MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SYNERGY¿ XD; coronary drug-eluting stent

Model Number	H7493941824300
Medical Device Problem Codes	Break (1069); Nonstandard Device (1420); Difficult to Remove (1528)
Health Effect - Clinical Codes	Bradycardia (1751); Cardiac Arrest (1762); Encephalopathy (1833); Low Blood Pressure/ Hypotension (1914); Myocardial Infarction (1969); Tachycardia (2095); Cardiogenic Shock (2262); Obstruction/Occlusion (2422); Respiratory Failure (2484); Foreign Body In Patient (2687); Insufficient Information (4580)
Date of Event	10/17/2024
Type of Reportable Event	Death
Event or Problem Description
It was reported that the patient died.A defective synergy xd was implanted resulting in a heart attack and death.
Event or Problem Description
It was reported that the patient died.A defective synergy xd was implanted resulting in a heart attack and death.It was further reported that the patient presented for elective left heart catheterization due to chest pain, shortness of breath and abnormal stress test.Angiography revealed patency of the stents previously placed in the left anterior descending artery (lad).An 80% stenosed and 24 mm long target lesion located in the right coronary artery (rca) with a vessel diameter of 3.0 mm was noted.A 3.00 x 20 mm synergy xd was selected for treatment.The device was deployed and inflated at 20 atm for 20 seconds.The procedure was complicated by retention of the delivery system ballon proximal to the deployed stent and iatrogenic occlusion of the rca/pda with infarction.Attempts to remove the balloon were unsuccessful.The catheter fractured and the fragment remained in the mid rca.A timi flow of 0 was noted following treatment.The patient became hypotensive and hemodynamically unstable.Cardiogenic shock occurred in the setting of acute myocardial infarction.Acute hypoxemic respiratory failure occurred secondary to shock followed by metabolic acidosis, encephalopathy in the setting of medications.The patient was intubated and placed on inotropic support with an intra-aortic balloon pump in place.Ventricular tachycardia was noted requiring defibrillation.The patient was transferred to the icu for further care and management.3 pressors for blood pressure support were initiated.The patient developed transient bradycardia which eventually resolved.Echo showed lvef of 45 to 50% with significant ventricular infarction with poor mobility of the right ventricle.Intravenous fluids were started.Despite ballon pump and pressor support blood pressure reading were tenuous.The patient continued to deteriorate and went into cardiac arrest.The patient was not resuscitated and died.

• 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 ; +1(763)494-1632
• MDR Report Key: 23924839
• Report Number: 2124215-2025-93755
• Device Sequence Number: 9012811
• Product Code: NIQ
• Combination Product (Y/N): Y
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P150003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/01/2026

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/29/2026
• Device Model Number: H7493941824300
• Device Catalogue Number: H7493941824300
• Device Lot Number: 0033975983
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/04/2025
• Supplement Date Received by Manufacturer: 08/03/2026
• Initial Report FDA Received Date: 12/30/2025
• Supplement Report FDA Received Date: 09/01/2026
• Date Device Manufactured: 04/29/2024
• 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 Age: 83 YR
• Patient Sex: Female