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	Vascular Dissection (3160); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/31/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient identifier: (b)(6).
Event or Problem Description
(b)(6) clinical trial.It was reported that a dissection occurred.The subject underwent treatment with three ranger drug coated balloons.The first target lesion was in the left proximal popliteal artery extending to left mid popliteal artery with proximal reference vessel diameter of 4.5 mm and distal reference vessel diameter of 4.0 mm with lesion length of 150 mm and 99% stenosis.Treatment of target lesion was performed by dilatation with study device, ranger drug coated balloon 4 mm x 150 mm.During treatment of the first target lesion, the subject was noted with a complication of dissection with severity grade of e and residual stenosis of 0%.A bailout stent was implanted, and complication was resolved.The procedure was continued.The second target lesion was in the entire length of left superficial femoral artery extending to left proximal popliteal artery with proximal reference vessel diameter of 5.0 mm and distal reference vessel diameter of 5.5 mm with lesion length of 200 mm and 95% stenosis.Treatment of target lesion was performed by dilatation with study device, ranger drug coated balloon 5 mm x 200 mm following post treatment, the final residual stenosis was noted to be 30%.The third target lesion was in the left proximal superficial femoral artery with proximal reference vessel diameter of 5.0 mm and distal reference vessel diameter of 5.0 mm with lesion length of 180 mm and 80% stenosis.Treatment of target lesion was performed by dilatation with study device, ranger drug coated balloon 5 mm x 80 mm.Following post treatment, the final residual stenosis was noted to be 20%.
Additional Manufacturer Narrative
A1 - patient identifier: (b)(6).
Event or Problem Description
Elegance clinical trial.It was reported that a dissection occurred.The subject underwent treatment with three ranger drug coated balloons.The first target lesion was in the left proximal popliteal artery extending to left mid popliteal artery with proximal reference vessel diameter of 4.5 mm and distal reference vessel diameter of 4.0 mm with lesion length of 150 mm and 99% stenosis.Treatment of target lesion was performed by dilatation with study device, ranger drug coated balloon 4 mm x 150 mm.During treatment of the first target lesion, the subject was noted with a complication of dissection with severity grade of e and residual stenosis of 0%.A bailout stent was implanted, and complication was resolved.The procedure was continued.The second target lesion was in the entire length of left superficial femoral artery extending to left proximal popliteal artery with proximal reference vessel diameter of 5.0 mm and distal reference vessel diameter of 5.5 mm with lesion length of 200 mm and 95% stenosis.Treatment of target lesion was performed by dilatation with study device, ranger drug coated balloon 5 mm x 200 mm following post treatment, the final residual stenosis was noted to be 30%.The third target lesion was in the left proximal superficial femoral artery with proximal reference vessel diameter of 5.0 mm and distal reference vessel diameter of 5.0 mm with lesion length of 180 mm and 80% stenosis.Treatment of target lesion was performed by dilatation with study device, ranger drug coated balloon 5 mm x 80 mm.Following post treatment, the final residual stenosis was noted to be 20%.It was further reported that on (b)(6) 2021, during treatment of the first target lesion of left proximal popliteal artery and mid popliteal artery, subject was noted with complication of dissection with severity grade of e due to non-bsc adjunctive device.As a response, bailout stent was implanted, and post treatment the final residual stenosis was noted to be 0%.
Event or Problem Description
Elegance clinical trial: it was reported that a dissection occurred.The subject underwent treatment with three ranger drug coated balloons.The first target lesion was in the left proximal popliteal artery extending to left mid popliteal artery with proximal reference vessel diameter of 4.5 mm and distal reference vessel diameter of 4.0 mm with lesion length of 150 mm and 99% stenosis.Treatment of target lesion was performed by dilatation with study device, ranger drug coated balloon 4 mm x 150 mm.During treatment of the first target lesion, the subject was noted with a complication of dissection with severity grade of e and residual stenosis of 0%.A bailout stent was implanted, and complication was resolved.The procedure was continued.The second target lesion was in the entire length of left superficial femoral artery extending to left proximal popliteal artery with proximal reference vessel diameter of 5.0 mm and distal reference vessel diameter of 5.5 mm with lesion length of 200 mm and 95% stenosis.Treatment of target lesion was performed by dilatation with study device, ranger drug coated balloon 5 mm x 200 mm following post treatment, the final residual stenosis was noted to be 30%.The third target lesion was in the left proximal superficial femoral artery with proximal reference vessel diameter of 5.0 mm and distal reference vessel diameter of 5.0 mm with lesion length of 180 mm and 80% stenosis.Treatment of target lesion was performed by dilatation with study device, ranger drug coated balloon 5 mm x 80 mm.Following post treatment, the final residual stenosis was noted to be 20%.It was further reported that on 31aug2021, during treatment of the first target lesion of left proximal popliteal artery and mid popliteal artery, subject was noted with complication of dissection with severity grade of e due to non-bsc adjunctive device.As a response, bailout stent was implanted, and post treatment the final residual stenosis was noted to be 0%.It was further reported that on 31aug2021, on the same day of index procedure, during the treatment of target lesion #001, dissection of grade e was noted in the left popliteal artery due to 4 mm x 150 mm ranger drug coated balloon.In response to the complication, bailout stent was placed and the final residual stenosis was noted to be 0%.On the same day, the complication of dissection was resolved, and the subject was discharged from the hospital on aspirin.
Additional Manufacturer Narrative
A1 - patient identifier: (b)(6).

• 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: 12569632
• Report Number: 2134265-2021-12302
• Device Sequence Number: 19050485
• Product Code: ONU
• UDI-Device Identifier: 08714729975861
• UDI-Public: 08714729975861
• Combination Product (Y/N): Y
• Initial Reporter State: OH
• 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): 12/11/2023

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: 01/05/2022
• Device Model Number: 1973-03
• Device Catalogue Number: 1973-03
• Device Lot Number: 0027250281
• 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: 09/13/2021
• Supplement Date Received by Manufacturer: 07/27/2022; 11/27/2023
• Initial Report FDA Received Date: 10/04/2021
• Supplement Report FDA Received Date: 08/19/2022; 12/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/06/2020
• 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 Age: 54 YR
• Patient Sex: Female
• Patient Race: Black Or African American