FDA Adverse Event
Injury
Summary report: N
PROMUS PREMIER
MDR report key: 8157611
·
Received December 12, 2018
Report
- Report Number
- 2134265-2018-63745
- Event Type
- Injury
- Date Received
- December 12, 2018
- Date of Event
- November 14, 2018
- Report Date
- December 12, 2018
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- NIQ
- UDI-DI
- 08714729844648
- PMA / PMN Number
- P110010
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
DEVICE IS A COMBINATION PRODUCT. (B)(6).
Description of Event or Problem · 1
IT WAS REPORTED THAT ARTERY DISSECTION OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. A 2.25X12MM PROMUS PREMIER DRUG-ELUTING STENT WAS USED FOR TREATMENT, BUT FAILED TO CROSS THE LESION. WHEN THE PHYSICIAN TRIED TO REMOVE THE DEVICE THE ARTERY A NON FLOW LIMITING DISSECTION OCCURRED. THE PHYSICIAN USED A DIFFERENT DEVICE TO OVERLAP THE DISSECTED ARTERY. NO SERIOUS INJURY AND NO FURTHER COMPLICATIONS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 994259 | PROMUS PREMIER | STENT, CORONARY, DRUG-ELUTING | NIQ | BOSTON SCIENTIFIC CORPORATION | 9583 | 0022211916 | 08714729844648 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |