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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 No Code Available (3191)
Date of Event 07/31/2020
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported via maude report mw5096781 that stent dislodgement occurred.The target lesion was located in the right coronary artery.A 3.50 x 12 synergy drug-eluting stent was advanced for treatment.However, the stent came off the balloon before inflation in the lesion.No further complications were 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 Key10823711
Report Number2134265-2020-15551
Device Sequence Number17093788
Product Code NIQ
UDI-Device Identifier08714729840060
UDI-Public08714729840060
Combination Product (Y/N)N
Initial Reporter StateOR
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 Other Health Care Professional
Type of Report Initial
Report Date (Section B) 11/11/2020
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 Date11/03/2021
Device Model Number10601
Device Catalogue Number10601
Device Lot Number0024792846
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 10/23/2020
Initial Report FDA Received Date11/11/2020
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;
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