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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 Fracture (1260)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 02/01/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Date of event: used the first date of the month of the aware date as no event date was provided.Device is a combination product.
 
Event or Problem Description
It was reported that shaft break occurred.A 2.25 x 12 synergy ii drug-eluting stent was advanced for treatment.However, it was found that the stent fractured inside the patient.The patient was treated by implanting another stent over the fractured stent.No patient complications were reported and the patients status is fine.
 
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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 Key9794761
Report Number2134265-2020-02523
Device Sequence Number11406413
Product Code NIQ
UDI-Device Identifier08714729840022
UDI-Public08714729840022
Combination Product (Y/N)N
Initial Reporter StateCA
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) 03/05/2020
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 Date09/15/2021
Device Model Number10601
Device Catalogue Number10601
Device Lot Number0024486410
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 02/17/2020
Initial Report FDA Received Date03/05/2020
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
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