FDA Adverse Event
Injury
Summary report: N
CYPHER SIROLIMUS-ELUTING CORONARY STENT
MDR report key: 1023342
·
Received April 1, 2008
Report
- Report Number
- 9616099-2008-00833
- Event Type
- Injury
- Date Received
- April 1, 2008
- Date of Event
- May 4, 2007
- Report Date
- March 7, 2008
- Manufacturer
- CORDIS DE MEXICO
- Product Code
- NIQ
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS DEVICE IS DISTRIBUTED OUTSIDE THE UNITED STATES: HOWEVER IT IS SIMILAR TO THE UNITED STATES PRODUCT. THIS DEVICE IS NONE OF TWO PRODUCTS ASSOCIATED WITH THIS EVENT. PLEASE REFER TO MFR. REPORT # 9616099-2008-00834. THE PRODUCT REMAINS IMPLANTED IN THE PATIENT AND IS NOT AVAILABLE FOR ANALYSIS. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN THIRTY DAYS UPON RECEIPT.
Description of Event or Problem · 1
THE MALE PATIENT RECEIVED 2.5 X 18 AND 2.5 X 08 CYPHER SELECT STENTS IN THE PROXIMAL LAD IN 2006. THE LESION WAS A BIFURCATION REQUIRING DOUBLE GUIDEWIRE AND WAS MODERATELY CALCIFIED. THE PATIENT WAS HOSPITALIZED FOR UNSTABLE ANGINA IN 2007. THE PATIENT HAD A PCI OF THE PREVIOUSLY TREATED TARGET LESION. THE PROXIMAL LAD WAS TREATED WITH A 3.5 X 8 MM CYPHER SELECT AT 12 ATM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CYPHER SIROLIMUS-ELUTING CORONARY STENT | DRUG-ELUTING (NIQ) | NIQ | CORDIS DE MEXICO | NA | I0706120 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 74 YR | Hospitalization| R |