FDA Adverse Event
Malfunction
Summary report: N
ENDURANT STENT GRAFT
MDR report key: 10592660
·
Received September 28, 2020
Report
- Report Number
- 9612164-2020-03654
- Event Type
- Malfunction
- Date Received
- September 28, 2020
- Date of Event
- March 20, 2020
- Report Date
- September 28, 2020
- Manufacturer
- MEDTRONIC IRELAND
- Product Code
- MIH
- PMA / PMN Number
- P100021
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
MEDTRONIC RECEIVED THE FOLLOWING INFORMATION OBTAINED FROM THE JOURNAL ARTICLE ENTITLED: PARTIAL ENDOGRAFT REMOVAL PRESERVES THE AORTIC WALLS DURING DELAYED OPEN CONVERSIONS OF ENDOVASCULAR AORTIC REPAIR MARONE ET AL, ANN VASC SURG 2020; 67: 546¿552 HTTPS://DOI.ORG/10.1016/J.AVSG.2020.02.024 A2: MEAN AGE A3: MEAN GENDER D6: EXACT DATE OF IMPLANT: UNKNOWN. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
ENDURANT STENT GRAFT SYSTEMS WERE IMPLANTED IN PATIENTS DURING UNKNOWN EVAR PROCEDURES ON UNKNOWN DATES. THE FOLLOWING ADVERSE EVENTS WERE REPORTED: TYPE IA AND IB ENDOLEAKS. THE CAUSE OF THE EVENTS ARE UNDETERMINED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1057303 | ENDURANT STENT GRAFT | SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | MIH | MEDTRONIC IRELAND | UNK-CV-SR-ENDURANT |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 73 YR | Required Intervention |