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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 10609
Medical Device Problem Code Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code No Code Available (3191)
Date of Event 01/09/2020
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 target lesion was located in the circumflex artery.A 2.25 x 12 synergy drug-eluting stent was advanced but upon tracking the very sharp angled lesion, the stent came off the balloon and had to be deployed proximal to the target lesion.Difficulty treating the target lesion was then encountered because they were trying to get an additional stent through the stent deployed in the wrong location.They had to balloon repeatedly with a non-compliant balloon catheter to complete the procedure.No 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 Key9654388
Report Number2134265-2020-00551
Device Sequence Number16715325
Product Code NIQ
UDI-Device Identifier08714729840503
UDI-Public08714729840503
Combination Product (Y/N)N
Initial Reporter StateOH
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2020
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 01/31/2020
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 Date07/17/2021
Device Model Number10609
Device Catalogue Number10609
Device Lot Number0024176477
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 01/09/2020
Initial Report FDA Received Date01/31/2020
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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