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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND SYNSIRO 2.5/13 CORONARY DRUG-ELUTING STENT

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BIOTRONIK AG, BUELACH, SWITZERLAND SYNSIRO 2.5/13 CORONARY DRUG-ELUTING STENT Back to Search Results
Model Number 396934
Device Problem Fracture (1260)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/12/2020
Event Type  Malfunction  
Event Description

A synsiro drug-eluting stent system was chosen for treatment of the proximal riva. The synsiro was introduced but got stuck inside the guiding catheter and could not be move back and forward. During the attempt to withdrawal it the shaft of the device fractured.

 
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Brand NameSYNSIRO 2.5/13
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 Key10488836
MDR Text Key205517501
Report Number1028232-2020-03771
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 09/03/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/03/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL Number396934
Device Catalogue NumberSEE MODEL NO.
Device LOT Number03203170
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer08/20/2020
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/14/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured04/06/2020
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: 09/03/2020 Patient Sequence Number: 1
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