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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SYNERGY CORONARY DRUG-ELUTING STENT

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BOSTON SCIENTIFIC CORPORATION SYNERGY CORONARY DRUG-ELUTING STENT Back to Search Results
Model Number 10622
Device Problems Fracture; Difficult to Remove
Event Date 10/12/2019
Event Type  Malfunction  
Manufacturer Narrative

Device is a combination product.

 
Event Description

It was reported that difficulty removing a stent and shaft break occurred. A 4. 5 x 32 synergy stent balloon and a 5. 00 x 32 synergy stent balloon were deployed in the target lesion. Post deployment, the 4. 5 x 32 synergy stent was removed with difficulty through the 6f catheter. When removing the 5. 00 x 32 synergy stent, greater difficulty was experienced and the shaft broke inside the guide catheter. It was noted that the cause of the shaft to break occurred after the balloon had been deflated and was likely due to the hard friction occurring while removing the device. The device was completely removed and the procedure was completed with another of the same device. No patient complications were reported in relation to this event and the patient was reported to be stable following the procedure.

 
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Brand NameSYNERGY
Type of DeviceCORONARY DRUG-ELUTING STENT
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
ballybrit business park
galway
EI 
Manufacturer Contact
jay johnson
two scimed place
maple grove , MN 55311
7634942574
MDR Report Key9292307
Report Number2134265-2019-13378
Device Sequence Number1
Product CodeNIQ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/08/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received11/07/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date01/28/2020
Device MODEL Number10622
Device Catalogue Number10622
Device LOT Number0022505680
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer11/27/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/19/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured08/01/2018
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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