FDA Adverse Event
Injury
Summary report: N
ENDEAVOR RX
MDR report key: 2023350
·
Received March 16, 2011
Report
- Report Number
- 9612164-2011-00069
- Event Type
- Injury
- Date Received
- March 16, 2011
- Date of Event
- December 8, 2010
- Report Date
- August 23, 2016
- Manufacturer
- MEDTRONIC IRELAND
- Product Code
- NIQ
- PMA / PMN Number
- P060033
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4). EVALUATION: RESULTS: (BASED ON THE INFORMATION PROVIDED, NO ROOT CAUSE CAN BE DETERMINED), (MI).
Description of Event or Problem · 1
ONE ENDEAVOR RX DRUG ELUTING STENT DIAMETER 3.5MM LENGTH 18MM WAS SUCCESSFULLY DEPLOYED TO THE MID RCA. APPROXIMATELY 1 YEAR POST INDEX PROCEDURE, A MYOCARDIAL INFARCTION WAS CONFIRMED WHICH RESULTED IN REVASCULARIZATION BEING CARRIED OUT WITH ONE ENDEAVOR STENT BEING DEPLOYED TO THE MID RCA. PROCEDURAL IMAGES OR PRODUCT IDENTIFICATION HAS NOT BEEN PROVIDED FOR REVIEW. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED. THE ACCOUNT STATED THAT THE CAUSAL RELATIONSHIPS WITH THE PRODUCT, PROCEDURE AND ZOTAROLIMUS ARE UNKNOWN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDEAVOR RX | STENT, CORONARY, DRUG-ELUTING | NIQ | MEDTRONIC IRELAND | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 52 YR | Required Intervention | CLOPIDOGREL |