FDA Adverse Event
Death
Summary report: N
OVATION IX ABDOMINAL STENT GRAFT SYSTEM
MDR report key: 5991916
·
Received September 30, 2016
Report
- Report Number
- 3008011247-2016-00109
- Event Type
- Death
- Date Received
- September 30, 2016
- Date of Event
- September 1, 2016
- Report Date
- September 1, 2016
- Manufacturer
- TRIVASCULAR, INC.
- Product Code
- MIH
- UDI-DI
- M701TVAB2680J1
- PMA / PMN Number
- P120006
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
DEVICE REMAINS IMPLANTED.
Description of Event or Problem · 1
AN OVATION IX ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED TO TREAT AN ABDOMINAL AORTIC ANEURYSM. THE FINAL ANGIOGRAM SHOWED THE PRESENCE OF A POTENTIAL TYPE IA ENDOLEAK. AS OF THE DATE OF THIS REPORT, THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED AND THE PATIENT WILL CONTINUE TO BE MONITORED.
Description of Event or Problem · 1
THE PREVIOUSLY REPORTED TYPE IA ENDOLEAK (3008011247-2016-00109) WAS RESOLVED THROUGH RE-INTERVENTION. THE PATIENT RETURNED A WEEK AFTER RE-INTERVENTION WITH SEVERE SEPSIS LEADING TO DEATH. AN ADJUDICATION WAS PERFORMED ON THIS EVENT WHICH FOUND THAT THE MOST LIKELY CAUSE OF THE INFECTION WAS RELATED TO THE RE-INTERVENTION PROCEDURE FOR THE TYPE IA ENDOLEAK.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 642237 | OVATION IX ABDOMINAL STENT GRAFT SYSTEM | ENDOVASCULAR GRAFT, ABDOMINAL AORTIC ANEURYSM | MIH | TRIVASCULAR, INC. | TV-AB2680-J | FS030316-36 | M701TVAB2680J1 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 94 YR | Other |