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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 10616
Device Problem Fracture
Event Date 11/20/2019
Event Type  Injury  
Manufacturer Narrative

Device is a combination product.

 
Event Description

It was reported that stent fracture occurred. The 80% stenosed target lesion was located in the middle left anterior descending artery. A 4. 00 x 8 synergy drug-eluting stent was advanced for treatment. However, during inflation of the 5. 5x8 nc balloon at 12 atmospheres, it was noticed that the stent was fractured. Another stent was implanted overlapping the synergy stent. There were no patient complications 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 CORPORATION
ballybrit business park
galway
EI 
Manufacturer Contact
jay johnson johnson
two scimed place
maple grove , MN 55311
7634942574
MDR Report Key9416725
Report Number2134265-2019-14880
Device Sequence Number1
Product CodeNIQ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/20/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/05/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date12/02/2019
Device MODEL Number10616
Device Catalogue Number10616
Device LOT Number0022224904
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer01/21/2020
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? Yes
Date Device Manufactured06/05/2018
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: 12/05/2019 Patient Sequence Number: 1
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