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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 10619
Device Problem Failure to Advance (2524)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/21/2020
Event Type  Malfunction  
Manufacturer Narrative

Device evaluated by mfr. : synergy ous mr 2. 50 x 20mm stent delivery system was returned for analysis. A visual examination of the stent found stent damage with struts in proximal region pulled distally. The undamaged stent outer diameter was measured using snap gauge, and the result is within maximum crimped stent profile measurement. The balloon cones were reviewed, and no issues were noted. The balloon wings were tightly wrapped, evenly folded, and were not subjected to positive pressure. A visual and microscopic examination of the bumper tip showed no signs of tip damage. A visual and tactile examination of the hypotube found multiple kinks. A visual and tactile examination of the outer and inner lumen, and mid-shaft section 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 09sep2020. It was reported that crossing difficulties were encountered. The 90% stenosed target lesion was located in the moderately tortuous, and severely calcified right coronary artery. Following pre-dilatation, a 2. 50 x 20mm synergy drug-eluting stent was advanced, but failed to cross the lesion. The procedure was completed with a different device. No patient complications were reported, and patient status was good. 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 Key10608784
MDR Text Key209242342
Report Number2134265-2020-13554
Device Sequence Number1
Product Code NIQ
Combination Product (Y/N)N
Reporter Country CodeKS
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 MODEL Number10619
Device Catalogue Number10619
Device LOT Number0024489973
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer08/17/2020
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/09/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured09/16/2019
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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