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

Model Number	24673
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Vascular Dissection (3160); Embolism/Embolus (4438)
Date of Event	03/03/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Elegance clinical study.It was reported that an embolism occurred.The subject underwent treatment with the eluvia drug-eluting stent on (b)(6) 2023 as a part of the elegance clinical trial.The target lesion was in the left proximal superficial femoral artery, left mid superficial femoral artery, left distal superficial femoral artery, left proximal popliteal artery extending to left mid popliteal artery with 6.0 mm proximal reference vessel diameter and 5.0 mm distal reference vessel diameter with lesion length of 400 mm and 100% stenosis and was classified as tasc ii d lesion.Prior to target lesion treatment with study device, pre-dilation was performed by using sizes of 5.0 mm x 200 mm and 6.0 mm x 150 mm mustang pta balloons.Treatment of target lesion was performed by placement using study devices of sizes of 6 mm x 120 mm and 6 mm x 60 mm eluvia drug eluting stents.Following post treatment, dilation was performed by using 6 mm x 200 mm mustang pta balloon, and the final residual stenosis was noted to be 0%.On (b)(6) 2023, on the same day of index procedure, during the treatment of target lesion #001, embolism was noted at the left anterior tibial artery due to 6 mm x 200 mm mustang pta balloon.Additionally, on the same day, dissection of grade a was noted in target lesion 001 during the index procedure.In response to the complication, aspiration thrombectomy was performed followed by the placement of bailout stent.Post treatment, the final residual stenosis was noted to be 0%.The complications of embolism and dissection were resolved.On (b)(6) 2023, the subject was discharged from the hospital.
Additional Manufacturer Narrative
Patient identifier: (b)(6).Initial reporter phone: (b)(6).
Additional Manufacturer Narrative
A3: patient age: 82 years old at time of enrollment.A1 - patient identifier: (b)(6).E1: initial reporter phone: (b)(6).
Event or Problem Description
Elegance clinical study.It was reported that an embolism occurred.The subject underwent treatment with the eluvia drug-eluting stent on (b)(6) 2023 as a part of the elegance clinical trial.The target lesion was in the left proximal superficial femoral artery, left mid superficial femoral artery, left distal superficial femoral artery, left proximal popliteal artery extending to left mid popliteal artery with 6.0 mm proximal reference vessel diameter and 5.0 mm distal reference vessel diameter with lesion length of 400 mm and 100% stenosis and was classified as tasc ii d lesion.Prior to target lesion treatment with study device, pre-dilation was performed by using sizes of 5.0 mm x 200 mm and 6.0 mm x 150 mm mustang pta balloons.Treatment of target lesion was performed by placement using study devices of sizes of 6 mm x 120 mm and 6 mm x 60 mm eluvia drug eluting stents.Following post treatment, dilation was performed by using 6 mm x 200 mm mustang pta balloon, and the final residual stenosis was noted to be 0%.On (b)(6) 2023, on the same day of index procedure, during the treatment of target lesion #001, embolism was noted at the left anterior tibial artery due to 6 mm x 200 mm mustang pta balloon.Additionally, on the same day, dissection of grade a was noted in target lesion 001 during the index procedure.In response to the complication, aspiration thrombectomy was performed followed by the placement of bailout stent.Post treatment, the final residual stenosis was noted to be 0%.The complications of embolism and dissection were resolved.On (b)(6) 2023, the subject was discharged from the hospital.It was further reported that on (b)(6) 2023, a grade a dissection occurred instead of embolism.The target lesion #001 was in the left proximal popliteal artery extending to left mid popliteal artery with 6.0 mm proximal reference vessel diameter and 5.0 mm distal reference vessel diameter with lesion length of 120 mm and 100% stenosis and was classified as tasc ii d lesion.Prior to target lesion treatment with study device, pre-dilation was performed by using sizes of 5.0 mm x 200 mm and 6.0 mm x 150 mm mustang pta balloons.Treatment of target lesion was performed by placement using study device of size 6 mm x 120 mm eluvia drug eluting stents.Following post treatment, dilation was performed by using 6 mm x 200 mm mustang pta balloon, and the final residual stenosis was noted to be 0%.The target lesion #002 was in the left proximal superficial femoral artery with 6.0 mm proximal reference vessel diameter and 5.0 mm distal reference vessel diameter with lesion length of 60 mm and 100% stenosis and was classified as tasc ii d lesion.

• Brand Name: MUSTANG
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; pmt 741 persiaran cassia selat; bandarcassia, pulau pinan 14110 ; MY 14110
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 17246891
• Report Number: 2124215-2023-32170
• Device Sequence Number: 17850279
• Product Code: LIT
• UDI-Device Identifier: 08714729793380
• UDI-Public: 08714729793380
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K103751
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/03/2024

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
• Operator of Device: Health Professional
• Device Model Number: 24673
• Device Catalogue Number: 24673
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/08/2023
• Supplement Date Received by Manufacturer: 12/20/2023
• Initial Report FDA Received Date: 07/03/2023
• Supplement Report FDA Received Date: 01/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Required Intervention
• Patient Age: 82 YR
• Patient Sex: Female
• Patient Race: Asian