FDA Adverse Event
Malfunction
Summary report: N
SYNERGY II EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM
MDR report key: 6096980
·
Received November 11, 2016
Report
- Report Number
- 2134265-2016-10257
- Event Type
- Malfunction
- Date Received
- November 11, 2016
- Date of Event
- October 21, 2016
- Report Date
- October 24, 2016
- Manufacturer
- BOSTON SCIENTIFIC - GALWAY
- Product Code
- NIQ
- UDI-DI
- 08714729840169
- PMA / PMN Number
- P150003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE IS A COMBINATION PRODUCT. (B)(4). DEVICE EVALUATED BY MANUFACTURER: THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS CONSIDERED HANDLING DAMAGE AS THE EVENT OCCURRED WITHOUT DIRECT PATIENT CONTACT. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT STENT DAMAGE OCCURRED. DURING UNPACKING OF A 2.75 X 20 SYNERGY II DRUG-ELUTING STENT, IT WAS NOTED THAT THE STENT WAS MANGLED ON THE BALLOON AND UNRAVELING OFF. THE DEVICE NEVER ENTERED THE PATIENT'S BODY AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 746061 | SYNERGY II EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM | BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM | NIQ | BOSTON SCIENTIFIC - GALWAY | H7493926020270 | 19562170 | 08714729840169 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |