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

Model Number	H7493941828350
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cardiac Enzyme Elevation (1838); Low Blood Pressure/ Hypotension (1914); Ventricular Fibrillation (2130); Obstruction/Occlusion (2422); Thrombosis/Thrombus (4440)
Date of Event	10/20/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a repeat angiogram revealed thrombosis of the lad stent that was treated with ptca and thrombectomy.The patient developed ventricular fibrillation refractory to at least 4 attempts at electrical defibrillation.Additional stent was deployed and thrombectomy was performed with return of timi 3 flow.Intra-aortic balloon pump (iabp) was placed to maximize coronary perfusion.In the cath lab, the patient received 4 units of packed red blood cells (prbc) and 5x 25% albumin.Hypotension requiring iabp insertion requiring 4u vasopressors and epinephrine for several hours before weaning off.Iabp removed on day 2 with no complications.Patient was extubated to high flow nasal cannula.Increased cardiac enzymes were noted 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: 23636639
• Report Number: 2124215-2025-86093
• Device Sequence Number: 16047347
• Product Code: NIQ
• UDI-Device Identifier: 08714729981077
• UDI-Public: (01)08714729981077(17)270311(10)36136901
• Combination Product (Y/N): Y
• Initial Reporter State: NY
• 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: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/24/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: H7493941828350
• Device Catalogue Number: H7493941828350
• Device Lot Number: 0036136901
• 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: 10/30/2025
• Initial Report FDA Received Date: 11/24/2025
• Date Device Manufactured: 03/11/2025
• 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
• Patient Age: 78 YR
• Patient Sex: Female
• Patient Weight: 61 KG