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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 10603
Medical Device Problem Code Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 07/01/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Date of event: used (b)(6) 2020 as the available information stated (b)(6) 2020 only.
 
Event or Problem Description
It was reported via medwatch (b)(4) that stent dislodgement occurred.A 4.00 x 20 synergy ii drug-eluting stent was advanced for treatment.However, during procedure, the stent was detached from the inflatable balloon.The physician was unable to recover the stent and so the device was deployed in the saphenous vein graft to posterior descending artery zone.No known patient 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 Key10513866
Report Number2134265-2020-11555
Device Sequence Number17028851
Product Code NIQ
UDI-Device Identifier08714729840190
UDI-Public08714729840190
Combination Product (Y/N)N
Initial Reporter StateAZ
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 Risk Manager
Type of Report Initial
Report Date (Section B) 09/10/2020
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 Date02/19/2022
Device Model Number10603
Device Catalogue Number10603
Device Lot Number0025259375
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 08/18/2020
Initial Report FDA Received Date09/10/2020
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 Age79 YR
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