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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 10620
Device Problem Fracture
Event Date 01/02/2019
Event Type  Injury  
Manufacturer Narrative

Device is a combination product.

 
Event Description

It was reported that stent fracture occurred. Vascular access was obtained via radial and femoral artery. The 70% stenosed, 34mm x 4. 0mm eccentric and the de novo target lesion was located in the moderately calcified, non tortuous left circumflex artery. The patients ejection fraction was 30%. Predilation was performed, leaving 50% residual stenosis in the lesion. A 4. 00 x 24mm synergy ii drug-eluting stent was implanted in the lesion; however, it was noted that the stent fragmented and was dismantled. The procedure was completed with a different device. No further patient complications were reported and the patient's status was stable.

 
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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 IRELAND LIMITED
ballybrit business park
galway
EI 
Manufacturer Contact
sonali arangil
two scimed place
maple grove , MN 55311
6515827403
MDR Report Key8268860
Report Number2134265-2019-00237
Device Sequence Number1
Product CodeNIQ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,DISTRI
Reporter Occupation
Type of Report Initial
Report Date 01/22/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/22/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date11/06/2019
Device MODEL Number10620
Device Catalogue Number10620
Device LOT Number0022136215
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 Received01/02/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured05/10/2018
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: 01/22/2019 Patient Sequence Number: 1
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