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

Model Number 2.75 X 26MM

Device Problem Component Missing (2306)

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

Event Type  malfunction  

Event Description

Resolute onyx stent inserted through guide liner into right coronary.Unable to pass lesion.Stent system removed.Upon exiting the guide liner when removing stent, cvt noticed stent was missing off the balloon.Entire system was removed and onyx stent found lodged in guide liner.Stent and stent system retained.New guide catheter was inserted.Orsiro stent inserted through guide into right coronary.Unable to pass lesion.Stent delivery system was removed.Upon exiting the guide catheter, cvt reported orsiro stent was not on the balloon.Entire system was removed and inspected.Surgical table and pt table inspected by two staff members.Stent not found.Pt x-rayed and stent not found.Procedure continued for treatment.Pt transferred to ct after procedure.All items retained with chain of command.Fda safety report id# (b)(4).

• Brand Name: BIOTRONIK ORSIRO
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BIOTRONIK AG
• MDR Report Key: 9592237
• MDR Text Key: 175480679
• Report Number: MW5092242
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/08/2021
• Device Model Number: 2.75 X 26MM
• Device Lot Number: 04193488
• Is the Reporter a Health Professional?: 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 Outcome(s): Other
• Patient Weight: 81