FDA Adverse Event
Malfunction
Summary report: N
CYPHER SIROLIMUS-ELUTING CORONARY STENT
MDR report key: 936615
·
Received April 9, 2007
Report
- Report Number
- 9616099-2007-00631
- Event Type
- Malfunction
- Date Received
- April 9, 2007
- Date of Event
- March 14, 2007
- Report Date
- March 16, 2007
- Manufacturer
- CORDIS DE MEXICO
- Product Code
- NIQ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SN
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS PRODUCT IS DISTRIBUTED OUTSIDE THE UNITED STATES. HOWEVER, IT IS SIMILAR TO US DISTRIBUTED DRUG ELUTING STENTS. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.
Description of Event or Problem · 1
DURING INFLATION, THE DISTAL BALLOON INFLATED BUT THE PROXIMAL BALLOON DIDN'T INFLATE UNTIL HIGH PRESSURE WAS APPLIED. DEFLATION OF THE BALLOON WAS DIFFICULT AND TOOK A LONG TIME (MORE THAN 30 SEC). A SYRINGE WAS USED. THE DISTAL END OF THE STENT LOOKED BIGGER IN DIAMETER THAN THE PROXIMAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CYPHER SIROLIMUS-ELUTING CORONARY STENT | DRUG-ELUTING STENT (NIQ) | NIQ | CORDIS DE MEXICO | NA | I1106032 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR | UNK SYRINGE |