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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 Failure to Advance (2524)
Health Effect - Clinical Code Injury (2348)
Date of Event 07/21/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Device is a combination product.
 
Event or Problem Description
It was reported that an adverse patient event occurred.A 3.50 x 28 synergy ii drug-eluting stent was advanced but failed to cross the lesion.However, the inability to cross the lesion caused a significant delay to the procedure that resulted in an adverse patient event.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 Key10407557
Report Number2134265-2020-10239
Device Sequence Number14054349
Product Code NIQ
UDI-Device Identifier08714729840305
UDI-Public08714729840305
Combination Product (Y/N)N
Initial Reporter StateAR
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) 08/14/2020
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 Date11/06/2021
Device Model Number10605
Device Catalogue Number10605
Device Lot Number0024815471
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 07/23/2020
Initial Report FDA Received Date08/14/2020
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 Other;
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