MESH SOFRADIM - PARIETEX¿ OPTIMIZED COMPOSITE MESH
Report
- Report Number
- 9615742-2019-01949
- Event Type
- Injury
- Date Received
- June 10, 2019
- Report Date
- January 9, 2025
- Manufacturer
- SOFRADIM PRODUCTION SAS
- Product Code
- FTL
- PMA / PMN Number
- K120506
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- 003
Narratives
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.
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.
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.
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 THERAPEUTIC TREATMENT OF A VENTRAL INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, BOWEL PERFORATION, BOWEL OBSTRUCTION, NERVE DAMAGE, FISTULA, ABSCESS, MESH MIGRATION, INFECTION, ADHESIONS, SEPSIS, ABDOMINAL PAIN, NAUSEA, VOMITING, HEMORRHAGIC FREE FLUID, HYPOTENSION, MURKY SEROUS FLUID, NECROTIC TISSUE, LOW GRADE FEVER, PURULENT DRAINAGE AND LEFT UPPER QUADRANT SEROMA WITH PURULENT FLUID. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, SMALL BOWEL RESECTION, MESH REMOVAL, PLACEMENT OF OPEN ABDOMINAL WOUND VAC AND REPAIR OF RECURRENT VENTRAL INCISIONAL HERNIA REPAIR WITH BARD XENMATRIX MESH.
THE PATIENT¿S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF A VENTRAL INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED FIBROADIPOSE TISSUE, LEUKOCYTOSIS, FOREIGN BODY GIANT CELLS, BACTERIAL INFECTION(KLEBSIELLA), PAIN, RECURRENCE, BOWEL PERFORATION, BOWEL OBSTRUCTION, NERVE DAMAGE, FISTULA, ABSCESS, MESH MIGRATION, INFECTION, ADHESIONS, SEPSIS, ABDOMINAL PAIN, NAUSEA, VOMITING, HEMORRHAGIC FREE FLUID, HYPOTENSION, MURKY SEROUS FLUID, NECROTIC TISSUE, LOW GRADE FEVER, PURULENT DRAINAGE AND LEFT UPPER QUADRANT SEROMA WITH PURULENT FLUID. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, SMALL BOWEL RESECTION, MESH REMOVAL, PLACEMENT OF OPEN ABDOMINAL WOUND VAC, REPAIR OF RECURRENT VENTRAL INCISIONAL HERNIA REPAIR WITH BARD XENMATRIX MESH, MEDICATION, CT-SCAN, AND REPLACEMENT LUQ DRAIN FOR ABDOMINAL ABSCESS. RELEVANT TESTS/LABORATORY DATA: (B)(6) 2016: LABORATORIES REVEALED LEUKOCYTOSIS AND LACTIC ACID > 5. CT SCAN SHOWED INCISIONAL HERNIA WITH SMALL BOWEL OBSTRUCTIVE CHANGES SUGGESTIVE OF PNEUMOPERITONEUM. (B)(6) 2016: PATHOLOGY REPORT FROM EXCISED MESH SPECIMEN SHOWED MESH IN FIBROVASCULAR AND FIBROADIPOSE TISSUE WITH PATCH OF CHRONIC INFLAMMATION INCLUDING FOREIGN BODY GIANT CELLS. (B)(6) 2017: THE OP NOTE STATED A CULTURE HAD SHOWN SCANT KLEBSIELLA. CT REVEALED POSTOPERATIVE SEROMA IN LEFT UPPER QUADRANT. (B)(6) 2017: PROCEDURE NOTE- CT IMAGING SHOWED MODERATE RECURRENCE AND ENLARGEMENT OF A LEFT UPPER QUADRANT SUBPHRENIC/PERISPLENIC ABSCESS WITH A SMALL CALIBER KINKED MALFUNCTIONING PIGTAIL DRAINAGE CATHETER IN PLACE.
THE PATIENT¿S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF A VENTRAL INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, BOWEL PERFORATION, BOWEL OBSTRUCTION, NERVE DAMAGE, FISTULA, ABSCESS, MESH MIGRATION, INFECTION, ADHESIONS, SEPSIS, ABDOMINAL PAIN, NAUSEA, VOMITING, HEMORRHAGIC FREE FLUID, HYPOTENSION, MURKY SEROUS FLUID, NECROTIC TISSUE, LOW GRADE FEVER, PURULENT DRAINAGE AND LEFT UPPER QUADRANT SEROMA WITH PURULENT FLUID. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, SMALL BOWEL RESECTION, MESH REMOVAL, PLACEMENT OF OPEN ABDOMINAL WOUND VAC, REPAIR OF RECURRENT VENTRAL INCISIONAL HERNIA REPAIR WITH BARD XENMATRIX MESH, AND REPLACEMENT LUQ DRAIN FOR ABDOMINAL ABSCESS.
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 VENTRAL INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, BOWEL PERFORATION, BOWEL OBSTRUCTION, INFECTION, ADHESIONS, SEPSIS, ABDOMINAL PAIN, NAUSEA, VOMITING, HEMORRHAGIC FREE FLUID, HYPOTENSION, MURKY SEROUS FLUID, NECROTIC TISSUE, LOW GRADE FEVER, PURULENT DRAINAGE AND LEFT UPPER QUADRANT SEROMA WITH PURULENT FLUID. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 478186 | MESH SOFRADIM - PARIETEX¿ OPTIMIZED COMPOSITE MESH | MESH, SURGICAL, POLYMERIC | FTL | SOFRADIM PRODUCTION SAS | PCO6VP | PQC0367 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Male | Required Intervention| L |