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

Medical Device Problem Codes	Device Damaged by Another Device (2915); Positioning Problem (3009)
Health Effect - Clinical Codes	Bradycardia (1751); Cardiac Arrest (1762); Chest Pain (1776); Thrombosis/Thrombus (4440)
Date of Event	06/03/2024
Type of Reportable Event	Death
Event or Problem Description
It was reported that patient complications and death occurred.The patient presented with triple vessel disease and had turned down surgery.The target lesion being treated was located in the moderately calcified and mildly tortuous right coronary artery (rca).The mid rca was prepared using an nc balloon, and a 3.50 lithotripsy balloon; the proximal/ostium rca was treated with a semi-compliant balloon and a 3.50 lithotripsy balloon.A 3.00 x 28 synergy xd stent was deployed, followed by a 4.00 x 20 synergy xd stent deployed in the rca ostium.Repositioning was performed several times before the 4.00 x 20 stent was implanted.The stents were deployed without issue and angiography showed the stents appeared to be sufficiently overlapped and the vessel looked open.The patient was sent to the intensive care unit (icu).Shortly after, the patient complained of chest pain and became bradycardic.The patient was put under anesthesia and intubated and was returned to the cath lab.The rca was re-engaged with difficulty; the guide could not fully engage, likely due to the stent struts at the ostium.The vessel was wired and mechanical thrombectomy was attempted but it was unsuccessful.It was then noticed that the portion of the stent that was out of the rca looked either fractured or damaged about 8-10 mm from the proximal edge.Surgical backup was requested, and the patient was returned to the icu.During that time, the patient coded 2-3 times and was brought back to the cath lab to attempt to use a non-boston scientific temporary ventricular support device and a pacemaker.The patient coded and was shocked several times.The patient died while awaiting surgery.

• 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 IRELAND LIMITED; galway ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 19595846
• Report Number: 2124215-2024-38555
• Device Sequence Number: 8410000
• Product Code: NIQ
• UDI-Device Identifier: 08714729981138
• UDI-Public: 08714729981138
• Combination Product (Y/N): Y
• Initial Reporter State: AZ
• 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): 06/24/2024

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?: Yes
• Operator of Device: Health Professional
• 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: 06/03/2024
• Initial Report FDA Received Date: 06/24/2024
• 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; Required Intervention
• Patient Sex: Female