MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SYNERGY XD; CORONARY DRUG-ELUTING STENT

Model Number	H7493941816400
Medical Device Problem Codes	Fracture (1260); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/28/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that stent fracture occurred.The patient presented with coronary artery disease and underwent percutaneous coronary intervention.A 4.00 x 16mm synergy xd drug-eluting stent was loaded onto wire and was moving through the vessel to the lesion; however, the physician noticed a stent fracture in the middle of the stent.The device was removed, and the procedure was completed with a new stent.There were no patient complications reported.
Event or Problem Description
It was reported that stent fracture occurred.The patient presented with coronary artery disease and underwent percutaneous coronary intervention.A 4.00 x 16mm synergy xd drug-eluting stent was loaded onto wire and was moving through the vessel to the lesion; however, the physician noticed a stent fracture in the middle of the stent.The device was removed, and the procedure was completed with a new stent.There were no patient complications reported.It was further reported that the stent was damaged in the middle and the stent delivery system was removed in one piece.

• Brand Name: SYNERGY XD
• Common Device Name: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 16088099
• Report Number: 2124215-2022-55529
• Device Sequence Number: 6733973
• Product Code: NIQ
• UDI-Device Identifier: 08714729981121
• UDI-Public: 08714729981121
• Combination Product (Y/N): Y
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/25/2024
• Device Model Number: H7493941816400
• Device Lot Number: 0029379884
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/15/2022
• Supplement Date Received by Manufacturer: 12/20/2022
• Initial Report FDA Received Date: 01/03/2023
• Supplement Report FDA Received Date: 01/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/26/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown