FDA Adverse Event
Injury
Summary report: N
ENDEAVOR RX CORONARY STENT SYSTEM
MDR report key: 1192566
·
Received October 8, 2008
Report
- Report Number
- 2953200-2008-00901
- Event Type
- Injury
- Date Received
- October 8, 2008
- Date of Event
- March 18, 2008
- Report Date
- September 8, 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
- BE
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
EVALUATION RESULTS: MYOCARDIAL INFARCTION, RESTENOSIS. PATIENT CODE: OTHER, SECONDARY INTERVENTION.
Description of Event or Problem · 1
ONE ENDEAVOR RX DRUG-ELUTING STENT WAS IMPLANTED IN THE PROXIMAL RCA. PATIENT WAS ASYMPTOMATIC AT 30 DAY & 6 MONTH FOLLOW UP. AN ACUTE STEMI IS REPORTED TO HAVE OCCURRED SEVEN MONTHS POST INITIAL STENT IMPLANT. PATIENT CAME TO EMERGENCY DEPARTMENT AT THE REFERRING HOSPITAL WHERE AN MI WAS DIAGNOSED. LOCATION OF MI WAS INFERIOR. REVASCULARIZATION OF THE TARGET LESION WAS CARRIED OUT DUE TO RESTENOSIS AFTER PREVIOUS PTCA. INVESTIGATOR HAS INDICATED THAT 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 RX CORONARY STENT SYSTEM | NIQ | MEDTRONIC CARDIOVASCULAR GALWAY | NA | 0000330367 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |