FDA Adverse Event
Injury
Summary report: N
PALMAZ SCHATZ STENT UNKNOWN
MDR report key: 1221968
·
Received November 3, 2008
Report
- Report Number
- 9610978-2008-00251
- Event Type
- Injury
- Date Received
- November 3, 2008
- Date of Event
- October 1, 2008
- Report Date
- October 28, 2008
- Manufacturer
- CORDIS EUROPA, N.V.
- Product Code
- MAF
- PMA / PMN Number
- NI
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE IS NOT AVAILABLE FOR EVALUATION AND TESTING. HOWEVER, ANY ADDITIONAL INFO WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.
Description of Event or Problem · 1
A REPORT FROM THE PT INDICATED A LESION IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY WAS TREATED WITH A PALMAZ SCHATZ STENT. HOWEVER, APPROXIMATELY 11 YEARS LATER, THE RESTENOSIS OF THE LAD WAS OBSERVED ADJACENT TO THE PALMAZ SCHATZ STENT. CONSEQUENTLY, THE PT WAS HOSPITALIZED AND A COBALT CHROMIUM STENT WAS IMPLANTED TO TREAT THE RESTENOSIS. ADDITIONALLY, THE PT WAS PRESCRIBED PLAVIZ 75MG.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PALMAZ SCHATZ STENT UNKNOWN | CORONARY SDS/STENTS (MAF) | MAF | CORDIS EUROPA, N.V. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR | Hospitalization| R |