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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND ORSIRO (US) 3.5/18 CORONARY DRUG-ELUTING STENT

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BIOTRONIK AG, BUELACH, SWITZERLAND ORSIRO (US) 3.5/18 CORONARY DRUG-ELUTING STENT Back to Search Results
Model Number 401751
Device Problem Fracture (1260)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/18/2020
Event Type  Malfunction  
Event Description

An orsio drug-eluting stents system was selected for treatment of the rca. During procedure the hypotube fractured approx. 5 inches from proximal end.

 
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Brand NameORSIRO (US) 3.5/18
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 Key9949275
MDR Text Key187256249
Report Number1028232-2020-01659
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,USER F
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 03/25/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/10/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number401751
Device Catalogue NumberSEE MODEL NO.
Device LOT Number06193108
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer04/01/2020
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/22/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured07/09/2019
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 04/10/2020 Patient Sequence Number: 1
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