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

Model Number	H7493941820350
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Codes	Non specific EKG/ECG Changes (1817); High Blood Pressure/ Hypertension (1908)
Date of Event	06/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3 date of event: used the first date of the month of the aware date as no event date was provided.D6a implant date: used the first date of the month of the aware date as no implant date was provided.
Event or Problem Description
It was reported via medwatch that balloon rupture occurred.The patient underwent ultrasound-guided right radial arterial access, followed by left selective coronary angiography and intravascular ultrasound (ivus) of the left anterior descending (lad) and left main coronary arteries.A percutaneous coronary intervention (pci) was performed on the ostial, proximal, and mid segments of the moderately calcified lad with 90% stenosis.A 3.0 mm x 48 mm synergy drug-eluting stent (des) was deployed at nominal pressure and overlapped proximally with a 3.5 mm x 20 mm synergy des deployed slightly above nominal pressure.During deployment, the stent balloon burst during initial inflation at approximately 4 mmhg, below its rated burst pressure of 16 mmhg, resulting in the patient's temporary st elevation and a temporary spike in blood pressure.The stent delivery system was retrieved intact, and the patient symptoms resolved without further intervention.The overlapping stent segments were subsequently post-dilated using the balloon from the proximal stent, and the procedure was completed successfully without further complications.The patient condition was good 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: 22583779
• Report Number: 2124215-2025-49161
• Device Sequence Number: 4502156
• Product Code: NIQ
• UDI-Device Identifier: 08714729981053
• UDI-Public: (01)08714729981053(17)261217(10)35586634
• Combination Product (Y/N): Y
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P150003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 07/23/2025

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 Model Number: H7493941820350
• Device Catalogue Number: H7493941820350
• Device Lot Number: 0035586634
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2025
• Initial Report FDA Received Date: 07/23/2025
• Date Device Manufactured: 12/17/2024
• 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 Age: 71 YR
• Patient Sex: Female
• Patient Weight: 99 KG
• Patient Race: Black Or African American