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

Model Number	H7493941820350
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that stent moved on the balloon.During unpacking of a 3.50 x 20mm synergy? xd drug-eluting stent, it was observed that the stent had slipped distally, though not fully detached, and was not fully positioned within the balloon area.The procedure was completed with another of the same device.No patient complications were reported.
Additional Manufacturer Narrative
Investigation results: device analysis findings: the device was disposed 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 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.During unpacking of a 3.50 x 20mm synergy? xd drug-eluting stent, it was observed that the stent had slipped distally, though not fully detached, and was not fully positioned within the balloon area.The complaint device was not returned to the complaint investigation site (cis) for analysis, and reported allegation cannot be confirmed.Based on the information available, it is most likely that an interaction between user and device during packaging removal could have caused the reported stent damage (stent movement on the balloon).
Event or Problem Description
It was reported that stent moved on the balloon.During unpacking of a 3.50 x 20mm synergy? xd drug-eluting stent, it was observed that the stent had slipped distally, though not fully detached, and was not fully positioned within the balloon area.The procedure was completed with another of the same device.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 14110 ; EI 14110
• Manufacturer Contact: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; 7634941632
• MDR Report Key: 24482935
• Report Number: 2124215-2026-11327
• Device Sequence Number: 20078541
• Product Code: NIQ
• UDI-Device Identifier: 08714729981053
• UDI-Public: (01)08714729981053
• 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): 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: H7493941820350
• Device Catalogue Number: H7493941820350
• 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: 02/03/2026
• Supplement Date Received by Manufacturer: 04/10/2026
• Initial Report FDA Received Date: 03/02/2026
• Supplement Report FDA Received Date: 04/28/2026
• 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