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 07/14/2022

Event Type  Injury  

Event Description

Elegance clinical study.It was reported that vessel dissection occurred.On (b)(6) 2022, the patient was 80 years old at time of enrollment and underwent treatment with the eluvia drug-eluting stent as a part of the elegance clinical trial.The 95% stenosed target lesion was located in the left distal superficial femoral artery with 5.4 mm proximal reference vessel diameter and 5.1 mm distal reference vessel diameter with 50 mm lesion length and was classified as trans-atlantic inter-society consensus ii d lesion.Prior to the treatment of target lesion with study device, embolization was performed using a 5 mm non-boston scientific device, followed by atherectomy using 2 mm non-boston scientific laser device and pre-dilation was performed by using 5 mm x 40 mm mustang pta balloon and 6 mm x 20 mm non-boston scientific percutaneous transluminal angioplasty balloon.A 6 mm x 60 mm eluvia drug eluting stent was placed as treatment to the target lesion.Post-dilation was performed using a 5 mm x 40 mm mustang pta balloon.Post treatment, the final residual stenosis was noted to be 10%.During treatment of target lesion, on the same day of index procedure, a complication of dissection of grade a occurred due to the 5 mm x 40 mm mustang pta balloon and 6 mm x 20 mm bard non-boston scientific pta balloon.In response to the complication, an eluvia stent was placed.Post treatment, the final residual stenosis was noted to be 10%.On the same day, the complication of dissection was considered resolved.Two days after, the patient was discharged on aspirin and clopidogrel.There were no further patient complications reported.

Manufacturer Narrative

A2 - age at time of event: 80 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 CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18694417
• MDR Text Key: 335243308
• Report Number: 2124215-2024-07487
• 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,Health Professional,Company Representative
• Reporter Occupation: Physician
• Report Date: 02/13/2024

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: Not provided
• Initial Date FDA Received: 02/13/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female
• Patient Race: Asian