N
Patient 1
DATE OF BIRTH: PATIENT WAS BORN IN THE YEAR OF (B)(6).
MAUDE MDR 9908473
- MDR report key
- 9908473
- Report number
- 2134265-2020-04200
- Event key
- 0
- Event type
- 3
- Date of event
- 2020-03-13
- Date received
- 2020-03-31
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 1
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- JAY JOHNSON
- Address
- TWO SCIMED PLACE MAPLE GROVE MN 55311 US
- Phone
- 763-763-7634
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | SYNERGY | BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM | BOSTON SCIENTIFIC CORPORATION | NIQ | 10602 | 10602 | 0024377318 | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2020-03-31 | 0 |
Event Narratives#
D
Patient 1
IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 2.50 X 16 SYNERGY DRUG-ELUTING STENT WAS SELECTED FOR USE. HOWEVER, STENT WAS NOT PROPERLY PLACED ON THE RING AND DURING PROCEDURE THE STENT GOT TWISTED ON THE WIRE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.