MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AGENT; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

Model Number 3825

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cardiac Enzyme Elevation (1838); Myocardial Infarction (1969); Vascular Dissection (3160)

Event Date 07/21/2021

Event Type  Injury  

Manufacturer Narrative

(b)(6).

Event Description

Agent dcb registry it was reported that a dissection occurred.On (b)(6) 2021, the subject presented with unstable angina and the index procedure was performed on the same day.The 86% stenosed target lesion was located in the distal left anterior descending artery (lad) and was 10mm long, with a reference vessel diameter of 2.25mm.The lesion was treated with predilation with a 2.25mm x 12mm balloon, followed by treatment with a 2.25mm x 15mm agent dcb and 2.00mm x 20mm agent dcb.While treating the target lesion with the second agent dcb balloon, a grade b dissection was noted.The dissection was treated with an unknown intervention.Post procedurally, 30% residual stenosis was noted.Post dilation was not performed.On (b)(6) 2021, the subject was discharged on clopidogrel.

Manufacturer Narrative

A1: patient indentifier: (b)(6).

Event Description

Agent dcb registry.It was reported that a dissection occurred.On (b)(6) 2021, the subject presented with unstable angina and the index procedure was performed on the same day.The 86% stenosed target lesion was located in the distal left anterior descending artery (lad) and was 10mm long, with a reference vessel diameter of 2.25mm.The lesion was treated with predilation with a 2.25mm x 12mm balloon, followed by treatment with a 2.25mm x 15mm agent dcb and 2.00mm x 20mm agent dcb.While treating the target lesion with the second agent dcb balloon, a grade b dissection was noted.The dissection was treated with an unknown intervention.Post procedurally, 30% residual stenosis was noted.Post dilation was not performed.On (b)(6) 2021, the subject was discharged on clopidogrel.It was further reported that the site confirmed that there is no reportable event associated with grade b dissection.On (b)(6) 2021, on the same day as the post index procedure, the subject was diagnosed with myocardial infarction (mi).No action was taken to treat the event.On (b)(6) 2021, the cardiac enzymes were noted to be elevated consistent with protocol definition of mi.On (b)(6) 2021, the event was considered to be recovered and resolved without sequelae.On the same day, the subject was discharged on clopidogrel.

• Brand Name: AGENT
• Type of Device: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 12477973
• MDR Text Key: 271662177
• Report Number: 2134265-2021-11643
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/18/2022
• Device Model Number: 3825
• Device Catalogue Number: 3825
• Device Lot Number: 04070H20
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/13/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR