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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 H7493926228400
Device Problems Stent (515); Bent (1059)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/13/2018
Event Type  Malfunction  
Manufacturer Narrative

Age at time of event: 18 years or older. Device is a combination product. (b)(4). Device evaluated by mfr: 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 id: 2134265-2018-05887. It was reported that stent damage occurred. The target lesion was located in a mildly tortuous and moderately calcified coronary artery. A 4. 00 x 28mm synergy¿ drug-eluting stent was advanced but failed to cross the lesion. However, when the device was removed, it was noted that distal end of the stent struts were flared. Pre-dilation was then performed, another 4. 00 x 28mm synergy¿ drug-eluting stent was advanced but also failed to cross the lesion and when the device was removed, it was also noted that the distal end of the stent struts were flared. The procedure was completed with another two 4. 0mm synergy stent. 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 Key7664195
MDR Text Key113287704
Report Number2134265-2018-05888
Device Sequence Number1
Product Code NIQ
Combination Product (Y/N)N
Reporter Country CodeHK
PMA/PMN NumberSIMILAR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial
Report Date 06/13/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/05/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date01/23/2019
Device MODEL NumberH7493926228400
Device Catalogue Number39262-2840
Device LOT Number21013601
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 Received06/13/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured08/24/2017
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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