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

Model Number	H7493960830300
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Chest Pain (1776); Dyspnea (1816); Myocardial Infarction (1969); Vascular Dissection (3160); Restenosis (4576)
Date of Event	08/09/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a nstemi requiring intervention occurred.In early (b)(6) 2026, the 2.75 mm x 25 mm target lesion located at the right posterior descending vessel was pretreated with a semi-compliant and non-compliant balloon with the largest balloon being 2.5 mm x 25 mm.Maximum inflation pressure was 16 with a total of 2 balloon inflations.Pretreatment resulted in 20% stenosis and timi flow 3.The target lesion was then successfully treated with a 3.0 mm x 30 mm agent dcb balloon, maximum inflation pressure was 8 with a total of 1 balloon inflation.Prior to the target lesion treatment, the non-target lesion located at the mid left anterior descending artery was also successfully treated with a 3.5 mm x 16 mm drug eluting stent and 3.75 mm x 12 mm balloon angioplasty catheter.Patient discharged on the same day of the procedure.Shortly after the procedure in (b)(6) 2026, the patient experienced dyspnea and had a nstemi that required an in-patient hospitalization, stent placement, target vessel revascularization and medication administration (heparin).Patient discharged.It was later reported: that shortly after the procedure in (b)(6) 2026, the patient also experienced chest pain.It was later reported: it was reported that 70% restenosis occurred.In (b)(6) 2026, the initial procedure was completed.The patient was on a prior regimen of aspirin (>= 72 hours).At the time of the procedure heparin or other antithrombotic and a loading dose of 180 mg ticagrelor were given.The 2.75 mm x 25 mm target lesion located at the right posterior descending artery (r-pda) was pretreated with two devices resulting in 20% residual stenosis and timi flow of 3.The largest pretreatment balloon was a 2.5 mm x 25 mm semi-compliant balloon and a non-compliant balloon.The target lesion was then successfully treated with a 3.0 mm x 30 mm agent dcb achieving 0% residual stenosis and timi flow 3.The non-target lesion located at the middle left anterior descending artery was also successfully treated prior to the target lesion with a 3.5 mm x 16 mm drug eluting stent and 3.75 mm x 12 mm balloon angioplasty catheter.The patient discharged home with the continuation of aspirin and ticagrelor medications.The patient presented with shortness of breath 5 days after the initial procedure which resulted in a hospitalization.Diagnostic coronary angiography revealed 70% stenosis and a coronary artery dissection at the r-pda.Subsequently the patient was successfully implanted with a drug-eluting stent.The patient discharged from the hospital.

• 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: 50619349
• Report Number: 2124215-2026-47437
• Device Sequence Number: 16083489
• Product Code: OOB
• UDI-Device Identifier: 00191506014896
• UDI-Public: (01)00191506014896(17)271124(10)13463H25
• Combination Product (Y/N): Y
• Initial Reporter State: NY
• 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): 09/10/2026

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 Model Number: H7493960830300
• Device Catalogue Number: H7493960830300
• Device Lot Number: 13463H25
• 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: Not provided
• Supplement Date Received by Manufacturer: 08/18/2026
• Initial Report FDA Received Date: 09/04/2026
• Supplement Report FDA Received Date: 09/10/2026
• Date Device Manufactured: 11/24/2025
• 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; Other; Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 226 LB