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)

Event Date 05/18/2023

Event Type  Injury  

Event Description

Elegance clinical study.It was reported that restenosis occurred, requiring revascularization.On 09-aug-2022, the subject underwent treatment with this 6.0 x 200mm, 150cm ranger paclitaxel-coated pta balloon catheter and 6x80, 130 cm eluvia drug-eluting vascular stent system as part of the elegance clinical trial.The target lesion was in the right proximal superficial femoral artery (sfa), right mid-sfa, extending up to right distal sfa with 5 mm proximal reference vessel diameter, and 5 mm distal reference vessel diameter, with lesion length 200 mm with 100% stenosis, and was classified as transatlantic intersociety consensus (tasc) ii d lesion.Prior to the target lesion treatment with the study device, atherectomy was performed, and pre-dilation was performed by using a 3 mm x 25 mm non-boston scientific percutaneous transluminal angioplasty (pta) balloon, a 4 mm x 220 mm pta balloon, a 5 mm x 200 mm pta balloon, and a 5 mm x 120 mm pta balloon.Treatment of the target lesion was then performed by dilation using the study devices, this 6 mm x 200 mm ranger drug coated balloon, and a 6 mm x 80 mm eluvia drug eluting stent.Post-dilation was performed using a 5 mm x 60 mm pta balloon, and the final residual stenosis was noted to be 10%.On 10-aug-2022, the subject was discharged from the hospital on dual antiplatelet therapy.On 18-may-2023, the subject was referred for bilateral lower extremity arterial duplex due to claudication and history of right sfa stent left iliac stent.Bilateral lower extremity arterial duplex was performed which revealed on the right side: more than 75% stenosis the proximal sfa, and calcification in external iliac, common femoral, mid-sfa and distal sfa, deep femoral, popliteal, posterior tibial, peroneal, anterior tibial and dorsalis pedis which was consistent with less than 50% stenosis.On 16-nov-2023, the subject presented to the hospital for peripheral angiogram and possible intervention of the right lower extremity due to complaints of progressively worsening right leg pain for the past one year.On the same day, abdominal aortogram revealed mild atherosclerotic changes of the distal abdominal aorta with no significant obstructive disease, the right ileo-femoral artery system was patent with no significant disease, patent right internal iliac artery, left common iliac artery stent was patent with no angiographic evidence of restenosis, patent left external iliac artery with no significant disease, occluded left internal iliac artery.Selective angiography of the right lower extremity revealed patent common femoral artery with no significant obstructive disease, occluded proximal sfa, occluded sfa at distal segment, patent deep femoral artery and extensive collaterals that reconstitute the right popliteal artery with three-vessel run off to the periphery.On the same day, occlusion noted in the right proximal sfa, right mid-sfa, and right distal sfa.These were treated using atherectomy and thrombectomy devices followed by dilation using balloon and drug coated balloon.Post treatment, the final residual stenosis was noted to be 5%.On the same day, the event was considered to be resolved.

Manufacturer Narrative

A1 patient identifier: (b)(6).A2 patient age: 66 years old at 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: 18318441
• MDR Text Key: 330382066
• Report Number: 2124215-2023-70175
• Device Sequence Number: 1
• Product Code: ONU
• UDI-Device Identifier: 08714729976202
• UDI-Public: 08714729976202
• 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
• Report Date: 12/13/2023

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: 02/02/2024
• Device Model Number: 1973-03
• Device Catalogue Number: 1973-03
• Device Lot Number: 01100H22
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/27/2023
• Initial Date FDA Received: 12/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/02/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: JETSTREAM, STERLING PTA, ELUVIA.
• Patient Outcome(s): Required Intervention
• Patient Sex: Female
• Patient Race: Black Or African American