FDA Adverse Event
Malfunction
Summary report: N
UNK-CV-SR
MDR report key: 13541101
·
Received February 16, 2022
Report
- Report Number
- 9612164-2022-00634
- Event Type
- Malfunction
- Date Received
- February 16, 2022
- Date of Event
- June 18, 2021
- Report Date
- February 16, 2022
- Manufacturer
- MEDTRONIC IRELAND
- Product Code
- MIH
- PMA / PMN Number
- P100021
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
MEDTRONIC RECEIVED THE FOLLOWING INFORMATION FROM A JOURNAL ARTICLE ENTITLED; LASER IN SITU FENESTRATION IN THORACIC ENDOVASCULAR AORTIC REPAIR: A SINGLE-CENTER ANALYSIS EVANS ET AL, ANN VASC SURG 2021; 76: 159¿167 HTTPS://DOI.ORG/10.1016/J.AVSG.2021.05.006 A2: MEAN AGE A3: MEAN GENDER D6A: EXACT DATE OF IMPLANT UNKNOWN. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 0
UNKNOWN MEDTRONIC STENT GRAFTS WERE IMPLANTED IN PATIENTS DURING THE ENDOVASCULAR TEVAR WITH LASER IN SITU FENESTRATION (LISF) ON UNKNOWN DATES. NON MDT STENT GRAFTS WERE ALSO IMPLANTED. THE FOLLOWING ADVERSE EVENTS WERE REPORTED: TYPE III ENDOLEAKS. THE CAUSE OF THE ENDOLEAKS ARE UNDETERMINED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 8755 | UNK-CV-SR | SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TR | MIH | MEDTRONIC IRELAND | UNK-CV-SR |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR | Male |