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

Model Number	H7493941832400
Medical Device Problem Codes	Break (1069); Nonstandard Device (1420)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/08/2025
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.4.00 x 32mm synergy? xd drug-eluting stent was advanced for treatment.However, during advancing, the stent shaft was broken.Subsequently, another 4.00 x 32mm synergy? xd stent was advanced, and the shaft was also broken.Both devices were pulled and removed from the patient.The procedure was completed with a different device successfully with no patient complications reported.
Event or Problem Description
It was reported that shaft break occurred.A 4.00 x 32mm synergy? xd drug-eluting stent was advanced for treatment.However, during advancing, the stent shaft was broken.Subsequently, another 4.00 x 32mm synergy? xd stent was advanced, and the shaft was also broken.Both devices were pulled and removed from the patient.The procedure was completed with a different device successfully with no patient complications reported.
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.Device evaluated by mfr.: a synergy xd mr us 4.00x32mm, stent delivery system was returned for analysis.Visual and tactile inspection identified a break on the hypotube at 27.7cm distal from the strain relief with multiple kinks along the length.No kinks or damages on the shaft polymer extrusion.A detailed microscopic examination of the balloon material identified no tears or pinholes in the balloon.No issues noted to the stent profile.The bumper tip showed signs of damage.A microscopic examination of the proximal and distal markerbands identified no damage.No other device issues were identified during returned product analysis.

• 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: 23860453
• Report Number: 2124215-2025-92205
• Device Sequence Number: 9650877
• Product Code: NIQ
• UDI-Device Identifier: 08714729981169
• UDI-Public: (01)08714729981169(17)270206(10)35882030
• 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): 02/20/2026

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: H7493941832400
• Device Catalogue Number: H7493941832400
• Device Lot Number: 0035882030
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/09/2025
• Supplement Date Received by Manufacturer: 02/05/2026
• Initial Report FDA Received Date: 12/21/2025
• Supplement Report FDA Received Date: 02/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/06/2025
• 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