FDA Adverse Event
Death
Summary report: N
ENDEAVOR SPRINT RX
MDR report key: 2843260
·
Received November 22, 2012
Report
- Report Number
- 9612164-2012-01689
- Event Type
- Death
- Date Received
- November 22, 2012
- Date of Event
- March 17, 2011
- Report Date
- March 10, 2014
- Manufacturer
- MEDTRONIC IRELAND
- Product Code
- NIQ
- PMA / PMN Number
- P060033
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BR
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
RESULTS: INHERENT RISK OF PROCEDURE (MI, DISSECTION, AND DEATH). (B)(4).
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
DURING THE INDEX PROCEDURE THE PATIENT HAD TWO ENDEAVOR SPRINT DRUG-ELUTING STENTS IMPLANTED IN THE LAD. A DISSECTION IS REPORTED TO HAVE OCCURRED DURING IMPLANTATION OF THE SECOND ENDEAVOR SPRINT STENT. THE INVESTIGATOR DID NOT ASSESS IF THE EVENT WAS RELATED TO THE STUDY DEVICE. IT WAS REPORTED THAT APPROXIMATELY 40 MONTHS POST THE INDEX PROCEDURE THE PATIENT SUFFERED A FATAL MI AND DIED ON THE SAME DAY. THE INVESTIGATOR HAS INDICATED THAT THE MI AND DEATH WERE POSSIBLY RELATED TO THE STUDY STENTS.
Description of Event or Problem · 1
THE PREVIOUSLY REPORTED MI AND DEATH EVENTS OCCURRED APPROXIMATELY 14 MONTHS POST INDEX PROCEDURE NOT 40 MONTHS AS PREVIOUSLY REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDEAVOR SPRINT RX | STENT, CORONARY, DRUG-ELUTING | NIQ | MEDTRONIC IRELAND | 0003163326 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00076 YR | Death | ASPIRIN AND CLOPIDOGREL |