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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 10610
Medical Device Problem Code Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes Device Embedded In Tissue or Plaque (3165); No Code Available (3191)
Date of Event 03/04/2020
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 90% stenosed target lesion was located in the severely tortuous and heavily calcified circumflex artery.A 2.50 x 16 synergy drug-eluting stent was advanced for treatment.However, the stent was dislodged from the delivery system.The stent was located in the vessel and was subsequently crushed and secured by a new stent.The procedure was completed and no patient complications nor injuries were reported.The patient was discharged.
 
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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 Key9898103
Report Number2134265-2020-03787
Device Sequence Number2415932
Product Code NIQ
UDI-Device Identifier08714729840572
UDI-Public08714729840572
Combination Product (Y/N)N
Initial Reporter StateTN
Initial Reporter CountryUS
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) 03/30/2020
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 Date03/27/2021
Device Model Number10610
Device Catalogue Number10610
Device Lot Number0023634067
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 03/09/2020
Initial Report FDA Received Date03/30/2020
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 Required Intervention;
Patient Age74 YR
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