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

Model Number	H7493941832450
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/02/2026
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.
Event or Problem Description
It was reported that balloon rupture occurred.The 75% stenosed target lesion was located in the mildly tortuous and mildly calcified coronary artery.A 4.50 x 32mm synergy xd drug-eluting stent was selected for treatment.However, during inflation, the balloon ruptured.The device was removed successfully with no fragments left, and the procedure was completed with a different device.No patient complications were reported.
Event or Problem Description
It was reported that balloon rupture occurred.The 75% stenosed target lesion was located in the mildly tortuous and mildly calcified coronary artery.A 4.50 x 32mm synergy xd drug-eluting stent was selected for treatment.However, during inflation, the balloon ruptured.The device was removed successfully with no fragments left, and the procedure was completed with a different device.No patient complications were reported.It was further reported that the target lesion was located in the right coronary artery.During inflation, contrast from the stent balloon was coming out from the shaft.
Additional Manufacturer Narrative
B5.Describe event or problem updated.E1.Initial reporter title updated.E1.Initial reporter first and name updated.E3.Occupation updated.Good faith effort attempts were made to try and retrieve additional details regarding the reported event, but further information was unable to be obtained.

• 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: 24125310
• Report Number: 2124215-2026-03735
• Device Sequence Number: 17639050
• Product Code: NIQ
• UDI-Device Identifier: 08714729981237
• UDI-Public: (01)08714729981237(17)270414(10)36323321
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• 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): 01/30/2026

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: H7493941832450
• Device Catalogue Number: H7493941832450
• Device Lot Number: 0036323321
• 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: 01/05/2026
• Supplement Date Received by Manufacturer: 01/20/2026
• Initial Report FDA Received Date: 01/20/2026
• Supplement Report FDA Received Date: 01/30/2026
• Date Device Manufactured: 04/14/2025
• 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