MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AGENT?; Drug-eluting percutaneous transluminal coronary angioplasty catheter

Model Number	H7493960830250
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cardiac Enzyme Elevation (1838); Myocardial Infarction (1969)
Date of Event	04/13/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient complications occurred.The 10 mm x 2.50 mm target lesion was located in the mid left anterior descending artery (lad).The patient was on a prior regimen of aspirin (>= 72 hours) and antiplatelet other than aspirin (>= 72 hours) at the time of index procedure.A loading dose of 325 mg of aspirin and 600 mg of clopidogrel were given prior to the procedure.The target lesion was pre-treated with four devices including a 2.50 mm x 12 mm non-compliant balloon angioplasty catheter resulting in 30% residual stenosis and timi flow 3.The target lesion was then successfully treated with a 2.50 mm x 30 mm agent dcb resulting in 0% residual stenosis and timi flow of 3.Post-procedure, elevated cardiac enzymes were detected, and the patient was diagnosed with myocardial infarction.The patient was discharged from the hospital with the continuation of aspirin, and clopidogrel medication was started.

• 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): FREUDENBERG MEDICAL; adenauerstrasse 15; wuerselen 52146 ; GM 52146
• Manufacturer Contact: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; +1(612)875-7234
• MDR Report Key: 50550390
• Report Number: 2124215-2026-45890
• Device Sequence Number: 10651437
• Product Code: OOB
• UDI-Device Identifier: 00191506014872
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P230035
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/22/2026

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: 08/27/2026
• Device Model Number: H7493960830250
• Device Catalogue Number: H7493960830250
• Device Lot Number: 08756H24
• 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: 08/04/2026
• Supplement Date Received by Manufacturer: 09/02/2026
• Initial Report FDA Received Date: 09/01/2026
• Supplement Report FDA Received Date: 09/22/2026
• Date Device Manufactured: 08/27/2024
• 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: Other
• Patient Age: 72 YR
• Patient Sex: Female
• Patient Race: White