MAUDE Adverse Event Report: BIOTRONIK AG ORSIRO; CORONARY DRUG-ELUTING STENT

Model Number	2.5/30/140
Medical Device Problem Codes	Break (1069); Device Slipped (1584)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/11/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Biotronik orsiro stent had shifted down the balloon and the front end of the stent was severely damaged.

• Brand Name: ORSIRO
• Common Device Name: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BIOTRONIK AG; 6024 jean road; lake oswego OR 97035
• MDR Report Key: 11250777
• Report Number: 11250777
• Device Sequence Number: 3164798
• Product Code: NIQ
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Type of Report: Initial
• Report Date (Section B): 01/21/2021
• Report Date (Section F): 01/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 2.5/30/140
• Device Catalogue Number: 401766
• Device Lot Number: 05202578
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 01/29/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/21/2021