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

Model Number	H7493941838400
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3 date of event: used the first day of the month of the bsc aware date since event date was not provided.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 stent moved on the balloon.A 4.00 x 38mm synergy? xd drug-eluting stent was advanced for treatment.However, the stent came off the balloon and was damaged.No patient complications were reported.
Additional Manufacturer Narrative
B3 date of event: used the first day of the month of the bsc aware date since event date was not provided.Good faith effort attempts were made to try and retrieve additional details regarding the reported event, but further information was unable to be obtained.E1 initial reporter facility name updated e1 initial reporter address updated e1 initial reporter city updated e1 initial reporter zip/post code updated the device was not returned for analysis.However, a photo was returned, showing a damaged stent along with a guide catheter and guidewire.The returned media is unable to confirm the reported allegation of stent moved on balloon.
Event or Problem Description
It was reported that stent moved on the balloon.A 4.00 x 38mm synergy? xd drug-eluting stent was advanced for treatment.However, the stent came off the balloon and was damaged.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: 23572438
• Report Number: 2124215-2025-82813
• Device Sequence Number: 10272719
• Product Code: NIQ
• UDI-Device Identifier: 08714729981176
• UDI-Public: (01)08714729981176(17)260514(10)34103183
• Combination Product (Y/N): Y
• Initial Reporter State: MI
• 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,Followup
• Report Date (Section B): 12/19/2025

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 Expiration Date: 05/14/2026
• Device Model Number: H7493941838400
• Device Catalogue Number: H7493941838400
• Device Lot Number: 0034103183
• 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: 10/23/2025
• Supplement Date Received by Manufacturer: 11/27/2025
• Initial Report FDA Received Date: 11/17/2025
• Supplement Report FDA Received Date: 12/19/2025
• Date Device Manufactured: 05/14/2024
• 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