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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND ORSIRO 2.25/40 CORONARY DRUG-ELUTING STENT

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BIOTRONIK AG, BUELACH, SWITZERLAND ORSIRO 2.25/40 CORONARY DRUG-ELUTING STENT Back to Search Results
Model Number 391238
Device Problem Fracture
Event Date 07/15/2019
Event Type  Malfunction  
Event Description

An orsiro drug-eluting stent system was chosen to treat a calcified lesion in the lad. The shaft of the delivery system broke at the distal part during attempt to position the orsiro stent.

 
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Brand NameORSIRO 2.25/40
Type of DeviceCORONARY DRUG-ELUTING STENT
Manufacturer (Section D)
BIOTRONIK AG, BUELACH, SWITZERLAND
ackerstrasse 6
buelach CH-81 80
CH  CH-8180
Manufacturer Contact
6024 jean road
lake oswego , OR 97035
8772459800
MDR Report Key9269966
Report Number1028232-2019-04831
Device Sequence Number1
Product CodeNIQ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 11/01/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received11/02/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number391238
Device Catalogue NumberSEE MODEL NO.
Device LOT Number10186961
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer10/29/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/09/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured11/15/2018
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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