MAUDE Adverse Event Report: BIOTRONIK, INC. BIOTRONIK ORSIRO STENT; CORONARY DRUG-ELUTING STENT

Model Number ORSIRO 2.25/13

Device Problem Failure to Advance (2524)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/10/2020

Event Type  malfunction  

Event Description

Stent was loaded and physician was unable to pass the guidewire over the lesion.It was removed and a balloon was loaded.The lesion was ballooned and the balloon was then removed.The stent was loaded again and it was discovered that the stent was no longer on the stent delivery balloon.It was discovered in the copilot.The patient was not injured by this event.

• Brand Name: BIOTRONIK ORSIRO STENT
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BIOTRONIK, INC. ; 6024 jean road; lake oswego OR 97035 3569
• MDR Report Key: 10459420
• MDR Text Key: 204704576
• Report Number: MW5096295
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 03196537118
• UDI-Public: 03196537-118
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Type of Report: Initial
• Report Date: 08/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/04/2021
• Device Model Number: ORSIRO 2.25/13
• Device Catalogue Number: 401735
• Device Lot Number: 03196537
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Weight: 73