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

Model Number	H7493941808250
Medical Device Problem Codes	Break (1069); Failure to Advance (2524)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	04/11/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that shaft break and vessel dissection occurred.The target lesion was located in a coronary artery.A 2.50 x 8mm synergy xd drug-eluting stent was advanced for treatment.However, during procedure, the shaft broke in half.The physician removed the pieces from catheter, and dissection was also noted.No further patient complications were reported.
Event or Problem Description
It was reported that shaft break and vessel dissection occurred.The target lesion was located in a coronary artery.A 2.50 x 8mm synergy xd drug-eluting stent was advanced for treatment.However, during procedure, the shaft broke in half.The physician removed the pieces from catheter, and dissection was also noted.No further patient complications were reported.It was further reported that the target lesion was located in proximal left anterior descending artery.During advancement of the stent through a 6f guide catheter, the shaft broke at the hemostasis valve.The procedure was completed with non-boston scientific device and the patient was stable after the procedure.

• Brand Name: SYNERGY XD
• Common Device Name: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 16786859
• Report Number: 2124215-2023-19174
• Device Sequence Number: 5679004
• Product Code: NIQ
• UDI-Device Identifier: 08714729980780
• UDI-Public: 08714729980780
• Combination Product (Y/N): Y
• Initial Reporter State: AZ
• 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): 05/24/2023

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 Date: 04/07/2024
• Device Model Number: H7493941808250
• Device Lot Number: 0029231977
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/12/2023
• Supplement Date Received by Manufacturer: 05/03/2023
• Initial Report FDA Received Date: 04/21/2023
• Supplement Report FDA Received Date: 05/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/08/2022
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown