FDA Adverse Event
Malfunction
Summary report: N
ENDURANT
MDR report key: 4251196
·
Received November 14, 2014
Report
- Report Number
- 2953200-2014-02404
- Event Type
- Malfunction
- Date Received
- November 14, 2014
- Date of Event
- October 3, 2014
- Report Date
- October 22, 2014
- Manufacturer
- MEDTRONIC IRELAND
- Product Code
- MIH
- PMA / PMN Number
- P100021
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PO
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 55 MM DIAMETER ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT RECENT IMAGING ON A CT WITH CONTRAST SHOWED THERE WAS AN UNKNOWN TYPE OF ENDOLEAK AND THE ANEURYSM WAS 49 MM IN DIAMETER. THE ENDOLEAK WAS LEFT UNCORRECTED. NO FURTHER INFORMATION WAS PROVIDED. NO CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 736165 | ENDURANT | SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | MIH | MEDTRONIC IRELAND | V00495366 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00071 YR |