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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY SYNERGY¿ CORONARY DRUG-ELUTING STENT

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BOSTON SCIENTIFIC - GALWAY SYNERGY¿ CORONARY DRUG-ELUTING STENT Back to Search Results
Model Number H7493926238220
Device Problems Stent (515); Bent (1059)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/06/2018
Event Type  Malfunction  
Manufacturer Narrative

Age at time of event: 18 years or older.   device is a combination product.   (b)(4). The device was not returned for analysis. The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications. The investigation conclusion is operational context as the product meets the design and manufacture specification but due to anatomical/procedural factors encountered during the procedure, performance was limited. (b)(4).

 
Event Description

Same case as mdr# 2134265-2018-05654. It was reported that stent damage occurred. Vascular access was obtained via the femoral artery. The 95% stenosed, 20-38mm x 2. 25-3. 0mm, eccentric and the de novo target lesion was located in the mildly tortuous and mildly calcified mid to distal right coronary artery extending to the bifurcation of the left circumflex artery. The lesion contained between a 45 and 95 degree bend. A 2. 50 x 20mm synergy¿ drug-eluting stent (des) was advanced for treatment; however, significant resistance was encountered during advancing. When the device was removed, it was noted that the stent was damaged. A 2. 25 x 38mm synergy¿ des was advanced but difficulty insertion into the lesion was also encountered. The device was removed and it was noted that the stent was deformed. Finally, the procedure was completed with another of same device. No patient 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 - GALWAY
Manufacturer (Section G)
BOSTON SCIENTIFIC - GALWAY
Manufacturer Contact
sonali arangil
one scimed place
maple grove, MN 55311
7634941700
MDR Report Key7655015
MDR Text Key112889536
Report Number2134265-2018-05655
Device Sequence Number1
Product Code NIQ
Combination Product (Y/N)N
Reporter Country CodeTW
PMA/PMN NumberSIMILAR
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 06/06/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/02/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date05/27/2019
Device MODEL NumberH7493926238220
Device Catalogue Number39262-3822
Device LOT Number0021498465
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 Received06/06/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured11/28/2017
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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