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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 10608
Medical Device Problem Codes Difficult to Remove (1528); Failure to Advance (2524); Material Deformation (2976)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 09/30/2021
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that stent damage and removal difficulty occurred.A 3.00 x 8 synergy ii drug-eluting stent was advanced for treatment but it failed to cross the lesion.It was noted that the stent was frayed and that it was hard to remove.There were no patient complications reported.
 
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Brand Name
SYNERGY
Common Device Name
BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key12638588
Report Number2134265-2021-12809
Device Sequence Number3292273
Product Code NIQ
UDI-Device Identifier08714729840473
UDI-Public08714729840473
Combination Product (Y/N)Y
Initial Reporter StateOH
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 10/15/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Expiration Date05/10/2023
Device Model Number10608
Device Catalogue Number10608
Device Lot Number0027365961
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 10/01/2021
Initial Report FDA Received Date10/15/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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