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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SYNERGY CORONARY DRUG-ELUTING STENT

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BOSTON SCIENTIFIC CORPORATION SYNERGY CORONARY DRUG-ELUTING STENT Back to Search Results
Model Number 10621
Device Problem Human-Device Interface Problem
Event Date 08/22/2019
Event Type  Malfunction  
Manufacturer Narrative

Device is a combination product. Device evaluated by mfr. : the device was returned for analysis. A visual examination of the stent found stent damage. Stent struts form the 5th distal stent strut row were found to be lifted from their crimped positions and pulled proximally. The undamaged stent outer diameter was measured and the result was within maximum crimped stent profile measurement. A review of the manufacturing stent profile data was performed and the stent length at the time of manufacture was within max crimped stent length measurement. 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. A visual and microscopic examination of the bumper tip showed signs of damage. A visual and tactile examination of the hypotube found no issues. A visual and tactile examination of the outer and mid-shaft section and a visual examination of the inner lumen found no issues along the shaft polymer extrusion. No other issues were identified during the product analysis.

 
Event Description

Reportable based on device analysis completed on 08-oct-2019. It was reported that stent failure to cover the lesion was encountered. A 2. 75 x 28 synergy drug-eluting stent was advanced for treatment. However, during advancing, it was noticed that the stent was shorter than the lesion and it failed to cover the lesion. The procedure was completed with another of the same device. No patient complications were reported and the patient's status was stable. However, returned device analysis revealed stent damage.

 
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Brand NameSYNERGY
Type of DeviceCORONARY DRUG-ELUTING STENT
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
ballybrit business park
galway
EI 
Manufacturer Contact
jay johnson
two scimed place
maple grove , MN 55311
7634942574
MDR Report Key9226886
Report Number2134265-2019-12660
Device Sequence Number1
Product CodeNIQ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial
Report Date 10/23/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/23/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number10621
Device Catalogue Number10621
Device LOT Number0023568036
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer09/17/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/08/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured03/19/2019
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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