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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 H7493941820300
Medical Device Problem Code Fracture (1260)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 07/21/2021
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported that stent fracture post deployment occurred requiring additional intervention.The target lesion was located in the left anterior descending artery.A 3.00 x 20mm synergy xd drug-eluting stent was implanted.However, post deployment, a stent fracture in the mid portion of the device was noted.A second stent was placed and additional balloons were used to complete the procedure.There were no patient complications reported and the patient status was stable.
 
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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 Key12288921
Report Number2134265-2021-09869
Device Sequence Number20001587
Product Code NIQ
UDI-Device Identifier08714729980971
UDI-Public08714729980971
Combination Product (Y/N)Y
Initial Reporter StateAZ
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) 08/06/2021
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 Date03/18/2023
Device Model NumberH7493941820300
Device Lot Number0027035729
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 07/21/2021
Initial Report FDA Received Date08/06/2021
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;
Patient Age72 YR
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