MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION MUSTANG; CATHETER, BILIARY, DIAGNOSTIC

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

Patient Problem Vascular Dissection (3160)

Event Date 06/21/2023

Event Type  Injury  

Event Description

Elegance clinical study it was reported that a grade f dissection was noted, requiring additional devices.On (b)(6) 2023, the subject underwent treatment with eluvia drug eluting stents as part of the elegance clinical trial.The target lesion was in the 100% stenosed left proximal superficial femoral artery (sfa) extending up to the left mid-sfa; with a 5 mm proximal reference vessel diameter, and a 5 mm distal reference vessel diameter, with a 240 mm lesion length.The lesion was classified as transatlantic intersociety consensus (tasc) ii c lesion.Multiple attempts were made to cross the occluded segment of left sfa with a v-18 guidewire combined with an unknown catheter.Therefore, retrograde passage was made through the left proximal popliteal artery to establish guidewire pathway.Prior to the treatment of the target lesion with the study devices, pre-dilation of the occluded left sfa was performed using 6 mm x 150 mm and 5 mm x 120 mm percutaneous transluminal angioplasty mustang balloons.Angiography was performed which revealed a grade f flow limiting dissection; therefore, was treated with the placement of eluvia stents.Post procedure, the final residual stenosis was noted to be 0%.On (b)(6) 2023, the subject was discharged from the hospital on dual anti-platelet therapy.

Manufacturer Narrative

Patient id: (b)(6).Patient age: 73 years old at time of enrollment.

• Brand Name: MUSTANG
• Type of Device: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC IRELAND LIMITED
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 19153940
• MDR Text Key: 340728142
• Report Number: 2124215-2024-22203
• Device Sequence Number: 1
• Product Code: FGE
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2024
• 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
• Date Manufacturer Received: 03/28/2024
• 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: 73 YR
• Patient Sex: Male
• Patient Race: Asian