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 Numbness (2415); Restenosis (4576)

Event Date 02/19/2024

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 30-aug-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 2 mm x 200 mm armada 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 (b)(6) 2023, subject was noted with symptoms related to restenosis in the left anterior tibial artery.On (b)(6) 2024, the subject experienced tightness in the left calf after walking for a long distance along with numbness.On (b)(6) 2023 revealed restenosis in left anterior tibial artery which was treated by atherectomy using a hawkone atherectomy device followed by angioplasty using 3.5 mm x 80 mm, 3 mm x 150 mm, and 2.5 mm x 80 mm ranger drug coated balloons.On (b)(6) 2024, subject was admitted to the hospital for further evaluation and treatment.On the same day, subject underwent angiography which revealed: aorta and iliac vessels revealed no significant disease.Right leg: normal flow was noted in the common femoral artery, profunda femoris artery, superficial femoral artery, popliteal artery.The flow was predominant via the anterior tibial artery with stenotic disease in the mid anterior tibial artery.Left leg (target limb): normal flow was noted in the common femoral artery, profunda femoris artery, superficial femoral artery, and popliteal artery.High grade stenosis was noted in the proximal anterior tibial artery as well as occlusion in its mid-section.The tibial vessels were noted to be occluded with flow into a very small dorsalis pedis artery via the collateral vessels.On (b)(6) 2024, 182 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 mm x 150 mm, and 2.5 mm x 120 mm ranger drug coated balloons.Post procedure, improved flow was noted through the anterior tibial artery down to the foot.On the same day, the event was considered resolved with sequelae.On (b)(6) 2024, the subject was discharged from the hospital.

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: 19095917
• MDR Text Key: 340016977
• Report Number: 2124215-2024-22079
• 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
• 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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/15/2024
• Initial Date FDA Received: 04/12/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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