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

Lot Number	0031338901
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Chest Pain (1776); Non specific EKG/ECG Changes (1817); Thrombosis/Thrombus (4440)
Date of Event	04/24/2024
Type of Reportable Event	Death
Event or Problem Description
It was reported that the patient died.The target lesions were located in the left anterior descending (lad) artery and left circumflex (lcx) artery.Six synergy xd drug eluting stents were implanted, a 2.25mm x 12mm, a 2.75mm x 12mm, a 3.00 x 16mm, a 3.00mm x 38mm, a 3.5mm x 28mm and a 3.5mm x 48mm, with no visible edge dissections.Twenty minutes after arriving in the recovery unit, the patient complained about chest pain and developed st segment elevation.The patient was brought back to the cardiac catheterization laboratory and the stents in both the lad and lcx were thrombosed.Thrombectomy was performed in an attempt to re-open the arteries.The patient coded for sixty minutes and expired.

• 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: 19368005
• Report Number: 2124215-2024-26142
• Device Sequence Number: 7528197
• Product Code: NIQ
• UDI-Device Identifier: 08714729980964
• UDI-Public: 08714729980964
• Combination Product (Y/N): Y
• Initial Reporter State: NV
• 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): 05/21/2024

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: 03/20/2025
• Device Lot Number: 0031338901
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/24/2024
• Initial Report FDA Received Date: 05/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/21/2023
• 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
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Male