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

Model Number	H7493941812400
Medical Device Problem Codes	Break (1069); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/17/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occurred.The 90% stenosed target lesion was located in the moderately tortuous and calcified mid-left anterior descending artery.Following predilatation with a 3.5mm non-compliant balloon, a 4.0 x 12mm synergy xd drug-eluting stent (des) was advanced for treatment.However, while attempting to cross the lesion, the shaft of the device broke.All equipment was removed, and the procedure was completed using a different device.No patient complications were reported, and the patient fully recovered.

• 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: 25112235
• Report Number: 2124215-2026-24767
• Device Sequence Number: 9326451
• Product Code: NIQ
• UDI-Device Identifier: 08714729981114
• UDI-Public: (01)08714729981114(17)280114(10)38443282
• Combination Product (Y/N): Y
• Initial Reporter State: NC
• 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,Followup
• Report Date (Section B): 06/30/2026

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: H7493941812400
• Device Catalogue Number: H7493941812400
• Device Lot Number: 0038443282
• 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: 04/17/2026
• Supplement Date Received by Manufacturer: 06/09/2026
• Initial Report FDA Received Date: 05/07/2026
• Supplement Report FDA Received Date: 07/01/2026
• Date Device Manufactured: 01/14/2026
• 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 Age: 60 YR
• Patient Sex: Unknown