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

Model Number	H7493941820250
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that stent fracture occurred.A 2.50 x 20 mm synergy xd drug-eluting stent was selected for treatment.However, during the procedure, the stent broke when the physician attempted to use it.No further issues and no patient complications were reported.
Event or Problem Description
It was reported that stent fracture occurred.A 2.50 x 20 mm synergy xd drug-eluting stent was selected for treatment.However, during the procedure, the stent broke when the physician attempted to use it.No further issues and no patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr: synergy xd mr us 2.50 x 20mm was returned for analysis.A visual and tactile examination identified a break in the hypotube.The break was located at the base of the strain relief.The distal section of the hypotube was kinked at various locations along its length.A visual, tactile and microscopic examination of the distal extrusion identified that the extrusion identified no damage.A microscopic examination of the crimped stent identified no damages.The stent was securely positioned between the proximal and distal markerbands.A microscopic examination of the balloon material identified no damages.The balloon was tightly folded and did not appear to have been subjected to any positive pressures.A microscopic examination of the tip identified no damages.The outer diameter of the crimped stent was measured and was found to be within device specification.

• 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: 21741080
• Report Number: 2124215-2025-18295
• Device Sequence Number: 21030176
• Product Code: NIQ
• UDI-Device Identifier: 08714729980810
• UDI-Public: (01)08714729980810(17)260813(10)34695489
• Combination Product (Y/N): Y
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/28/2025

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: 08/13/2026
• Device Model Number: H7493941820250
• Device Catalogue Number: H7493941820250
• Device Lot Number: 0034695489
• 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: 03/03/2025
• Supplement Date Received by Manufacturer: 05/07/2025
• Initial Report FDA Received Date: 04/01/2025
• Supplement Report FDA Received Date: 05/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/13/2024
• 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