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	Arteriosclerosis/ Atherosclerosis (4437)
Date of Event	08/18/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that claudication occurred requiring surgical intervention.The subject underwent treatment with the ranger drug-coated balloon on (b)(6) 2021 as a part of the elegance clinical trial.The target lesion was in the left profunda femoral artery with 6.00 mm proximal reference vessel diameter and 6.00 mm distal reference vessel diameter with lesion length 20 mm with 90% stenosis and was classified as tasc ii a lesion.Prior to target lesion treatment with study device, atherectomy was performed with a non-boston scientific atherectomy device.The treatment of the target lesion was performed by dilatation using study device 6 mm x 40 mm, ranger drug coated balloon.Post treatment, the final residual stenosis was noted to be 20%.On the same day, the subject was discharged on dapt.On (b)(6) 2022, the subject was noted with symptoms related to claudication of left lower extremity.In response to event, subject underwent target lesion revascularization.
Additional Manufacturer Narrative
Patient identifier: (b)(6).Age at time of enrollment: 61 years.
Additional Manufacturer Narrative
A1: patient identifier- (b)(4).A2: age at time of enrollment- 61 years.B6: additional medical history added.
Event or Problem Description
It was reported that claudication occurred requiring surgical intervention.The subject underwent treatment with the ranger drug-coated balloon on (b)(6) 2021 as a part of the elegance clinical trial.The target lesion was in the left profunda femoral artery with 6.00 mm proximal reference vessel diameter and 6.00 mm distal reference vessel diameter with lesion length 20 mm with 90% stenosis and was classified as tasc ii a lesion.Prior to target lesion treatment with study device, atherectomy was performed with a non-boston scientific atherectomy device.The treatment of the target lesion was performed by dilatation using study device 6 mm x 40 mm, ranger drug coated balloon.Post treatment, the final residual stenosis was noted to be 20%.On the same day, the subject was discharged on dapt.On (b)(6) 2022, the subject was noted with symptoms related to claudication of left lower extremity.In response to event, subject underwent target lesion revascularization.It was further reported that on (b)(6) 2022, the subject had visited the hospital for study specific 6 month follow up and on the same day bilateral lower extremity duplex ultrasound was performed which revealed in the left leg a total occlusion of sfa, partial reconstitution of flow in popliteal artery, low velocity/low volume flow from the level of the popliteal artery and occluded anterior tibial artery.Based on the symptoms and previously known disease, subject was referred for peripheral catheterization with possible revascularization of left lower extremity.Subsequently, peripheral angiography performed revealed in the left leg moderate diffuse disease in common iliac artery, severe 70% stenosis in ostial profunda femoral artery, chronic total occlusion of superficial femoral artery reconstituted via collaterals.On (b)(6) 2022, 280 days post index procedure, 70% stenosis noted in the ostial profunda femoral artery was treated with balloon angioplasty using 7 mm x 40 mm drug coated balloon.In addition, chronic total occlusion noted in the left superficial femoral artery was treated with balloon angioplasty using 3 mm x100 mm non-boston scientific balloon and 3 mmx 120 mm coyote balloon.Post procedure, angiography performed revealed less than 30% residual stenosis and no immediate complications were noted.On the same day, the event was considered resolved and the subject was recommended to continue aspirin 81 mg and plavix 75 mg.
Event or Problem Description
It was reported that claudication occurred requiring surgical intervention.The subject underwent treatment with the ranger drug-coated balloon on (b)(6) 2021 as a part of the elegance clinical trial.The target lesion was in the left profunda femoral artery with 6.00 mm proximal reference vessel diameter and 6.00 mm distal reference vessel diameter with lesion length 20 mm with 90% stenosis and was classified as tasc ii a lesion.Prior to target lesion treatment with study device, atherectomy was performed with a non-boston scientific atherectomy device.The treatment of the target lesion was performed by dilatation using study device 6 mm x 40 mm, ranger drug coated balloon.Post treatment, the final residual stenosis was noted to be 30%.On the same day, the subject was discharged on dapt.On (b)(6) 2022, the subject was noted with symptoms related to claudication of left lower extremity.In response to event, subject underwent target lesion revascularization.It was further reported that on (b)(6) 2022, the subject had visited the hospital for study specific 6 month follow up and on the same day bilateral lower extremity duplex ultrasound was performed which revealed in the left leg a total occlusion of sfa, partial reconstitution of flow in popliteal artery, low velocity/low volume flow from the level of the popliteal artery and occluded anterior tibial artery.Based on the symptoms and previously known disease, subject was referred for peripheral catheterization with possible revascularization of left lower extremity.Subsequently, peripheral angiography performed revealed in the left leg moderate diffuse disease in common iliac artery, severe 70% stenosis in ostial profunda femoral artery, chronic total occlusion of superficial femoral artery reconstituted via collaterals.On (b)(6) 2022, 280 days post index procedure, 70% stenosis noted in the ostial profunda femoral artery was treated with balloon angioplasty using 7 mm x 40 mm drug coated balloon.In addition, chronic total occlusion noted in the left superficial femoral artery was treated with balloon angioplasty using 3 mm x100 mm non-boston scientific balloon and 3 mmx 120 mm coyote balloon.Post procedure, angiography performed revealed less than 30% residual stenosis and no immediate complications were noted.On the same day, the event was considered resolved and the subject was recommended to continue aspirin 81 mg and plavix 75 mg.
Additional Manufacturer Narrative
A1: patient identifier- (b)(6).A2: age at time of enrollment- 61 years.B5: final % stenosis corrected to 30%.

• 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): BOSTON SCIENTIFIC CORPORATION; 500 commander shea boulevard; quincy MA 02171
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 15451401
• Report Number: 2124215-2022-35361
• Device Sequence Number: 6005725
• Product Code: ONU
• UDI-Device Identifier: 08714729976080
• UDI-Public: 08714729976080
• Combination Product (Y/N): Y
• Initial Reporter State: NY
• 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
• Report Date (Section B): 12/18/2023

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: 03/06/2022
• Device Model Number: 1973-03
• Device Catalogue Number: 1973-03
• Device Lot Number: 0027396209
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/24/2022
• Supplement Date Received by Manufacturer: 09/27/2022; 12/15/2023
• Initial Report FDA Received Date: 09/19/2022
• Supplement Report FDA Received Date: 10/24/2022; 12/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/06/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male
• Patient Race: White