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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 Problems Failure to Advance (2524); Material Deformation (2976)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/07/2020
Event Type  Malfunction  
Event Description

It was reported that stent damage occurred. Vascular access was obtained via the femoral artery. The 95% stenosed, 3. 0mmx24mm, eccentric, restenotic target lesion containing a bend between >45 and <90 degrees was located in the mildly tortuous and mildly calcified mid to proximal left circumflex artery. A 6f non-bsc guide catheter and a non-bsc guide wire were used to cross the lesion and pre-dilation was then performed with a non-bsc balloon resulting in 85% residual stenosis. A 3. 00 x 24 synergy drug-eluting stent was advanced for treatment, however, the device failed to cross the lesion. Upon removal, the tip of the stent itself was found to be deformed. The procedure was completed with another of the same device. 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
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key10603896
MDR Text Key209157926
Report Number2134265-2020-13503
Device Sequence Number1
Product Code NIQ
Combination Product (Y/N)N
Reporter Country CodeTW
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,DISTRI
Reporter Occupation
Type of Report Initial
Report Date 09/29/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/29/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number10620
Device Catalogue Number10620
Device LOT Number0024222795
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 Received09/07/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/29/2019
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: 09/29/2020 Patient Sequence Number: 1
Treatment
BALLOON CATHETERS: M2 1.5/20, 3.0/20; GUIDE CATHETER: EBU 3.5 6F; GUIDE WIRE: SION BLUE, FC
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