SIDED TROCARS. THERE WAS A LARGE AMOUNT OF OMENTAL ADHESIONS TO THE ANTERIOR ABDOMINAL WALL. WE ALSO NOTED THAT THE LEFT LATERAL SEGMENT OF THE LIVER WAS STUCK TO THE ANTERIOR ABDOMINAL WALL. SHARP DISSECTION AS WELL AS A MINIMAL AMOUNT OF ELECTROCAUTERY WAS USED TO DISSECT THE LATERAL SEGMENT OF THE LIVER FROM THE ANTERIOR ABDOMINAL WALL. ONCE THIS WAS DONE, WE NOTED A VERY SMALL BILE LEAK FROM THE LIVER EDGE. WE PLACED CLIPS TO ACHIEVE CONTROL OF BILE LEAKAGE DRAINAGE. WE NEXT BEGAN METICULOUS LYSIS OF ADHESIONS USING SHARP DISSECTION WITH MINIMUM AMOUNTS OF ELECTROCAUTERY TO OBTAIN HEMOSTASIS. GREATER THAN THREE HOURS WERE SPENT TAKING DOWN NUMEROUS OMENTAL ADHESIONS TO THE ABDOMINAL WALL. THE ANTERIOR ABDOMINAL WALL RESEMBLED SWISS CHEESE WITH RESPECT TO THE NUMBER OF SMALL AND LARGE DEFECTS. EACH OF THESE DEFECTS CONTAINED OMENTUM THAT WERE EACH SYSTEMICALLY REDUCED. THERE WAS NO EVIDENCE OF BOWEL WITHIN THESE HERNIAS. THE LARGEST WAS IN THE RIGHT LOWER QUADRANT. ONCE ALL ADHESIONS WERE TAKEN DOWN, WE CONFIRMED NO EVIDENCE OF BOWEL INJURY.¿ ¿ IMPLANT SIZE AND FIXATION: ¿NEXT, WE MEASURED THE DEFECT SIZE WITH APPROPRIATE SURROUNDING MARGINS. A 24 X 18 CM PIECE OF GORE-TEX DUAL MESH WAS CHOSEN. THE MESH WAS PREPARED ON THE BACK TABLE PLACING FOUR GORE SUTURES ON THE INFERIOR, SUPERIOR, AND LATERAL ASPECT OF THE MESH. THE MESH WAS SUBSEQUENTLY PLACED WITHIN THE ABDOMEN. ONCE THE MESH WAS UNROLLED AND ORIENTED PROPERLY, THE PREVIOUSLY PLACED GORE SUTURES WERE BROUGHT OUT IN A TRANSFASCIAL MANNER IN THEIR RESPECTIVE ORIENTATION USING GORE SUTURE PASSING DEVICE. THE MESH WAS INSPECTED AND FOUND TO BE UNDER THE APPROPRIATE AMOUNT OF TENSION. WE NEXT SECURED THE MESH CIRCUMFERENTIALLY AROUND THE DEFECTS USING A PROTACK DEVICE. THE STAPLES WERE THEN PLACED IN 1 CM INTERVALS CIRCUMFERENTIALLY. AT THIS POINT, WE PLACED FOUR ADDITIONAL GORE SUTURES IN A TRANSFASCIAL MANNER TO SECURE THE MESH TO ANTERIOR ABDOMINAL WALL. ONCE THIS WAS COMPLETED, THE MESH WAS INSPECTED AND FOUND TO BE IN GOOD POSITION. EACH OF TROCARS WERE REMOVED AND ABDOMINAL INSUFFLATION WAS RELEASED. THE SKIN AT THE TROCAR SITES WERE CLOSED USING 4-0 MONOCRYL SUBCUTICULAR SUTURES.¿ ¿ (B)(6) 2009: DISCHARGE INSTRUCTIONS: ¿NO STRENUOUS ACTIVITY 4 WEEKS. FOLLOW UP WITH SURGERY, DR. M. IN TWO WEEKS.¿ EXPLANT PREOPERATIVE COMPLAINTS: ¿ (B)(6) 2015: PREOPERATIVE DIAGNOSES: ¿CHRONIC ABDOMINAL WOUND INFECTION.¿ EXPLANT PROCEDURE: EXPLORATORY LAPAROSCOPY, LAPAROSCOPIC EXTENSIVE LYSIS OF ADHESIONS >2 HOURS, LAPAROSCOPIC ASSISTED SMALL BOWEL RESECTION, LAPAROSCOPIC EXCISION OF INFECTED MESH. EXPLANT DATE: (B)(6) 2015 [HOSPITALIZATION DATES: (B)(6) 2015 THROUGH (B)(6) 2015] ¿ WOUND CLASSIFICATION: NOT PROVIDED. ¿ FINDINGS: ¿LARGE PIECE OF CHRONICALLY INFECTED DUOMESH WITH LOOP OF SMALL BOWEL FISTULIZING TO THE WOUND WITH PENETRATING TACKS.¿ ¿ SENT TO PATHOLOGY.¿ ¿ PROCEDURE: ¿A 5 MM INCISION WAS MADE IN THE LUQ [LEFT UPPER QUADRANT] AND A VERESS NEEDLE INSERTED AND THE ABDOMEN WAS INSUFFLATED TO 18 MMHG AND REPLACED WITH 5 MM PORT. 2 ADDITIONAL 12 MM AND 5 MM PORTS WERE PLACED ALONG THE LEFT FLANK. IMMEDIATELY ENCOUNTERED DENSE OMENTAL ADHESIONS TO THE INFECTED MESH. EXTENSIVE LYSIS OF ADHESIONS AS PERFORMED FOR GREATER THAN 2 HOURS. WE ALSO ENCOUNTERED A LOOP OF SMALL BOWEL THAT WAS INCARCERATED INTO THE PREVIOUS HERNIA SAC/HEMATOMA WITH MULTIPLE SPIRAL TITANIUM TACKS ERODING THROUGH THE BOWEL. THE SMALL BOWEL WAS SHARPLY DISSECTED AWAY FROM THE MESH AND SURROUNDING OMENTUM. MULTIPLE SEROSAL INJURIES WERE NOTED ALONG INCARCERATED SEGMENTS OF THE SMALL BOWEL. A 3-0 VICRYL MARKING SUTURE WAS PLACED AT THE MIDPOINT OF THE INJURED BOWEL. THE DUOMESH APPEARED TO BE BUNCHED UP AND ENTRAPPED IN THE HEMATOMA SAC. THE MESH WAS EXCISED ALONG WITH SURROUNDING TITANIUM SPIRAL TACKS. NEXT A 10 CM SUPRAUMBILICAL MIDLINE LAPAROTOMY INCISION WAS MADE THROUGH THE FASCIA GIVEN THE LARGE AMOUNT OF SCARRED MESH AND MORE MESH MATERIAL WAS IDENTIFIED AND EXTRACTED. OLD HEMATOMA MATERIAL WAS ALSO EXTRACTED. THE EXCISED MESH WAS THEN NEXT EXTRACTED THROUGH THE MINI-LAPAROTOMY INCISION. THE MARKED SEGMENT OF SMALL BOWEL WAS ALSO EXTERIORIZED. THE SEGMENT WAS DIVIDED PROXIMALLY AND DISTALLY WITH TAN 60 MM ENDOGIA STAPLER AND THE MESENTERY LIGATED AND DIVIDED WITH THE HARMONIC ULTRASONIC SHEAR. ONCE GOOD MESENTERIC ALIGNMENT WAS ACHIEVED, TWO ENTEROTOMIES WERE MADE AT THE DIVIDED ENDS AND A SIDE-BY-SIDE FUNCTIONAL ANASTOMOSIS WAS MADE USING ADDITIONAL LOAD OF THE 60 TAN ENDOGIA STAPLER. THE COMMON ENTEROTOMY WAS CLOSED WITH 2 LAYERS OF 3- PDS IN RUNNING FASHION AND THE MESENTERY DEFECT APPROXIMATED WITH 2-0 SILK. EXCELLENT ANASTOMOTIC PATENCY WAS PALPATED AND BOWEL RETURNED TO THE ABDOMEN. THE ABDOMEN WAS IRRIGATED WITH 3L OF WARM SALINE. THE FASCIAL DEFECT WAS CLOSED SECURED TO THE LLQ [LEFT LOWER QUADRANT] WITH 3-0 NYLON. THE ABDOMEN RE-INSUFFLATED AND THE 2 12 MM PORT SITES WERE CLOSED [SIC] WITH #1 PDS WITH THE CARTER-THOMPSON SUTURE PASSER. 30 ML OF BUPIVICAINE [SIC] WAS USED TO PERFORM A LEFT SIDED TAP NERVE BLOCK UNDER DIRECT LAPAROSCOPIC VISUALIZATION. LIQUEFIED SEPRAFILM WAS ALSO INJECTED INTO THE ABDOMINAL CAVITY. ALL PORTS WERE REMOVED AND FASCIAL DEFECTS CLOSED. SKIN WOUNDS WERE CLOSED [CLOSED] WITH 4-0 MONOCRYL AND DRESSED WITH SS AND TEGADERM.¿ ¿ PATHOLOGY REPORT FOR SPECIMENS REMOVED DURING THE 06/16/15 PROCEDURE WAS NOT PROVIDED. ¿ (B)(6) 2015: ¿PREOPERATIVE DIAGNOSIS. ¿SEPTIC SHOCK.¿ ¿ (B)(6) 2015: INDICATION. ¿NEED FOR HEMODYNAMIC MONITORING.: ¿ (B)(6) 2015: PROCEDURE PERFORMED. ¿PLACEMENT OF RIGHT RADIAL ARTERIAL LINE.¿ CONCLUSION: IT SHOULD BE NOTED THAT THE GORE® DUALMESH® BIOMATERIAL INSTRUCTIONS FOR USE INCLUDE WARNINGS AND ADDRESSES THE FOLLOWING ADVERSE REACTIONS AMONG OTHERS: ¿POSSIBLE ADVERSE REACTIONS WITH THE USE OF ANY TISSUE DEFICIENCY PROSTHESIS MAY INCLUDE, BUT ARE NOT LIMITED TO, CONTAMINATION, INFECTION, INFLAMMATION, ADHESION, FISTULA FORMATION, SEROMA FORMATION, HEMATOMA, AND RECURRENCE.¿ 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. MEDICAL RECORDS THAT INDICATE MESH ¿MOVEMENT¿ OR THAT THE DEVICE LOST ANCHORAGE MAY BE A FUNCTION OF A PATIENT¿S POOR TISSUE QUALITY LEADING TO FASCIAL DEHISCENCE OR LOSS OF ANCHORAGE OF FIXATION, OR MAY BE RELATED TO THE HERNIA TYPE, INDIVIDUAL PATIENT COMORBIDITIES, AND TECHNICAL AND PROCEDURAL ASPECTS OF THE REPAIR. THESE FACTORS INCLUDE BUT ARE NOT LIMITED TO, FIXATION TYPE, MESH SHAPE/SIZING USED, AND DEFECT CLOSURE DECISIONS. 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 SHRINKAGE, 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. THERE IS INSUFFICIENT INFORMATION AVAILABLE FOR GORE TO REASONABLY DRAW CONCLUSIONS RELATED TO ASPECTS OF THE EVENT, THEREFORE CONCLUSION CODE "D15: CAUSE NOT ESTABLISHED" IS BEING USED. INSUFFICIENT INFORMATION MAY INCLUDE LIMITED OR MISSING RELEVANT MEDICAL RECORDS, INVOLVEMENT OF MULTIPLE IMPLANTED DEVICES (INCLUDING NON-GORE DEVICES) IN THE FIELD OF TREATMENT, PATIENT NON-COMPLIANCE, AND/OR A GENERAL LACK OF AVAILABLE DETAIL OR SPECIFICITY RELATED TO AN ADVERSE EVENT AND/OR DEVICE. 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.
(B)(4). (B)(6). 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 LAPAROSCOPIC INCISIONAL HERNIA REPAIR ON (B)(6) 2009 WHEREBY A GORE® DUALMESH® BIOMATERIAL WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2015, AN ADDITIONAL PROCEDURE OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: INFECTION, REMOVAL OF MESH, MESH CONTRACTED ("BUNCHED UP"), ENTWINED WITH AND ERODED INTO THE BOWEL, BECOMING CHRONICALLY INFECTED. TWO HOURS WERE SPENT LYSING ADHESIONS AND REMOVING THE MESH. THE MESH WAS ALSO NOTED TO BE SIGNIFICANTLY ¿¿SCARRED.¿¿ TREATED FOR SEPTIC SHOCK POST-OPERATIVELY. REQUIRED ADDITIONAL SURGERY RELATED TO INFECTION ON OR ABOUT (B)(6) 2017. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 692686 | GORE DUALMESH® BIOMATERIAL | MESH, SURGICAL, POLYMERIC | FTL | W.L. GORE & ASSOCIATES | 1DLMC06 | 05960133 | 00733132600991 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 84 YR | Female | Hospitalization| R |