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

Model Number	H7493941812500
Medical Device Problem Codes	Difficult to Remove (1528); Failure to Advance (2524); Detachment of Device or Device Component (2907); Failure to Deflate (4060)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon issues occurred.The target lesion was located in the severely calcified left main.A 5.00 x 12mm synergy xd drug-eluting stent was selected for used but was unable to cross the lesion.Afterwards, dilation was performed with a non-boston scientific (non-bsc) scoring balloon and the stent was then able to cross the lesion.Following stent deployment, the delivery system balloon was difficult to deflate so the doctor did two extra negative pulls on the inflation device.When the doctor attempted to withdraw the balloon, it would not retract into the guide catheter.When the stent delivery system catheter was finally able to be removed, it was noted that the balloon had detached and was still on the non-bsc guidewire, in the left main coronary artery.The guidewire and balloon were able to be snared for removal.There were no patient complications reported.

• 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: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; 7634941632
• MDR Report Key: 21690600
• Report Number: 2124215-2025-16527
• Device Sequence Number: 13116566
• Product Code: NIQ
• UDI-Device Identifier: 08714729981244
• UDI-Public: 08714729981244
• Combination Product (Y/N): Y
• Initial Reporter State: ND
• Initial Reporter Country: US
• PMA/510(K) Number: P150003
• 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
• Report Date (Section B): 03/25/2025

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: 06/18/2026
• Device Model Number: H7493941812500
• Device Catalogue Number: H7493941812500
• Device Lot Number: 0034370996
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2025
• Initial Report FDA Received Date: 03/25/2025
• Date Device Manufactured: 06/18/2024
• 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