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

Model Number	H7493941824400
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Vascular Dissection (3160)
Date of Event	11/14/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that shaft break occurred and resulted in an unretrieved device fragment.A 4.00 x 24 mm synergy xd drug-eluting stent was selected for treatment; however, during the procedure, a shaft break occurred.The device was partially explanted; however, a portion remains implanted.A the procedure was completed using an alternate device, and no patient complications were reported.
Additional Manufacturer Narrative
B2.Outcomes attrib to adv event updated.B5.Describe event or problem updated.H6.Patient code and impact code updated.
Event or Problem Description
It was reported that shaft break occurred and resulted in an unretrieved device fragment.A 4.00 x 24 mm synergy xd drug-eluting stent was selected for treatment; however, during the procedure, a shaft break occurred.The device was partially explanted; however, a portion remains implanted.The procedure was completed using an alternate device, and no patient complications were reported.It was further reported that the target lesion was over 50% stenosed, with a 90-degree bend located in the severely tortuous and severely calcified left circumflex artery (lcx).The shaft break occurred at the distal section of the device and a snare was used in an unsuccessful attempt to remove the device fragment.A stent was then placed over the device fragment.This resulted in a lcx dissection, which could not be retrieved or reopened.
Additional Manufacturer Narrative
H6.Evaluation conclusion codes corrected.
Event or Problem Description
It was reported that shaft break occurred and resulted in an unretrieved device fragment.A 4.00 x 24 mm synergy xd drug-eluting stent was selected for treatment; however, during the procedure, a shaft break occurred.The device was partially explanted; however, a portion remains implanted.The procedure was completed using an alternate device, and no patient complications were reported.It was further reported that the target lesion was over 50% stenosed, with a 90-degree bend located in the severely tortuous and severely calcified left circumflex artery (lcx).The shaft break occurred at the distal section of the device and a snare was used in an unsuccessful attempt to remove the device fragment.A stent was then placed over the device fragment.This resulted in a lcx dissection, which could not be retrieved or reopened.

• 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: 20739262
• Report Number: 2124215-2024-72013
• Device Sequence Number: 12882512
• Product Code: NIQ
• UDI-Device Identifier: 08714729981145
• UDI-Public: 08714729981145
• Combination Product (Y/N): Y
• Initial Reporter Country: AS
• 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,Followup
• Report Date (Section B): 02/20/2025

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 Model Number: H7493941824400
• Device Catalogue Number: H7493941824400
• 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: 11/14/2024
• Supplement Date Received by Manufacturer: 11/24/2024; 02/04/2025
• Initial Report FDA Received Date: 11/20/2024
• Supplement Report FDA Received Date: 12/16/2024; 02/20/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown