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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SYNERGY BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM

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BOSTON SCIENTIFIC CORPORATION SYNERGY BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM Back to Search Results
Model Number 10607
Device Problem Failure to Advance (2524)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/15/2020
Event Type  Malfunction  
Manufacturer Narrative

A synergy ii us mr 4. 00 x 38mm stent delivery system was returned for analysis. An examination of the crimped stent identified proximal stent damage with stent strut lifted and bunched distally. The undamaged crimped stent outer diameter 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 no issues. 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. A 4. 00 x 38mm synergy drug eluting stent was advanced for treatment; however, the stent could not cross the lesion. There were no patient complications reported. However, returned device analysis revealed stent damage.

 
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Brand NameSYNERGY
Type of DeviceBIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM
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 Key10609752
MDR Text Key209351724
Report Number2134265-2020-13563
Device Sequence Number1
Product Code NIQ
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberP150003
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
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 Number10607
Device Catalogue Number10607
Device LOT Number0024998257
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer08/11/2020
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 Manufactured01/02/2020
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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