FDA Adverse Event
Injury
Summary report: N
CYPHER SIROLIMUS-ELUTING CORONARY STENT
MDR report key: 1212596
·
Received October 24, 2008
Report
- Report Number
- 3003742446-2008-00231
- Event Type
- Injury
- Date Received
- October 24, 2008
- Report Date
- September 30, 2008
- Manufacturer
- CORDIS LLC (PR)
- Product Code
- NIQ
- PMA / PMN Number
- P020026
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS REPORT IS FOR AN UNK CYPHER STENT. 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
JOHNSON & JOHNSON HAS BEEN INFORMED OF THE INTENT FOR LEGAL ACTION OR POTENTIAL LITIGATION; THERE IS NO OTHER INFO AVAILABLE AT THIS TIME. BASED UPON THE ATTACHED FILE, THIS PT SUFFERED SERIOUS AND PERMANENT INJURY. IT IS PRESUMED THAT THE PT SUFFERED STENT THROMBOSIS OF A CYPHER STENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CYPHER SIROLIMUS-ELUTING CORONARY STENT | DRUG-ELUTING STENT (NIQ) | NIQ | CORDIS LLC (PR) | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Hospitalization |