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

Lot Number	0029104122
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Chest Pain (1776); Ventricular Fibrillation (2130); Thrombosis/Thrombus (4440)
Date of Event	01/11/2024
Type of Reportable Event	Death
Event or Problem Description
It was reported that acute thrombosis and death occurred.The patient presented with chest pain.Vascular access was obtained via the right radial artery.The target lesion was located in the proximal left anterior descending artery.Following pre-dilation with a 2.50 x 20 non-boston scientific (non-bsc) balloon, intravascular ultrasound was performed.A 3.50 x 38mm synergy xd drug eluting stent (des) was advanced for treatment and implanted at 14 atm for 12 seconds.The stent was post-dilated for 7 seconds and 4 seconds each at 12 atm, and then for 6 seconds at 16 atm, using a 4.00 x 15 nc non-bsc balloon.Intravascular ultrasound was again performed to complete the procedure.There were no adverse events, and the patient was transferred to the patient care unit.The patient started having acute chest pain within 30-60 minutes post procedure and was brought back to the catheter lab.It was discovered that the stent was clotted at the proximal edge.The physician ballooned and placed two more synergy stents as well as a heart pump and a temporary pacer.The patient returned to the patient care unit and died sometime that night.Cause of death was acute vessel closure leading to ventricular fibrillation and the inability to resuscitate.

• 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: 18611173
• Report Number: 2124215-2024-05055
• Device Sequence Number: 2369269
• Product Code: NIQ
• UDI-Device Identifier: 08714729981091
• UDI-Public: 08714729981091
• 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): 01/30/2024

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: 03/10/2024
• Device Lot Number: 0029104122
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/12/2024
• Initial Report FDA Received Date: 01/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/11/2022
• 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; Hospitalization; Required Intervention
• Patient Age: 63 YR
• Patient Sex: Female