FDA Adverse Event
Injury
Summary report: N
ENDEAVOR SPRINT RX CORONARY STENT SYSTEM
MDR report key: 2103678
·
Received May 20, 2011
Report
- Report Number
- 9612164-2011-00461
- Event Type
- Injury
- Date Received
- May 20, 2011
- Date of Event
- November 6, 2008
- Report Date
- April 27, 2011
- Manufacturer
- MEDTRONIC IRELAND
- Product Code
- NIQ
- PMA / PMN Number
- P060033
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4). EVAL, RESULTS: (MYOCARDIAL INFARCTION).
Description of Event or Problem · 1
ONE ENDEAVOR SPRINT RX DRUG-ELUTING STENT WAS IMPLANTED AT THE PROXIMAL LAD. FOLLOWING CLINICAL EVALUATIONS COMMITTEE (CEC) REVIEW AN MI IS REPORTED TO HAVE OCCURRED ON THE SAME DAY AS THE INDEX PROCEDURE. MI IS REPORTED TO BE A NON-Q WAVE MI IN THE TERRITORY OF THE TARGET VESSEL. A SPONTANEOUS MENORRHAGIA BLEED IS REPORTED TO HAVE OCCURRED APPROX 3 MONTHS FOLLOWING INDEX PROCEDURE. INVESTIGATOR INDICATED THAT EVENT WAS NOT RELATED TO THE STUDY STENT. PT WAS TAKING ASA AND CLOPIDOGREL/TICLOPIDINE 24 HOURS PRIOR TO EVENT. PT WAS ASYMPTOMATIC/FREE OF SYMPTOMS AT 30 DAY FOLLOW UP, 6 MONTH FOLLOW UP, 1 YEAR FOLLOW UP, 1.5 YEAR FOLLOW UP, 2 YEAR FOLLOW UP AND 2.5 YEAR FOLLOW UP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDEAVOR SPRINT RX CORONARY STENT SYSTEM | NIQ | MEDTRONIC IRELAND | NA | 0000818918 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 48 YR |