FDA Adverse Event
Malfunction
Summary report: N
ENDEAVOR RESOLUTE RX
MDR report key: 3020526
·
Received March 26, 2013
Report
- Report Number
- 9612164-2013-00335
- Event Type
- Malfunction
- Date Received
- March 26, 2013
- Date of Event
- February 18, 2013
- Report Date
- March 11, 2013
- Manufacturer
- MEDTRONIC IRELAND
- Product Code
- NIQ
- PMA / PMN Number
- P110013
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
RESULTS: DEFORMATION. LESION MORPHOLOGY. DEFORMATION PROBLEM. CONCLUSIONS: LESION MORPHOLOGY. DEFORMATION. (B)(4).
Description of Event or Problem · 1
PHYSICIAN WAS ATTEMPTING TO DEPLOY ONE ENDEAVOR RESOLUTE DRUG-ELUTING STENT TO A SEVERELY CALCIFIED LESION IN THE LAD BUT IT COULD NOT PASS THE LESION AND WAS WITHDRAWN. EVALUATION SUMMARY: THE STENT WAS POSITIONED BETWEEN THE MARKER BANDS AS PER SPECIFICATIONS. THE 1ST PROXIMAL SEGMENT WAS RAISED AND DEFORMED. PLEASE NOTE THAT THIS DEVICE (ENDEAVOR RESOLUTE) IS DISTRIBUTED OUTSIDE THE UNITED STATES; HOWEVER, IT IS SIMILAR TO THE UNITED STATES DISTRIBUTED PRODUCT (RESOLUTE INTEGRITY).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 124096 | ENDEAVOR RESOLUTE RX | STENT, CORONARY, DRUG-ELUTING | NIQ | MEDTRONIC IRELAND | 0006141249 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00056 YR |