SYMBOTEX
Report
- Report Number
- 9615742-2024-00811
- Event Type
- Death
- Date Received
- June 7, 2024
- Date of Event
- May 10, 2024
- Report Date
- June 27, 2024
- Manufacturer
- SOFRADIM PRODUCTION SAS
- Product Code
- FTL
- UDI-DI
- 10884521190511
- PMA / PMN Number
- K142908
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
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 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.
ACCORDING TO THE REPORTER, DURING AN OPEN VENTRAL HERNIA PROCEDURE ON A PATIENT DUE TO HERNIA INCARCERATION, MECHANICAL ILEUS, AND VISCERAL ATTACHMENTS AS RESULT OF PREVIOUS MEDICAL CONDITION, A MESH WAS USED IN IDEAL CONDITION USING THE INLAY TECHNIQUE AND WAS FIXATED BY SUTURES. HOWEVER, THREE MONTHS LATER, THE PATIENT CAME TO THE HOSPITAL WITH HYPERTENSION, HEART FIBRILLATION, AND WITH CLINICAL PICTURE OF ACUTE ABDOMEN. THE PATIENT HAD TISSUE DAMAGE DUE TO INTESTINAL PERFORATION. THE SURGEON PERFORMED EXTIRPATION OF PARTS OF THE MESH, RESECTION OF SMALL INTESTINES, ILEOSTOMY WITH TERMINAL ILEOFISTULA, AND DRAINAGE. THE PATIENT DIED A DAY AFTER THE PROCEDURE.
ACCORDING TO THE REPORTER, DURING AN OPEN VENTRAL HERNIA PROCEDURE ON A PATIENT DUE TO HERNIA INCARCERATION, MECHANICAL ILEUS, AND VISCERAL ATTACHMENTS AS RESULT OF PREVIOUS MEDICAL CONDITION, A MESH WAS USED IN IDEAL CONDITION USING THE INLAY TECHNIQUE AND WAS FIXATED BY SUTURES. HOWEVER, THREE MONTHS LATER, THE PATIENT CAME TO THE HOSPITAL WITH HYPERTENSION, HEART FIBRILLATION, AND WITH CLINICAL PICTURE OF ACUTE ABDOMEN. THE PATIENT HAD TISSUE DAMAGE DUE TO INTESTINAL PERFORATION. THE SURGEON PERFORMED EXTIRPATION OF PARTS OF THE MESH, RESECTION OF SMALL INTESTINES, ILEOSTOMY WITH TERMINAL ILEOFISTULA, AND DRAINAGE. THE REACTION BETWEEN THE MESH AND THE BOWEL THAT THE MESH HAD BEEN ADHERENT TO, HAVE CAUSED THE NECROSIS OF THE BOWEL AND THE PERFORATION OF THE BOWEL. DURING THE SURGERY, THE MESH WAS EXCISED, AND IT WAS NOT PRESERVED. THE PATIENT WAS ADMITTED TO THE INTENSIVE CARE UNIT POST-OPERATIVE. IN THE INTENSIVE CARE UNIT, THE PATIENT WAS ON MECHANICAL VENTILATION AND INOTROPIC SUPPORT WITH OTHER MEDICATIONS AND INFUSIONAL REHYDRATION METHODS. THE PATIENT DIED THE FOLLOWING DAY DUE TO ENDOGENOUS INTOXICATION CAUSED BY PERFORATION OF THE BOWEL AND PERITONITIS AND SUBSEQUENT SEPSIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1310267 | SYMBOTEX | MESH, SURGICAL, POLYMERIC | FTL | SOFRADIM PRODUCTION SAS | SYM3020 | PWI1459X | 10884521190511 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Female | Hospitalization| D| R |