FDA Adverse Event
Death
Summary report: N
ENDEAVOR RX CORONARY STENT SYSTEM
MDR report key: 1686041
·
Received May 11, 2010
Report
- Report Number
- 2953200-2010-00809
- Event Type
- Death
- Date Received
- May 11, 2010
- Date of Event
- February 3, 2010
- Report Date
- April 15, 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
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B) (4): EVALUATION RESULTS: DEATH.
Description of Event or Problem · 1
A 2.5 MM DIAMETER X 24 M LENGTH ENDEAVOR RX DRUG-ELUTING CORONARY STENT WAS DEPLOYED IN TO A PATIENT WITH NO ISSUE REPORTED. THE TARGET LESION, LOCATED IN THE PROX LAD, WAS PRE-DILATED. DURING PROCEDURE, ONE OTHER ENDEAVOR RX STENT WAS DEPLOYED IN THE MID LAD WITH NO ISSUE REPORTED (MFR REPORT # 2953200-2010-00810). HOWEVER, IT WAS REPORTED THAT APPROXIMATELY 3 MONTHS POST DEPLOYMENT, THE PATIENT DIED DUE TO HEART FAILURE. THE PHYSICIAN ASSESSED NO RELATIONSHIPS BETWEEN THE PATIENT'S DEATH AND THE RELEVANT DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDEAVOR RX CORONARY STENT SYSTEM | NIQ | MEDTRONIC CARDIOVASCULAR GALWAY | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 83 YR | Death |