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 Hematoma (1884); Ischemia (1942); Obstruction/Occlusion (2422)

Event Date 01/06/2023

Event Type  Injury  

Event Description

Elegance study: it was reported that vessel occlusion was observed, and additional devices were required.The subject underwent treatment with ranger drug coated balloons on (b)(6) 2022 as a part of the elegance clinical trial.The target lesion was in the right proximal sfa, mid sfa, distal sfa, extending up to proximal popliteal artery with proximal reference vessel diameter of 5 mm and distal reference vessel diameter of 5 mm with lesion length of 330 mm and 100% stenosis and tasc ii d lesion.Prior to target lesion treatment with study device, atherectomy was performed using 2.2 mm x 1290 mm non-boston scientific (bsc) atherectomy device.Treatment of target lesion was performed by dilatation using study devices of sizes 5 mm x 200 mm and 5 mm x 150 mm of ranger drug-coated balloons.Following post treatment by placement of 6 mm x 80 mm innova bare metal stent, the final residual stenosis was noted to be 10%.On (b)(6) 2022, subject was discharged on dual antiplatelet therapy.Per edc, on (b)(6) 2023, subject was noted with symptoms related to occlusion in right sfa and popliteal artery.Of note, per source, on (b)(6) 2022, right lower extremity arterial duplex revealed occluded right superficial femoral artery stent.On (b)(6) 2023, subject presented with sudden onset of right foot pain, bilateral lower extremity coldness and discoloration with right leg greater than left.On examination, subject was noted to have a cold, pulseless, discolored right and left foot.Subsequently, on the same day, subject was admitted to the hospital and was recommended for aorto iliac stenting on later date.Per source, on (b)(6) 2023, 235 days post index procedure, occlusion noted in right superficial femoral artery stent and popliteal artery were treated by aspiration thrombectomy followed by placement of 3 mm x 60 mm sterling balloon to treat the persistent stenosis within the popliteal artery.Post treatment, final residual stenosis was noted to be 10%.Additionally, on the same day, occlusion noted in right common iliac artery and right external iliac artery were treated by angioplasty using 4 mm x 80 mm mustang balloon.Subsequently, tpa infusion was initiated at 0.5 mg/hour through catheter at the popliteal artery into the tibial vessel to treat the small vessel thrombosis.On (b)(6) 2023, repeat angiogram revealed less than 30% stenosis and vessel spasm in right proximal posterior tibial artery and anterior tibial artery.Stenosis noted in posterior and anterior tibial artery was treated by balloon angioplasty using 2.5 mm x 80 mm sterling balloon.Follow up imaging performed revealed persistent vessel spasm which was treated with infusion of 400 mcg of nitroglycerine through the catheter into tibial peroneal trunk and anterior tibial artery.Repeat imaging performed revealed significant improvement in the vessel appearance and on examination, subject had 1+ palpable pulse of the dorsalis pedis artery.Post procedure, small hematoma noted in left femoral access site was treated with additional manual pressure.On (b)(6) 2023, 240 days post index procedure, right common femoral artery, profundal femoral artery and superficial femoral artery endarterectomy was performed.Additionally, on the same day, left common femoral artery, profundal femoral artery and superficial femoral artery endarterectomy was performed.Stenosis noted in left common femoral artery and external iliac artery was treated with placement of 8 mm x 79 mm non-bsc stent in left common femoral artery and 8 mm x 59 mm non-bsc and 9 mm x 50 mm non-bsc stent in left external iliac artery.Stenosis noted in the right common iliac artery and external iliac artery was treated with placement of 9 mm x 59 mm and 9 mm x 7.5 mm non-bsc stent, respectively.Per edc, on (b)(6) 2023, the event was considered to be resolved.On (b)(6) 2023, subject was discharged from the hospital in stable condition.

Manufacturer Narrative

A1: patient identifier: (b)(6).A2: patient age at time of enrollment: 58 years old.

• 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: 17227702
• MDR Text Key: 318117866
• Report Number: 2124215-2023-33618
• Device Sequence Number: 1
• Product Code: ONU
• UDI-Device Identifier: 08714729976028
• UDI-Public: 08714729976028
• 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: 06/29/2023

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: 01/27/2024
• Device Model Number: 1973-03
• Device Catalogue Number: 1973-03
• Device Lot Number: 00861H22
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/08/2023
• Initial Date FDA Received: 06/29/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/27/2022
• 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: White