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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 Difficult to Advance (2920); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code No Code Available (3191)
Date of Event 10/11/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Device is a combination product.
 
Event or Problem Description
It was reported that the stent dislodged inside the patient.The target lesion was located in a coronary artery.A 3.50x16mm synergy ii drug-eluting stent was advanced for treatment.However, the device was unable to cross the lesion and during removal, the stent sheared off in the left main.A 4.0x12mm non-bsc stent was used to crush the detached stent to the vessel wall.No patient complications were reported and the patient's status was good.
 
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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 Key9328931
Report Number2134265-2019-13916
Device Sequence Number16712348
Product Code NIQ
UDI-Device Identifier08714729840121
UDI-Public08714729840121
Combination Product (Y/N)N
Initial Reporter StateNY
Initial Reporter CountryUS
PMA/510(K) Number
P150003
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 11/15/2019
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 Model Number10602
Device Catalogue Number10602
Device Lot Number0024056734
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 10/23/2019
Initial Report FDA Received Date11/15/2019
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;
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