FDA Adverse Event
Injury
Summary report: N
JOSTENT GRAFTMASTER
MDR report key: 1200653
·
Received October 16, 2008
Report
- Report Number
- 2024168-2008-00964
- Event Type
- Injury
- Date Received
- October 16, 2008
- Date of Event
- September 16, 2008
- Report Date
- September 16, 2008
- Manufacturer
- ABBOTT VASCULAR-CARDIAC THERAPIES
- Product Code
- MAF
- PMA / PMN Number
- HDE00001
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE JOSTENT GRAFTMASTER IS BEING REPORTED UNDER ANOTHER MANUFACTURING NUMBER.
Description of Event or Problem · 1
REPORTING STATUS: SERIOUS INJURY - MEDICAL INTERVENTION. REPORTING RATIONALE: FAILURE TO CROSS WITH A GRAFTMASTER IS AN ISSUE KNOWN TO REQUIRE A SECOND DEVICE OR ADDITIONAL PROCEDURE. DEVICE ISSUE: FAILURE TO CROSS. IT WAS REPORTED THAT A PERFORATION OCCURRED WITH THE USE OF ANOTHER DEVICE WHICH REQUIRED TREATMENT WITH A GRAFTMASTER STENT. TWO GRAFTMASTER DEVICES WERE UNABLE TO CROSS THE LESION; THEREFORE, FAILED TO TREAT THE VESSEL INJURY UPON INITIAL USAGE. AN IABP WAS PLACED TO STABILIZE THE PATIENT. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | JOSTENT GRAFTMASTER | MAF | ABBOTT VASCULAR-CARDIAC THERAPIES | NA | 509961 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 81 YR | Required Intervention | STENT: JOSTENT GRAFTMASTER| (PART # 12747-16 |