FDA Adverse Event
Malfunction
Summary report: N
ENDURANT
MDR report key: 4182535
·
Received October 17, 2014
Report
- Report Number
- 2953200-2014-02119
- Event Type
- Malfunction
- Date Received
- October 17, 2014
- Date of Event
- September 23, 2014
- Report Date
- September 23, 2014
- Manufacturer
- MEDTRONIC IRELAND
- Product Code
- MIH
- PMA / PMN Number
- P100021
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- 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 7.9 CM IN DIAMETER ABDOMINAL AORTIC ANEURYSM. VESSEL MORPHOLOGY WAS REPORTED AS THERE WERE UNDESIRABLE CHARACTERISTICS, THROMBOSIS, ANGULATION, 25 MM IN DIAMETER AT THE RENAL ARTERY AND 36 MM IN DIAMETER 18 MM BELOW THE RENAL ARTERY IN THE AORTIC NECK. IT WAS REPORTED THAT THERE WAS A PROXIMAL TYPE I ENDOLEAK PRESENT. THE AORTIC NECK WAS MODELLED WITH A BALLOON LIGHTLY BUT THE TYPE I ENDOLEAK WAS NOT RESOLVED. THE PHYSICIAN ELECTED TO MONITOR THE PATIENT. NO CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 661235 | ENDURANT | SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | MIH | MEDTRONIC IRELAND | V05899931 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00090 YR |