PARIETEX
Report
- Report Number
- 9615742-2017-05650
- Event Type
- Death
- Date Received
- November 7, 2017
- Report Date
- October 21, 2022
- Manufacturer
- SOFRADIM PRODUCTION SAS
- Product Code
- FTL
- PMA / PMN Number
- K110816
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- 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.
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 MESH EROSION, ADHESIONS, ABDOMINAL WALL ABSCESS WITH INFECTED MESH, DRAINING SINUS TRACT, SIGNIFICANT SCAR TISSUE, ADMITTED TO HOSPITAL FOR DEHYDRATION AND DEVELOPED CLOSTRIDIUM DIFFICILE COLITIS AND HEP A WHILE AT HOSPITAL, OPEN WOUND WITH DRAINAGE, BOWEL ERODED INTO THE MESH, FISTULA, ABSCESS OF ABDOMINAL WALL, ANASARCA, STAGE II SACRAL DECUBITUS ULCER, SEVERE SEPSIS WITH ACUTE ORGAN DYSFUNCTION, TOXIC ENCEPHALOPATHY, ABDOMINAL PAIN, PURULENT FOUL SMELLING DRAINAGE FROM WOUNDS, WOUND DEHISCENCE, SUBCUTANEOUS EDEMA IN THE BODY WALL, AREAS OF FLUID AND BUBBLES OF AIR, HERNIA, AND MESH MIGRATION. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, URGENT EXPLORATORY LAPAROTOMY, OPEN LYSIS OF EXTENSIVE ADHESIONS, SMALL BOWEL RESECTION, PRIMARY ANASTOMOSIS, REMOVAL OF THE ERODED MESH, EXPLORATION OF ABDOMINAL WALL WOUND, BOWEL REMOVAL, AND PLACEMENT OF VAC DRESSING. INFORMATION RECEIVED INDICATES THE PATIENT IS DECEASED. NO INFORMATION WAS PROVIDED REGARDING THE CIRCUMSTANCES OF EXPIRATION.
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 MESH EROSION, ADHESIONS, ABDOMINAL WALL ABSCESS WITH INFECTED MESH, DRAINING SINUS TRACT, SIGNIFICANT SCAR TISSUE, ADMITTED TO HOSPITAL FOR DEHYDRATION AND DEVELOPED CLOSTRIDIUM DIFFICILE COLITIS AND HEP A WHILE AT HOSPITAL, OPEN WOUND WITH DRAINAGE, BOWEL ERODED INTO THE MESH, FISTULA, ABSCESS OF ABDOMINAL WALL, ANASARCA, STAGE II SACRAL DECUBITUS ULCER, SEVERE SEPSIS WITH ACUTE ORGAN DYSFUNCTION, TOXIC ENCEPHALOPATHY, ABDOMINAL PAIN, PURULENT FOUL SMELLING DRAINAGE FROM WOUNDS, WOUND DEHISCENCE, SUBCUTANEOUS EDEMA IN THE BODY WALL, AREAS OF FLUID AND BUBBLES OF AIR, HERNIA, AND MESH MIGRATION. POST-OPERATIVE PATIENT TREATMENT INCLUDED HERNIA REPAIR WITH NEW MESH, WOUND CARE, ABDOMINAL WASHOUT, MEDICATION, CT SCAN, REVISION SURGERY, URGENT EXPLORATORY LAPAROTOMY, OPEN LYSIS OF EXTENSIVE ADHESIONS, SMALL BOWEL RESECTION, PRIMARY ANASTOMOSIS, REMOVAL OF THE ERODED MESH, EXPLORATION OF ABDOMINAL WALL WOUND, BOWEL REMOVAL, AND PLACEMENT OF VAC DRESSING. 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.
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.
THE PATIENT¿S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF VENTRAL INCISIONAL HERNIA. THE PROCEDURE PERFORMED WAS DIAGNOSTIC LAPAROSCOPY, LAPAROSCOPY CONVERTED TO OPEN VENTRAL INCISIONAL HERNIA REPAIR WITH MESH AND ELEVATION OF SUBCUTANEOUS TISSUE FLAPS. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT UNDERWENT A PROCEDURE FOR URGENT EXPLORATORY LAPAROTOMY, OPEN LYSIS OF EXTENSIVE ADHESIONS, SMALL BOWEL RESECTION, PRIMARY ANASTOMOSIS AND REMOVAL OF THE ERODED MESH. THE PATIENT ALSO UNDERWENT A SECOND PROCEDURE FOR EXPLORATION OF ABDOMINAL WALL WOUND AND PLACEMENT OF VAC DRESSING. THE PREOPERATIVE AND POSTOPERATIVE DIAGNOSIS WAS ABDOMINAL WALL ABSCESS WITH INFECTED MESH AT THE SITE OF HERNIA REPAIR. THE PATIENT HAS EXPERIENCED ADHESIONS, BOWEL REMOVAL, INFECTION, DRAINING SINUS TRACT, SIGNIFICANT SCAR TISSUE, ADMITTED TO HOSPITAL FOR DEHYDRATION AND DEVELOPED CLOSTRIDIUM DIFFICILE COLITIS AND (B)(6) WHILE AT HOSPITAL, OPEN WOUND WITH DRAINAGE, BOWEL ERODED INTO THE MESH, FISTULA, ABSCESS OF ABDOMINAL WALL, ANASARCA, STAGE II SACRAL DECUBITUS ULCER, SEVERE SEPSIS WITH ACUTE ORGAN DYSFUNCTION, TOXIC ENCEPHALOPATHY, ABDOMINAL PAIN, PURULENT FOUL SMELLING DRAINAGE FROM WOUNDS, WOUND DEHISCENCE, MESH REVISION AND REMOVAL.
THE PATIENT¿S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF VENTRAL INCISIONAL HERNIA. THE PROCEDURE PERFORMED WAS DIAGNOSTIC LAPAROSCOPY, LAPAROSCOPY CONVERTED TO OPEN VENTRAL INCISIONAL HERNIA REPAIR WITH MESH AND ELEVATION OF SUBCUTANEOUS TISSUE FLAPS. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT UNDERWENT A PROCEDURE FOR URGENT EXPLORATORY LAPAROTOMY, OPEN LYSIS OF EXTENSIVE ADHESIONS, SMALL BOWEL RESECTION, PRIMARY ANASTOMOSIS AND REMOVAL OF THE ERODED MESH. THE PATIENT ALSO UNDERWENT A SECOND PROCEDURE FOR EXPLORATION OF ABDOMINAL WALL WOUND AND PLACEMENT OF VAC DRESSING. THE PREOPERATIVE AND POSTOPERATIVE DIAGNOSIS WAS ABDOMINAL WALL ABSCESS WITH INFECTED MESH AT THE SITE OF HERNIA REPAIR. THE PATIENT HAS EXPERIENCED ADHESIONS, BOWEL REMOVAL, INFECTION, DRAINING SINUS TRACT, SIGNIFICANT SCAR TISSUE, ADMITTED TO HOSPITAL FOR DEHYDRATION AND DEVELOPED CLOSTRIDIUM DIFFICILE COLITIS AND (B)(6) WHILE AT HOSPITAL, OPEN WOUND WITH DRAINAGE, BOWEL ERODED INTO THE MESH, FISTULA, ABSCESS OF ABDOMINAL WALL, ANASARCA, STAGE II SACRAL DECUBITUS ULCER, SEVERE SEPSIS WITH ACUTE ORGAN DYSFUNCTION, TOXIC ENCEPHALOPATHY, ABDOMINAL PAIN, PURULENT FOUL SMELLING DRAINAGE FROM WOUNDS, WOUND DEHISCENCE, MESH REVISION AND REMOVAL. INFORMATION RECEIVED INDICATES THE PATIENT IS DECEASED. NO INFORMATION WAS PROVIDED REGARDING THE CIRCUMSTANCES OF EXPIRATION OR ANY ASSOCIATION WITH THIS DEVICE.
THE PATIENT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE RESULTING IN AN UNSPECIFIED ADVERSE OUTCOME. PRODUCT WAS USED FOR THERAPEUTIC TREATMENT. PREOPERATIVE AND POSTOPERATIVE DIAGNOSIS WAS VENTRAL INCISIONAL HERNIA. THE PROCEDURE PERFORMED WAS DIAGNOSTIC LAPAROSCOPY, LAPAROSCOPY CONVERTED TO OPEN VENTRAL INCISIONAL HERNIA REPAIR WITH MESH AND ELEVATION OF SUBCUTANEOUS TISSUE FLAPS. LAST YEAR- THE PATIENT UNDERWENT A PROCEDURE FOR URGENT EXPLORATORY LAPAROTOMY, OPEN LYSIS OF EXTENSIVE ADHESIONS, SMALL BOWEL RESECTION, PRIMARY ANASTOMOSIS AN REMOVAL OF THE ERODED MESH. LAST YEAR - THE PATIENT UNDERWENT A SECOND PROCEDURE FOR EXPLORATION OF ABDOMINAL WALL WOUND AND PLACEMENT OF VAC DRESSING. THE PREOPERATIVE AND POSTOPERATIVE DIAGNOSIS WAS ABDOMINAL WALL ABSCESS WITH INFECTED MESH AT THE SITE OF HERNIA REPAIR. THE PATIENT HAS HAD A ADDITIONAL SURGERY; ADHESIONS; BOWEL REMOVAL; INFECTION; MESH REMOVAL AND REVISION
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 787232 | PARIETEX | MESH, SURGICAL, POLYMERIC | FTL | SOFRADIM PRODUCTION SAS | PCO1510OSX | PNF0534 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 51 YR | Female | Required Intervention| O| D |