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 Problem Restenosis (4576)

Event Date 03/02/2023

Event Type  Injury  

Manufacturer Narrative

A1: patient identifier: (b)(6).A2: age at time of event: 83 years old at the time of study enrollment.

Event Description

Elegance clinical trial it was reported that restenosis occurred.The subject underwent treatment with the ranger drug coated balloons on 15-jun-2022 as a part of the elegance clinical trial.The target lesion was in the right anterior tibial artery with 3.5 mm proximal reference vessel diameter and 2 mm distal reference vessel diameter with lesion length 320 mm with 100% stenosis and was classified as tasc ii c lesion.Prior to the target lesion treatment with the study device, pre-dilation was performed using 2 mm x 150 mm coyote pta balloon.Treatment of target lesion was performed by dilation using study devices, 2.5 mm x 120 mm, 3 mm x 120 mm and 3.5 mm x 150 mm ranger drug coated balloons.Following treatment, the final residual stenosis was noted to be 15%.On the (b)(6) 2022, the subject was discharged from the hospital on dual antiplatelet therapy.On 02-mar-2023, subject was noted with symptoms related to restenosis of right anterior tibial artery and was hospitalized for further evaluation and treatment.On 03-mar-2023, 261 days post index procedure, 70% stenosis noted in the right anterior tibial artery was treated with balloon dilation using coyote pta balloon.Post treatment, the final residual stenosis was noted to be 0%.On the same day, the event was considered to be resolved and on (b)(6) 2023, the subject was discharged from the hospital.

• 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: 18366147
• MDR Text Key: 331010165
• Report Number: 2124215-2023-72167
• Device Sequence Number: 1
• Product Code: ONU
• Combination Product (y/n): Y
• Reporter Country Code: GM
• 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: 12/20/2023

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: 11/18/2023
• Device Model Number: 1584-01
• Device Catalogue Number: 1584-01
• Device Lot Number: 07316H21
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/28/2023
• Initial Date FDA Received: 12/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/18/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Race: White