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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 10619
Device Problems Fracture; Obstruction of Flow
Event Date 10/13/2018
Event Type  Injury  
Manufacturer Narrative

Age at time of event: 18 years or older. Device is a combination product.

 
Event Description

It was reported that acute stent thrombosis and stent fracture occurred. The 80% stenosed target lesion was located in the moderately tortuous and moderately calcified mid left anterior descending artery. A 3. 00x20mm synergy drug-eluting stent was deployed to treat the lesion. After the physician inserted the stent into the lesion, dilatation was conducted with the original stent balloon. However, it was noted that a slight thrombus was found in the lesion where the stent was inserted and the strut of the stent was fractured. Following post dilatation with a non-bsc non-compliant balloon, the fracture of the strut was more clearly visible. The procedure was completed with a longer 3. 0x28mm synergy drug-eluting stent. No further patient complications were reported and the patient was stabilized. The patient was safely treated and discharged. After three days follow-up examination showed that there was still a small amount of thrombus left. The physician decided to take an angiography after six months and watch the patient's progress.

 
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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 Key8013693
Report Number2134265-2018-62199
Device Sequence Number1
Product CodeNIQ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial
Report Date 10/29/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/29/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date12/10/2019
Device MODEL Number10619
Device Catalogue Number10619
Device LOT Number0022262514
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 Received10/20/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured06/13/2018
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: 10/29/2018 Patient Sequence Number: 1
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