FDA Adverse Event
Injury
Summary report: N
ENDEAVOR RX CORONARY STENT SYSTEM
MDR report key: 1963266
·
Received January 14, 2011
Report
- Report Number
- 2953200-2011-00109
- Event Type
- Injury
- Date Received
- January 14, 2011
- Date of Event
- September 11, 2007
- Report Date
- December 16, 2010
- Manufacturer
- MEDTRONIC CARDIOVASCULAR GALWAY
- Product Code
- NIQ
- PMA / PMN Number
- P060033
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BE
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4). EVALUATION, RESULTS: MI AND DISSECTION.
Description of Event or Problem · 1
DURING THE INDEX PROCEDURE, TWO ENDEAVOR RX DRUG-ELUTING STENTS WERE IMPLANTED IN THE PROXIMAL RCA, 2ND STENT WAS IMPLANTED TO TREAT COMPLICATION/DISSECTION/BAILOUT (REF: MFR # 2953200-2011-00110). IT WAS REPORTED THAT AN MI OCCURRED ON THE SAME DAY AS THE STENT IMPLANTATION. EVENT WAS IDENTIFIED BY THE CLINICAL EVENTS COMMITTEE AND DEEMED TO BE CONSISTENT WITH AN MI. MI WAS CATEGORIZED AS A NON Q WAVE MI, IN THE TERRITORY OF THE TARGET VESSEL. NO FURTHER DETAILS ARE AVAILABLE. IT WAS CONFIRMED THAT THE PT WAS FREE OF SYMPTOMS AT THE 30 DAY, 6 MONTH, 1 YEAR, 1.5 YEAR, 2 YEAR AND 2.5 YEAR FOLLOW-UPS POST THE INDEX PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDEAVOR RX CORONARY STENT SYSTEM | NIQ | MEDTRONIC CARDIOVASCULAR GALWAY | NA | 0000431633 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR |