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	Obstruction/Occlusion (2422)
Date of Event	03/14/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A1: patient identifier:(b)(6).A2: patient age: 58 years old at time of enrollment.
Event or Problem Description
Elegance clinical trial.It was reported that an occlusion occurred.The subject underwent treatment with the ranger drug coated balloons on (b)(6) 2022 as a part of the elegance clinical trial.The target lesion #001 was in the right proximal superficial femoral artery, right mid superficial femoral artery, right distal superficial femoral artery and right distal popliteal artery with 5.0 mm proximal reference vessel diameter and 5.0 mm distal reference vessel diameter with lesion length of 330 mm and 100% stenosis was classified as tasc ii d lesion.Prior to target lesion treatment with study device, atherectomy was performed with 2.2 mm x 1290 mm non-boston scientific atherectomy device.Treatment of target lesion was performed by dilation using two 5 mm x 200 mm and 5.0 mm x 150 mm ranger drug coated balloons study devices.Following post treatment by placement of 6 mm x 80 mm innova bare metal stent, the final residual stenosis was noted to be 10%.On the same day of the index procedure, during treatment of the target lesion #001, dissection of grade c was noted due to ranger drug coated balloons.Two ranger drug coated balloons of sizes 5 mm x 200 mm and 5.0 mm x 150 mm were used to treat the target lesion #001.In response to the complication, a bailout stent was placed.Following the treatment, the final residual stenosis was noted to be 10%.Additionally, hematoma was noted due perforation in the right mid popliteal artery which was treated with balloon dilation using 5 mm x 40 mm mustang balloon.On (b)(6) 2022, the subject was discharged from the hospital on dual antiplatelet therapy.On (b)(6) 2023, the subject visited as an outpatient for worsening right lower extremity pain with dependent rubor and was found to have occluded right superficial femoral artery (sfa), distal popliteal stent with right posterior tibial flow.The subject was recommended for bypass surgery versus below knee amputation on a later date.On (b)(6) 2023, the subject revisited the emergency department with complaints of worsening right lower extremity pain.Physical examinations revealed right dorsalis pedis (dp) and posterior tibial (pt) pulses were absent, right lower extremities was cool to touch with dependent rubor to foot and anterior leg and nonpitting edema.Rutherford classification assessed revealed, category 5 critical limb ischemia.On (b)(6) 2023, arterial duplex of right lower extremities performed revealed total in-stent occlusion of the right mid sfa, distal sfa and popliteal artery consistent with no blood flow and 50-75% stenosis of right profunda femoris artery.On (b)(6) 2023, 309 days post index procedure, right above the knee amputation was performed as below the knee tissue exploration identified necrotic muscle with no viability.Post procedure, wound was dressed using xeroform, gauze and a light ace wrap.Subject was transferred to intermediate floor for the post-operative care and was recommended to apply shrink sock and stump protector daily.On (b)(6) 2023, the subject was discharged from the hospital to rehabilitation center on dual antiplatelet therapy.On (b)(6) 2023, the event was considered to be resolved.

• 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: 17895597
• Report Number: 2124215-2023-55173
• Device Sequence Number: 14316233
• Product Code: ONU
• UDI-Device Identifier: 08714729976028
• UDI-Public: 08714729976028
• Combination Product (Y/N): Y
• Initial Reporter State: NC
• 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
• Report Date (Section B): 10/09/2023

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: 01/27/2024
• Device Model Number: 1973-03
• Device Catalogue Number: 1973-03
• Device Lot Number: 00861H22
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/11/2023
• Initial Report FDA Received Date: 10/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/27/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female
• Patient Race: White