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

Model Number	H7493941820400
Medical Device Problem Codes	Break (1069); Deformation Due to Compressive Stress (2889); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/14/2025
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported that shaft break occurred.The target lesion was located in the circumflex artery.After a non-boston scientific guidewire and guidezilla ii guide extension catheter crossed the lesion, a 4.00 x 20mm synergy? xd drug-eluting stent was advanced for treatment but could not deliver through the lesion.However, during the procedure, the stent was withdrawn, during which the wire was lost, and it was then noted that the stent shaft was fractured.Both devices were removed.The vessel was rewired, the guidezilla was reintroduced, and again deliver the 4.0 20 mm synergy? xd stent was attempted; however, delivery was still unsuccessful.A non-bsc catheter was then utilized, but the new synergy? des again could not be delivered.Finally, the procedure was completed with a 3.5 16 mm synergy? stent.No patient complications were reported and the patient fully recovered.
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.The device was not returned for analysis; therefore, a technical analysis could not be performed.A photo was returned with the complaint information, showing a break in the hypotube and a slight kink a few centimeters from the strain relief.
Event or Problem Description
It was reported that shaft break occurred.The target lesion was located in the circumflex artery.After a non-boston scientific guidewire and guidezilla ii guide extension catheter crossed the lesion, a 4.00 x 20mm synergy? xd drug-eluting stent was advanced for treatment but could not deliver through the lesion.However, during the procedure, the stent was withdrawn, during which the wire was lost, and it was then noted that the stent shaft was fractured.Both devices were removed.The vessel was rewired, the guidezilla was reintroduced, and again deliver the 4.0 20 mm synergy? xd stent was attempted; however, delivery was still unsuccessful.A non-bsc catheter was then utilized, but the new synergy? des again could not be delivered.Finally, the procedure was completed with a 3.5 16 mm synergy? stent.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: 23743031
• Report Number: 2124215-2025-87819
• Device Sequence Number: 10464630
• Product Code: NIQ
• UDI-Device Identifier: 08714729981138
• UDI-Public: (01)08714729981138(17)270311(10)36173113
• Combination Product (Y/N): Y
• Initial Reporter State: PA
• 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): 01/06/2026

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: H7493941820400
• Device Catalogue Number: H7493941820400
• Device Lot Number: 0036173113
• 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: 11/14/2025
• Supplement Date Received by Manufacturer: 12/16/2025
• Initial Report FDA Received Date: 12/08/2025
• Supplement Report FDA Received Date: 01/06/2026
• Date Device Manufactured: 03/11/2025
• 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