FDA Adverse Event
Death
Summary report: N
JOSTENT GRAFTMASTER
MDR report key: 3111956
·
Received August 3, 2006
Report
- Report Number
- 9616290-2006-00098
- Event Type
- Death
- Date Received
- August 3, 2006
- Date of Event
- June 23, 2006
- Report Date
- July 5, 2006
- Manufacturer
- ABBOTT VASCULAR INSTRUMENTS DEUTSCHLAND
- Product Code
- MAF
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS NOT RETURNED, HOWEVER, THE LOT INFORMATION WAS PROVIDED. REVIEW OF THE DEVICE HISTORY RECORD FOR THIS LOT IS FORTHCOMING. ANY RELEVANT FINDING WILL BE SUBMITTED IN A FOLLOW UP REPORT.
Description of Event or Problem · 1
A PHYSICIAN IMPLANTED A GRAFTMASTER STENT AT A MAXIMUM PRESSURE OF 19 ATMS, IT WAS REPORTED THE PERFORATION WAS SEALED. AN UNKNOWN COMPLICATION OCCURRED AND THE PATIENT EXPIRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | JOSTENT GRAFTMASTER | CORONARY STENT GRAFT | MAF | ABBOTT VASCULAR INSTRUMENTS DEUTSCHLAND | NA | 230860 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR | Death |