MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-08 for PK PAPYRUS 2.5/20 369386 SEE MODEL NO. manufactured by Biotronik Ag, Buelach, Switzerland.
[144673905]
Ous mdr - the pk papyrus covered coronary stent system was chosen to cover a perforation in the mid lad which occurred during the post-dilatation after the placement of three drug-eluting stents. At that time a balloon was inflated just before the leaking area. The pk papyrus was taken but could not be advanced while the other balloon was deflated and was withdrawn. After withdrawal it was noticed that the pk papyrus stent dislodged in the guiding catheter.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1028232-2019-01852 |
| MDR Report Key | 8590983 |
| Date Received | 2019-05-08 |
| Date of Report | 2019-04-26 |
| Date of Event | 2019-04-17 |
| Date Mfgr Received | 2019-07-09 |
| Device Manufacturer Date | 2017-07-20 |
| Date Added to Maude | 2019-05-08 |
| 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 | 0 |
| Brand Name | PK PAPYRUS 2.5/20 |
| Generic Name | COVERED CORONARY STENT |
| Product Code | NIV |
| Date Received | 2019-05-08 |
| Model Number | 369386 |
| Catalog Number | SEE MODEL NO. |
| Lot Number | 06174775 |
| Device Expiration Date | 2019-06-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2019-05-08 |