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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 10621
Device Problem Fracture
Event Date 02/06/2020
Event Type  Injury  
Manufacturer Narrative

Device is a combination product.

 
Event Description

It was reported that stent fracture occurred. The patient underwent emergency cardiac catheterization that revealed significant stenosis in the right coronary artery (rca). The target lesion had diffuse involvement and high calcification. A guidezilla guidewire was used to improve support in advancing the devices through the lesion. A 2. 75x28mm synergy drug-eluting stent was initially implanted but angiography revealed stent fracture and a non-bsc stent was implanted in a proximal third. The fracture region consisted of the initial curve of the rca, where the guidezilla microcatheter was extensively manipulated. Another 2. 25 x 28mm synergy drug-eluting stent was advanced but during navigation in the guide catheter, resistance was noted and the stent was trapped in the initial portion of the guidezilla guide catheter. The devices were removed and it was noticed that the stent mesh was damaged. The procedure was completed with another of the same device. No further patient complications were reported.

 
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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 Key9825493
Report Number2134265-2020-02704
Device Sequence Number1
Product CodeNIQ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,DISTRI
Reporter Occupation
Type of Report Initial
Report Date 03/12/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/12/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number10621
Device Catalogue Number10621
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 Received02/20/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/19/2019
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: 03/12/2020 Patient Sequence Number: 1
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