FDA Adverse Event
Injury
Summary report: N
ENDEAVOR RX CORONARY STENT SYSTEM
MDR report key: 2051107
·
Received April 5, 2011
Report
- Report Number
- 9612164-2011-00156
- Event Type
- Injury
- Date Received
- April 5, 2011
- Date of Event
- December 1, 2010
- Report Date
- March 9, 2011
- Manufacturer
- MEDTRONIC IRELAND
- Product Code
- NIQ
- PMA / PMN Number
- P060033
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4): EVALUATION, RESULTS: (CVA/STROKE).
Description of Event or Problem · 1
DURING THE INDEX PROCEDURE, THE PATIENT HAD ONE ENDEAVOR RAPID EXCHANGE (RX) DRUG-ELUTING STENT IMPLANTED TO THE MID LAD. PATIENT WAS ASYMPTOMATIC/FREE OF SYMPTOMS AT 30 DAY, 6 MONTH, 1 YEAR, 1.5 YEAR AND 2 YEAR FOLLOW-UP. APPROXIMATELY 29 MONTHS POST INDEX PROCEDURE THE PATIENT WAS PROVIDED HOSPITALIZED FOR A CEREBRAL HEMORRHAGE. THE INVESTIGATOR ASSESSED THAT THERE WAS NO RELATIONSHIP BETWEEN THE EVENT AND THE STUDY STENT OR STUDY PROCEDURES. PATIENT WAS ASYMPTOMATIC/FREE OF SYMPTOMS AT 2.5 YEAR FOLLOW-UP AND NO CLINICAL SEQUELAE WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDEAVOR RX CORONARY STENT SYSTEM | NIQ | MEDTRONIC IRELAND | NA | 0000635769 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | Hospitalization | ASA |