MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RANGER SL; CATHETER, PERCUTANEOUS

Model Number 1584-01

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

Patient Problems Restenosis (4576); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/13/2023

Event Type  Injury  

Event Description

Elegance clinical trial it was reported that restenosis occurred requiring additional intervention.The subject underwent treatment with the ranger drug coated balloon on (b)(6) 2023 as a part of the elegance clinical trial.The target lesion 1 was in the left anterior tibial artery with 2 mm proximal reference vessel diameter and 1.4 mm distal reference vessel diameter with lesion length 150 mm with 100% stenosis.Prior to the treatment of target lesion with the study device, pre-dilation was performed using a 2 mm x 200 mm non-boston scientific (bsc) pta balloon.Treatment of target lesion was performed by dilation using 2.5 mm x 150 mm ranger drug coated balloon, study device.Post treatment, the final residual stenosis was noted to be 10%.On the following day, the subject was discharged from the hospital on clopidogrel.On (b)(6) 2023, subject was noted with symptoms related to restenosis in the left anterior tibial artery.On (b)(6) 2023, subject was admitted to the hospital for further treatment of ischemic left leg symptoms.On the same day, subject underwent angiography which revealed: aorta and iliac vessels revealed no significant disease.Right leg: common femoral artery, superficial femoral artery, profunda femoris, popliteal artery, and anterior tibial artery were noted to have no disease.Left leg (target limb): normal flow was noted in the common femoral artery and profunda femoris, multiple areas of minor stenosis noted in the proximal superficial femoral artery, popliteal artery was noted with distal tapering disease and heavily stenosed anterior tibial artery running down to the foot via collaterals, discontinuous flow was noted in the peroneal artery.On (b)(6) 2023, 83 days post index procedure, restenosis noted in left anterior tibial artery was treated by atherectomy using a non-boston scientific (bsc) atherectomy device, followed by drug coated balloon angioplasty using 3.5 mm x 80 mm, 3 mm x 150 mm, and 2.5 mm x 80 mm ranger drug coated balloons.In addition, left distal popliteal artery was also treated by atherectomy using a non-boston scientific (bsc) atherectomy device followed by drug coated balloon angioplasty using 3.5 mm x 80 mm, 3 mm x 150 mm, and 2.5 mm x 80 mm ranger drug coated balloons.Post-procedure, improved flow was noted through the left anterior tibial artery and left popliteal artery with run-off vessel to the foot.On the following day, the event was considered resolved with sequelae.On (b)(6) 2023, the subject was discharged from the hospital.

Manufacturer Narrative

A1 - patient identifier: (b)(6).

Event Description

Elegance clinical trial it was reported that restenosis occurred requiring additional intervention.The subject underwent treatment with the ranger drug coated balloon on (b)(6) 2023 as a part of the elegance clinical trial.The target lesion 1 was in the left anterior tibial artery with 2 mm proximal reference vessel diameter and 1.4 mm distal reference vessel diameter with lesion length 150 mm with 100% stenosis.Prior to the treatment of target lesion with the study device, pre-dilation was performed using a 2 mm x 200 mm non-boston scientific (bsc) pta balloon.Treatment of target lesion was performed by dilation using 2.5 mm x 150 mm ranger drug coated balloon, study device.Post treatment, the final residual stenosis was noted to be 10%.On the following day, the subject was discharged from the hospital on clopidogrel.On (b)(6) 2023, subject was noted with symptoms related to restenosis in the left anterior tibial artery.On (b)(6) 2023, subject was admitted to the hospital for further treatment of ischemic left leg symptoms.On the same day, subject underwent angiography which revealed: aorta and iliac vessels revealed no significant disease.Right leg: common femoral artery, superficial femoral artery, profunda femoris, popliteal artery, and anterior tibial artery were noted to have no disease.Left leg (target limb): normal flow was noted in the common femoral artery and profunda femoris, multiple areas of minor stenosis noted in the proximal superficial femoral artery, popliteal artery was noted with distal tapering disease and heavily stenosed anterior tibial artery running down to the foot via collaterals, discontinuous flow was noted in the peroneal artery.On (b)(6) 2023, 83 days post index procedure, restenosis noted in left anterior tibial artery was treated by atherectomy using a non-boston scientific (bsc) atherectomy device, followed by drug coated balloon angioplasty using 3.5 mm x 80 mm, 3 mm x 150 mm, and 2.5 mm x 80 mm ranger drug coated balloons.In addition, left distal popliteal artery was also treated by atherectomy using a non-boston scientific (bsc) atherectomy device followed by drug coated balloon angioplasty using 3.5 mm x 80 mm, 3 mm x 150 mm, and 2.5 mm x 80 mm ranger drug coated balloons.Post-procedure, improved flow was noted through the left anterior tibial artery and left popliteal artery with run-off vessel to the foot.On the following day, the event was considered resolved with sequelae.On 23-nov-2023, the subject was discharged from the hospital.It was further reported that for elegance ranger paclitaxel coated pta balloon catheter (lot# 05551h22), restenosis of anterior tibial artery left leg on (b)(6) 2024 (and subsequent intervention on (b)(6) 2023) was assessed as not related to the study device.

Manufacturer Narrative

A1 - patient identifier: (b)(6).

• Brand Name: RANGER SL
• Type of Device: CATHETER, PERCUTANEOUS
• 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: 18927136
• MDR Text Key: 337944180
• Report Number: 2124215-2024-15792
• Device Sequence Number: 1
• Product Code: ONU
• Combination Product (y/n): Y
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/12/2024

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 Model Number: 1584-01
• Device Catalogue Number: 1584-01
• Device Lot Number: 05551H22
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/18/2024
• Supplement Dates Manufacturer Received: 03/15/2024
• Supplement Dates FDA Received: 04/12/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/12/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 87 YR
• Patient Sex: Female
• Patient Race: White