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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND ORSIRO 2.5/15 CORONARY DRUG-ELUTING STENT SYSTEM

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BIOTRONIK AG, BUELACH, SWITZERLAND ORSIRO 2.5/15 CORONARY DRUG-ELUTING STENT SYSTEM Back to Search Results
Model Number 364482
Device Problem Fracture (1260)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/21/2020
Event Type  Malfunction  
Event Description

An orsiro drug-eluting stent system was selected for treatment of a moderately calcified lesion (75 percent stenosis degree) in a severely tortuous lad. After predilatation it was tried to cross the lesion with the orsiro but after several attempts the shaft broke. Therefore the system was removed from the patients body.

 
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Brand NameORSIRO 2.5/15
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 Key10422809
MDR Text Key203449730
Report Number1028232-2020-03465
Device Sequence Number1
Product Code NIQ
Combination Product (Y/N)N
Reporter Country CodeCH
PMA/PMN NumberP170030
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 08/17/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/18/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number364482
Device Catalogue NumberSEE MODEL NO.
Device LOT Number01191529
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 Received10/13/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured02/01/2019
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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