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

Model Number	H7493941816350
Medical Device Problem Codes	Break (1069); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2025
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.
Event or Problem Description
It was reported that shaft break occurred.The target lesion was located in a non-tortuous and mildly calcified coronary artery.A 3.50 x 16mm synergy? xd drug-eluting stent was advanced for treatment but could not cross the lesion.However, it was noticed that the shaft was broken on the stent.The procedure was completed with a different device without any patient complications reported.
Additional Manufacturer Narrative
B5 - updated describe event or problem.
Event or Problem Description
It was reported that shaft break occurred.The target lesion was located in a non-tortuous and mildly calcified coronary artery.A 3.50 x 16mm synergy? xd drug-eluting stent was advanced for treatment but could not cross the lesion.However, it was noticed that the shaft was broken on the stent.The procedure was completed with a different device without any patient complications reported.It was further reported that the target lesion was located in a mildly tortuous and severely calcified coronary artery.

• 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: 22020898
• Report Number: 2124215-2025-31068
• Device Sequence Number: 9504490
• Product Code: NIQ
• UDI-Device Identifier: 08714729981046
• UDI-Public: (01)08714729981046(17)260917(10)35001817
• Combination Product (Y/N): Y
• Initial Reporter State: NC
• 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: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/27/2025

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: 09/17/2026
• Device Model Number: H7493941816350
• Device Catalogue Number: H7493941816350
• Device Lot Number: 0035001817
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/01/2025
• Supplement Date Received by Manufacturer: 05/14/2025
• Initial Report FDA Received Date: 05/14/2025
• Supplement Report FDA Received Date: 05/27/2025
• Date Device Manufactured: 09/17/2024
• 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