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

Model Number	H7493941824300
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	01/23/2026
Type of Reportable Event	Serious Injury
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 a dissection occurred.A 3.00 x 24mm synergy? xd drug-eluting stent was advanced for treatment.However, the device failed to cross the lesion, and a dissection was observed.No further patient complications were reported.
Event or Problem Description
It was reported that a dissection occurred.A 3.00 x 24mm synergy? xd drug-eluting stent was advanced for treatment.However, the device failed to cross the lesion, and a dissection was observed.No further 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.Investigation results: device analysis findings: the device was not returned for analysis; therefore, a technical analysis could not be performed.Device history record review: it was confirmed that this device met manufacturing specifications prior to distribution and there were 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 (prr).This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Investigation conclusion: his investigation is assigned a most probable investigation conclusion code of cause not established.This code was selected as the most probable complaint cause based on the information available.It was reported that the device failed to cross the lesion, and a dissection was observed.No further patient complications were reported.The device was not returned to the cis for testing and analysis.Due to the nature of the complaint, it would not have been possible to test the device, under laboratory conditions, for the device's ability to track through patient anatomy.Therefore, the complaint event cannot be confirmed.Dissection is listed within the instructions for use (ifu) as a potential risk associated with the procedure and use of the synergy device.Based on the medical review task conducted for this complaint, the reported clinical event is anticipated per the ifu.As per information currently available, the reported serious injury/illness/impairment is considered to be a clinical consequence of the vessel dissection that occurred during the 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: 24403334
• Report Number: 2124215-2026-09612
• Device Sequence Number: 8158993
• Product Code: NIQ
• UDI-Device Identifier: 08714729980988
• UDI-Public: (01)08714729980988(17)270922(10)37585754
• Combination Product (Y/N): Y
• Initial Reporter State: AZ
• 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): 04/09/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: H7493941824300
• Device Catalogue Number: H7493941824300
• Device Lot Number: 0037585754
• 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: 01/26/2026
• Supplement Date Received by Manufacturer: 03/25/2026
• Initial Report FDA Received Date: 02/20/2026
• Supplement Report FDA Received Date: 04/09/2026
• Date Device Manufactured: 09/22/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 70 YR
• Patient Sex: Male