MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RANGER PACLITAXEL-COATED PTA BALLOON CATHETER; DRUG-ELUTING PERIPHERAL TRANSLUMINAL ANGIOPLASTY CATHETER

Model Number 1973-03

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

Patient Problems Ischemia (1942); Cramp(s) /Muscle Spasm(s) (4521); Restenosis (4576)

Event Date 04/10/2023

Event Type  Injury  

Manufacturer Narrative

A1: patient identifier- (b)(6).A2: patient age at time of enrollment- 65 years old.

Event Description

Elegance study it was reported that restenosis occurred, requiring intervention.The subject underwent treatment with ranger drug-coated balloons on (b)(6) 2022 as a part of the elegance clinical trial.The first target lesion was in the right proximal superficial femoral artery (sfa) with 5 mm proximal reference vessel diameter and 5 mm distal reference vessel diameter with lesion length of 60 mm and 80% stenosis and tasc ii b lesion.Prior to target lesion treatment with study device, atherectomy was performed using 2 mm x 1100 mm non-boston scientific (bsc) atherectomy device.Treatment of target lesion was performed by dilation using 5 mm x 150 mm ranger drug-coated balloon study device.Post target lesion treatment was performed by placement of 6 mm x 60 mm non-bsc bare metal stent and dilation using 5 mm x 60 mm of mustang pta balloon.Following treatment, the final residual stenosis was noted to be 10%.The second target lesion was in the right distal sfa with 5 mm proximal reference vessel diameter and 5 mm distal reference vessel diameter with lesion length of 60 mm and 80% stenosis and tasc ii b lesion.Treatment of target lesion was performed by dilation using 5 mm x 60 mm ranger drug-coated balloon study device.Post treatment, the final residual stenosis was noted to be 30%.On the same day, during index procedure, 80% stenosis noted in the right mid popliteal artery was treated with 5 mm x 60 mm non-bsc lithotripsy balloon.Post treatment, final residual stenosis was noted to be less than 10%.On the same day, the subject was discharged from hospital on dual antiplatelet therapy.On 10-april-2023, the subject was noted with right calf cramping after walking 30 feet and coldness in right foot.On 28-april2023, the subject presented for planned right lower extremity arterial duplex test due to prior noted symptoms of right calf cramping while walking more than 30 feet with right foot cooler compared to left foot, but denies resting pain in the foot.Of note, on 01-march-2023, subject visited the hospital for 12 month follow up visit, during which dus performed revealed patent target lesions.Ankle-brachial index (abi) assessment was noted to be 0.42 and 1.05 in the right and left leg respectively.Toe brachial index (tbi) was noted to be 0.18 and 0.89 in the right and left leg, respectively.On the same day, right lower extremity (target limb) arterial duplex test revealed monophasic waveforms throughout right lower extremity, 50 to 75% stenosis in right mid common femoral artery, greater than 75% stenosis in right proximal profundal artery, patent stent in proximal sfa but no flow was visualized in the distal sfa stent with flow reconstitution in proximal popliteal artery.On 01-may-2023, subject presented for right lower extremities angiogram which revealed greater than 90% stenosis in proximal edge of the right proximal sfa stent but the rest of artery was diffusely diseased, occlusion in mid portion of distal sfa, 60% stenosis in proximal and mid popliteal artery, occluded peroneal artery with reconstitution of the proximal popliteal artery, tibial arteries and 2 vessel tibial runoff.On the same day, greater than 90% stenosis noted in proximal edge of the right proximal sfa stent was treated by atherectomy using 6 french non-bsc device followed by drug coated balloon angioplasty using 4 mm x 100 mm non-bsc balloon in the right proximal sfa.Subsequently, occlusion noted in right distal sfa was treated by drug coated balloon angioplasty using 4 mm x 100 mm non-bsc balloon.Post treatment, final residual stenosis noted in right proximal superficial femoral artery was 30% and in right distal superficial femoral artery was 10%.In addition, during revascularization procedure, 60% stenosis in right proximal and mid popliteal artery were treated by atherectomy using 6 french non-bsc device followed by drug coated balloon angioplasty using 4 mm x 100 mm non-bsc balloon and the final residual stenosis was noted to be 30%.On 01-may-2023, the event was considered resolved with no peri-procedural complications.

• Brand Name: RANGER PACLITAXEL-COATED PTA BALLOON CATHETER
• Type of Device: DRUG-ELUTING PERIPHERAL TRANSLUMINAL ANGIOPLASTY CATHETER
• 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: 18806883
• MDR Text Key: 336551414
• Report Number: 2124215-2024-05278
• Device Sequence Number: 1
• Product Code: ONU
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P190019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/29/2024

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 Expiration Date: 01/04/2024
• Device Model Number: 1973-03
• Device Catalogue Number: 1973-03
• Device Lot Number: 00046H22
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/25/2024
• Initial Date FDA Received: 02/29/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/04/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female
• Patient Race: Black Or African American