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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 Problems Fracture; Activation Failure
Event Date 04/25/2019
Event Type  Injury  
Manufacturer Narrative

Device is a combination product.

 
Event Description

It was reported that stent fracture and under-expansion of the stent occurred. The 70% stenosed target lesion was located in the proximal left anterior descending artery. Following deployment of a 2. 50 x 28 synergy drug-eluting stent, post dilatation was performed with a 3. 0 x 12 mm quantum nc balloon. After angiographic control, it was observed that there was an important under-expansion area in the stent body with an intra-stent haziness. Intravascular ultrasound revealed a fracture area of the newly implanted stent (discontinuation of the struts) and longitudinal retraction. A 2. 75 x 38 mm drug-eluting stent was implanted to complete the procedure safely. The patient progressed well, without elevation of cardiac markers after intervention, and was discharged after 48 hours. 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 Key9136457
Report Number2134265-2019-11710
Device Sequence Number1
Product CodeNIQ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial
Report Date 09/30/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/30/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date03/25/2020
Device MODEL Number10621
Device Catalogue Number10621
Device LOT Number0022755854
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 Received09/11/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/27/2018
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: 09/30/2019 Patient Sequence Number: 1
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