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

Model Number	H7493941816500
Medical Device Problem Codes	Break (1069); Nonstandard Device (1420)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2025
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 the event date is 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 shaft break occurred.A 5.00 x 16mm synergy? xd drug-eluting stent was advanced for treatment.However, the shaft broke while entering the patient.The device was safely removed, and the procedure was completed with another stent.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 the event date is 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.Device evaluated by mfr: synergy xd mr us 5.00 x 16mm stent delivery system catheter was returned for analysis.A visual and tactile inspection identified a hypotube break 23.5cm distal to the distal end of the strain relief with multiple kinks along the length.No kinks and damages with the shaft polymer extrusion.A detailed microscopic examination of the balloon material identified no tears or pinholes in the balloon.The bumper tip showed no signs of tip damage.A microscopic examination of the proximal and distal markerbands identified no damage.No other device issues were identified during returned product analysis.
Event or Problem Description
It was reported that shaft break occurred.A 5.00 x 16mm synergy? xd drug-eluting stent was advanced for treatment.However, the shaft broke while entering the patient.The device was safely removed, and the procedure was completed with another stent.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: 23729558
• Report Number: 2124215-2025-89398
• Device Sequence Number: 10631437
• Product Code: NIQ
• UDI-Device Identifier: 08714729981251
• UDI-Public: (01)08714729981251(17)260103(10)33154761
• Combination Product (Y/N): Y
• Initial Reporter State: LA
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/22/2026

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 Expiration Date: 01/03/2026
• Device Model Number: H7493941816500
• Device Catalogue Number: H7493941816500
• Device Lot Number: 0033154761
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/19/2025
• Supplement Date Received by Manufacturer: 01/06/2026
• Initial Report FDA Received Date: 12/05/2025
• Supplement Report FDA Received Date: 01/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/04/2024
• 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