FDA Adverse Event
Injury
Summary report: N
ENDEAVOR SPRINT RX CORONARY STENT SYSTEM
MDR report key: 2080647
·
Received April 26, 2011
Report
- Report Number
- 9612164-2011-00301
- Event Type
- Injury
- Date Received
- April 26, 2011
- Date of Event
- March 16, 2011
- Report Date
- March 20, 2014
- Manufacturer
- MEDTRONIC IRELAND
- Product Code
- NIQ
- PMA / PMN Number
- P060033
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4). EVAL RESULTS: DISSECTION.
Description of Event or Problem · 1
THE DISSECTION OCCURRED AFTER THE IMPLANTATION OF THE FIRST ENDEAVOR SPRINT STENT. THE SECOND ENDEAVOR SPRINT STENT WAS IMPLANTED TO TREAT THE DISSECTION.
Description of Event or Problem · 1
TWO ENDEAVOR SPRINT RAPID EXCHANGE (RX) DRUG ELUTING STENTS WERE IMPLANTED IN THE PROXIMAL RCA DURING THE INDEX PROCEDURE. IT IS REPORTED THAT A DISSECTION OCCURRED FOLLOWING STENT IMPLANT AND INTERVENTION WAS REQUIRED. (REF MFR # 9612164-2011-00300).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDEAVOR SPRINT RX CORONARY STENT SYSTEM | NIQ | MEDTRONIC IRELAND | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | Required Intervention |