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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND ORSIRO CORONARY DRUG ELUDING STENT

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BIOTRONIK AG, BUELACH, SWITZERLAND ORSIRO CORONARY DRUG ELUDING STENT Back to Search Results
Catalog Number SEE MODEL NO.
Device Problem Physical Resistance/Sticking (4012)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/15/2019
Event Type  Malfunction  
Event Description

After the successful implantation of the orsiro drug-eluting stent system it was decided to place another stent distal to the orsiro. As it was attempted to deliver it through the orsiro the stent got caught at the struts of the orsiro. Therefore the stent was crushed against the wall of the implanted orsiro.

 
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Brand NameORSIRO
Type of DeviceCORONARY DRUG ELUDING 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 Key9069871
MDR Text Key158636479
Report Number1028232-2019-04012
Device Sequence Number1
Product Code NIQ
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberP170030
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 08/16/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/16/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberSEE MODEL NO.
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 Received11/06/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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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