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

Model Number	H7493941820300
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/27/2026
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.Investigation results: media review: an image was provided with the complaint which shows a purchase order.This returned media cannot confirm the reported allegation.Device analysis finding: the device was not returned; 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 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.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 unintended use error caused or contributed to event.This conclusion code is based on the available information and the record review conducted at the boston scientific site.It was reported that the stent was not properly on the balloon when removing it from the hoop.The device is not indicated as returning for testing and analysis.Based on the available information it is likely that this reported damage occurred due to product handling and unintentionally excessive force being applied to the delivery system while unpacking and preparing for the procedure.A review of the product record did not identify any issues during the manufacturing of the finished goods batch which may have contributed to the event.
Event or Problem Description
It was reported that stent moved on balloon occurred.During removal of a 3.00 x 20mm synergy? xd drug-eluting stent from the hoop, the stent was found not to be properly mounted on the balloon.The procedure was completed using an alternate device, and 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: 25553602
• Report Number: 2124215-2026-32717
• Device Sequence Number: 20217479
• Product Code: NIQ
• UDI-Device Identifier: 08714729980971
• UDI-Public: (01)08714729980971(17)270915(10)37519676
• Combination Product (Y/N): Y
• Initial Reporter State: IL
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/18/2026

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: H7493941820300
• Device Catalogue Number: H7493941820300
• Device Lot Number: 0037519676
• 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: 05/27/2026
• Initial Report FDA Received Date: 06/18/2026
• Date Device Manufactured: 09/15/2025
• 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