GORE DUALMESH PLUS BIOMATERIAL
Report
- Report Number
- 3003910212-2019-00154
- Event Type
- Injury
- Date Received
- May 30, 2019
- Report Date
- August 6, 2021
- Manufacturer
- W.L. GORE & ASSOCIATES
- Product Code
- FTL
- PMA / PMN Number
- K063435
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- 003
Narratives
H6: HEALTH EFFECT IMPACT CODE: F26: NO HEALTH CONSEQUENCES OR IMPACT. H6: MEDICAL DEVICE COMPONENT: G04088: MEMBRANE. 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. PREVIOUS PATIENT CODES (1695, 2240, 3191: USED FOR ¿MESH DETACHED¿) WERE REPORTED BASED ON THE ORIGINAL COMPLAINT AND ARE NO LONGER APPLICABLE PER GORE¿S INVESTIGATION. MEDICAL RECORDS: THE KNOWN MEDICAL RECORDS SPAN OCTOBER 12, 2009 THROUGH JANUARY 27, 2015 AND NOT ALL RECORDS RECEIVED IN THIS TIME SPAN ARE RELEVANT TO THE GORE® DUALMESH® PLUS BIOMATERIAL. THE MEDICAL RECORDS FROM MAY 18, 2011 THROUGH JANUARY 21, 2015 WERE NOT PROVIDED. PATIENT INFORMATION: MEDICAL HISTORY: DIABETES MELLITUS: (B)(6) 2010: METFORMIN, LEVEMIR, INSULIN OBESITY: (B)(6) 2009: 238 LBS., BMI 46.5. (B)(6) 2011: 256 LBS., BMI 50. GASTROESOPHAGEAL REFLUX DISEASE [GERD]. HYPERTENSION. PRIOR SURGICAL PROCEDURES: 1994: LOW-TRANSVERSE CESAREAN SECTION. 1998: LOW-TRANSVERSE CESAREAN SECTION. (B)(6) 2000: LOW-TRANSVERSE CESAREAN SECTION, BILATERAL TUBAL LIGATION. LAPAROSCOPIC REPAIR OF INCISIONAL HERNIA. IMPLANT: GORE® DUALMESH® PLUS BIOMATERIAL. LAPAROSCOPIC REPAIR OF RECURRENT INCARCERATED INCISIONAL HERNIA. IMPLANT: GORE® DUALMESH® PLUS BIOMATERIAL. IMPLANT #1 PREOPERATIVE COMPLAINTS: (B)(6) 2009: ¿HERE FOR DIABETES AND HYPERTENSION FOLLOW UP. OVERWEIGHT, VENTRAL HERNIA ABDOMEN. REFERRAL TO STRONG MEMORIAL HOSPITAL TO EVALUATE VENTRAL HERNIA.¿ IMPLANT #1 PROCEDURE: LAPAROSCOPIC REPAIR OF INCISIONAL HERNIA. [IMPLANT: GORE® DUALMESH® PLUS BIOMATERIAL, 1DLMCP04/ILLEGIBLE, 15CM X 19CM X 1MM THICK, OVAL). IMPLANT #1 DATE: (B)(6) 2010: DESCRIPTION OF HERNIA BEING TREATED: ¿ADHESIONS TO THE INCISIONAL HERNIA WERE TAKEN DOWN USING A HARMONIC SCALPEL. THE HERNIA DEFECT WAS AT THE UPPER ASPECT OF THE PREVIOUS LOWER MIDLINE INCISION.¿ IMPLANT SIZE AND FIXATION: ¿A PATCH OF GORE-TEX DUAL MESH PLUS WAS THEN CUT TO SIZE TO OVERLAP THE EDGES BY AT LEAST 3 CM. CORNER SUTURES WERE PLACED AND THE PATCH INSERTED INTO THE ABDOMINAL CAVITY. THE CORNER SUTURES WERE AFFIXED USING THE SUTURE PASSER DEVICE. THE PATCH WAS TACKED CIRCUMFERENTIALLY WITH THE SORBA-TACK [SIC] DEVICE. THE FENESTRATED SIDE OF THE PATCH FACED THE FASCIA. THE PATCH WAS INTACT, NOT UNDER TENSION, AND COVERED THE DEFECT COMPLETELY. EXCELLENT HEMOSTATIC WAS OBTAINED.¿ RELEVANT MEDICAL INFORMATION: (B)(6) 2011: ¿SMALL HERNIA JUST TO RIGHT OF UMBILICUS. REFER ...; RECURRENT UMBILICAL HERNIA.¿ IMPLANT #2 PREOPERATIVE COMPLAINTS: (B)(6) 2011: ¿BACK TODAY TO DISCUSS RECURRENT INCISIONAL HERNIA. CT SCAN IN FEBRUARY SHOWED RECURRENT INCISIONAL HERNIA AT INFERIOR ASPECT PREVIOUS PATCH PLACED 2010. OCCASIONALLY UNCOMFORTABLE BUT EATING AND MAINTAINING WEIGHT. ABDOMEN SOFT, NONTENDER AND NONDISTENDED. CAN FEEL BULGING AT INFERIOR ASPECT OF PREVIOUS PLACED PATCH. WOULD LIKE TO UNDERGO REPAIR.¿ IMPLANT #2 PROCEDURE: LAPAROSCOPIC REPAIR OF RECURRENT INCARCERATED INCISIONAL HERNIA. [IMPLANT: GORE® DUALMESH® PLUS BIOMATERIAL, 1DLMCP04/(B)(6), 15CM X 19CM, 1 MM THICK, OVAL) [NO ALLEGATIONS AGAINST THIS DEVICE]. IMPLANT #2 DATE: (B)(6) 2011: ¿THERE WAS INCARCERATED OMENTUM AND SMALL BOWEL IN A HERNIA WHERE THE PREVIOUSLY PLACED PATCH HAD DETACHED. USING CAREFUL SHARP DISSECTION AS WELL AS DISSECTION WITH THE HARMONIC SCALPEL THE ADHESIONS TO THE PREVIOUS PATCH WERE COMPLETELY FREED AND THE BOWEL AND HERNIA CONTENTS WERE COMPLETELY REDUCED. THERE WAS NO INJURY OR COMPROMISE TO THE BOWEL AT ANY TIME. A NEW PATCH OF GORE-TEX DUAL MESH PLUS WAS MEASURED TO COMPLETELY COVER THE OLD PATCH AND ALL DEFECTS AND OVERLAP ONTO THE CLEAN LATERAL ASPECTS OF THE ABDOMINAL WALL BY AT LEAST 3 CM. THE PATCH MEASURED 15 X 15 CM. CORNER SUTURES WERE PLACED AND THE PATCH WAS THEN PLACED INTO THE PERITONEAL CAVITY. THE CORNER SUTURES WERE AFFIXED THROUGH THE ABDOMINAL WALL WITH THE SUTURE PASSER. THE PATCH WAS THEN TACKED CIRCUMFERENTIALLY TO THE ANTERIOR ABDOMINAL WALL USING THE PRO-TACK DEVICE. THE PATCH WAS INTACT, NOT UNDER TENSION, AND COMPLETELY COVERED ALL DEFECTS AND THE OLD PATCH. EXCELLENT HEMOSTATIC WAS OBTAINED. THE AREA WAS IRRIGATED CLEAR. THE FENESTRATED SIDE OF THE PATCH WAS FACING THE FASCIA.¿ RELEVANT MEDICAL INFORMATION: (B)(6) 2015: ¿HISTORY OF 2X REPAIR OF INCISIONAL HERNIA, LAST TIME LAPAROSCOPICALLY IN (B)(6) 2011. HAS BEEN DOING WELL SINCE AND HAS INTENTIONALLY LOST 100LBS. HAS RECENTLY NOTICED ACTIVITY RELATED DISCOMFORT ON THE RIGHT SIDE OF THE PREVIOUS REPAIR. NO GI SYMPTOMS. NO FEELING OF POPPING OR SEEING AN OBVIOUS BULGE... WILL GET CT SCAN TO ELUCIDATE THE ANATOMY AND PROCEED FROM THAT POINT.¿ (B)(6) 2015: CT ABDOMEN: ¿INTACT ABDOMINAL WALL MESH. LARGE HETEROGENEOUS MASS SEEN CENTRALLY WITHIN PELVIS. LARGE HETEROGENEOUS PELVIC MASS LIKELY RELATED TO UTERUS. MAY REPRESENT MULTIPLE FIBROIDS. ANTERIOR ABDOMINAL WALL MESH IS AGAIN IDENTIFIED. APPEARS TO BE GROSSLY INTACT.¿ CONCLUSION: IMPLANT #1 GORE® DUALMESH® PLUS BIOMATERIAL (1DLMCP04/ILLEGIBLE). IMPLANT #2 GORE® DUALMESH® PLUS BIOMATERIAL (1DLMCP04/(B)(6)) (NO ALLEGATIONS). IT SHOULD BE NOTED THAT THE GORE® DUALMESH® PLUS BIOMATERIAL INSTRUCTIONS FOR USE INCLUDES WARNINGS AND ADDRESSES THE FOLLOWING ADVERSE REACTIONS AMONG OTHERS: ¿POSSIBLE ADVERSE REACTIONS WITH THE USE OF ANY TISSUE DEFICIENCY PROSTHESIS MAY INCLUDE, BUT ARE NOT LIMITED TO, CONTAMINATION, INFECTION, INFLAMMATION, ADHESION, FISTULA FORMATION, SEROMA FORMATION, HEMATOMA, AND RECURRENCE.¿ THE INSTRUCTIONS FOR USE FURTHER STATE: ¿STAPLES OR HELICAL TACKS (ALSO KNOWN AS HELICAL COILS) CAN BE USED AS AN ALTERNATIVE TO SUTURES. STAPLE SIZE AND STAPLE OR TACK SPACING SHOULD BE DETERMINED BY SURGEON PREFERENCE TO PROVIDE FOR ADEQUATE TISSUE FIXATION AND TO PREVENT REHERNIATION.¿ MEDICAL RECORDS THAT INDICATE MESH ¿MOVEMENT¿ OR THAT THE DEVICE LED TO A RECURRENCE MAY REFLECT A RECURRENCE AS 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. ADDITIONALLY, A NEW, UNRELATED HERNIA CAN OCCUR BUT MAY BE REFERRED TO AS A RECURRENT HERNIA. ALL FIXATION DEVICES SHOULD BE USED IN ACCORDANCE WITH THE MANUFACTURER¿S INSTRUCTIONS FOR USE. THE PHYSICIAN SHOULD REFERENCE THE MANUFACTURER¿S INSTRUCTIONS FOR USE AND ANY SUPPORTING CLINICAL LITERATURE REGARDING ANY POTENTIAL WARNINGS, PRECAUTIONS, AND ADVERSE EVENTS RELATED TO FIXATION DEVICES. 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. BASED UPON THE INFORMATION RECEIVED, THE DEVICE REMAINS IN THE PATIENT AND WAS NOT AVAILABLE FOR EVALUATION. AFTER MULTIPLE REQUESTS, SPECIFIC LOT NUMBER INFORMATION WAS NOT PROVIDED FOR THIS DEVICE, BUT PRODUCT TYPE HAS BEEN CONFIRMED. REVIEW OF THE MANUFACTURING AND STERILIZATION RECORDS COULD NOT BE PERFORMED AS A VALID LOT NUMBER WAS NOT PROVIDED. SECTION C1: NAME: PLUS ANTIMICROBIAL PRODUCT COATING. MANUFACTURER/COMPOUNDER: W. L. GORE & ASSOCIATES, INC. LOT NUMBER: UNK. 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.
D4: ADDED CATALOG #. H6: PRODUCT IDENTIFICATION RECORDS FOR THE ALLEGED GORE DEVICE WERE PROVIDED, HOWEVER, THEY ARE ILLEGIBLE, THEREFORE A REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE PERFORMED. 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: RECORDS PRIOR TO 1/5/2010 WERE NOT PROVIDED. (B)(6) 2010: (B)(6) HOSPITAL. (B)(6) MD; (B)(6) MD. OPERATIVE REPORT. PRE/POSTOP DIAGNOSIS: INCISIONAL HERNIA. OPERATIVE PROCEDURE: LAPAROSCOPIC REPAIR OF INCISIONAL HERNIA. DESCRIPTION OF PROCEDURE: ¿THE PATIENT WAS TAKEN TO THE OPERATING ROOM AND PLACED ON THE OR TABLE IN THE SUPINE POSITION. AFTER ADEQUATE GENERAL ANESTHESIA WAS OBTAINED, THE PATIENT WAS PREPPED AND DRAPED IN A STERILE FASHION. A 11MM INCISION WAS MADE IN THE LUQ AND THE ABDOMEN WAS INSUFFLATED TO A PRESSURE OF 15 MMHG USING THE VERESS NEEDLE. AN 11 MM TROCAR WAS PLACED UNDER DIRECT VISION WITHOUT INCIDENT. PLACEMENT WAS CORRECT AND WITHOUT INJURY. THREE ADDITIONAL 5 MM PORTS WERE PLACED ALL UNDER DIRECT VISION, TWO ON THE RIGHT AND ONE IN THE LLQ. ADHESIONS TO THE INCISIONAL HERNIA WERE TAKEN DOWN USING A HARMONIC SCALPEL. THE HERNIA DEFECT WAS AT THE UPPER ASPECT OF THE PREVIOUS LOWER MIDLINE INCISION. A PATCH OF GORE-TEX DUAL MESH PLUS WAS THEN CUT TO SIZE TO OVERLAP THE EDGES BY AT LEAST 3 CM. CORNER SUTURES WERE PLACED AND THE PATCH INSERTED INTO THE ABDOMINAL CAVITY. THE CORNER SUTURES WERE AFFIXED USING THE SUTURE PASSER DEVICE. THE PATCH WAS TACKED CIRCUMFERENTIALLY WITH THE SORBA-TACK DEVICE. THE FENESTRATED SIDE OF THE PATCH FACED THE FASCIA. THE PATCH WAS INTACT, NOT UNDER TENSION, AND COVERED THE DEFECT COMPLETELY. EXCELLENT HEMOSTATIC WAS OBTAINED. THE FASCIA WAS AT THE 11 MM TROCAR SITE WAS CLOSED WITH 0-VICRYL ON THE ENDO-CLOSE NEEDLE. ALL TROCARS WERE REMOVED UNDER DIRECT VISION AND THE ABDOMEN ALLOWED TO DESUFFLATE. THE SKIN WAS CLOSED USING A RUNNING SUBCUTICULAR SUTURE OF 4-0 MONOCRYL. STERILE DRESSINGS WERE THEN PLACED WITH DERMABOND. SPONGE AND NEEDLE COUNTS WERE CORRECT X 2. THERE WERE NO COMPLICATIONS. ESTIMATED BLOOD LOSS WAS MINIMAL. THE PATIENT WAS TAKEN TO THE PACU WITH VITAL SIGNS STABLE.¿ (B)(6) 2010: (B)(6) HOSPITAL. SURGICAL RECORD. IMPLANT RECORD. DESCRIPTION: MESH DUAL PLUS [ILLEGIBLE]. SITE: ABDOMEN. LOT NO.: ILLEGIBLE. CAT NO.: 1DLMCP04. MANUFACTURER: W.L. GORE AND ASSOCIATES. (B)(6) 2010: (B)(6) HOSPITAL. BILLING RECORD. MESH DUAL PLUS. 15 CM 19 CM. THE RECORDS CONFIRM A GORE® DUALMESH® PLUS BIOMATERIAL (1DLMCP04/LOT # ILLEGIBLE) WAS IMPLANTED DURING THE PROCEDURE. (B)(6) 2011: (B)(6) HOSPITAL. (B)(6) , MD; (B)(6) , MD, RES. OPERATIVE REPORT. PRE/POSTOP DIAGNOSIS: RECURRENT INCARCERATED INCISIONAL HERNIA. OPERATIVE PROCEDURE: LAPAROSCOPIC REPAIR OF RECURRENT INCARCERATED INCISIONAL HERNIA. DESCRIPTION OF PROCEDURE: ¿THE PATIENT WAS TAKEN TO THE OPERATING ROOM AND PLACED ON THE OR TABLE IN THE SUPINE POSITION. AFTER ADEQUATE GENERAL ANESTHESIA WAS OBTAINED, THE PATIENT WAS PREPPED AND DRAPED IN STERILE FASHION. USING THE DIRECT VISUALIZATION TECHNIQUE THE VISI-PORT WAS INSERTED IN THE LUQ WITHOUT INCIDENT. THE ABDOMEN WAS THEN INSUFFLATED TO A PRESSURE OF 15 MM HG AND THE 10 MM TELESCOPE PLACED INDICATING PROPER PLACEMENT AND LACK OF INJURY. THREE ADDITIONAL 5 MM TROCARS WERE PLACED, ALL UNDER DIRECT VISION; TWO ON THE RIGHT AND ONE IN THE LLQ. THERE WAS INCARCERATED OMENTUM AND SMALL BOWEL IN A HERNIA WHERE THE PREVIOUSLY PLACED PATCH HAD DETACHED. USING CAREFUL SHARP DISSECTION AS WELL AS DISSECTION WITH THE HARMONIC SCALPEL THE ADHESIONS TO THE PREVIOUS PATCH WERE COMPLETELY FREED AND THE BOWEL AND HERNIA CONTENTS WERE COMPLETELY REDUCED. THERE WAS NO INJURY OR COMPROMISE TO THE BOWEL AT ANY TIME. A NEW PATCH OF GORE-TEX DUAL MESH PLUS WAS MEASURED TO COMPLETELY COVER THE OLD PATCH AND ALL DEFECTS AND OVERLAP ONTO THE CLEAN LATERAL ASPECTS OF THE ABDOMINAL WALL BY AT LEAST 3 CM. THE PATCH MEASURED 15 X 15 CM. CORNER SUTURES WERE PLACED AND THE PATCH WAS THEN PLACED INTO THE PERITONEAL CAVITY. THE CORNER SUTURES WERE AFFIXED THROUGH THE ABDOMINAL WALL WITH THE SUTURE PASSER. THE PATCH WAS THEN TACKED CIRCUMFERENTIALLY TO THE ANTERIOR ABDOMINAL WALL USING THE PRO-TACK DEVICE. THE PATCH WAS INTACT, NOT UNDER TENSION, AND COMPLETELY COVERED ALL DEFECTS AND THE OLD PATCH. EXCELLENT HEMOSTATIC WAS OBTAINED. THE AREA WAS IRRIGATED CLEAR. THE FENESTRATED SIDE OF THE PATCH WAS FACING THE FASCIA. THE FASCIA AT THE 10MM TROCAR SITE WAS CLOSED WITH 0-VICRYL ON THE ENDOCLOSE NEEDLE. ALL TROCARS WERE REMOVED UNDER DIRECT VISION AND THE ABDOMEN WAS ALLOWED TO DESUFFLATE. THE SKIN WAS CLOSED USING A RUNNING SUBCUTICULAR SUTURE OF 4-0 MONOCRYL. STERILE DRESSINGS WERE PLACED WITH BENZOIN. SPONGE AND NEEDLE COUNTS WERE CORRECT X 2. THERE WAS NO COMPLICATIONS. ESTIMATED BLOOD LOSS WAS MINIMAL. THE PATIENT WAS THEN TAKEN TO THE PACU WITH VITAL SIGNS STABLE.¿ (B)(6) 2011: (B)(6) HOSPITAL. SURGICAL RECORD. IMPLANT RECORD. DESCRIPTION: MESH DUAL PLUS 15CM 19CM. SITE: ABDOMEN. LOT NO.: 8294899. CAT NO.: 1DLMCP04. MANUFACTURER: W.L. GORE AND ASSOCIATES. THE RECORDS CONFIRM A GORE® DUALMESH® PLUS BIOMATERIAL (B)(4) WAS IMPLANTED DURING THE PROCEDURE. THERE IS NO MENTION OF GORE DEVICE REMOVAL IN THE RECORDS. A POTENTIAL RELATIONSHIP, IF ANY, BETWEEN THE ALLEGED INJURIES OR COMPLICATIONS AND THE GORE DEVICE IS UNCLEAR FROM THE PROVIDED INFORMATION AT THIS TIME. IT SHOULD BE NOTED THAT THE GORE® DUALMESH® PLUS BIOMATERIAL INSTRUCTIONS FOR USE INCLUDES WARNINGS AND ADDRESSES THE FOLLOWING ADVERSE REACTIONS AMONG OTHERS: ¿POSSIBLE ADVERSE REACTIONS WITH THE USE OF ANY TISSUE DEFICIENCY PROSTHESIS MAY INCLUDE, BUT ARE NOT LIMITED TO, CONTAMINATION, INFECTION, INFLAMMATION, ADHESION, FISTULA FORMATION, SEROMA FORMATION, HEMATOMA, AND RECURRENCE.¿ W.L. GORE & ASSOCIATES, INC. (GORE) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY GORE, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. BLANK FIELDS PRESENT ON THIS REPORT INCLUDE REQUIRED FIELDS AND FIELDS DETERMINED TO BE NOT APPLICABLE. BLANK REQUIRED FIELDS INDICATE THAT THE INFORMATION WAS NOT PROVIDED, WAS DEEMED UNAVAILABLE OR WAS NOT APPLICABLE. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, GORE, OR ITS ASSOCIATES THAT THE DEVICE, GORE OR ITS ASSOCIATES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY "DEFECTS" OR HAS "MALFUNCTIONED". THESE WORDS ARE INCLUDED IN THE REPORT AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA, TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REPORTING PURSUANT TO PART 803. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT.
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: 10/12/09: (B)(6) MD. OFFICE NOTES. HERE FOR DIABETES AND HYPERTENSION FOLLOW UP. EXAM: WEIGHT 238 LBS, OVERWEIGHT, VENTRAL HERNIA ABDOMEN. REFERRAL TO STRONG MEMORIAL HOSPITAL TO EVALUATE VENTRAL HERNIA. 01/10/11: (B)(6), MD. OFFICE NOTES. NEEDS REFILLS BUT NEW PROBLEMS. MEDICAL HISTORY: GASTROESOPHAGEAL REFLUX DISEASE, CESAREAN SECTION/BILATERAL TUBAL LIGATION- CLASSICAL INCISION 06/00. MEDICATIONS: ASPIRIN, LEVEMIR, METFORMIN. WEIGHT 256 LBS, BMI 49.99. SMALL HERNIA JUST TO RIGHT OF UMBILICUS. REFER TO (B)(6); RECURRENT UMBILICAL HERNIA. A POTENTIAL RELATIONSHIP, IF ANY, BETWEEN THE ALLEGED INJURIES OR COMPLICATIONS AND THE GORE DEVICE HAS NOT BEEN ESTABLISHED AT THIS TIME BASED ON AVAILABLE INFORMATION. IT SHOULD BE NOTED THAT THE INSTRUCTIONS FOR GORE® DUALMESH® PLUS BIOMATERIAL USE INCLUDES WARNINGS AND ADDRESSES THE FOLLOWING ADVERSE REACTIONS AMONG OTHERS: ¿POSSIBLE ADVERSE REACTIONS WITH THE USE OF ANY TISSUE DEFICIENCY PROSTHESIS MAY INCLUDE, BUT ARE NOT LIMITED TO, CONTAMINATION, INFECTION, INFLAMMATION, ADHESION, FISTULA FORMATION, SEROMA FORMATION, HEMATOMA, AND RECURRENCE.¿ W.L. GORE & ASSOCIATES, INC. (GORE) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY GORE, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. BLANK FIELDS PRESENT ON THIS REPORT INCLUDE REQUIRED FIELDS AND FIELDS DETERMINED TO BE NOT APPLICABLE. BLANK REQUIRED FIELDS INDICATE THAT THE INFORMATION WAS NOT PROVIDED, WAS DEEMED UNAVAILABLE OR WAS NOT APPLICABLE. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, GORE, OR ITS ASSOCIATES THAT THE DEVICE, GORE OR ITS ASSOCIATES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY "DEFECTS" OR HAS "MALFUNCTIONED". THESE WORDS ARE INCLUDED IN THE REPORT AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA, TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REPORTING PURSUANT TO PART 803. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT.
ADDITIONAL DETAILS REGARDING THE PATIENT'S CLINICAL COURSE WERE ASCERTAINED FROM A REVIEW OF MEDICAL RECORDS AND ARE AS FOLLOWS: 02/??/2011: [MISSING RECORDS: RECORDS FOR THE CT SCAN SHOWING THE ¿RECURRENT INCISIONAL HERNIA AT INFERIOR ASPECT PREVIOUS PATCH¿ WERE NOT PROVIDED.] 04/21/11. (B)(6)CENTER. (B)(6) OFFICE NOTES. BACK TODAY TO DISCUSS RECURRENT INCISIONAL HERNIA. CT SCAN IN FEBRUARY SHOWED RECURRENT INCISIONAL HERNIA AT INFERIOR ASPECT PREVIOUS PATCH PLACED 2010. OCCASIONALLY UNCOMFORTABLE BUT EATING AND MAINTAINING WEIGHT. EXAM: ABDOMEN SOFT, NONTENDER AND NONDISTRESSED. CAN FEEL BULGING AT INFERIOR ASPECT OF PREVIOUS PLACED PATCH. WOULD LIKE TO UNDERGO REPAIR. TENTATIVELY SCHEDULED FOR (B)(6) 2011. 01/22/1205: (B)(6) CENTER. (B)(6) OFFICE NOTES. HISTORY 2X REPAIR INCISIONAL HERNIA. INTENTIONALLY LOST 100 LB. RECENTLY NOTICED ACTIVITY RELATED DISCOMFORT ON RIGHT SIDE OF PREVIOUS REPAIR. NO GI [GASTROINTESTINAL] SYMPTOMS. NO FEELING POPPING OR SEEING OBVIOUS BULGE. EXAM: CANNOT FEEL FASCIAL DEFECT OR RECURRENT HERNIA. VITAL SIGNS: WEIGHT 76.9 KG (169 LBS 9.6 OZ). PLAN: WILL GET CT SCAN TO ELUCIDATE ANATOMY AND PROCEED FROM THAT POINT. 01/27/2015: (B)(6). (B)(6) RADIOLOGY-CT ABDOMEN/PELVIS WITH CONTRAST. ORDERING CLINICAL INFORMATION: TWICE RECURRENT MID ABDOMINAL INCISIONAL HERNIA WITH RECURRENT DISCOMFORT. PLEASE EVALUATE ANATOMY FOR RECURRENCE. CT ABDOMEN FINDINGS: LOWER THORAX UNREMARKABLE. CT PELVIS FINDINGS: INTACT ABDOMINAL WALL MESH. LARGE HETEROGENEOUS MASS SEEN CENTRALLY WITHIN PELVIS. IMPRESSION: LARGE HETEROGENEOUS PELVIC MASS LIKELY RELATED TO UTERUS. MAY REPRESENT MULTIPLE FIBROIDS. ANTERIOR ABDOMINAL WALL MESH IS AGAIN IDENTIFIED. APPEARS TO BE GROSSLY INTACT. 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 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.
PRODUCT IDENTIFICATION RECORDS FOR THE ALLEGED GORE DEVICE WAS NOT PROVIDED. THEREFORE, A REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE PERFORMED. (B)(6). IT SHOULD BE NOTED THAT THE GORE® DUALMESH® PLUS BIOMATERIAL INSTRUCTIONS FOR USE INCLUDES WARNINGS AND ADDRESSES THE FOLLOWING ADVERSE REACTIONS AMONG OTHERS: ¿POSSIBLE ADVERSE REACTIONS WITH THE USE OF ANY TISSUE DEFICIENCY PROSTHESIS MAY INCLUDE, BUT ARE NOT LIMITED TO, CONTAMINATION, INFECTION, INFLAMMATION, ADHESION, FISTULA FORMATION, SEROMA FORMATION, HEMATOMA, AND RECURRENCE".
IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT LAPAROSCOPIC INCISIONAL HERNIA REPAIR ON (B)(6) 2010, WHEREBY A GORE® DUALMESH® PLUS BIOMATERIAL WAS IMPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: MESH DETACHED, ADHESIONS, ADDITIONAL SURGERY, RECURRENT INCARCERATED HERNIA. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 449137 | GORE DUALMESH PLUS BIOMATERIAL | MESH, SURGICAL, POLYMERIC | FTL | W.L. GORE & ASSOCIATES |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 35 YR | Hospitalization| R |