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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 10618
Device Problem Human-Device Interface Problem
Event Date 10/11/2018
Event Type  Malfunction  
Manufacturer Narrative

Device is a combination product.

 
Event Description

Reportable based on device analysis completed on 15nov2018. It was reported that stent could not be used due to vessel calcification. The target lesion was located in the carotid artery. A 3. 50x16 synergy ii drug-eluting stent was selected for use to treat the lesion. However, it was noted that the vessel calcification was changed and the stent could not be used. The procedure was completed with another of the same device. No patient complications were reported and the patient status was stable. However, returned device analysis revealed stent damage. Synergy ous mr 3. 50 x 16 mm stent delivery system was returned for analysis. A visual and microscopic examination found that the first proximal stent row was flared. The undamaged crimped stent outer diameter was measured and the result was within maximum crimped stent profile 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 the inner lumen and mid-shaft section found no issues along the shaft polymer extrusion. No other issues were identified during the product analysis.

 
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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 IRELAND LIMITED
ballybrit business park
galway
EI 
Manufacturer Contact
sonali arangil
two scimed place
maple grove , MN 55311
6515827403
MDR Report Key8148541
Report Number2134265-2018-63718
Device Sequence Number1
Product CodeNIQ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,DISTRI
Reporter Occupation
Type of Report Initial
Report Date 12/10/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/10/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date09/08/2019
Device MODEL Number10618
Device Catalogue Number10618
Device LOT Number0021892423
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer11/08/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/15/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured03/12/2018
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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