D
Patient 1
THE SYNSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR USE. THE STENT DISLODGED FROM THE DELIVERY BALLOON INSIDE THE GUIDING CATHETER.
MAUDE MDR 9901555
- MDR report key
- 9901555
- Report number
- 1028232-2020-01503
- Event key
- 0
- Event type
- 3
- Date of event
- 2020-03-06
- Date received
- 2020-03-30
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 100
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Address
- 6024 JEAN ROAD LAKE OSWEGO OR 97035 US
- Phone
- 877-877-8772
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | SYNSIRO 3.0/15 | CORONARY DRUG-ELUTING STENT | BIOTRONIK AG, BUELACH, SWITZERLAND | NIQ | 396942 | SEE MODEL NO. | 05192041 | * | R |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2020-03-30 | 0 |