FDA Adverse Event
Malfunction
Summary report: N
PROMUS PREMIER?
MDR report key: 4171051
·
Received October 14, 2014
Report
- Report Number
- 2134265-2014-06150
- Event Type
- Malfunction
- Date Received
- October 14, 2014
- Date of Event
- August 30, 2014
- Report Date
- September 19, 2014
- Manufacturer
- BOSTON SCIENTIFIC - GALWAY
- Product Code
- NIQ
- PMA / PMN Number
- P110010
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
DEVICE IS A COMBINATION PRODUCT. (B)(4). THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT STENT DAMAGE OCCURRED. IT WAS NOTICED THAT THERE WAS A STRUT LIFT ON THE PROXIMAL END OF A 3.00X38MM PROMUS PREMIER¿ STENT. NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT IS FINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 651736 | PROMUS PREMIER? | STENT, CORONARY, DRUG-ELUTING | NIQ | BOSTON SCIENTIFIC - GALWAY | H7493952838300 | 0017104552 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 77 YR |