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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND ORSIRO (US) 3.0/9 CORONARY DRUG-ELUTING STENT

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BIOTRONIK AG, BUELACH, SWITZERLAND ORSIRO (US) 3.0/9 CORONARY DRUG-ELUTING STENT Back to Search Results
Model Number 401732
Device Problem Fracture
Event Date 01/15/2020
Event Type  Malfunction  
Event Description

An orsiro drug-eluting stent system was chosen for treatment. The lesion could not be crossed with the device. After withdrawal it was noticed that the stent seemed to be fractured.

 
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Brand NameORSIRO (US) 3.0/9
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 Key9741715
Report Number1028232-2020-00898
Device Sequence Number1
Product CodeNIQ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,USER F
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 01/31/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/21/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number401732
Device Catalogue NumberSEE MODEL NO.
Device LOT Number04193925
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/22/2020
Was Device Evaluated By Manufacturer? Yes
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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