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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 H7493926228300
Device Problems Stent (515); Stretched (1601)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/02/2016
Event Type  Malfunction  
Manufacturer Narrative

Device is a combination product. (b)(4).

 
Event Description

It was reported that stent damage occurred. The target lesion was located in a calcified coronary artery. A 3. 00 x 28 synergy¿ drug-eluting stent was advanced but failed to cross the lesion. When the device was attempted to be removed, the device came into contact with the calcification and the stent became stretched. The procedure was completed with another 3. 00 x 28 synergy¿ drug-eluting stent. No patient complications were reported and the patient's status was good.

 
Manufacturer Narrative

Device evaluated by mfr. : the stent delivery system (sds) was returned for analysis. A visual examination of the crimped stent found distal stent damage with struts from the 11th most proximal row onwards, distorted, lifted from the stent profile and stretched distally on the bumper tip. The outer diameter (od) of the undamaged proximal side of the stent was measured and was within specifications. 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 bumper tip of the device showed no signs of damage. A visual and tactile examination found multiple kinks along the hypotube shaft. This type of damage is consistent with excessive force being applied to the delivery system. A visual and tactile examination of the outer and mid-shaft section found no issues. The inner lumen and bi-component bond showed no signs of damage or strain. No other issues were identified during the product analysis. The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications. The most probable root cause is operational context as device performance was limited due to anatomical/procedural factors. (b)(4).

 
Event Description

It was reported that stent damage occurred. The target lesion was located in a calcified coronary artery. A 3. 00 x 28 synergy¿ drug-eluting stent was advanced but failed to cross the lesion. When the device was attempted to be removed, the device came into contact with the calcification and the stent became stretched. The procedure was completed with another 3. 00 x 28 synergy¿ drug-eluting stent. 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 Key6190709
MDR Text Key62913759
Report Number2134265-2016-11769
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,Followup
Report Date 12/02/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/20/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date11/13/2017
Device MODEL NumberH7493926228300
Device Catalogue Number39262-2830
Device LOT Number19275429
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer12/07/2016
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/11/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured06/01/2016
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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