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 Problems Obstruction/Occlusion (2422); Arteriosclerosis/ Atherosclerosis (4437)

Event Date 09/05/2023

Event Type  Injury  

Manufacturer Narrative

A1: patient identifier- (b)(6).A2: patient age at time of enrollment- 55 years old.

Event Description

Elegance study: it was reported that the subject presented with symptoms of claudication 56 days after the index procedure, and a vessel occlusion required revascularization.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 was in the right mid superficial femoral artery with 4 mm proximal reference vessel diameter and 4 mm distal reference vessel diameter with lesion length 100 mm with 100% stenosis and was classified as tasc ii a lesion.Prior to the target lesion treatment with the study device, a non-boston scientific (bsc) re-entry catheter device was used followed by pre-dilation using 4 mm x 60 mm non-bsc balloon.Treatment of target lesion was performed by dilation using 4 mm x 100 mm ranger drug-coated balloon study device.Post treatment was performed by placement of 6 mm x 80 mm non-bsc bare metal stent, and the final residual stenosis was noted to be 0%.On (b)(6) 2023, the subject was discharged on clopidogrel.On (b)(6) 2023, the subject underwent mr angiography on the pelvic and leg arteries which revealed occlusion of the right superficial femoral artery (sfa) at the origin and the occlusion line was 12 cm and severe arteriosclerosis of the proximal superficial femoral artery in the left leg.On (b)(6) 2023, the subject was admitted to the day clinic for the planned endovascular revascularization (evr) of the right lower extremity.On the same day, 56 days post index procedure, subject underwent digital subtraction angiography (dsa) which revealed 30% stenosis at the origin of sfa, 6 cm occlusion in the proximal segment of superficial femoral artery, thrombotic occlusion in the stent, 2 cm occlusion distally of the stent with total lesion length of 14 cm.Recanalization of the stent thrombosis was performed subintimal with the guidewire, but the recanalization could not be completed despite using several wires and the stent itself got recanalized with 0.035 wire.Then thrombectomy was performed using a non-bsc device and the device got struck in the proximal segment of stent, hence, further thrombectomy was not possible but ultimately freed.Subsequently, pre-dilation was performed by using 4 mm x 40 mm non-bsc balloon and 4 mm x 150 mm balloon in superficial femoral artery.Severe residual obstructions were found in all segments.Then dilation was performed on the sfa by using 5 mm x 150 mm non-bsc balloon and further treatment was preformed by using 6 mm x 150 mm non-bsc stent and post-dilation was performed using 5 mm x 150 mm balloon without residual stenosis.On (b)(6) 2023, the event was resolved and on (b)(6) 2023, the subject was discharged from the hospital on clopidogrel.

• 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: 17871591
• MDR Text Key: 324932183
• Report Number: 2124215-2023-54370
• Device Sequence Number: 1
• Product Code: ONU
• Combination Product (y/n): Y
• Reporter Country Code: AU
• 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: 10/04/2023

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 Model Number: 1177-01
• Device Catalogue Number: 1177-01
• Device Lot Number: 01563H23
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/11/2023
• Initial Date FDA Received: 10/04/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/21/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Male
• Patient Race: White