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

Model Number	H7493941828250
Medical Device Problem Codes	Difficult to Advance (2920); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that stent balloon damage occurred.A 2.50 x 28mm synergy? xd was advanced but unable to pass through the guide catheter.Upon inspection, a slight bulge was noticed on the balloon beyond the tip of the stent and was believed to be the cause of difficulty passing through the guide catheter.The procedure was completed with a different synergy des.There were no patient complications reported.
Additional Manufacturer Narrative
Returned media inspection: a photo was returned with the complaint information, showing the stent struts and the distal balloon folds and tip.Returned media cannot confirm the reported allegation.
Event or Problem Description
It was reported that stent balloon damage occurred.A 2.50 x 28mm synergy? xd was advanced but unable to pass through the guide catheter.Upon inspection, a slight bulge was noticed on the balloon beyond the tip of the stent and was believed to be the cause of difficulty passing through the guide catheter.The procedure was completed with a different synergy des.There were no patient complications 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: 23222226
• Report Number: 2124215-2025-68413
• Device Sequence Number: 9478597
• Product Code: NIQ
• UDI-Device Identifier: 08714729980834
• UDI-Public: (01)08714729980834(17)260619(10)34341386
• 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): 11/19/2025

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: 06/19/2026
• Device Model Number: H7493941828250
• Device Catalogue Number: H7493941828250
• Device Lot Number: 0034341386
• 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: 09/11/2025
• Supplement Date Received by Manufacturer: 10/30/2025
• Initial Report FDA Received Date: 10/06/2025
• Supplement Report FDA Received Date: 11/19/2025
• Date Device Manufactured: 06/19/2024
• 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