FDA Adverse Event
Malfunction
Summary report: N
ENDEAVOR SPRINT RX CORONARY STENT SYSTEM
MDR report key: 1993161
·
Received February 7, 2011
Report
- Report Number
- 2953200-2011-00292
- Event Type
- Malfunction
- Date Received
- February 7, 2011
- Date of Event
- January 10, 2011
- Report Date
- January 31, 2013
- Manufacturer
- MEDTRONIC CARDIOVASCULAR GALWAY
- Product Code
- NIQ
- PMA / PMN Number
- P060033
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BR
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4). EVALUATION RESULTS: NO ROOT CAUSE OF EVENT CAN BE DETERMINED BASED ON LIMITED INFORMATION AVAILABLE, STENT DEFORMATION. EVAL CONCLUSION: NO ROOT CAUSE OF EVENT CAN BE DETERMINED BASED ON LIMITED INFORMATION AVAILABLE.
Description of Event or Problem · 1
AN ATTEMPT WAS MADE TO DEPLOY A 2.5MM DIAMETER X 18MM LENGTH ENDEAVOR SPRINT RAPID EXCHANGE (RX) DRUG ELUTING CORONARY STENT IN TO A PT. PRIOR TO THIS, TWO OTHER ENDEAVOR SPRINT RX DRUG ELUTING CORONARY STENTS WERE DEPLOYED TO PROX LAD WITH NO ISSUE REPORTED. HOWEVER, IT WAS REPORTED THAT THE RELEVANT DEVICE DID NOT PASS THROUGH THE STRUT OF A PREVIOUS STENT AND UPON REMOVAL IT WAS NOTED THAT THE STENT WAS DAMAGED. NO ISSUE TO THE PT HAS BEEN REPORTED. NO OTHER CLINICAL SEQUELAE WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDEAVOR SPRINT RX CORONARY STENT SYSTEM | NIQ | MEDTRONIC CARDIOVASCULAR GALWAY | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | ASPIRIN, CLOPIDOGREL |