FDA Adverse Event
Injury
Summary report: N
ENDURANT II
MDR report key: 3874597
·
Received June 16, 2014
Report
- Report Number
- 2953200-2014-01196
- Event Type
- Injury
- Date Received
- June 16, 2014
- Date of Event
- May 1, 2014
- Report Date
- May 22, 2014
- Manufacturer
- MEDTRONIC IRELAND
- Product Code
- MIH
- PMA / PMN Number
- P100021
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. VESSEL MORPHOLOGY IS UNKNOWN. IT WAS REPORTED THAT APPROXIMATELY THREE WEEKS POST-OP, A LIMB OCCLUSION WAS SEEN. A FEM-FEM BYPASS WAS PERFORMED TO RESOLVE THE OCCLUSION. ONE OF THE HYPOGASTRIC ARTERIES WAS ALSO INTENTIONALLY COVERED DURING THE PROCEDURE. THE PHYSICIAN DOES NOT HAVE AN OPINION AS TO THE CAUSE OF THE OCCLUSION. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 352043 | ENDURANT II | SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | MIH | MEDTRONIC IRELAND | V04181297 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00072 YR | Required Intervention |