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

Model Number	H7493941824350
Medical Device Problem Codes	Nonstandard Device (1420); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/02/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that stent moved on balloon occurred.The target lesion was located in a coronary artery.A 3.50 x 24mm synergy xd drug-eluting stent was selected for use.However, after advancing the stent through the guide, the physician noticed the stent moved on the balloon.The device was removed and completed the procedure with a different device.There were no patient complications.
Additional Manufacturer Narrative
Investigation results: device analysis findings: synergy xd mr us 3.50 x 24mm stent delivery system (sds) was returned for analysis.Visual and tactile inspection found multiple kinks along the shaft.No issues were identified on the shaft polymer extrusion profile.Microscopic analysis revealed that struts was lifted at mid-section.Balloon cones were reviewed, and no issues were noted.Tip was found with no issues.Device history record (dhr) 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 table.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Investigation conclusion: the investigation will be assigned an investigation conclusion code of unintended use error caused or contributed to event.This code was selected as the most probable complaint cause based on the information available.The product record review confirmed that this is not a new failure type, and the risk is anticipated.There was no evidence of a manufacturing issue or design issue which could have caused the complaint.It was reported that after advancing the stent through the guide, the physician noticed the stent moved on the balloon.The complaint device was returned to the complaint investigation site (cis) for analysis, and reported allegation was not confirmed.There were no movement of the stent on the balloon.Additionally, there were multiple unreported kinks along the hypotube noted, as well as the unreported lifted stent struts at mid-section of the stent.Based on the reported event, it is most likely that a restriction was met during attempts to advance the stent through the guide, and the physician had to maneuver the shaft of the device, and this movement and force may have led to the kinks, and to unreported stent damage.Most likely those damages occurred as a result of an unintentional user error but the stage of procedure at which it occurred (preparation/during procedure/handling post procedure) cannot be established.
Event or Problem Description
It was reported that stent moved on balloon occurred.The target lesion was located in a coronary artery.A 3.50 x 24mm synergy xd drug-eluting stent was selected for use.However, after advancing the stent through the guide, the physician noticed the stent moved on the balloon.The device was removed and completed the procedure with a different 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: 24282956
• Report Number: 2124215-2026-06988
• Device Sequence Number: 15533468
• Product Code: NIQ
• UDI-Device Identifier: 08714729981060
• UDI-Public: (01)08714729981060(17)270311(10)36164891
• Combination Product (Y/N): Y
• Initial Reporter State: OH
• 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): 04/28/2026

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: H7493941824350
• Device Catalogue Number: H7493941824350
• Device Lot Number: 0036164891
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/14/2026
• Supplement Date Received by Manufacturer: 04/08/2026
• Initial Report FDA Received Date: 02/06/2026
• Supplement Report FDA Received Date: 04/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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