FDA Adverse Event
Injury
Summary report: N
ENDURANT ABDOMINAL STENT GRAFT
MDR report key: 2181396
·
Received July 21, 2011
Report
- Report Number
- 2953200-2011-01305
- Event Type
- Injury
- Date Received
- July 21, 2011
- Date of Event
- November 10, 2015
- Report Date
- November 15, 2015
- Manufacturer
- MEDTRONIC CARDIOVASCULAR IRELAND
- Product Code
- MIH
- PMA / PMN Number
- P100021
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 1
(B)(4). EVALUATION, RESULTS: (ENDOLEAK). RESULTS AND CONCLUSIONS: (90 DEGREE ANGULATED NECK).
Description of Event or Problem · 1
AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 3.0 CM ILIAC ANEURYSM. VESSEL MORPHOLOGY WAS REPORTED AS MILD TORTUOSITY; MILD PROXIMAL NECK CALCIFICATION; MILD NECK THROMBUS; MODERATE BILATERAL ILIAC CALCIFICATION; AORTIC NECK DIAMETER OF 22 - 23 MM OVER A 2.5 CM LENGTH; AND A 90 DEGREE AORTIC NECK ANGULATION. AFTER IMPLANTATION, THERE WAS A PROXIMAL TYPE I ENDOLEAK. AN INTERNAL REVIEW OF FILMS CONFIRMS A LIKELY TYPE I ENDOLEAK WITH A MUCH ANGULATED NECK. NO CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE MONITORED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDURANT ABDOMINAL STENT GRAFT | MIH | MEDTRONIC CARDIOVASCULAR IRELAND | NA | V00881924 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 96 YR | Female | UNK. |