MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AGENT?; DRUG-ELUTING PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY CATHETER

Model Number	H7493960815300
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Chest Pain (1776); Myocardial Infarction (1969); Obstruction/Occlusion (2422); Thrombosis/Thrombus (4440)
Date of Event	05/29/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that thrombosis and a myocardial infarction occurred.The patient was presented with in-stent restenosis.The 95% stenosed target lesion was located in the mildly tortuous and very mildly calcified mid left anterior descending artery (lad).The target lesion first prepped with a 2.50 x 15 nc emerge balloon, followed by a 3.00 x 15 non-boston scientific balloon.Treatment of the restenosis was completed using a 3.00 x 15mm agent drug-coated balloon (dcb), yielding excellent results.The procedure was initially concluded, and the patient was taken off the table.However, approximately an hour later, the patient experienced ekg changes and chest pain.Upon re-evaluation, an acute occlusion of the left anterior descending artery was identified, along with acute thrombosis and a myocardial infarction in the previously treated mid-segment.A 2.50 x 48 mm stent was placed, followed by post-dilation with a 3.00 x 20 nc emerge balloon.The patient recovered well, remained under observation overnight and was discharged the next day without complications, having made a full recovery.

• Brand Name: AGENT?
• Common Device Name: DRUG-ELUTING PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): HEMOTEQ AG; adenauerstrasse 15; wuerselen 52146 ; GM 52146
• Manufacturer Contact: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; 7634941632
• MDR Report Key: 22378500
• Report Number: 2124215-2025-42583
• Device Sequence Number: 9436292
• Product Code: OOB
• UDI-Device Identifier: 00191506014759
• UDI-Public: (01)00191506014759(17)260419(10)3002H24
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P230035
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 07/01/2025

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: 04/19/2026
• Device Model Number: H7493960815300
• Device Catalogue Number: H7493960815300
• Device Lot Number: 03002H24
• 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: 06/05/2025
• Initial Report FDA Received Date: 07/01/2025
• Date Device Manufactured: 04/19/2024
• 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: Hospitalization; Required Intervention
• Patient Sex: Unknown