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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 10605
Medical Device Problem Code Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 08/01/2020
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Date of event: used the first day of the month of the bsc aware date since no event date provided.
 
Event or Problem Description
It was reported that stent dislodgement occurred.The target lesion was located in a very tortuous artery.A 3.50 x 28 synergy ii drug-eluting stent was advanced for treatment but failed to cross the lesion.However, the stent sheared off of the balloon and was recovered in the guideliner.No further information available.
 
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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 Key10567599
Report Number2134265-2020-13033
Device Sequence Number16930323
Product Code NIQ
UDI-Device Identifier08714729840305
UDI-Public08714729840305
Combination Product (Y/N)N
Initial Reporter StateMO
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 Other Health Care Professional
Type of Report Initial
Report Date (Section B) 09/22/2020
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 Date11/18/2021
Device Model Number10605
Device Catalogue Number10605
Device Lot Number0024840282
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 08/27/2020
Initial Report FDA Received Date09/22/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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