FDA Adverse Event
Malfunction
Summary report: N
ENDURANT STENT GRAFT
MDR report key: 9231557
·
Received October 24, 2019
Report
- Report Number
- 9612164-2019-04485
- Event Type
- Malfunction
- Date Received
- October 24, 2019
- Date of Event
- August 23, 2018
- Report Date
- October 24, 2019
- Manufacturer
- MEDTRONIC IRELAND
- Product Code
- MIH
- PMA / PMN Number
- P100021
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
MEDTRONIC RECEIVED THE FOLLOWING INFORMATION FROM THE JOURNAL ARTICLE ENTITLED; OUTCOMES OF SURGICAL EXPLANTATION OF INFECTED AORTIC GRAFTS AFTER ENDOVASCULAR AND OPEN ABDOMINAL ANEURYSM REPAIR. JOHANNES F. SCHAEFERS, GIUSEPPE PANUCCIO, BERND KASPRZAK, BENJAMIN HEINE, GIOVANNI B. TORSELLO, NANI OSAD AND MARCO V. USAI JOURNAL OF ENDOVASCULAR THERAPY 2019 57(1) HTTPS://DOI.ORG/10.1016/J.EJVS.2018.07.021. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
ENDURANT STENT GRAFTS WERE IMPLANTED IN PATIENT FOR ENDOVASCULAR ANEURYSM REPAIR AND WERE EXPLANTED DUE TO STENT GRAFT INFECTION. THE FOLLOWING EVENTS WERE REPORTED- MALFUNCTION: TYPE I ENDOLEAK STENT GRAFT PERFORATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1026441 | ENDURANT STENT GRAFT | SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | MIH | MEDTRONIC IRELAND |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |