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

Lot Number	0033677707
Medical Device Problem Codes	Break (1069); Material Deformation (2976)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Ventricular Fibrillation (2130); Obstruction/Occlusion (2422)
Date of Event	05/22/2025
Type of Reportable Event	Death
Additional Manufacturer Narrative
Good faith effort attempts were made to try and retrieve additional details regarding the reported event, but further information was unable to be obtained.
Event or Problem Description
It was reported that the patient died.The patient was admitted for an elective coronary angiogram following a positive ct coronary angiogram (ctca).The procedure was initiated via right radial artery access, and a 7f non-boston scientific radial sheath was inserted.Angiography revealed severely calcified left anterior descending (lad) artery lesions, which was also noted to be moderately tortuous.A 6f guidezilla ii guide extension catheter was engaged to assist device advancement.Rotational atherectomy was performed using a 1.50 mm rotapro device.Intravascular ultrasound (ivus) was then performed followed by multiple balloon inflations with 3.00mm x 15mm, 2.75mm x 12mm and 2.50mm x 12mm nc emerge balloon catheters.The balloon inflations were carried out in the proximal and mid-lad segments.During this process, hypotensive episodes were observed and managed with multiple aramine boluses.A 2.50 x 32 mm synergy xd drug-eluting stent was then advanced down the lad.While optimal positioning was performed, the stent shaft was sheared, noted possibly due to contact with heavily calcified plaque.A portion of the shaft, including the undeployed stent and stent balloon, became detached and lodged within the lad, resulting in vessel occlusion.The patients condition began to deteriorate, and a code blue was activated.A cardiothoracic surgeon was urgently contacted, and advanced life support (als) measures were initiated.The patient went into ventricular fibrillation (vf) and was defibrillated with 200 joules.Cardiopulmonary resuscitation (cpr) was performed, and sinus rhythm was restored after the initial shock.Preparation began to transfer the patient to cardiac surgery.The patient was intubated and then deteriorated back into vf, which required four additional defibrillation shocks, three 1 mg doses of adrenaline, and 300 mg of amiodarone, administered according to als protocol.A lucas mechanical cpr device was applied, and resuscitative efforts were continued during transfer to the cardiac surgery room for urgent coronary artery bypass grafting (cabg).An emergency sternotomy was performed, and cardiopulmonary bypass was initiated via femoral cannulation.The patient underwent cabg to right coronary artery (rca) x 2, lad, and distal posterior descending artery (pda), with left atrial appendage (laa) ligation also completed.The stent, balloon, and sheared shaft were successfully retrieved during surgery.The procedure was completed.The retrieved stent strut was also noted to be deformed.The patient was subsequently transferred to the intensive care unit (icu).However, despite all interventions, the patient passed away the following day.

• 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: 22248204
• Report Number: 2124215-2025-37627
• Device Sequence Number: 13102409
• Product Code: NIQ
• UDI-Device Identifier: 08714729980193
• UDI-Public: (01)08714729980193(17)260307(10)33677707
• Combination Product (Y/N): Y
• Initial Reporter Country: AS
• 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
• Report Date (Section B): 06/17/2025

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?: No
• Operator of Device: Health Professional
• Device Lot Number: 0033677707
• 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: 05/23/2025
• Initial Report FDA Received Date: 06/17/2025
• Date Device Manufactured: 03/07/2024
• 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: Death
• Patient Sex: Unknown