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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 Problem Fracture
Event Date 10/08/2018
Event Type  Injury  
Manufacturer Narrative

Device is a combination product.

 
Event Description

It was reported that stent fracture occurred. Vascular access was obtained via the femoral artery. The completely occluded, eccentric target lesion was located in the moderately tortuous and severely calcified left anterior descending artery. After crossing the lesion with a wire, pre-dilation was performed with a 2. 5x12mm balloon obtaining a flow. Subsequently, a 2. 75 x 32mm synergy ii drug-eluting stent was implanted where eccentric calcification was noted proximal to the implanted stent. It was then found after post dilation under fluoroscopy, that a stent fracture occurred. The procedure was completed by covering the gap with another synergy stent. No 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 Key8067366
Report Number2134265-2018-62763
Device Sequence Number1
Product CodeNIQ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,DISTRI
Reporter Occupation
Type of Report Initial
Report Date 11/13/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/13/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date10/22/2019
Device MODEL Number10622
Device Catalogue Number10622
Device LOT Number0022104036
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 Received10/21/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured04/25/2018
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: 11/13/2018 Patient Sequence Number: 1
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