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

Model Number	H7493941812250
Medical Device Problem Codes	Break (1069); Nonstandard Device (1420)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/22/2026
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.A 2.50 x 12mm synergy xd drug-eluting stent was selected for treatment.However, the shaft broke while trying to introduce to the artery.The procedure was completed using an alternate device.No patient complications were reported, and the patient fully recovered.
Event or Problem Description
It was reported that shaft break occurred.A 2.50 x 12mm synergy xd drug-eluting stent was selected for treatment.However, the shaft broke while trying to introduce to the artery.The procedure was completed using an alternate device.No patient complications were reported, and the patient fully recovered.
Additional Manufacturer Narrative
Investigation results: device analysis findings: synergy xd mr us 2.50 x 12mm stent delivery system was returned for analysis.A visual and tactile examination identified a hypotube break at 44.2cm distal from strain relief.Both sections of the hypotube were kinked at various locations along their lengths.A visual inspection of the outer and inner lumen and tactile examination of the entire extrusion found no issues, and a microscopic examination of the distal extrusion identified no damage.A microscopic examination identified no sign of damage, stretching or lifting of the stent struts.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.Device history record review: it was confirmed that this device met manufacturing specification prior to distribution and there no manufacturing deviations which could have contributed to the reported event.Labeling review: review of the instructions for use (ifu) confirmed there was relevant content and sufficient guidance with respect to the circumstances described within this complaint.No updates are required to the ifu as a result of this event.Risk review: a risk review was performed, and it confirmed that the event was defined in the risk documentation and is recorded accordingly in the product record review.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Investigation conclusion: this investigation is assigned a most probable investigation conclusion code of cause not established.This conclusion code is based on the available information.Based on the limited information available it is likely that some form of resistance was encountered which resulted in excessive forces being applied to the device, resulting in the break.Potential interactions with challenging anatomy and interactions with other devices used during the procedure may have contributed to the reported break.It is unknown if the unreported kinks, identified along the hypotube, occurred during the procedure or during device handling post procedure.

• 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: 24220120
• Report Number: 2124215-2026-05438
• Device Sequence Number: 8326043
• Product Code: NIQ
• UDI-Device Identifier: 08714729980797
• UDI-Public: (01)08714729980797(17)260730(10)34616133
• Combination Product (Y/N): Y
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/19/2026

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 Expiration Date: 07/30/2026
• Device Model Number: H7493941812250
• Device Catalogue Number: H7493941812250
• Device Lot Number: 0034616133
• 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: 01/22/2026
• Supplement Date Received by Manufacturer: 03/31/2026
• Initial Report FDA Received Date: 01/30/2026
• Supplement Report FDA Received Date: 04/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/30/2024
• 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