MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WOLVERINE CORONARY CUTTING BALLOON; CATHETER, PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA), CUTTING/SCORING

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

Patient Problem Vascular Dissection (3160)

Event Date 07/15/2021

Event Type  Injury  

Event Description

Agent ide study the subject presented with stable angina and was randomized into the agent ide study on (b)(6) 2021.The index procedure was performed on the same day.Heparin or other antithrombotic medication was administered at the time of index procedure.The target lesion was located from the mid right coronary artery (rca) to distal rca and was 25 mm long with a reference vessel diameter of 3.80 mm.During the index procedure, the target lesion was first inserted with unknown boston scientific guidewires and initial pre-dilation was performed using a 2.50 mm x 15 mm nc quantum apex.Then a 3.00 mm x 20 mm nc quantum apex was inflated at the target lesion and ruptured.This was followed by treating the target lesion with laser atherectomy, a 3.50 mm x 20 mm nc quantum apex and 3.00 mm x 15 mm nc quantum apex balloon.Inflation of a 3.50 mm x 15 mm nc quantum apex was attempted, but failed to cross the lesion.The lesion was then treated with a 4.00 mm x 15 mm nc quantum apex and intravascular ultrasound (ivus) revealed under expansion at the target lesion.The lesion was treated with a 3.00 mm x 10 mm wolverine and the final pre-dilation was performed with a 3.00 mm x 20 mm nc quantum apex which significantly recoiled.Following pre-dilation, the lesion was treated with a 4.00 mm x 30 mm agent dcb study device successfully, with 40% residual stenosis and thrombolysis in myocardial infarction (timi) flow of 3.Final angiography after the index procedure revealed a nhlbi grade c focal dissection at the distal portion of the lesion without staining or flow impairment.The dissection was noted prior to the use of agent dcb study device.On 15-jul-2021, the event was considered resolved/recovered.On (b)(6) 2021, the subject was discharged on prasugrel and aspirin.

• Brand Name: WOLVERINE CORONARY CUTTING BALLOON
• Type of Device: CATHETER, PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA), CUTTING/SCORING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 19091713
• MDR Text Key: 339986947
• Report Number: 2124215-2024-22182
• Device Sequence Number: 1
• Product Code: NWX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/11/2024

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/25/2024
• Initial Date FDA Received: 04/11/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Race: White