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

Model Number	H7493941812300
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the stent fracture occurred.The 90% stenosed target lesion was located in a tortuous and moderately calcified artery.A 3.00 x 12mm synergy xd mr us and 6f long guidezilla ii were selected for percutaneous coronary intervention.During the procedure, it was noted that the stent struts were fractured as half the stent remained on the balloon and the other half was left in the guidezilla.The entire system was removed from the patient once the stent strut fracture occurred.The procedure was completed with a different same device.No complications were reported, and the patient was stable post procedure.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.A visual and tactile examination revealed no issues identified with the hypotube shaft.A visual inspection of the outer and inner lumen and tactile examination of the entire extrusion found no issues.Microscopic examination of the stent identified struts pulled from both the distal and proximal section and bunched in the mid-section.Balloon cones were reviewed, and no issues were noted.Balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure.Bumper tip showed no signs of distal tip damage.The undamaged crimped stent od (outer diameter) at the time of manufacturing was within max crimped stent profile measurement as per document.
Event or Problem Description
It was reported that the stent fracture occurred.The 90% stenosed target lesion was located in a tortuous and moderately calcified artery.A 3.00 x 12mm synergy xd mr us and 6f long guidezilla ii were selected for percutaneous coronary intervention.During the procedure, it was noted that the stent struts were fractured as half the stent remained on the balloon and the other half was left in the guidezilla.The entire system was removed from the patient once the stent strut fracture occurred.The procedure was completed with a different same device.No complications were reported, and the patient was stable post procedure.

• 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: 21288044
• Report Number: 2124215-2025-04045
• Device Sequence Number: 9320180
• Product Code: NIQ
• UDI-Device Identifier: 08714729980957
• UDI-Public: 08714729980957
• Combination Product (Y/N): Y
• Initial Reporter State: MI
• 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): 03/25/2025

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: 06/17/2026
• Device Model Number: H7493941812300
• Device Catalogue Number: H7493941812300
• Device Lot Number: 0034308345
• 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: 01/08/2025
• Supplement Date Received by Manufacturer: 03/04/2025
• Initial Report FDA Received Date: 01/31/2025
• Supplement Report FDA Received Date: 03/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/17/2024
• 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