MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2020-03-31 for ORSIRO (US) 3.0/35 404669 SEE MODEL NO. manufactured by Biotronik Ag, Buelach, Switzerland.
[185940300]
An orsiro drug-eluting stent system was chosen for treatment of a svg. The device could not be advanced through a 6f guideliner and was removed. After removal it was detected that the stent was deformed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1028232-2020-01504 |
| MDR Report Key | 9908661 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-12 |
| Date of Event | 2020-03-10 |
| Date Mfgr Received | 2020-03-12 |
| Device Manufacturer Date | 2018-11-12 |
| Date Added to Maude | 2020-03-31 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Street | 6024 JEAN ROAD |
| Manufacturer City | LAKE OSWEGO OR 97035 |
| Manufacturer Country | US |
| Manufacturer Postal | 97035 |
| Manufacturer Phone | 8772459800 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ORSIRO (US) 3.0/35 |
| Generic Name | CORONARY DRUG-ELUTING STENT |
| Product Code | NIQ |
| Date Received | 2020-03-31 |
| Model Number | 404669 |
| Catalog Number | SEE MODEL NO. |
| Lot Number | 10186924 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOTRONIK AG, BUELACH, SWITZERLAND |
| Manufacturer Address | ACKERSTRASSE 6 BUELACH CH-8180 CH CH-8180 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2020-03-31 |