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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 H7493926224400
Device Problem Mechanical Problem (1384)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/01/2018
Event Type  Malfunction  
Manufacturer Narrative

Device is a combination product. Device evaluated by mfr: stent delivery system was returned for analysis. A visual examination of the stent found that on the distal section of the stent; stent struts were overlapping and bunched in a proximal direction. The undamaged proximal section of the crimped stent outer diameter was measured and was within the maximum crimped stent profile measurement. Stent damage most likely occurred due to interaction between the stent and the guide catheter extension. The balloon cones were reviewed and no issues were noted. The balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure. The tip was visually and microscopically examined and signs of damage were noted at the distal edge of the tip. This type of damage most likely occurred when the tip was pushed against a restriction. A visual and tactile examination found multiple kinks along several locations of the hypotube shaft. This type of damage is consistent with excessive force being applied on the delivery system. A visual and tactile examination of the outer and mid-shaft section found no issues with the extrusion shaft. The bi-component bond showed no signs of damage or strain. No other issues were identified during the product analysis. Hte manufacturing batch record review confirmed that the device met all material, assembly and performance specifications. The investigation conclusion is caused by other device as another device/drug/subsequent procedure caused the complaint event. (b)(4).

 
Event Description

Reportable based on device analysis completed on 06-april-2018. It was reported that device interaction occurred. The target lesion was located in a coronary artery. A 4. 00 x 24mm synergy¿ drug-eluting stent was advanced for treatment. However, the stent got caught in the collar part of the 6f non-bsc guide extension catheter. The stent was removed together with the guide extension catheter and the procedure was completed with a different device. No patient complications were reported and the patient's status was good. However, returned device analysis revealed distal stent damaged.

 
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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 Key7473189
MDR Text Key106916264
Report Number2134265-2018-03502
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,DISTRI
Reporter Occupation
Type of Report Initial
Report Date 04/06/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/30/2018
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 NumberH7493926224400
Device Catalogue Number39262-2440
Device LOT Number21074125
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer03/20/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/06/2018
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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