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

Model Number	H7493941828250
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft leak occurred.The 80% stenosed target lesion was located in the mildly tortuous and moderately calcified left anterior descending artery.The lesion was initially treated with multiple balloon inflations and the shockwave device, followed by pre-dilation using a 2.5mm balloon.A 2.50 x 28mm synergy xd drug-eluting stent was advanced and delivered; however, the physician was not able to fully inflate the balloon, only about a 1mm segment at the proximal end of the stent.The stent was removed from the guide catheter and remained intact on the balloon catheter.Further inspection was performed, and a leak was noted at the connection of the flexible and stiff shafts, with a hole in the catheter.The device was removed from the sterile field, and the procedure was completed with a non-boston scientific device.No patient complications were reported except for just a short delay in stent placement.
Additional Manufacturer Narrative
Good faith effort attempts were made to try and retrieve additional details regarding the reported event, but further information was unable to be obtained.

• 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: 22952549
• Report Number: 2124215-2025-60231
• Device Sequence Number: 9867811
• Product Code: NIQ
• UDI-Device Identifier: 08714729980834
• UDI-Public: (01)08714729980834(17)270128(10)35838146
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• 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): 09/03/2025

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 Model Number: H7493941828250
• Device Catalogue Number: H7493941828250
• Device Lot Number: 0035838146
• 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: 08/08/2025
• Initial Report FDA Received Date: 09/03/2025
• Date Device Manufactured: 01/28/2025
• 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