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

Model Number 1177-01

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

Patient Problem Vascular Dissection (3160)

Event Date 01/31/2024

Event Type  Injury  

Manufacturer Narrative

Patient identifier: (b)(6).

Event Description

Elegance clinical trial.It was reported that vessel dissection occurred.The subject underwent treatment with ranger drug coated balloons on (b)(6) 2024 as a part of the elegance clinical trial.The target lesion was in the left mid superficial femoral artery with 5 mm proximal reference vessel diameter and 4 mm distal reference vessel diameter with lesion length 200 mm with 100% stenosis and was classified as tasc ii c lesion.Prior to the target lesion treatment with the study devices, atherectomy was performed using 6 mm non-boston scientific (bsc) atherectomy device and pre-dilation was performed using 4.0 mm x 120 mm and 3.0 mm x 80 mm non-bsc pta balloons.Treatment of target lesion was performed by dilation using two 5 mm x 100 mm ranger drug-coated balloons, study device.Post treatment was performed by dilation using 6 mm x 40 mm non-bsc pta balloon and placement of 6 mm x 40 mm innova bare metal stent.Following treatment, the final residual stenosis was noted to be 20%.On (b)(6) 2024, on the same day of index procedure, during the treatment of target lesion, small dissection of grade b was noted in left mid superficial femoral artery post dilation using ranger drug coated balloon which was treated by the placement of 6 mm x 40 mm innova bare metal stent.In response to the event, medications were given.On the same day, the event was considered resolved.On (b)(6) 2024, the subject was discharged from the hospital on dual antiplatelet therapy.

Manufacturer Narrative

A1- patient identifier: (b)(6).A2 - patient age: 54 years old at time of enrollment.

Event Description

Elegance clinical trial.It was reported that vessel dissection occurred.The subject underwent treatment with ranger drug coated balloons on (b)(6) 2024 as a part of the elegance clinical trial.The target lesion was in the left mid superficial femoral artery with 5 mm proximal reference vessel diameter and 4 mm distal reference vessel diameter with lesion length 200 mm with 100% stenosis and was classified as tasc ii c lesion.Prior to the target lesion treatment with the study devices, atherectomy was performed using 6 mm non-boston scientific (bsc) atherectomy device and pre-dilation was performed using 4.0 mm x 120 mm and 3.0 mm x 80 mm non-bsc pta balloons.Treatment of target lesion was performed by dilation using two 5 mm x 100 mm ranger drug-coated balloons, study device.Post treatment was performed by dilation using 6 mm x 40 mm non-bsc pta balloon and placement of 6 mm x 40 mm innova bare metal stent.Following treatment, the final residual stenosis was noted to be 20%.On (b)(6) 2024, on the same day of index procedure, during the treatment of target lesion, small dissection of grade b was noted in left mid superficial femoral artery post dilation using ranger drug coated balloon which was treated by the placement of 6 mm x 40 mm innova bare metal stent.In response to the event, medications were given.On the same day, the event was considered resolved.On (b)(6) 2024, the subject was discharged from the hospital on dual antiplatelet therapy.It was further reported that the target lesion was in the left mid superficial femoral artery and left distal superficial femoral artery.Treatment of left mid superficial femoral artery was performed by dilation using 5 mm x 100 mm ranger drug-coated balloon and left distal superficial femoral artery was performed by dilation using 5 mm x 100 mm ranger drug-coated balloon study devices.Post treatment, 6 mm x 40 mm innova bare metal stent was placed in mid sfa and post dilated using 6 mm x 40 mm non-bsc pta balloon.On (b)(6) 2024, on the same day of index procedure, during the treatment of target lesion, small dissection of grade b in left mid superficial femoral artery post dilation using 5 mm x 100 mm ranger drug coated balloon and recoil was noted in the target lesion which was treated by the placement of 6 mm x 40 mm innova bare metal stent.Post dilation of the stent was performed using 6 mm x 40 mm non-bsc pta balloon.On the same day, the events were considered to be resolved.

• Brand Name: RANGER
• 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: 18857553
• MDR Text Key: 337124884
• Report Number: 2124215-2024-11243
• 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,Followup
• Report Date: 04/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1177-01
• Device Catalogue Number: 1177-01
• Device Lot Number: 05148H23
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/12/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/05/2023
• 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): Required Intervention
• Patient Age: 54 YR
• Patient Sex: Male
• Patient Race: White