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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 10601
Medical Device Problem Code Break (1069)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 04/04/2019
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Patient is approximately (b)(6) years old.Device is a combination product.
 
Event or Problem Description
It was reported that shaft break occurred.The target lesion was located in the right coronary artery.A 3.50 x 12mm synergy ii drug-eluting stent was advanced but failed to cross the lesion.The lesion was pre-dilated again and when the stent was inserted, the shaft kinked and subsequently snapped outside the patient's body.The procedure was completed with another of the same device.There was no patient complication nor blood loss 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 Key8566635
Report Number2134265-2019-04633
Device Sequence Number2260350
Product Code NIQ
UDI-Device Identifier08714729840060
UDI-Public08714729840060
Combination Product (Y/N)N
Initial Reporter StateIA
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) 04/30/2019
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 Date09/16/2020
Device Model Number10601
Device Catalogue Number10601
Device Lot Number0022705530
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 04/05/2019
Initial Report FDA Received Date04/30/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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