FDA Adverse Event
Injury
Summary report: N
SYNERGY II EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM
MDR report key: 6707514
·
Received July 12, 2017
Report
- Report Number
- 2134265-2017-07000
- Event Type
- Injury
- Date Received
- July 12, 2017
- Date of Event
- June 12, 2017
- Report Date
- June 26, 2017
- Manufacturer
- BOSTON SCIENTIFIC - GALWAY
- Product Code
- NIQ
- UDI-DI
- 08714729840336
- PMA / PMN Number
- P150003
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MFR: THE COMPLAINT DEVICE WAS NOT RECEIVED FOR ANALYSIS. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE WAS UNABLE TO BE DETERMINED. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED VIA FACILITY MEDWATCH# 5070388 THAT STENT FRACTURE OCCURRED. IN (B)(6) 2016, A 2.50 X 32 SYNERGY II DRUG-ELUTING STENT WAS DEPLOYED AND THE PROCEDURE WAS COMPLETED. HOWEVER IN (B)(6) 2017, DURING CARDIAC CATHETERIZATION, IT WAS NOTED THAT THE PREVIOUSLY DEPLOYED STENT HAD 360 DEGREES FRACTURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 487073 | SYNERGY II EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM | BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM | NIQ | BOSTON SCIENTIFIC - GALWAY | H7493926032250 | 0019474943 | 08714729840336 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |