MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RANGER?; DRUG-ELUTING PERIPHERAL TRANSLUMINAL ANGIOPLASTY CATHETER

Model Number	H74939419500810
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	06/29/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that vessel dissection occurred, requiring intervention.On (b)(6) 2023, the subject underwent treatment with the ranger drug-coated balloon and eluvia drug eluting stents as part of clinical trial.The target lesion #001 was in the left proximal superficial femoral artery, left mid superficial femoral artery and left distal superficial femoral artery with 5 mm proximal reference vessel diameter and 5 mm distal reference vessel diameter with 100 mm lesion length with 90 % stenosis and was classified as transatlantic intersociety consensus (tasc) ii c lesion.Treatment of target lesion was performed by dilation using 5 mm x 80 mm ranger drug coated balloon and placement of 6 mm x 60 mm and 6 mm x 40 mm eluvia drug eluting stents, study device.Post treatment was performed by dilation of mustang pta balloon.Post procedure, the final residual stenosis was noted to be 10%.On (b)(6) 2023, on the same day of index procedure, during the treatment of target lesion #001, dissection of grade e was noted in the left distal superficial femoral artery due to 5 mm x 80 mm ranger drug-coated balloon.In response to the complication, eluvia stent was placed as a bailout stent, and balloon dilation was performed.Post treatment, the final residual stenosis was noted to be 10%.On the same day, the event was considered to be resolved, and the subject was discharged from hospital on dual antiplatelet therapy.
Additional Manufacturer Narrative
A2 - age at time of event: 60 years old at the time of enrollment.
Additional Manufacturer Narrative
A2 - age at time of event: 60 years old at the time of enrollment, b5.Describe event or problem: added information, based on additional information.
Event or Problem Description
It was reported that vessel dissection occurred, requiring intervention.On (b)(6) 2023, the subject underwent treatment with the ranger drug-coated balloon and eluvia drug eluting stents as part of clinical trial.The target lesion #001 was in the left proximal superficial femoral artery, left mid superficial femoral artery and left distal superficial femoral artery with 5 mm proximal reference vessel diameter and 5 mm distal reference vessel diameter with 100 mm lesion length with 90 % stenosis and was classified as transatlantic intersociety consensus (tasc) ii c lesion.Treatment of target lesion was performed by dilation using 5 mm x 80 mm ranger drug coated balloon and placement of 6 mm x 60 mm and 6 mm x 40 mm eluvia drug eluting stents, study device.Post treatment was performed by dilation of mustang pta balloon.Post procedure, the final residual stenosis was noted to be 10%.On (b)(6) 2023, on the same day of index procedure, during the treatment of target lesion #001, dissection of grade e was noted in the left distal superficial femoral artery due to 5 mm x 80 mm ranger drug-coated balloon.In response to the complication, eluvia stent was placed as a bailout stent, and balloon dilation was performed.Post treatment, the final residual stenosis was noted to be 10%.On the same day, the event was considered to be resolved, and the subject was discharged from hospital on dual antiplatelet therapy.It was further reported that in response to the dissection, 6 mm x 60 mm eluvia drug eluting stent was placed which was post-dilated using 5 mm x 60 mm mustang pta balloon.Completion angiogram revealed excellent flow through the superficial femoral artery with residual stenosis of 10%.On the same day, the event was considered to be resolved, and the subject was discharged from hospital in stable condition on dual antiplatelet therapy.It was further reported that the target lesion #001 was in the left proximal superficial femoral artery and left distal superficial femoral artery with 5 mm proximal reference vessel diameter and 5 mm distal reference vessel diameter with 100 mm lesion length with 90 % stenosis and was classified as transatlantic intersociety consensus (tasc) ii c lesion.
Event or Problem Description
It was reported that vessel dissection occurred, requiring intervention.On (b)(6) 2023, the subject underwent treatment with the ranger drug-coated balloon and eluvia drug eluting stents as part of clinical trial.The target lesion #001 was in the left proximal superficial femoral artery, left mid superficial femoral artery and left distal superficial femoral artery with 5 mm proximal reference vessel diameter and 5 mm distal reference vessel diameter with 100 mm lesion length with 90 % stenosis and was classified as transatlantic intersociety consensus (tasc) ii c lesion.Treatment of target lesion was performed by dilation using 5 mm x 80 mm ranger drug coated balloon and placement of 6 mm x 60 mm and 6 mm x 40 mm eluvia drug eluting stents, study device.Post treatment was performed by dilation of mustang pta balloon.Post procedure, the final residual stenosis was noted to be 10%.On (b)(6) 2023, on the same day of index procedure, during the treatment of target lesion #001, dissection of grade e was noted in the left distal superficial femoral artery due to 5 mm x 80 mm ranger drug-coated balloon.In response to the complication, eluvia stent was placed as a bailout stent, and balloon dilation was performed.Post treatment, the final residual stenosis was noted to be 10%.On the same day, the event was considered to be resolved, and the subject was discharged from hospital on dual antiplatelet therapy.It was further reported that in response to the dissection, 6 mm x 60 mm eluvia drug eluting stent was placed which was post-dilated using 5 mm x 60 mm mustang pta balloon.Completion angiogram revealed excellent flow through the superficial femoral artery with residual stenosis of 10%.On the same day, the event was considered to be resolved, and the subject was discharged from hospital in stable condition on dual antiplatelet therapy.
Additional Manufacturer Narrative
A2 - age at time of event: 60 years old at the time of enrollment.B5.Describe event or problem: added information, based on additional information.
Additional Manufacturer Narrative
A2 - age at time of event: 60 years old at the time of enrollment b5.Describe event or problem: added information, based on additional information.
Event or Problem Description
It was reported that vessel dissection occurred, requiring intervention.On (b)(6) 2023, the subject underwent treatment with the ranger drug-coated balloon and eluvia drug eluting stents as part of clinical trial.The target lesion #001 was in the left proximal superficial femoral artery, left mid superficial femoral artery and left distal superficial femoral artery with 5 mm proximal reference vessel diameter and 5 mm distal reference vessel diameter with 100 mm lesion length with 90 % stenosis and was classified as transatlantic intersociety consensus (tasc) ii c lesion.Treatment of target lesion was performed by dilation using 5 mm x 80 mm ranger drug coated balloon and placement of 6 mm x 60 mm and 6 mm x 40 mm eluvia drug eluting stents, study device.Post treatment was performed by dilation of mustang pta balloon.Post procedure, the final residual stenosis was noted to be 10%.On (b)(6) 2023, on the same day of index procedure, during the treatment of target lesion #001, dissection of grade e was noted in the left distal superficial femoral artery due to 5 mm x 80 mm ranger drug-coated balloon.In response to the complication, eluvia stent was placed as a bailout stent, and balloon dilation was performed.Post treatment, the final residual stenosis was noted to be 10%.On the same day, the event was considered to be resolved, and the subject was discharged from hospital on dual antiplatelet therapy.It was further reported that in response to the dissection, 6 mm x 60 mm eluvia drug eluting stent was placed which was post-dilated using 5 mm x 60 mm mustang pta balloon.Completion angiogram revealed excellent flow through the superficial femoral artery with residual stenosis of 10%.On the same day, the event was considered to be resolved, and the subject was discharged from hospital in stable condition on dual antiplatelet therapy.It was further reported that the target lesion #001 was in the left proximal superficial femoral artery and left distal superficial femoral artery with 5 mm proximal reference vessel diameter and 5 mm distal reference vessel diameter with 100 mm lesion length with 90 % stenosis and was classified as transatlantic intersociety consensus (tasc) ii c lesion.It was further reported that findings for target lesion 001 dated (b)(6) 2023 revealed: grade 0 thrombus and timi flow 3, absence of aneurysm, with 64.55% baseline stenosis and tasc ii type of a in left proximal superficial femoral artery.In addition, post study device analysis for drug coated balloon revealed grade 0 thrombus, absence of aneurysm or dissection, timi flow of grade 0.Post study device analysis for drug eluting stent revealed grade 0 thrombus, absence of aneurysm or dissection and timi flow of grade 3.Findings for target lesion 002 dated (b)(6) 2023 revealed: grade 0 thrombus and timi flow 3, aneurysm, with 65.57% baseline stenosis and tasc ii type of a in left distal superficial femoral artery.In addition, post study device analysis for drug coated balloon revealed grade 0 thrombus, absence of aneurysm or dissection, timi flow of grade 0.Post study device analysis for drug eluting stent revealed grade 0 thrombus and aneurysm, absence of dissection with timi flow of grade 3.

• Brand Name: RANGER?
• 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: 22035945
• Report Number: 2124215-2025-29518
• Device Sequence Number: 9411645
• Product Code: ONU
• UDI-Device Identifier: 08714729975960
• UDI-Public: (01)08714729975960(17)250119(10)677H23
• 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): 12/05/2025

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: 01/19/2025
• Device Model Number: H74939419500810
• Device Catalogue Number: H74939419500810
• Device Lot Number: 00677H23
• 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: 04/22/2025
• Supplement Date Received by Manufacturer: 05/22/2025; 06/19/2025; 11/13/2025
• Initial Report FDA Received Date: 05/16/2025
• Supplement Report FDA Received Date: 06/20/2025; 07/14/2025; 12/05/2025
• Date Device Manufactured: 01/20/2023
• 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: 60 YR
• Patient Sex: Female
• Patient Race: White