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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 H7493926216400
Device Problems Stent (515); Bent (1059)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/30/2018
Event Type  Malfunction  
Manufacturer Narrative

Device is a combination product. (b)(4). Device evaluated by mfr. : synergy ous mr 4. 00 x 16mm stent delivery system was returned for analysis. An examination of the crimped stent revealed proximal stent damage. Proximal struts 1- 5 were damage with struts lifted and pulled in a distal direction. The remainder of the stent was undamaged. The undamaged crimped stent outer diameter was within the specification. The balloon cones were reviewed and there were no issues to note. The balloon wings were tightly wrapped and evenly folded. A visual and tactile examination of the hypotube revealed multiple kinks. An examination of the shaft polymer extrusion found no issues. There were no signs of damage or strain to the port bond. The tip was visually examined and damage was noted. No other issues were identified during the product analysis. The investigation conclusion is operational context as the product meets the design & manufacture specification but due to anatomical/procedural factors encountered during the procedure, performance was limited. (b)(4).

 
Event Description

It was reported that stent damage occurred. The 85% stenosed target lesion was located in the severely tortuous and moderately calcified left main trunk of the coronary artery. A 4. 00 x 16 synergy¿ stent was advanced but it failed to cross the tortuous part in the area before reaching the lesion. Pre-dilatation was performed several times and the physician re-inserted the device but it still failed to cross. It was further reported that the stent damaged occurred during the second insertion. No replacement device was available and the procedure was completed with plain old balloon angioplasty. No patient complications were reported and the patient's status was good.

 
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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 Key7664278
MDR Text Key113285418
Report Number2134265-2018-05861
Device Sequence Number1
Product Code NIQ
Combination Product (Y/N)N
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 Date02/11/2019
Device MODEL NumberH7493926216400
Device Catalogue Number39262-1640
Device LOT Number21070597
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/04/2018
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? Yes
Date Device Manufactured09/10/2017
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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