FDA Adverse Event
Injury
Summary report: N
ENDEAVOR SPRINT RX CORONARY STENT SYSTEM
MDR report key: 1071341
·
Received July 8, 2008
Report
- Report Number
- 2953200-2008-00518
- Event Type
- Injury
- Date Received
- July 8, 2008
- Date of Event
- May 22, 2008
- Report Date
- June 9, 2008
- Manufacturer
- MEDTRONIC CARDIOVASCULAR GALWAY
- Product Code
- NIQ
- PMA / PMN Number
- P060033
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
LACK OF INFORMATION.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE LESION WAS LOCATED IN THE MID LAD. ONE ENDEAVOR SPRINT RX STENT WAS IMPLANTED (3.00 X 18MM). ON THE SAME DAY AS IMPLANT, THE PATIENT SUFFERED AN ACUTE NON-STEMI. PATIENT'S PAIN SETTLED AND PATIENT SENT HOME, SUBSEQUENT REVIEW OF BLOODS SHOW RAISED ENZYMES. THE INVESTIGATOR ASSESSED THE EVENT AS UNSTABLE ANGINA & THAT IT WAS NON DETERMINABLE AS TO WHETHER THE EVENT WAS RELATED TO THE STUDY STENT. 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 SPRINT RX CORONARY STENT SYSTEM | NIQ | MEDTRONIC CARDIOVASCULAR GALWAY | NA | 0000512508 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |