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

Model Number	H7493941848400
Medical Device Problem Codes	Break (1069); Nonstandard Device (1420); Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a fracture occurred.The target lesion was located in the moderately tortuous and moderately calcified coronary artery.A 4.00 x 48mm synergy xd drug-eluting stent was advanced for treatment.However, while advancing over the wire, the proximal portion of the device kinked and the catheter broke.The procedure was completed another of the same device.There were no patient complications.
Additional Manufacturer Narrative
Device evaluated by mfr.: synergy xd mr us 4.00 x 48mm stent delivery system (sds) was returned for analysis.A visual and tactile examination identified a hypotube break 26.2cm distal to the distal end of the strain relief and multiple hypotube kinks along the length of the hypotube shaft.A visual inspection of the outer and inner lumen and tactile examination of the entire extrusion found no issues.Microscopic examination of the stent identified struts lifted at the proximal section.Balloon cones were reviewed under microscopic examination, and no issues were noted.Balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure.Bumper tip showed no signs of distal tip damage.
Event or Problem Description
It was reported that a fracture occurred.The target lesion was located in the moderately tortuous and moderately calcified coronary artery.A 4.00 x 48mm synergy xd drug-eluting stent was advanced for treatment.However, while advancing over the wire, the proximal portion of the device kinked and the catheter broke.The procedure was completed another of the same device.There were no patient complications.

• 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: 23918962
• Report Number: 2124215-2025-93618
• Device Sequence Number: 8824609
• Product Code: NIQ
• UDI-Device Identifier: 08714729985242
• UDI-Public: (01)08714729985242(17)270603(10)36729206
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• 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): 02/24/2026

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: H7493941848400
• Device Catalogue Number: H7493941848400
• Device Lot Number: 0036729206
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/08/2025
• Supplement Date Received by Manufacturer: 02/09/2026
• Initial Report FDA Received Date: 12/29/2025
• Supplement Report FDA Received Date: 02/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/03/2025
• 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 Age: 74 YR
• Patient Sex: Male