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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND ORSIRO 3.0/18 CORONARY DRUG-ELUTING STENT SYSTEM

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BIOTRONIK AG, BUELACH, SWITZERLAND ORSIRO 3.0/18 CORONARY DRUG-ELUTING STENT SYSTEM Back to Search Results
Model Number 364490
Device Problem Fracture
Event Date 01/28/2020
Event Type  Malfunction  
Event Description

An orsiro drug-eluting stent system was selected for treatment of a lesion in a proximal rca by direct stenting. After implantation the orsiro stent seemed fractured on the angiographic images.

 
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Brand NameORSIRO 3.0/18
Type of DeviceCORONARY DRUG-ELUTING STENT SYSTEM
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 Key9757313
Report Number1028232-2020-00945
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 02/25/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/26/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number364490
Device Catalogue NumberSEE MODEL NO.
Device LOT Number01194680
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/07/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured02/13/2019
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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