FDA Adverse Event
Malfunction
Summary report: N
ENDEAVOR RESOLUTE RX CORONARY STENT SYSTEM
MDR report key: 1102017
·
Received August 7, 2008
Report
- Report Number
- 2953200-2008-00663
- Event Type
- Malfunction
- Date Received
- August 7, 2008
- Date of Event
- July 7, 2008
- Report Date
- July 8, 2008
- Manufacturer
- MEDTRONIC CARDIOVASCULAR GALWAY
- Product Code
- NIQ
- PMA / PMN Number
- P060033
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
EVAL RESULTS: (EMBOLISM-DEVICE).
Description of Event or Problem · 1
AN ENDEAVOR RESOLUTE RX DRUG-ELUTING STENT WAS INSERTED IN A PT FOR TREATMENT OF A DISTAL LAD LESION. IT WAS REPORTED THAT THE STENT DETACHED FROM THE BALLOON BEFORE DEPLOYMENT (INSIDE PT). TRYING TO STENT THE DISTAL LAD LESION, THE STENT WAS DETACHED FROM THE BALLOON AND DISLODGED IN THE PROXIMAL LEFT CIRCUMFLEX. WAS MANAGED BY CRUSHING IT USING 3X18 MM ENDEAVOR DRUG-ELUTING STENT. GOOD OUTCOME WITH NO COMPLICATIONS. PLEASE NOTE THAT THIS DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDEAVOR RESOLUTE RX CORONARY STENT SYSTEM | NIQ | MEDTRONIC CARDIOVASCULAR GALWAY | NA | 0000620249 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |