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 Code	Restenosis (4576)
Date of Event	11/20/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A1 patient identifier: (b)(6).A2 age at time of event: 64 years old at the time of enrollment.
Event or Problem Description
Elegance clinical trial.It was reported that restenosis occurred.The subject underwent treatment with the ranger paclitaxel-coated pta balloon catheter on (b)(6) 2023 as a part of the elegance clinical trial.The target lesion was in the right mid superficial femoral artery (sfa), right distal superficial femoral artery, right tibial peroneal trunk and right peroneal artery with 6mm proximal reference vessel diameter and 6mm distal reference vessel diameter with lesion length 200mm with 100% stenosis and was classified as tasc ii c lesion.Prior to the treatment of target lesion with the study device, pre-dilation was performed using 5mm mustang pta balloon.Treatment of target lesion was performed by dilation using 5mm x 200mm ranger paclitaxel-coated pta balloon catheter study device.Following post-treatment was performed by placement of 6mm x 200mm innova bare metal stent and the final residual stenosis was noted to be 0%.On the same day, the subject was discharged from the hospital.On (b)(6) 2023, the subject was noted with symptoms related to in-stent restenosis in the right sfa.On (b)(6) 2023, arteriogram was performed which revealed severe in-stent restenosis in right proximal sfa and right distal sfa, occlusion in posterior tibial artery stent, and patency in right common femoral artery (cfa), popliteal arteries, tibio peroneal trunk and peroneal artery.On the same day, 257 days post index procedure, 90% stenosis noted in the right proximal, mid and distal sfa were treated by pre-dilation using 6mm sterling balloon.Subsequently, post-dilation was performed using 6mm ranger paclitaxel-coated pta balloon with the final residual stenosis noted to be 10%.Post procedure, improved results were observed.The outcome of the event is considered as ongoing.
Additional Manufacturer Narrative
A1 patient identifier: (b)(6).A2 age at time of event: 64 years old at the time of enrollment.
Event or Problem Description
Elegance clinical trial.It was reported that restenosis occurred.The subject underwent treatment with the ranger paclitaxel-coated pta balloon catheter on (b)(6) 2023 as a part of the elegance clinical trial.The target lesion was in the right mid superficial femoral artery (sfa), right distal superficial femoral artery, right tibial peroneal trunk and right peroneal artery with 6mm proximal reference vessel diameter and 6mm distal reference vessel diameter with lesion length 200mm with 100% stenosis and was classified as tasc ii c lesion.Prior to the treatment of target lesion with the study device, pre-dilation was performed using 5mm mustang pta balloon.Treatment of target lesion was performed by dilation using 5mm x 200mm ranger paclitaxel-coated pta balloon catheter study device.Following post-treatment was performed by placement of 6mm x 200mm innova bare metal stent and the final residual stenosis was noted to be 0%.On the same day, the subject was discharged from the hospital.On (b)(6) 2023, the subject was noted with symptoms related to in-stent restenosis in the right sfa.On (b)(6) 2023, arteriogram was performed which revealed severe in-stent restenosis in right proximal sfa and right distal sfa, occlusion in posterior tibial artery stent, and patency in right common femoral artery (cfa), popliteal arteries, tibio peroneal trunk and peroneal artery.On the same day, 257 days post index procedure, 90% stenosis noted in the right proximal, mid and distal sfa were treated by pre-dilation using 6mm sterling balloon.Subsequently, post-dilation was performed using 6mm ranger paclitaxel-coated pta balloon with the final residual stenosis noted to be 10%.Post procedure, improved results were observed.The outcome of the event is considered as ongoing.It was further reported that the target lesion was in the right mid sfa extending up to right distal sfa.On the same day, 257 days post index procedure, 90% stenosis noted were treated by pre-dilation using 6mmx100mm sterling balloon.
Event or Problem Description
Elegance clinical trial.It was reported that restenosis occurred.The subject underwent treatment with the ranger paclitaxel-coated pta balloon catheter on (b)(6) 2023 as a part of the elegance clinical trial.The target lesion was in the right mid superficial femoral artery (sfa), right distal superficial femoral artery, right tibial peroneal trunk and right peroneal artery with 6mm proximal reference vessel diameter and 6mm distal reference vessel diameter with lesion length 200mm with 100% stenosis and was classified as tasc ii c lesion.Prior to the treatment of target lesion with the study device, pre-dilation was performed using 5mm mustang pta balloon.Treatment of target lesion was performed by dilation using 5mm x 200mm ranger paclitaxel-coated pta balloon catheter study device.Following post-treatment was performed by placement of 6mm x 200mm innova bare metal stent and the final residual stenosis was noted to be 0%.On the same day, the subject was discharged from the hospital.On (b)(6) 2023, the subject was noted with symptoms related to in-stent restenosis in the right sfa.On (b)(6) 2023, arteriogram was performed which revealed severe in-stent restenosis in right proximal sfa and right distal sfa, occlusion in posterior tibial artery stent, and patency in right common femoral artery (cfa), popliteal arteries, tibio peroneal trunk and peroneal artery.On the same day, 257 days post index procedure, 90% stenosis noted in the right proximal, mid and distal sfa were treated by pre-dilation using 6mm sterling balloon.Subsequently, post-dilation was performed using 6mm ranger paclitaxel-coated pta balloon with the final residual stenosis noted to be 10%.Post procedure, improved results were observed.The outcome of the event is considered as ongoing.It was further reported that the target lesion was in the right mid sfa extending up to right distal sfa.On the same day, 257 days post index procedure, 90% stenosis noted were treated by pre-dilation using 6mmx100mm sterling balloon.It was further reported that on (b)(6) 2023, the event was considered to be resolved.
Additional Manufacturer Narrative
A1 patient identifier: (b)(6).A2 age at time of event: 64 years old at the time of enrollment.
Additional Manufacturer Narrative
A2 age at time of event: 64 years old at the time of enrollment.
Event or Problem Description
It was reported that restenosis occurred.The subject underwent treatment with the ranger paclitaxel-coated pta balloon catheter on (b)(6) 2023 as a part of the clinical trial.The target lesion was in the right mid superficial femoral artery (sfa), right distal superficial femoral artery, right tibial peroneal trunk and right peroneal artery with 6mm proximal reference vessel diameter and 6mm distal reference vessel diameter with lesion length 200mm with 100% stenosis and was classified as tasc ii c lesion.Prior to the treatment of target lesion with the study device, pre-dilation was performed using 5mm mustang pta balloon.Treatment of target lesion was performed by dilation using 5mm x 200mm ranger paclitaxel-coated pta balloon catheter study device.Following post-treatment was performed by placement of 6mm x 200mm innova bare metal stent and the final residual stenosis was noted to be 0%.On the same day, the subject was discharged from the hospital.On 11-dec-2023, the subject was noted with symptoms related to in-stent restenosis in the right sfa.On (b)(6) 2023, arteriogram was performed which revealed severe in-stent restenosis in right proximal sfa and right distal sfa, occlusion in posterior tibial artery stent, and patency in right common femoral artery (cfa), popliteal arteries, tibio peroneal trunk and peroneal artery.On the same day, 257 days post index procedure, 90% stenosis noted in the right proximal, mid and distal sfa were treated by pre-dilation using 6mm sterling balloon.Subsequently, post-dilation was performed using 6mm ranger paclitaxel-coated pta balloon with the final residual stenosis noted to be 10%.Post procedure, improved results were observed.The outcome of the event is considered as ongoing.It was further reported that the target lesion was in the right mid sfa extending up to right distal sfa.On the same day, 257 days post index procedure, 90% stenosis noted were treated by pre-dilation using 6mmx100mm sterling balloon.It was further reported that on 20-dec-2023, the event was considered to be resolved.It was further reported that on (b)(6) 2023, the subject presented to hospital for study specific 6-month follow-up examination and was noted with right lower extremity toe blanching with movement.On the same day, lower extremity abi was noted to be 0.70 on right leg with dampening waveform at the calf level consistent with femoral-popliteal occlusive disease.Subsequently, right lower extremity duplex ultrasound revealed elevated velocities in proximal femoral artery stent suggestive of 75-99% stenosis.The posterior tibial artery was occluded in the proximal and mid segment with collateral reconstituted into distal segment.Unable to detect any doppler flow in the anterior tibial and dorsalis pedis artery which was suggestive of occlusion.The common femoral, profunda, popliteal and peroneal arteries were patent.Based on the above findings, arteriogram and possible intervention was planned for later date.On (b)(6) 2023, the subject presented to hospital for pre-operative evaluation prior to arteriogram and reported numbness and tingling in right foot after walking about a block.

• 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: 18586880
• Report Number: 2124215-2024-01487
• Device Sequence Number: 17911596
• Product Code: ONU
• UDI-Device Identifier: 08714729976042
• UDI-Public: 08714729976042
• Combination Product (Y/N): Y
• Initial Reporter State: PA
• 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,Followup,Followup
• Report Date (Section B): 06/04/2025

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: 10/12/2024
• Device Model Number: 1973-03
• Device Catalogue Number: 1973-03
• Device Lot Number: 08513H22
• 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: 12/29/2023
• Supplement Date Received by Manufacturer: 02/16/2024; 05/16/2024; 05/09/2025
• Initial Report FDA Received Date: 01/26/2024
• Supplement Report FDA Received Date: 03/06/2024; 06/03/2024; 06/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/13/2022
• 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 Sex: Female
• Patient Race: White