FDA Adverse Event
Malfunction
Summary report: N
ENDEAVOR SPRINT RX CORONARY STENT SYSTEM
MDR report key: 2241095
·
Received August 16, 2011
Report
- Report Number
- 9612164-2011-00939
- 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: TARGET LESION EXHIBITED EXCESSIVE TORTUOSITY AND SEVERE CALCIFICATION. STENT DAMAGE, FAILURE TO DELIVER THE STENT. CONCLUSIONS: TARGET LESION EXHIBITED EXCESSIVE TORTUOSITY AND SEVERE CALCIFICATION.
Description of Event or Problem · 1
THE PHYSICIAN INTENDED TO IMPLANT A 2.75 MM DIAMETER X 18MM LENGTH ENDEAVOR SPRINT RAPID EXCHANGE (RX) DRUG-ELUTING STENT TO TREAT A LESION IN A PT. THE TARGET LESION EXHIBITED EXCESSIVE TORTUOSITY AND SEVERE CALCIFICATION. THE STENT COULD NOT CROSS THE LESION AND THE DEVICE WAS REMOVED. STENT DEFORMATION WAS OBSERVED ON REMOVAL. 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 | 0005482254 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |