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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 Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code Device Embedded In Tissue or Plaque (3165)
Date of Event 08/21/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Device is a combination product.
 
Event or Problem Description
It was reported that stent dislodgment occurred.The 80% stenosed target lesion was located in the mildly tortuous and mildly calcified left anterior descending artery.A 2.25 x 12 synergy drug-eluting stent was advanced for treatment.However, prior to deployment, the stent came off the balloon.The dislodged stent was trapped by another stent.The procedure was completed with another synergy stent.No patient complications were reported and the patient was 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 Key9009958
Report Number2134265-2019-11008
Device Sequence Number16738402
Product Code NIQ
UDI-Device Identifier08714729840022
UDI-Public08714729840022
Combination Product (Y/N)N
Initial Reporter StateOH
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) 09/12/2019
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 Expiration Date02/10/2021
Device Model Number10601
Device Catalogue Number10601
Device Lot Number0023363075
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 08/21/2019
Initial Report FDA Received Date09/12/2019
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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