MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RANGER PACLITAXEL-COATED PTA BALLOON CATHETER; DRUG-ELUTING PERIPHERAL TRANSLUMINAL ANGIOPLASTY CATHETER

Model Number	1973-03
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Arteriosclerosis/ Atherosclerosis (4437); Thrombosis/Thrombus (4440); Restenosis (4576)
Date of Event	10/28/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Elegance clinical study.It was reported that the subject had occlusion of the right popliteal artery, requiring intervention.On (b)(6) 2022, the subject underwent treatment with 4.0 x 100mm, 135cm ranger paclitaxel-coated pta balloon catheter.As a part of the elegance clinical trial.The target lesions were in the right proximal superficial femoral artery (sfa), right mid-sfa, right distal sfa, right proximal popliteal artery, and the right mid-popliteal artery extending up to the right distal popliteal artery with 5mm proximal reference vessel diameter and 4mm distal reference vessel diameter, with a lesion length of 450 mm and 100% stenosis.Prior to target lesion treatment with the study device, atherectomy was performed with a non-boston scientific (bsc) laser atherectomy device, followed by pre-dilation using two non-bsc balloons.Treatment of the target lesion was then performed by dilation using 5 mm x 200 mm, 5 mm x 200 mm, and 4 mm x 100 mm ranger drug coated balloon study devices.Post dilatation treatment was performed with a non-bsc cutting balloon, and the final residual stenosis was noted to be 10%.On (b)(6) 2022, on the day of discharge, the subject complained of recurrent leg pain.A lower extremity arterial duplex scan revealed re-occlusion of the right popliteal artery.Based on the above findings the subject was scheduled for angiography of the lower extremity vessels with possible percutaneous endovascular intervention.On the same day, the abdominal aortogram revealed: mild atherosclerotic changes of the distal abdominal aorta with no significant obstructive disease, patent right and left ileo-femoral artery systems and patent right and left internal iliac arteries.Right limb showed 60-70% stenosis atin right common femoral artery, patent stent at thein ostium/proximal segment of sfa, occluded stent at proximal to mid popliteal artery, occluded anterior tibial artery, tibial peroneal trunk, and posterior tibial artery.On the same day, occlusions in the right proximal popliteal artery, right mid popliteal artery, and right distal popliteal artery were treated using a boston scientific thrombectomy device, followed by an atherectomy device to debulk the totally occluded right popliteal artery.Subsequently, balloon angioplasty was performed using a non-bsc balloon along the entire length of the occlusion.The final angiogram revealed excellent dilation with no significant residual stenosis.In addition, 60-70% tubular stenosis noted in the right common femoral artery was treated using atherectomy device and following balloon angioplasty using non-bsc balloon the final residual stenosis was noted to be 10%.The occlusion noted in the right tibio-peroneal trunk was treated with jetstream xc thrombectomy and atherectomy device followed by balloon angioplasty using 2.5 mm x 80 mm and 3.0 mm x 80 mm non-bsc balloon and post procedure the final residual stenosis was noted to be 10%.On the same day, the event was considered resolved.On (b)(6) 2022, the subject was discharged from the hospital on dual antiplatelet therapy.
Additional Manufacturer Narrative
A1: patient identifier: (b)(6).A2: patient age: 62 years old at time of enrollment.
Additional Manufacturer Narrative
A1: patient identifier: (b)(6).A2: patient age: 62 years old at time of enrollment.
Event or Problem Description
Elegance clinical study.It was reported that the subject had occlusion of the right popliteal artery, requiring intervention.On (b)(6) 2022, the subject underwent treatment with 4.0 x 100mm, 135cm ranger paclitaxel-coated pta balloon catheter as a part of the elegance clinical trial.The target lesions were in the right proximal superficial femoral artery (sfa), right mid-sfa, right distal sfa, right proximal popliteal artery, and the right mid-popliteal artery extending up to the right distal popliteal artery with 5mm proximal reference vessel diameter and 4mm distal reference vessel diameter, with a lesion length of 450 mm and 100% stenosis.Prior to target lesion treatment with the study device, atherectomy was performed with a non-boston scientific (bsc) laser atherectomy device, followed by pre-dilation using two non-bsc balloons.Treatment of the target lesion was then performed by dilation using 5 mm x 200 mm, 5 mm x 200 mm, and 4 mm x 100 mm ranger drug coated balloon study devices.Post dilatation treatment was performed with a non-bsc cutting balloon, and the final residual stenosis was noted to be 10%.On (b)(6) 2022, on the day of discharge, the subject complained of recurrent leg pain.A lower extremity arterial duplex scan revealed re-occlusion of the right popliteal artery.Based on the above findings the subject was scheduled for angiography of the lower extremity vessels with possible percutaneous endovascular intervention.On the same day, the abdominal aortogram revealed: mild atherosclerotic changes of the distal abdominal aorta with no significant obstructive disease, patent right and left ileo-femoral artery systems and patent right and left internal iliac arteries.Right limb showed 60-70% stenosis in the right common femoral artery, patent stent in the ostium/proximal segment of sfa, occluded stent at proximal to mid popliteal artery, occluded anterior tibial artery, tibial peroneal trunk, and posterior tibial artery.On the same day, occlusions in the right proximal popliteal artery, right mid popliteal artery, and right distal popliteal artery were treated using a boston scientific thrombectomy device, followed by an atherectomy device to debulk the totally occluded right popliteal artery.Subsequently, balloon angioplasty was performed using a non-bsc balloon along the entire length of the occlusion.The final angiogram revealed excellent dilation with no significant residual stenosis.In addition, 60-70% tubular stenosis noted in the right common femoral artery was treated using atherectomy device and following balloon angioplasty using non-bsc balloon the final residual stenosis was noted to be 10%.The occlusion noted in the right tibio-peroneal trunk was treated with jetstream xc thrombectomy and atherectomy device followed by balloon angioplasty using 2.5 mm x 80 mm and 3.0 mm x 80 mm non-bsc balloon and post procedure the final residual stenosis was noted to be 10%.On the same day, the event was considered resolved.On (b)(6) 2022, the subject was discharged from the hospital on dual antiplatelet therapy.It was further reported that on (b)(6) 2022, 4 days post index procedure, thrombotic occlusion was noted in the right proximal popliteal artery, right mid popliteal artery, and right distal popliteal artery.

• Brand Name: RANGER PACLITAXEL-COATED PTA BALLOON CATHETER
• Common Device Name: DRUG-ELUTING PERIPHERAL TRANSLUMINAL ANGIOPLASTY CATHETER
• 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: 19938374
• Report Number: 2124215-2024-45509
• Device Sequence Number: 14671551
• Product Code: ONU
• UDI-Device Identifier: 08714729975823
• UDI-Public: 08714729975823
• Combination Product (Y/N): Y
• Initial Reporter State: DC
• Initial Reporter Country: US
• PMA/510(K) Number: P190019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/06/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/27/2023
• Device Model Number: 1973-03
• Device Catalogue Number: 1973-03
• Device Lot Number: 05606H21
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/16/2024
• Supplement Date Received by Manufacturer: 11/04/2024
• Initial Report FDA Received Date: 08/08/2024
• Supplement Report FDA Received Date: 11/06/2024
• Date Device Manufactured: 08/27/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 5 MM X 200 MM RANGER BALLOONS; 5 MM X 200 MM RANGER BALLOONS
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female
• Patient Race: Black Or African American