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

Model Number	H7493941816400
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/25/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a device issue occurred, and additional intervention was required.A significant lesion was located in the moderately tortuous and severely calcified left circumflex artery.A 4.00 x 16mm synergy xd drug-eluting stent was selected for treatment.However, while advancing the stent through the aortic arch, approximately 6 inches of the distal portion of the stent delivery system broke off from the shaft and became lodged inside the patient.After an additional six hours, the device fragment was successfully retrieved intravascularly with a snare without the need for open heart surgery.The procedure was aborted after retrieving the device fragment and the patient was transferred to the icu.Follow-up indicated that the patient has been extubated and is recovering.Per the physician, no further complications are expected, and no other issues 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: 22543727
• Report Number: 2124215-2025-45969
• Device Sequence Number: 8468302
• Product Code: NIQ
• UDI-Device Identifier: 08714729981121
• UDI-Public: (01)08714729981121(17)260527(10)34224382
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• 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
• Report Date (Section B): 07/17/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/27/2026
• Device Model Number: H7493941816400
• Device Catalogue Number: H7493941816400
• Device Lot Number: 0034224382
• 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: 06/25/2025
• Initial Report FDA Received Date: 07/18/2025
• Date Device Manufactured: 05/27/2024
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown