MESH SOFRADIM - PARIETEX¿ OPTIMIZED COMPOSITE MESH
Report
- Report Number
- 9615742-2017-05554
- Event Type
- Death
- Date Received
- October 17, 2017
- Report Date
- March 23, 2026
- Manufacturer
- SOFRADIM PRODUCTION SAS
- Product Code
- FTL
- UDI-DI
- 10884521179745
- PMA / PMN Number
- K173796
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- ATTORNEY
- Health Professional
- N
Narratives
ADDITIONAL INFORMATION: B5, D8, E1 (INITIAL REPORTER: FACILITY NAME, STREET 1, CITY, REGION, POSTAL CODE), H4, H6 (PATIENT, DEVICE, AND IMF CODES) MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.
ADDITIONAL INFORMATION: B5, B7, D4 (UDI #), G4 (510K #), H6 (DEVICE CODES). MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.
THE PATIENT¿S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF AN UMBILICAL HERNIA. IT WAS REPORTED THAT AFTER UNDERLAY IMPLANT, THE PATIENT EXPERIENCED UNINCORPORATED MESH, RETRACTION, ADHESIONS, RECURRENCE WITH INCARCERATION, BULGING, EMOTIONAL DISTRESS, AND PARTIAL SMALL BOWEL OBSTRUCTION. POST-OPERATIVE PATIENT TREATMENT INCLUDED LAPAROSCOPIC LYSIS OF ADHESIONS, REDUCTION OF INCARCERATED SMALL BOWEL, CT SCAN, AND LAPAROSCOPIC INTRACROP. IT HAS SINCE BEEN REPORTED THAT THE PATIENT HAD EXPIRED. INFORMATION REGARDING THE DATE AND CAUSE OF DEATH IS UNAVAILABLE.
THE PATIENT¿S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF AN UMBILICAL HERNIA. IT WAS REPORTED THAT AFTER UNDERLAY IMPLANT, THE PATIENT EXPERIENCED OBSTRUCTION, MESH MIGRATION, MESH SHRINKAGE, PAIN, SUFFERING, DEFECTIVE MESH, UNINCORPORATED MESH, RETRACTION, ADHESIONS, RECURRENCE WITH INCARCERATION, BULGING, EMOTIONAL DISTRESS, PARTIAL SMALL BOWEL OBSTRUCTION AND DEATH. POST-OPERATIVE PATIENT TREATMENT INCLUDED ABDOMINAL X-RAYS, MESH REVISION, HERNIA REPAIR WITH NEW MESH, LAPAROSCOPIC LYSIS OF ADHESIONS, REDUCTION OF INCARCERATED SMALL BOWEL, CT SCAN, AND LAPAROSCOPIC INTRACORP. INFORMATION RECEIVED INDICATES THE PATIENT IS DECEASED. NO INFORMATION WAS PROVIDED REGARDING THE CIRCUMSTANCES OF EXPIRATION.
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.
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.
(B)(4) - SURGICAL REVISION. 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 THERAPEUTIC TREATMENT OF A RECURRENT VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED UNINCORPORATED MESH, RETRACTION, ADHESIONS, RECURRENCE WITH IN CARCERATION, AND PARTIAL SMALL BOWEL OBSTRUCTION. POST-OPERATIVE PATIENT TREATMENT INCLUDED LAPAROSCOPIC LYSIS OF ADHESIONS, REDUCTION OF INCARCERATED SMALL BOWEL AND LAPAROSCOPIC INTERCROP. IT HAS SINCE BEEN REPORTED THAT THE PATIENT HAD EXPIRED. INFORMATION REGARDING THE DATE AND CAUSE OF DEATH IS UNAVAILABLE. IT IS UNKNOWN AT THIS TIME IF THE DEVICE CAUSED OR CONTRIBUTED TO THE EVENT.
THE PATIENT¿S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF AN UMBILICAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED UNINCORPORATED MESH, RETRACTION, ADHESIONS, RECURRENCE WITH INCARCERATION, AND PARTIAL SMALL BOWEL OBSTRUCTION. POST-OPERATIVE PATIENT TREATMENT INCLUDED LAPAROSCOPIC LYSIS OF ADHESIONS, REDUCTION OF INCARCERATED SMALL BOWEL AND LAPAROSCOPIC INTRACROP. IT HAS SINCE BEEN REPORTED THAT THE PATIENT HAD EXPIRED. INFORMATION REGARDING THE DATE AND CAUSE OF DEATH IS UNAVAILABLE.
THE PATIENT¿S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF AN UMBILICAL HERNIA. IT WAS REPORTED THAT AFTER UNDERLAY IMPLANT, THE PATIENT EXPERIENCED UNINCORPORATED MESH, RETRACTION, ADHESIONS, RECURRENCE WITH INCARCERATION, BULGING, AND PARTIAL SMALL BOWEL OBSTRUCTION. POST-OPERATIVE PATIENT TREATMENT INCLUDED LAPAROSCOPIC LYSIS OF ADHESIONS, REDUCTION OF INCARCERATED SMALL BOWEL AND LAPAROSCOPIC INTRACROP. IT HAS SINCE BEEN REPORTED THAT THE PATIENT HAD EXPIRED. INFORMATION REGARDING THE DATE AND CAUSE OF DEATH IS UNAVAILABLE.
THE PATIENT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE RESULTING IN AN UNSPECIFIED ADVERSE OUTCOME. PRODUCT WAS USED FOR THERAPEUTIC TREATMENT. THE PATIENT HAS HAD AN UNINCORPORATED MESH RETRACTED IN INFERIOR AND SUPERIOR ASPECT. THE MESH WAS COMPLETELY COVERED BY OMENTAL ADHESIONS. THE PATIENT HAD A SURGICAL REVISION APPROXIMATELY 1 YEAR AND 6 MONTHS POST OP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 48105 | MESH SOFRADIM - PARIETEX¿ OPTIMIZED COMPOSITE MESH | MESH, SURGICAL, POLYMERIC | FTL | SOFRADIM PRODUCTION SAS | PCO12X | PLI00548 | 10884521179745 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Male | Required Intervention| O| D |