FDA Adverse Event
Malfunction
Summary report: N
ENDEAVOR SPRINT RX CORONARY STENT SYSTEM
MDR report key: 2241105
·
Received August 16, 2011
Report
- Report Number
- 9612164-2011-00940
- Event Type
- Malfunction
- Date Received
- August 16, 2011
- Date of Event
- July 18, 2011
- Report Date
- July 19, 2011
- Manufacturer
- MEDTRONIC IRELAND
- Product Code
- NIQ
- PMA / PMN Number
- P060033
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TU
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4): RESULTS AND CONCLUSIONS: DEVICE USED PAST ITS LABELED EXPIRATION DATE.
Description of Event or Problem · 1
THE PHYSICIAN INTENDED TO IMPLANT A 2.75 MM DIAMETER X 14MM LENGTH ENDEAVOR SPRINT RAPID EXCHANGE (RX) DRUG-ELUTING STENT IN A LESION IN THE LAD, WHICH EXHIBITED EXCESSIVE TORTUOSITY AND SEVERE CALCIFICATION. THE STENT COULD NOT CROSS THE LESION AND THE DEVICE WAS REMOVED. ON INVESTIGATION OF THE EVENT, IT WAS NOTED THAT THE PHYSICIAN HAD ATTEMPTED TO IMPLANT THE DEVICE PAST ITS LABELED USE BY DATE (UBD). NO CLINICAL SEQUELAE WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDEAVOR SPRINT RX CORONARY STENT SYSTEM | NIQ | MEDTRONIC IRELAND | NA | 0000512504 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |