MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-30 for ORSIRO 2.75/40 391240 SEE MODEL NO. manufactured by Biotronik Ag, Buelach, Switzerland.
[185702916]
The orsiro drug-eluting stent system was selected for use. The device was inserted but the target lesion could not be crossed. After withdrawal it was detected that the stent was distally deformed and shifted to the distal position.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1028232-2020-01501 |
| MDR Report Key | 9901636 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-26 |
| Date of Event | 2020-03-09 |
| Date Mfgr Received | 2020-03-26 |
| Device Manufacturer Date | 2018-08-30 |
| Date Added to Maude | 2020-03-30 |
| 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 2.75/40 |
| Generic Name | CORONARY DRUG-ELUTING STENT |
| Product Code | NIQ |
| Date Received | 2020-03-30 |
| Model Number | 391240 |
| Catalog Number | SEE MODEL NO. |
| Lot Number | 08182869 |
| 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 | 2020-03-30 |