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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 10602
Medical Device Problem Codes Break (1069); Material Deformation (2976)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 12/07/2020
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported that shaft break occurred.The 99% stenosed targe lesion was located in the right coronary artery.A 3.00 x 16 synergy drug-eluting stent was advanced for treatment.However, during procedure, it was noted that stent shaft was kinked while advancing and found that the shaft was broken during removal.A buddy wire was introduced.The physician advanced a balloon over the buddy wire to trap the synergy delivery system in the guide catheter.Once trapped, the entire system was removed.The lesion was rewired and treated successfully with a new stent.No patient complications were 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 Key11012994
Report Number2134265-2020-17828
Device Sequence Number3944733
Product Code NIQ
UDI-Device Identifier08714729840114
UDI-Public08714729840114
Combination Product (Y/N)N
Initial Reporter StateTN
Initial Reporter CountryUS
PMA/510(K) Number
P150003
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 12/15/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Expiration Date10/07/2022
Device Model Number10602
Device Catalogue Number10602
Device Lot Number0026182008
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 12/08/2020
Initial Report FDA Received Date12/15/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
Patient Age77 YR
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