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

Model Number	H7493941832450
Medical Device Problem Codes	Break (1069); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/21/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occurred.The patient presented with coronary artery disease and underwent percutaneous coronary intervention.After the lesion was pre-dilated with good expansion, a non-boston scientific (non-bsc) guide catheter and a non-bsc guidewire were used.A 4.50 x 32 mm synergy? xd drug-eluting stent was advanced for treatment.The physician encountered resistance during advancement in the proximal portion of the guide just past the touhy valve but was eventually able to advance the system.The stent was successfully deployed.During withdrawal of the delivery system from the guide, the shaft broke in half.The entire device was removed from the patient without issue, and the procedure was completed.No patient complications were reported.
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.
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.Investigation results: device analysis findings: the device was implanted and will not be returned for analysis; therefore, a technical analysis could not be performed.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.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 event description and lack of information provided.Based on the information provided, there is no evidence to suggest a device malfunction or manufacturing defect associated with the synergy xd drug eluting stent system.The complaint device was not returned to the boston scientific site for analysis.As it is not possible to test the device for navigation through patient anatomy, the complaint allegation cannot be confirmed.Based on this event review and details provided it was not possible to determine whether procedural technique, patient anatomy or another factor may have contributed to the shaft break occurring during the procedure.As a result, a definitive cause cannot be confirmed based on the available information.
Event or Problem Description
It was reported that shaft break occurred.The patient presented with coronary artery disease and underwent percutaneous coronary intervention.After the lesion was pre-dilated with good expansion, a non-boston scientific (non-bsc) guide catheter and a non-bsc guidewire were used.A 4.50 x 32 mm synergy? xd drug-eluting stent was advanced for treatment.The physician encountered resistance during advancement in the proximal portion of the guide just past the touhy valve but was eventually able to advance the system.The stent was successfully deployed.During withdrawal of the delivery system from the guide, the shaft broke in half.The entire device was removed from the patient without issue, and the procedure was completed.No patient complications were reported.

• 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: 25186857
• Report Number: 2124215-2026-26393
• Device Sequence Number: 10427771
• Product Code: NIQ
• UDI-Device Identifier: 08714729981237
• UDI-Public: (01)08714729981237(17)270414(10)36323321
• Combination Product (Y/N): Y
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: P150003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• 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): 06/02/2026

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: H7493941832450
• Device Catalogue Number: H7493941832450
• Device Lot Number: 0036323321
• 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: 04/22/2026
• Supplement Date Received by Manufacturer: 05/28/2026
• Initial Report FDA Received Date: 05/15/2026
• Supplement Report FDA Received Date: 06/02/2026
• Date Device Manufactured: 04/14/2025
• 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