FDA Adverse Event
Injury
Summary report: N
RAPAMYCIN CLINICAL 3.0 X 18 MM
MDR report key: 1101863
·
Received August 6, 2008
Report
- Report Number
- 9610978-2008-00199
- Event Type
- Injury
- Date Received
- August 6, 2008
- Date of Event
- July 17, 2005
- Report Date
- July 7, 2008
- Manufacturer
- CORDIS EUROPA, N.V.
- Product Code
- NIQ
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IS
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE PROD REMAINS IMPLANTED IN THE PT AND IS NOT AVAILABLE FOR ANALYSIS. ADD'L INFO WILL BE SUBMITTED WITHIN THIRTY DAYS UPON RECEIPT.
Description of Event or Problem · 1
AS PER THE STUDY, THE MALE PT REC'D A CYPHER STENT IN THE PROXIMAL LAD IN 2001. IN LATE 2007, THE PT WAS HOSPITALIZED DUE TO CHEST PAIN. CARDIAC CATHETERIZATION SHOWED 70-90 % OCCLUSION IN THE LAD PAST THE FIRST BRANCH. PT WAS TREATED WITH PTCA, DIAGNOSIS WAS ISCHEMIC HEART DISEASE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RAPAMYCIN CLINICAL 3.0 X 18 MM | NONE | NIQ | CORDIS EUROPA, N.V. | NA | S0601971 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 47 YR | Hospitalization| R | PLAVIX| ASPIRIN |