MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RANGER SL; CATHETER, PERCUTANEOUS

Model Number 1584-01

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

Patient Problems Ischemia (1942); Restenosis (4576)

Event Date 06/06/2023

Event Type  Injury  

Manufacturer Narrative

A1 - patient identifier: (b)(6).

Event Description

Elegance clinical study.It was reported that restenosis and ischemia occurred.The subject underwent treatment with the ranger drug coated balloon on (b)(6) 2022 as a part of the elegance clinical trial.The target lesion 1 was in the left proximal superficial femoral artery (sfa) and left distal superficial femoral artery (sfa) with 4.0 mm proximal reference vessel diameter and 4.0 mm distal reference vessel diameter with lesion length 150 mm with 80 % stenosis and was classified as tasc ii b lesion.Prior to target lesion treatment with study device, pre-dilation was performed by using 2.0 mm x 80 mm, 4.0 mm x 120 mm, and 3.5 mm x 120 mm non-boston scientific (bsc) pta balloons.Treatment of target lesion was performed by dilation using 4.0 mm x 150 mm ranger drug coated balloon study device.Following post treatment, dilation was performed by using 5.0 mm x 120 mm non-bsc drug coated balloon, 5 mm x 150 mm non-bsc pta deb drug coated balloon and 5 mm x 150 non-bsc 035 deb drug coated balloon followed by the placement of 5.5 mm x 40 mm non-bsc bare metal stent, and the final residual stenosis was noted to be 10%.Of note, per source, during the treatment of the target lesion 1 (left proximal sfa and left distal sfa), a severe dissection was noted in distal sfa due to 5 mm x 150 non-bsc 035 deb drug coated balloon which was treated by placement of a 5.5 x 40 mm x 120 cm non-bsc peripheral stent and post dilated with balloon catheter and on the same day, the complication was resolved.On (b)(6) 2022, the subject was discharged from hospital on clopidogrel.On (b)(6) 2023, bilateral lower limbs cyanotic changes were noted hence, lower extremity ct was performed which revealed the following.Left: moderate to severe stenosis in sfa, occluded proximal popliteal arteries, severe stenosis or occlusion of anterior tibial artery, severe stenosis of posterior tibial artery and occlusion of peroneal artery.Based on the above findings, angioplasty was arranged on (b)(6) 2023.On (b)(6) 2023, duplex performed revealed severe stenosis in left common femoral artery, superficial femoral artery with monophasic flow in popliteal artery.On (b)(6) 2023, peripheral angiography performed revealed the following.Left: 40% stenosis in proximal sfa, 60% calcified stenosis in mid sfa, in-stent occlusion in distal sfa with suspect for thrombus, occlusion in proximal popliteal artery, 80% stenosis in distal popliteal artery, chronic total occlusion in proximal segment of ata, 99% in-stent restenosis in proximal posterior tibial artery and patent common iliac artery, external iliac artery, common femoral artery, and peroneal artery.On (b)(6) 2023, 307 days post index procedure, in-stent thrombotic occlusion noted in left distal sfa and popliteal artery was treated by balloon angioplasty using 2.5mm x 120mm, 3mm x 220 mm and 5mm x 80mm non-bsc balloons (002/tlr).Subsequently during the procedure, angiography performed revealed thrombus in left popliteal artery which was treated by placement of 3 mm x 38 mm non-bsc stent from left popliteal artery to tibio-peroneal trunk and post dilated using 4mm x 20mm non-bsc balloon and 5mm x 120 mm non-bsc drug coated balloon.Followed by placement of 5.5 mm x 80 mm non-bsc peripheral stent from distal sfa to popliteal artery.Post dilation using 5mm x 120 mm non-bsc drug coated balloon and 5mm x 15mm nc emerge mr balloons, the final residual stenosis noted was 15%.On the same day, the event (ae002) was considered to be resolved with sequelae.

Manufacturer Narrative

A1 - patient identifier: (b)(6).

Event Description

Elegance clinical study it was reported that restenosis and ischemia occurred.The subject underwent treatment with the ranger drug coated balloon on (b)(6) 2022 as a part of the elegance clinical trial.The target lesion 1 was in the left proximal superficial femoral artery (sfa) and left distal superficial femoral artery (sfa) with 4.0 mm proximal reference vessel diameter and 4.0 mm distal reference vessel diameter with lesion length 150 mm with 80 % stenosis and was classified as tasc ii b lesion.Prior to target lesion treatment with study device, pre-dilation was performed by using 2.0 mm x 80 mm, 4.0 mm x 120 mm, and 3.5 mm x 120 mm non-boston scientific (bsc) pta balloons.Treatment of target lesion was performed by dilation using 4.0 mm x 150 mm ranger drug coated balloon study device.Following post treatment, dilation was performed by using 5.0 mm x 120 mm non-bsc drug coated balloon, 5 mm x 150 mm non-bsc pta deb drug coated balloon and 5 mm x 150 non-bsc 035 deb drug coated balloon followed by the placement of 5.5 mm x 40 mm non-bsc bare metal stent, and the final residual stenosis was noted to be 10%.Of note, per source, during the treatment of the target lesion 1 (left proximal sfa and left distal sfa), a severe dissection was noted in distal sfa due to 5 mm x 150 non-bsc 035 deb drug coated balloon which was treated by placement of a 5.5 x 40 mm x 120 cm non-bsc peripheral stent and post dilated with balloon catheter and on the same day, the complication was resolved.On (b)(6) 2022, the subject was discharged from hospital on clopidogrel.On (b)(6) 2023, bilateral lower limbs cyanotic changes were noted hence, lower extremity ct was performed which revealed the following.Left: moderate to severe stenosis in sfa, occluded proximal popliteal arteries, severe stenosis or occlusion of anterior tibial artery, severe stenosis of posterior tibial artery and occlusion of peroneal artery.Based on the above findings, angioplasty was arranged on (b)(6) 2023.On (b)(6) 2023, duplex performed revealed severe stenosis in left common femoral artery, superficial femoral artery with monophasic flow in popliteal artery.On (b)(6) 2023, peripheral angiography performed revealed the following.Left: 40% stenosis in proximal sfa, 60% calcified stenosis in mid sfa, in-stent occlusion in distal sfa with suspect for thrombus, occlusion in proximal popliteal artery, 80% stenosis in distal popliteal artery, chronic total occlusion in proximal segment of ata, 99% in-stent restenosis in proximal posterior tibial artery and patent common iliac artery, external iliac artery, common femoral artery, and peroneal artery.On (b)(6) 2023, 307 days post index procedure, in-stent thrombotic occlusion noted in left distal sfa and popliteal artery was treated by balloon angioplasty using 2.5mm x 120mm, 3mm x 220 mm and 5mm x 80mm non-bsc balloons (002/tlr).Subsequently during the procedure, angiography performed revealed thrombus in left popliteal artery which was treated by placement of 3 mm x 38 mm non-bsc stent from left popliteal artery to tibio-peroneal trunk and post dilated using 4mm x 20mm non-bsc balloon and 5mm x 120 mm non-bsc drug coated balloon.Followed by placement of 5.5 mm x 80 mm non-bsc peripheral stent from distal sfa to popliteal artery.Post dilation using 5mm x 120 mm non-bsc drug coated balloon and 5mm x 15mm nc emerge mr balloons, the final residual stenosis noted was 15%.On the same day, the event (ae002) was considered to be resolved with sequelae.It was further reported that target lesion #1 was in the left proximal superficial femoral artery and left mid superficial femoral artery extending up to left distal superficial femoral artery.Prior to target lesion treatment with study device, pre-dilation was performed by using 2.0 mm x 80 mm and 4.0mm x 120 mm non-bsc pta balloons.Following post treatment, dilation was performed by using 5.0 mm x 120 mm non-bsc drug coated balloon, 5 mm x 150 mm non-bsc pta deb drug coated balloon and 5 mm x 150 non-bsc 035 deb drug coated balloon, 5mm x 15mm nc emerge ous pta balloon and by the placement of 5.5 mm x 40 mm non-bsc bare metal stent.Post procedure, the final residual stenosis was noted to be 10%.

• Brand Name: RANGER SL
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): HEMOTEQ AG; adenauerstrasse 15; wuerselen 52146 ; GM 52146
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18847997
• MDR Text Key: 337024379
• Report Number: 2124215-2024-11925
• Device Sequence Number: 1
• Product Code: ONU
• Combination Product (y/n): Y
• Reporter Country Code: TW
• 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,Followup
• Report Date: 05/06/2024

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
• Device Expiration Date: 10/28/2023
• Device Model Number: 1584-01
• Device Catalogue Number: 1584-01
• Device Lot Number: 06863H21
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/07/2024
• Initial Date FDA Received: 03/06/2024
• Supplement Dates Manufacturer Received: 04/12/2024
• Supplement Dates FDA Received: 05/06/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/28/2021
• 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 Age: 81 YR
• Patient Sex: Female
• Patient Race: Asian