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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SYNERGY XD; CORONARY DRUG-ELUTING STENT
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BOSTON SCIENTIFIC CORPORATION SYNERGY XD; CORONARY DRUG-ELUTING STENT Back to Search Results
Model Number H7493941832350
Medical Device Problem Code Material Deformation (2976)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 05/27/2021
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported that stent damage occurred.The 75% in-stent restenosed target lesion was located in the mildly tortuous middle right coronary artery (rca).Following pre-dilatation, a 3.50 x 32mm synergy xd drug-eluting stent was advanced without resistance being encountered and was deployed.Damage was then noted under angio/intravascular ultrasound.The stent had not been post dilated.Another synergy stent was deployed to cover the damaged portion of the stent.There were no patient complications nor injuries reported.
 
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Brand Name
SYNERGY XD
Common Device Name
CORONARY DRUG-ELUTING STENT
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key11971152
Report Number2134265-2021-07490
Device Sequence Number11885119
Product Code NIQ
UDI-Device Identifier08714729981084
UDI-Public08714729981084
Combination Product (Y/N)Y
Initial Reporter StateOH
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2021
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 06/09/2021
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 Date01/09/2023
Device Model NumberH7493941832350
Device Lot Number0026633338
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 05/28/2021
Initial Report FDA Received Date06/09/2021
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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