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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 10623
Device Problem Failure to Advance (2524)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/27/2020
Event Type  Malfunction  
Manufacturer Narrative

Device evaluation by mfr. : synergy ous mr 3. 50 x 38mm stent delivery system was returned for analysis. An examination of the crimped stent identified stent damage with middle stent struts lifted and pulled from crimped position. The undamaged crimped stent outer diameter was measured and the result was within max crimped stent profile measurement. The balloon was 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 tactile examination of the hypotube found multiple hypotube kinks. A examination of the shaft polymer extrusion found no issues. An examination of the tip found damage to the tip. No other issues were identified during the product analysis.

 
Event Description

Reportable based on device analysis completed on 09sep2020. It was reported that crossing difficulty was encountered. The 80% stenosed target lesion was located in the moderately tortuous and severely calcified right coronary artery. Following pre-dilatation, a 3. 50 x 38 synergy ii drug-eluting stent was advanced but failed to cross the lesion. The procedure was completed with another of the same device. No patient complications nor injuries were reported. 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 Key10609541
MDR Text Key209350534
Report Number2134265-2020-13559
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 Number10623
Device Catalogue Number10623
Device LOT Number0024765878
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer08/12/2020
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 Manufactured11/04/2019
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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