MAUDE Adverse Event Report: 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 Cellulitis (1768); Necrosis (1971); Embolism/Embolus (4438); Restenosis (4576)

Event Date 06/26/2021

Event Type  Injury  

Manufacturer Narrative

Patient identifier - (b)(6).

Event Description

(b)(6) clinical study.It was reported that cellulitis and toe amputation occurred.The subject underwent treatment with the ranger drug coated balloons on (b)(6) 2021 as a part of the elegance clinical trial.The first target lesion was in the left proximal popliteal artery with unknown proximal and distal reference vessel diameter, unknown length and 90% stenosis.Pre-dilatation was not performed, and treatment of target lesion was performed by dilatation with study devices, ranger drug coated balloons 6 mm x 200 mm, 5 x 80 mm and 5 x 120 mm.No adjunctive devices were used.The second target lesion was located in the left external iliac artery extending to left common femoral artery with unknown proximal and distal reference vessel diameter, unknown length and 100% stenosis (chronic total occlusion).Pre-dilatation was performed with charger pta balloon 5 mm x 150 mm and treatment of target lesion was performed by dilatation with study device, ranger drug coated balloon 7 mm x 150 mm.Post target lesion treatment was done by stenting with 8 mm x 37 mm express ld otw bare metal stent and 8 mm x 57 mm express ld otw bare metal stent as adjunctive devices.The proximal superficial femoral artery (sfa) and left dorsal pedal had 10% residual stenosis.On (b)(6) 201, the subject was discharged from the hospital on dual antiplatelet therapy.On (b)(6) 2021, the subject visited the outlying hospital due to worsening left lower extremity redness.On arrival, the subject was noted with ischemic necrosis of left toe cellulitis.Subsequently, the subject was hospitalized for further evaluation and treatment.On the same day on examination, the subject, did have a dopplerable lower extremity pulse.In response to the event, the subject received vancomycin and zosyn.On (b)(6) 2021, the subject was transferred from outlying hospital to study site.The subject was experiencing worsening left lower extremity pain was found to have very cold left lower extremity with petechia on the left foot with decrease sensation on the left toe was still getting purple.On examination, the subject was noted to have femoral pulse and 1+ palpable posterior tibial pulse.There was no pulse in the feet and there was not any good distal runoff past the calf.The tibial's were occluded.A lower arterial duplex was performed which revealed the right leg was patent stent mid to distal sfa and 75% stenosis in the profunda femoris.Waveforms in trifurcation vessel were monophasic suggesting severe trifurcation disease.The left leg was patent stent in the proximal and distal external iliac artery, more than 80% stenosis noted in the proximal stent of the stent in common femoral artery to proximal sfa and patent mid and distal sfa stent.Total occlusion noted in the proximal profunda femoris artery with distal reconstituted flow.Based on the duplex findings, the subject was planned to perform repeat angiography considering attempt to revascularize both the sfa and profunda femoris artery.The subjects presentation represented some degree of atheroembolism although there was poor runoff.On (b)(6) 2021, the subject was noted with existing ischemic necrosis of the left great toe and erythema of foot was rubor related to ischemia.Based on the finding, the subject was recommended for left great amputation on (b)(6) 2021.The subjects 2-4th toes appeared dusky and might not recover and hence possibility of requiring transmetatarsal amputation (tma) or below the knee amputation (bka) in the future due to severe peripheral artery disease.Per physician, the subject would likely benefit from attempted recanalization of the left profunda femoris that was occluded in the origin as well as angioplasty of the left superficial femoral artery stent.On (b)(6) 2021, left great amputation was performed through the metatarsal (minor amputation, per protocol definition).The next day, angiography was performed in the left sfa revealed 80% in-stent stenosis in the proximal sfa with 100 mmhg gradient which was treated by balloon angioplasty using 6.0 mm x 2.00 mm cutting balloon.Post balloon angioplasty, residual stenosis was noted to be 10%.Additionally, 80% stenosis noted in the dorsal pedal artery was treated by balloon angioplasty using armada 18 otw 2.5 mm x 40 mm balloon.On (b)(6) 2021, the subject was discharged from the hospital.On (b)(6) 2021, the subject revisited for follow up to left great toe amputation.The subject denied of having calf pain with ambulation or nocturnal rest pain.On examination, the subject was noted with expected complaint of post-operative pain.The subject was recommended to continue current pain regimen.The amputation site was noted with serosanguinous drainage.The amputation site was redressed with folded 4 x 4 gauze and wrapped in kerlex.His foot was warm and viable and had faint palpable pulse and expected reperfusion edema and erythema was noted.On (b)(6) 2021, the subject visited for another follow up to left great toe amputation.On examination, the subject was noted with pain/ discomfort.Dressing was removed, serosanguinous drainage was noted.3 areas of necrosis 0.8 cm x 0.8 cm each noted on the amputation site.The amputation site was redressed with a folded 4 x 4 gauze.His foot was warm and viable and had faint palpable pulse and expected reperfusion erythema was noted in the 1-3 dorsal, metatarsal region.No edema was noted.The subject was recommended to continue his medications including aspirin, a statin and plavix.

Manufacturer Narrative

A1: patient identifier - (b)(6).B3.Date of event and b5.Describe event or problem were updated per additional information provided.

Event Description

Elegance clinical study it was reported that cellulitis and toe amputation occurred.The subject underwent treatment with the ranger drug coated balloons on (b)(6) 2021 as a part of the elegance clinical trial.The first target lesion was in the left proximal popliteal artery with unknown proximal and distal reference vessel diameter, unknown length and 90% stenosis.Pre-dilatation was not performed, and treatment of target lesion was performed by dilatation with study devices, ranger drug coated balloons 6 mm x 200 mm, 5 x 80 mm and 5 x 120 mm.No adjunctive devices were used.The second target lesion was located in in the left external iliac artery extending to left common femoral artery with unknown proximal and distal reference vessel diameter, unknown length and 100% stenosis (chronic total occlusion).Pre-dilatation was performed with charger pta balloon 5 mm x 150 mm and treatment of target lesion was performed by dilatation with study device, ranger drug coated balloon 7 mm x 150 mm.Post target lesion treatment was done by stenting with 8 mm x 37 mm express ld otw bare metal stent and 8 mm x 57 mm express ld otw bare metal stent as adjunctive devices.The proximal superficial femoral artery (sfa) and left dorsal pedal had 10% residual stenosis.On (b)(6) 2021, the subject was discharged from the hospital on dual antiplatelet therapy.On (b)(6) 2021, the subject visited the outlying hospital due to worsening left lower extremity redness.On arrival, the subject was noted with ischemic necrosis of left toe cellulitis.Subsequently, the subject was hospitalized for further evaluation and treatment.On the same day on examination, the subject, did have a dopplerable lower extremity pulse.In response to the event, the subject received vancomycin and zosyn.On (b)(6) 2021, the subject was transferred from outlying hospital to study site.The subject was experiencing worsening left lower extremity pain was found to have very cold left lower extremity with petechia on the left foot with decrease sensation on the left toe was still getting purple.On examination, the subject was noted to have femoral pulse and 1+ palpable posterior tibial pulse.There was no pulse in the feet and there was not any good distal runoff past the calf.The tibials were occluded.A lower arterial duplex was performed which revealed the right leg was patent stent mid to distal sfa and 75% stenosis in the profunda femoris.Waveforms in trifurcation vessel were monophasic suggesting severe trifurcation disease.The left leg was patent stent in the proximal and distal external iliac artery, more than 80% stenosis noted in the proximal stent of the stent in common femoral artery to proximal sfa and patent mid and distal sfa stent.Total occlusion noted in the proximal profunda femoris artery with distal reconstituted flow.Based on the duplex findings, the subject was planned to perform repeat angiography considering attempt to revascularize both the sfa and profunda femoris artery.The subjects presentation represented some degree of atheroembolism although there was poor runoff.On (b)(6) 2021, the subject was noted with existing ischemic necrosis of the left great toe and erythema of foot was rubor related to ischemia.Based on the finding, the subject was recommended for left great amputation on (b)(6) 2021.The subjects 2-4th toes appeared dusky and might not recover and hence possibility of requiring transmetatarsal amputation (tma) or below the knee amputation (bka) in the future due to severe peripheral artery disease.Per physician, the subject would likely benefit from attempted recanalization of the left profunda femoris that was occluded in the origin as well as angioplasty of the left superficial femoral artery stent.On (b)(6) 2021, left great amputation was performed through the metatarsal (minor amputation, per protocol definition).The next day, angiography was performed in the left sfa revealed 80% in-stent stenosis in the proximal sfa with 100 mmhg gradient which was treated by balloon angioplasty using 6.0 mm x 2.00 mm cutting balloon.Post balloon angioplasty, residual stenosis was noted to be 10%.Additionally, 80% stenosis noted in the dorsal pedal artery was treated by balloon angioplasty using armada 18 otw 2.5 mm x 40 mm balloon.On (b)(6) 2021, the subject was discharged from the hospital.On (b)(6) 2021, the subject revisited for follow up to left great toe amputation.The subject denied of having calf pain with ambulation or nocturnal rest pain.On examination, the subject was noted with expected complaint of post-operative pain.The subject was recommended to continue current pain regimen.The amputation site was noted with serosanguinous drainage.The amputation site was redressed with folded 4 x 4 gauze and wrapped in kerlex.His foot was warm and viable and had faint palpable pulse and expected reperfusion edema and erythema was noted.On (b)(6) 2021, the subject visited for another follow up to left great toe amputation.On examination, the subject was noted with pain/ discomfort.Dressing was removed, serosanguinous drainage was noted.3 areas of necrosis 0.8 cm x 0.8 cm each noted on the amputation site.The amputation site was redressed with a folded 4 x 4 gauze.His foot was warm and viable and had faint palpable pulse and expected reperfusion erythema was noted in the 1-3 dorsal, metatarsal region.No edema was noted.The subject was recommended to continue his medications including aspirin, a statin and plavix.It was further reported that on (b)(6) 2021 that pathology of toe amputation showed gangrene and no signs of osteomyelitis.Per physician, amputation was due to atheroembolization.

• Brand Name: RANGER PACLITAXEL-COATED PTA BALLOON CATHETER
• Type of Device: DRUG-ELUTING PERIPHERAL TRANSLUMINAL ANGIOPLASTY CATHETER
• MDR Report Key: 12548651
• MDR Text Key: 274001326
• Report Number: 2134265-2021-11883
• Device Sequence Number: 1
• Product Code: ONU
• UDI-Device Identifier: 08714729975960
• UDI-Public: 08714729975960
• Combination Product (y/n): Y
• PMA/PMN Number: P190019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/19/2021

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: 12/07/2021
• Device Model Number: 1973-03
• Device Catalogue Number: 1973-03
• Device Lot Number: 04321H20
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/01/2021
• Initial Date FDA Received: 09/29/2021
• Supplement Dates Manufacturer Received: 09/29/2021
• Supplement Dates FDA Received: 10/19/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/10/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 77 YR