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

Lot Number	0032340396
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Chest Pain (1776); Non specific EKG/ECG Changes (1817); Ischemia (1942); Myocardial Infarction (1969)
Date of Event	01/11/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient experienced myocardial infarction and chest pain requiring additional intervention.Following pre-dilatation, intravascular ultrasound (ivus) was performed.A 4.00 x 20mm synergy xd drug-eluting stent was advanced for treatment.Following post-dilatation, ivus was again performed to complete the procedure.There were no adverse events, and the patient was transferred to the patient care unit.The patient complained of chest pain, and electrocardiogram (ekg) changes were shown approximately 60 minutes post-implantation.It was noted that the patient experienced myocardial infarction and ischemia.The patient was brought back to the cardiac catheterization lab, ivus was completed and balloon angioplasty was performed to expand the stent.The patient returned to the patient care unit and tolerated the procedure well.There were no patient complications reported and the patient was expected to fully recover.

• 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 shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18672724
• Report Number: 2124215-2024-05321
• Device Sequence Number: 17678076
• Product Code: NIQ
• UDI-Device Identifier: 08714729981138
• UDI-Public: 08714729981138
• 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): 02/08/2024

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
• Device Expiration Date: 08/15/2025
• Device Lot Number: 0032340396
• 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: 02/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/16/2023
• 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: Hospitalization; Required Intervention
• Patient Age: 58 YR
• Patient Sex: Male
• Patient Weight: 83 KG