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

Model Number	H7493960820250
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	02/18/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that elevated cardiac enzymes and myocardial infarction occurred.The patient was on a prior regimen of antiplatelet other than aspirin (>= 72 hours).At the time of the procedure, heparin or other antithrombotic medication and a loading dose of 325 mg of aspirin and 300 mg of clopidogrel were given.The 3.0 mm x 33 mm target lesion located at the distal circumflex (cx) vessel in the main branch was pretreated with 3.0 mm x 15 mm non-compliant balloon angioplasty catheter resulting in 0% residual stenosis and timi flow 3.The lesion was then successfully treated with 3.0 mm x 33 mm drug eluting stent (non-boston scientific device) achieving 0% residual stenosis with timi flow 3.The other 2.5 mm x 15 mm target lesion located at the 2nd obtuse marginal vessel in the side branch was pretreated with a 2.5 mm x 15 mm non-compliant balloon angioplasty catheter resulting in 0% residual stenosis and timi flow 3.The lesion was then successfully treated with the 2.5 mm x 20 mm agent dcb achieving 0% residual stenosis with timi flow 3.One day post procedure, the 18-24-hour post procedure lab draw demonstrated elevated levels of troponin t hs and troponin-i hs which met the criteria for myocardial infarction.The patient discharged the same day with the continuation of aspirin and clopidogrel.
Event or Problem Description
It was reported that elevated cardiac enzymes and myocardial infarction occurred.The patient was on a prior regimen of antiplatelet other than aspirin (>= 72 hours).At the time of the procedure, heparin or other antithrombotic medication and a loading dose of 325 mg of aspirin and 300 mg of clopidogrel were given.The 3.0 mm x 33 mm target lesion located at the distal circumflex (cx) vessel in the main branch was pretreated with 3.0 mm x 15 mm non-compliant balloon angioplasty catheter resulting in 0% residual stenosis and timi flow 3.The lesion was then successfully treated with 3.0 mm x 33 mm drug eluting stent (non-boston scientific device) achieving 0% residual stenosis with timi flow 3.The other 2.5 mm x 15 mm target lesion located at the 2nd obtuse marginal vessel in the side branch was pretreated with a 2.5 mm x 15 mm non-compliant balloon angioplasty catheter resulting in 0% residual stenosis and timi flow 3.The lesion was then successfully treated with the 2.5 mm x 20 mm agent dcb achieving 0% residual stenosis with timi flow 3.One day post procedure, the 18-24-hour post procedure lab draw demonstrated elevated levels of troponin t hs and troponin-i hs which met the criteria for myocardial infarction.The patient discharged the same day with the continuation of aspirin and clopidogrel.
Additional Manufacturer Narrative
Investigation results device analysis findings: the device was not returned for analysis; therefore, a technical analysis could not be performed.Device history record (dhr) review: review confirmed that the device met all material, assembly, and performance specifications prior to distribution.Labeling review: review of the instructions for use (ifu) confirmed there was relevant content and sufficient guidance with respect to the circumstances described within this complaint.No updates are required to the ifu as a result of this event.Risk review: a risk review was performed and confirmed that the event was defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Investigation conclusion: boston scientific has assigned an investigation conclusion code of adverse event related to patient condition based upon the information available.It was reported that elevated cardiac enzymes and myocardial infarction occurred.The reported event is most likely attributable to the patients underlying disease progression and clinical condition.The event of myocardial infarction is listed as a known adverse event associated with device use and the elevated cardiac enzymes are a key indicator of a myocardial infarction.

• 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: 50550330
• Report Number: 2124215-2026-45899
• Device Sequence Number: 10266387
• Product Code: OOB
• UDI-Device Identifier: 00191506014803
• UDI-Public: (01)00191506014803(17)260709(10)6945H24
• Combination Product (Y/N): Y
• Initial Reporter State: GA
• 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): 10/02/2026

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: 07/09/2026
• Device Model Number: H7493960820250
• Device Catalogue Number: H7493960820250
• Device Lot Number: 06945H24
• 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: 09/04/2026
• Initial Report FDA Received Date: 09/01/2026
• Supplement Report FDA Received Date: 10/02/2026
• Date Device Manufactured: 07/09/2024
• 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: 51 YR
• Patient Sex: Male
• Patient Race: White