MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RANGER PACLITAXEL-COATED PTA BALLOON CATHETER; DRUG-ELUTING PERIPHERAL TRANSLUMINAL ANGIOPLASTY CATHETER

Model Number 1973-03

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Obstruction/Occlusion (2422); Arteriosclerosis/ Atherosclerosis (4437); Restenosis (4576)

Event Date 05/01/2023

Event Type  Injury  

Manufacturer Narrative

A1: patient identifier- (b)(6).A2: patient age- patient was 69 years old at the time of enrollment.

Event Description

Elegance study: it was reported that the subject presented with symptoms of claudication and an occlusion.The subject underwent treatment with the ranger drug coated balloon on (b)(6) 2022 as a part of the elegance clinical trial.The target lesion was in the left proximal popliteal artery, left mid popliteal artery extending up to left distal popliteal artery with 5 mm proximal reference vessel diameter and 5 mm distal reference vessel diameter with lesion length of 200 mm and 100% stenosis and was classified as tasc ii d lesion.Prior to target lesion treatment with study device lithotripsy was performed with 5 mm x 60 mm non-boston scientific (bsc) lithotripsy device, atherectomy was performed with non-bsc atherectomy device, and pre-dilation was performed by using 2.0 mm x 150 mm and 5.0 mm x 150 mm sterling pta balloons and 2.0 mm x 150 mm non-bsc pta balloon.Treatment of target lesion was performed by dilation using 5 mm x 200 mm ranger drug-coated balloon study device.Following treatment, the final residual stenosis was noted to be 10%.On the same day, the subject was discharged from hospital on aspirin.On (b)(6) 2023, the subject was presented with the symptoms related to recurrence of peripheral artery disease.On (b)(6) 2023, 299 days post index procedure, occlusion noted in the left proximal popliteal artery, left mid popliteal artery, and left distal popliteal artery were revascularized using percutaneous transluminal angioplasty and drug coated balloon.Post procedure, the final residual stenosis was noted to be 10%.

Event Description

Elegance study.It was reported that the subject presented with symptoms of claudication and an occlusion.The subject underwent treatment with the ranger drug coated balloon on (b)(6) 2022 as a part of the elegance clinical trial.The target lesion was in the left proximal popliteal artery, left mid popliteal artery extending up to left distal popliteal artery with 5 mm proximal reference vessel diameter and 5 mm distal reference vessel diameter with lesion length of 200 mm and 100% stenosis and was classified as tasc ii d lesion.Prior to target lesion treatment with study device lithotripsy was performed with 5 mm x 60 mm non-boston scientific (bsc) lithotripsy device, atherectomy was performed with non-bsc atherectomy device, and pre-dilation was performed by using 2.0 mm x 150 mm and 5.0 mm x 150 mm sterling pta balloons and 2.0 mm x 150 mm non-bsc pta balloon.Treatment of target lesion was performed by dilation using 5 mm x 200 mm ranger drug-coated balloon study device.Following treatment, the final residual stenosis was noted to be 10%.On the same day, the subject was discharged from hospital on aspirin.On (b)(6) 2023, the subject was presented with the symptoms related to recurrence of peripheral artery disease.On (b)(6) 2023, 299 days post index procedure, occlusion noted in the left proximal popliteal artery, left mid popliteal artery, and left distal popliteal artery were revascularized using percutaneous transluminal angioplasty and drug coated balloon.Post procedure, the final residual stenosis was noted to be 10%.It was further reported that on (b)(6) 2023, subject was noted symptoms related to claudication.The subject was scheduled for peripheral angiogram with possible percutaneous endovascular intervention.On (b)(6) 2023, subject visited the hospital with the complaints of mild intermittent left lower extremity claudication and peripheral neuropathy of bilateral hands and feet.Additionally, subject was on clopidogrel but had stopped taking aspirin.On the same day, physical examination revealed bilateral radial/dp/pt pulses were not palpable however, right pt pulses were palpable by doppler.Abi was noted to be 1.3 and 0.71 on right and left leg respectively.On the same day, selective angiogram of left lower extremity revealed patent common femoral artery and superficial femoral artery, occluded popliteal artery that reconstitutes at p3 segment with 3 vessel runoffs to the peripheral arteries.On (b)(6) 2023, 299 days post index procedure, heavily classified occlusion noted in the left entire length of popliteal artery was revascularized by atherectomy using non-bsc orbital atherectomy device followed by 4mm x 200 mm non-bsc balloon angioplasty and 5 mm x 200 mm ranger drug coated balloon.Post procedure, the final residual stenosis was noted to be 10%.On (b)(6) 2023, physical examination revealed 2+ radial/dp/pt pulses.On the same day, the event was considered to be resolved, and subject was discharged on dual antiplatelet therapy.

Manufacturer Narrative

A1: patient identifier- (b)(6).A2: patient age- patient was 69 years old at the time of enrollment.

• Brand Name: RANGER PACLITAXEL-COATED PTA BALLOON CATHETER
• Type of Device: 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: 17635841
• MDR Text Key: 322102499
• Report Number: 2124215-2023-45236
• Device Sequence Number: 1
• Product Code: ONU
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P190019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/05/2023

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
• Device Operator: Health Professional
• Device Expiration Date: 03/15/2024
• Device Model Number: 1973-03
• Device Catalogue Number: 1973-03
• Device Lot Number: 02762H22
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/02/2023
• Initial Date FDA Received: 08/28/2023
• Supplement Dates Manufacturer Received: 11/27/2023
• Supplement Dates FDA Received: 12/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/16/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female
• Patient Race: White