SYMBOTEX
Report
- Report Number
- 9615742-2017-05781
- Event Type
- Death
- Date Received
- November 16, 2017
- Report Date
- April 5, 2023
- Manufacturer
- SOFRADIM PRODUCTION SAS
- Product Code
- FTL
- UDI-DI
- 10884521190450
- PMA / PMN Number
- K142908
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- 003
Narratives
ADDITIONAL INFORMATION: B2, B5, D8, E1 (FACILITY NAME, STREET 1, CITY, REGION, POSTAL CODE), G1 (MFR CONTACT FIRST NAME, LAST NAME, STREET 1, MFR CITY, REGION, POSTAL CODE, EMAIL, PHONE NUMBER), G3, G4 (510K). MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE 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 FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT.
ADDITIONAL INFO: H6 (PATIENT CODES, IME E2402: ABNORMAL LEVELS OF CREATININE; ALBUMIN; WHITE BLOOD CELL COUNT; ANION GAP; HEMOGLOBIN; HEMATOCRIT, NODE, LEUKOCYTOSIS, GAS COLLECTION, CYSTITIS, LOSS OF DOMAIN, HYPONATREMIA, PRERENAL AZOTEMIA, MALNUTRITION, HAUSTRA). MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE 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 FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
THE PATIENT¿S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR LAPAROSCOPIC THERAPEUTIC TREATMENT OF A VENTRAL INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED SEVERE PAIN, RECURRENT HERNIA DEFECTS, ADHESIONS, ABDOMINAL WALL ABSCESS, SCAR, MESH EROSION INTO SMALL BOWEL, INFECTION, BECAME SEPTIC, SCAR TISSUE, MENTAL PAIN, PERMANENT IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, DEFECTIVE MESH, INFLAMMATION AND MESH MIGRATION. POST-OPERATIVE PATIENT TREATMENT INCLUDED LYSIS OF ADHESIONS, EXCISION OF SCAR, WOUND CARE WITH WOUND VAC, EMERGENCY SURGERY, HOSPITAL READMISSION, MESH INTERVENTION SURGERY AND RECURRENCE REPAIR.
THE PATIENT¿S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR LAPAROSCOPIC THERAPEUTIC TREATMENT OF A VENTRAL INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED SEVERE PAIN, RECURRENT HERNIA DEFECTS, ADHESIONS, ABDOMINAL WALL ABSCESS, SCAR, MESH EROSION INTO SMALL BOWEL, INFECTION, BECAME SEPTIC, SCAR TISSUE, MENTAL PAIN, PERMANENT IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, DEFECTIVE MESH, INFLAMMATION, MESH MIGRATION, BACTERIAL INFECTION, ABNORMAL LEVELS OF BUN; CREATININE; CALCIUM; ALBUMIN; CO2; SODIUM; MAGNESIUM; WHITE BLOOD CELL COUNT; CHLORIDE; ANION GAP; HEMOGLOBIN; HEMATOCRIT, FLUID COLLECTION, GAS COLLECTION, DISTENDED SMALL BOWEL LOOP, FISTULA, OPEN WOUND, DEHISCENCE, PLEURAL EFFUSIONS, CYSTITIS, LOSS OF DOMAIN, SWOLLEN/TIGHTENING BELLY, FEVER, HYPOTENSIVE, TENDERNESS, HYPOTENSION, TACHYCARDIA, ACUTE RENAL FAILURE SYNDROME, HYPONATREMIA, DEHYDRATION, ACUTE KIDNEY INJURY, TUBULAR NECROSIS, PRERENAL AZOTEMIA, ABDOMINAL PAIN, LEUKOCYTOSIS, DRAINAGE, NODE NEXT TO WOUND, WOUND INFECTION, LOW BLOOD PRESSURE, MALNUTRITION, ANEMIA, NON-HEALING WOUND, HAUSTRA, ABDOMINAL SORENESS, CARDIOMYOPATHY, DUODENAL PERFORATION, & DEATH. POST-OPERATIVE PATIENT TREATMENT INCLUDED LYSIS OF ADHESIONS, EXCISION OF SCAR, WOUND CARE WITH WOUND VAC, EMERGENCY SURGERY, HOSPITAL READMISSION, MESH INTERVENTION SURGERY, RECURRENCE REPAIR, CT SCAN, ICU, FLUID BOLUS, IV FLUIDS, IV ANTIBIOTICS, EVACUATION OF ABDOMINAL WALL ABSCESS, REPAIR OF SMALL BOWEL, REMOVAL OF MESH, HERNIA REPAIR WITH BIOLOGICAL MESH, VASOPRESSOR SUPPORT, CENTRAL LINE PLACEMENT, ELECTROLYTE REPLETION, PAIN MEDICATION, PICC LINE PLACEMENT, USE OF ABDOMINAL BINDER, ABDOMINAL WALL REC ONSTRUCTION, COMPONENT SEPARATION, HERNIA REPAIR WITH XENMATRIX MESH, EXPLORATORY LAPAROTOMY, REMOVAL OF HERNIA SAC, PAIN MANAGEMENT, NG TUBE, & JP DRAIN PLACEMENT. INFORMATION RECEIVED INDICATES THE PATIENT IS NOW DECEASED, DUE TO CARDIOMYOPATHY.
(B)(4). A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
THIS INFORMATION WAS RECEIVED AS A PART OF AN EXTENSIVE MESH LITIGATION SUBMISSION TO MEDTRONIC. THE FDA WAS NOTIFIED OF THIS LARGE COMPLAINT RECEIPT. DUE TO THE VOLUME OF COMPLAINT INFORMATION RECEIVED BY MEDTRONIC, THIS RESULTED IN A REPORT BEYOND THE 30 DAY TARGET. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
THIS INFORMATION WAS RECEIVED AS A PART OF AN EXTENSIVE MESH LITIGATION SUBMISSION TO MEDTRONIC. THE FDA WAS NOTIFIED OF THIS LARGE COMPLAINT RECEIPT. DUE TO THE VOLUME OF COMPLAINT INFORMATION RECEIVED BY MEDTRONIC, THIS RESULTED IN A REPORT BEYOND THE 30 DAY TARGET. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
THE PATIENT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE RESULTING IN AN UNSPECIFIED ADVERSE OUTCOME. PRODUCT WAS USED FOR THERAPEUTIC TREATMENT. PRE-OPERATIVE DIAGNOSIS: VENTRAL INCISIONAL HERNIA. POST-OPERATIVE DIAGNOSIS: VENTRAL INCISIONAL HERNIA X 3. PROCEDURE: VENTRAL INCISIONAL HERNIA REPAIR, LAPAROSCOPIC ASSISTED WITH MESH. EVENTS: THE PATIENT HAD SURGICAL REVISIONS, PAIN, INFECTIONS, RECURRENCE, AND ABSCESS.
THE PATIENT¿S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR LAPAROSCOPIC THERAPEUTIC TREATMENT OF A VENTRAL INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED SEVERE PAIN, RECURRENT HERNIA DEFECTS, ADHESIONS, ABDOMINAL WALL ABSCESS, SCAR, MESH EROSION INTO SMALL BOWEL, INFECTION, BECAME SEPTIC, SCAR TISSUE, AND HOSPITAL READMISSION. POST-OPERATIVE PATIENT TREATMENT INCLUDED LYSIS OF ADHESIONS, EXCISION OF SCAR, WOUND CARE WITH WOUND VAC, EMERGENCY SURGERY AND RECURRENCE REPAIR.
THE PATIENT¿S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED SEVERE PAIN, RECURRENT HERNIA DEFECTS, ADHESIONS, ABDOMINAL WALL ABSCESS, MESH EROSION INTO SMALL BOWEL, MESH EXCISION, LOSS OF DOMAIN.
THE PATIENT¿S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR LAPAROSCOPIC THERAPEUTIC TREATMENT OF A VENTRAL INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED SEVERE PAIN, RECURRENT HERNIA DEFECTS, ADHESIONS, ABDOMINAL WALL ABSCESS, SCAR, AND MESH EROSION INTO SMALL BOWEL. POST-OPERATIVE PATIENT TREATMENT INCLUDED LYSIS OF ADHESIONS, EXCISION OF SCAR, AND RECURRENCE REPAIR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 817886 | SYMBOTEX | MESH, SURGICAL, POLYMERIC | FTL | SOFRADIM PRODUCTION SAS | SYM2015 | POA0797X | 10884521190450 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR | Male | Hospitalization| R| O| S| D |