FDA Adverse Event
Death
Summary report: N
JOSTENT GRAFTMASTER
MDR report key: 1201378
·
Received October 17, 2008
Report
- Report Number
- 2024168-2008-00981
- Event Type
- Death
- Date Received
- October 17, 2008
- Date of Event
- September 19, 2008
- Report Date
- September 19, 2008
- Manufacturer
- ABBOTT VASCULAR-CARDIAC THERAPIES
- Product Code
- MAF
- PMA / PMN Number
- HDE00001
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE JOSTENT GRAFTMASTER IS BEING FILED UNDER ANOTHER MANUFACTURING NUMBER.
Description of Event or Problem · 1
REPORTING STATUS: DEATH. REPORTING RATIONALE: PERFORATION NOT SEALED AND THE PT SUBSEQUENTLY DIED. DEVICE ISSUE: FAILURE TO SEAL THE PERFORATION. IT WAS REPORTED THAT THE GRAFTMASTER STENTS WERE IMPLANTED IN AN ATTEMPT TO TREAT A PERFORATION IN THE MID LAD; HOWEVER, THE PERFORATION WAS NOT SEALED AND THE PT DIED. NO ADDITIONAL EVENT OR PT INFO IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | JOSTENT GRAFTMASTER | MAF | ABBOTT VASCULAR-CARDIAC THERAPIES | NA | 377388 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR | Death | (PART # 12746-12| STENT: JOSTENT GRAFTMASTER |