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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 Failure to Advance (2524)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/16/2020
Event Type  Malfunction  
Manufacturer Narrative

Device evaluated by manufacturer: a synergy 2. 25 x 16 mm stent delivery system was returned for analysis. A visual examination of the stent found signs of stent damage. Stent struts from the mid to distal stent region were noted to be lifted form their crimped position and pulled in a distal direction over the distal balloon cone. The undamaged 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 no signs of damage. A visual and tactile examination of the hypotube shaft found multiple kinks along the length of the hypotube shaft as well as a kink in the lasercut region measured at 345 mm proximal to the distal tip. A visual examination of the outer and inner lumen and mid-shaft section found multiple kinks along the length of the shaft polymer extrusion. No other issues were identified during the product analysis.

 
Event Description

Reportable based on device analysis completed on 07sep2020: it was reported that crossing difficulty occurred. The target lesion was located in the left coronary artery. A 2. 25 mm x 16 mm synergy drug eluting stent was advanced but failed to cross the lesion. The procedure was completed with another of 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 Key10610895
MDR Text Key209350828
Report Number2134265-2020-13576
Device Sequence Number1
Product Code NIQ
Combination Product (Y/N)N
Reporter Country CodeCH
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 09/30/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/30/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date07/19/2020
Device MODEL Number10618
Device Catalogue Number10618
Device LOT Number0023243401
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer08/10/2020
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/07/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured01/21/2019
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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