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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY SYNERGY II EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM

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BOSTON SCIENTIFIC - GALWAY SYNERGY II EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM Back to Search Results
Model Number H7493926020250
Device Problems Stylet; Device Damaged Prior to Use ; Physical Resistance
Event Date 09/14/2016
Event Type  Malfunction  
Manufacturer Narrative

Device is a combination product. (b)(4). Device evaluated by mfr. : the stent delivery system (sds) was returned for analysis without the distal part of the device including parts of the midshaft, outer, inner , balloon, stent and tip. A visual and tactile examination of the midshaft section found the midshaft broken at 164mm distal from the hypotube to the midshaft bond. The damage most likely occurred due to excessive tensile force being applied to the delivery system. A review of the outer extrusion, inner lumen and bi-component bond could not be completed as the distal part of the device was not returned for examination. Additional information on how the distal part detached and if it was still available for analysis had been requested from the customer however no response was received. A visual and tactile examination found the corewire kinked and no other issues with the hypotube shaft. This type of damage is consistent with excessive force being applied to the delivery system. Distal part of the delivery catheter was not returned for analysis. The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications. The most probable root cause was unable to be determined. (b)(4).

 
Event Description

Reportable based on device analysis completed on 14-dec-2016. It was reported that difficulty prepping device was encountered. During preparation of a 2. 50 x 20 synergy ii drug-eluting stent, the stylet got stuck in the stent and could not be removed. The procedure was completed with another 2. 50 x 20 synergy ii drug-eluting stent. No patient complications were reported. However, returned device analysis revealed shaft break.

 
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Brand NameSYNERGY II EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM
Type of DeviceBIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM
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 Key6237462
Report Number2134265-2016-12201
Device Sequence Number1
Product CodeNIQ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 12/14/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/10/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date03/22/2017
Device MODEL NumberH7493926020250
Device Catalogue Number39260-2025
Device LOT Number0019075247
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer10/11/2016
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/14/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured04/08/2016
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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