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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Arrhythmia (1721); Cardiac Arrest (1762)

Event Date 11/01/2023

Event Type  Death  

Manufacturer Narrative

A4 weight: 69.9 kg.B3 date of event: estimated to capture approximate onset of experienced ventricular tachycardia.

Event Description

Japan alliance registry.It was reported that the patient died.The patient presented to the emergency department with st elevation acute myocardial infarction and cardiogenic shock on (b)(6), 2023.Coronary angiography showed 90% stenosis in the left main trunk origin (lmt-lad) and 90% stenosis in the mildly calcified proximal left circumflex (lcx).That same day, the lmt-lad was treated with a 3.50 x 48 mm synergy and the lcx was treated with a 2.75 x 15 mm agent dcb and the assistance of a heart pump.The patient was hospitalized to undergo cardiac rehabilitation and non-sustained ventricular tachycardia was noted.On (b)(6), 2023, the patient was discharged with a wearable cardioverter-defibrillator (wcd), but there was little improvement in cardiac function.Implantation of a subcutaneous implantable defibrillator (s-icd) was scheduled for a later date.On (b)(6) 2024, the patient was reportedly living normally.The following day, the patent collapsed at home and emergency medical assistance was required.An electrocardiogram performed by the emergency medical team showed cardiac arrest, resuscitation was performed and the patient was transported to the hospital, but the patient did not respond, and death was confirmed.A fatal arrhythmia or heart failure was suspected as the cause of death, but could not be confirmed as the patient was not wearing the wcd at the time of cardiac arrest.

• Brand Name: SYNERGY XD
• Type of Device: 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: 19202933
• MDR Text Key: 341284944
• Report Number: 2124215-2024-25751
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/08/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization
• Patient Age: 64 YR
• Patient Sex: Male