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

Lot Number	0032702550
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Arrhythmia (1721); Cardiac Arrest (1762); Non specific EKG/ECG Changes (1817); Vascular Dissection (3160); Asystole (4442)
Date of Event	04/15/2024
Type of Reportable Event	Death
Event or Problem Description
It was reported that the patient died.The target lesion was located in right coronary artery (rca).A 1.5mm rotapro burr was set to 160k revolution per minute (rpm).The physician wired the rca with a rotawire drive floppy wire.A temporary pacer was suggested, and the physician opted for an aminophylline approach.The physician passed the burr once in the rca with no drastic drop in rpms.A 3.0x15 non-boston scientific balloon catheter was then used to dilate the artery.Upon injection after balloon utilization, a type b dissection was observed along with no reflow in the proximal to middle rca.A 4.00 x 32mm synergy xd drug-eluting stent was deployed, and the patient remained stable.A microcatheter was placed down the vessel and nicardipine was administered to the patient.A reperfusion arrhythmia appeared with significant st elevation.The patient suddenly went asystole.Cardiopulmonary resuscitation was performed and return of spontaneous circulation was started.A temporary pacer and impella were inserted, and the patient was intubated.However, before leaving the cardiac catheterization lab, the patient died.The official cause of death was cardiac arrest.

• 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: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 19285952
• Report Number: 2124215-2024-25612
• Device Sequence Number: 8426105
• Product Code: NIQ
• UDI-Device Identifier: 08714729981169
• UDI-Public: 08714729981169
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 05/10/2024

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 Expiration Date: 10/03/2025
• Device Lot Number: 0032702550
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/15/2024
• Initial Report FDA Received Date: 05/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/04/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: BALLOON CATHETER - 3.0X15 EUPHORA; ROTAPRO 1.50MM
• Outcome Attributed to Adverse Event: Death
• Patient Age: 84 YR
• Patient Sex: Female