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 Necrosis (1971); Obstruction/Occlusion (2422); Restenosis (4576)

Event Date 03/02/2023

Event Type  Injury  

Manufacturer Narrative

A1 - patient identifier: (b)(6).

Event Description

Elegance clinical trial.It was reported that restenosis occurred requiring additional intervention.The subject underwent treatment with the ranger drug-coated balloons on (b)(6) 2022 as a part of the elegance clinical trial.The target lesion was in the left proximal superficial femoral artery, left mid superficial femoral artery extending up to left distal superficial femoral artery with 5 mm proximal reference vessel diameter and 5 mm distal reference vessel diameter with lesion length 380 mm with 100% stenosis and was classified as tasc ii d lesion.Prior to the target lesion treatment with the study device, atherectomy was performed using a non-boston scientific (bsc) exchangeable system 1.50 solid atherectomy device and pre-dilation was performed using 4 mm x 300 mm non-bsc 014 pta balloon.Treatment of target lesion was performed by dilation using two 5 mm x 200 mm ranger drug-coated balloons study devices.Following treatment, the final residual stenosis was noted to be 0%.On the same day, the subject was discharged from the hospital.On (b)(6) 2023, 287 days post index procedure, the subject was noted with symptoms related to stenosis in the left superficial femoral artery and was hospitalized on the same day for further evaluation and treatment.Occlusion noted in left proximal superficial femoral artery, left mid superficial femoral artery, and left distal superficial femoral was treated by placement of drug eluting stent.Post procedure, the final residual stenosis was noted to be 0%.On the same day, the event was considered to be resolved.

Event Description

Elegance clinical trial it was reported that restenosis occurred requiring additional intervention.The subject underwent treatment with the ranger drug-coated balloons on 19-may-2022 as a part of the elegance clinical trial.The target lesion was in the left proximal superficial femoral artery (sfa), left mid superficial femoral artery extending up to left distal superficial femoral artery with 5 mm proximal reference vessel diameter and 5 mm distal reference vessel diameter with lesion length 380 mm with 100% stenosis and was classified as tasc ii d lesion.Prior to the target lesion treatment with the study device, atherectomy was performed using a non-boston scientific (bsc) exchangeable system 1.50 solid atherectomy device and pre-dilation was performed using 4 mm x 300 mm non-bsc 014 pta balloon.Treatment of target lesion was performed by dilation using two 5 mm x 200 mm ranger drug-coated balloons study devices.Following treatment, the final residual stenosis was noted to be 0%.On the same day, the subject was discharged from the hospital.On (b)(6) 2023, 287 days post index procedure, the subject was noted with symptoms related to stenosis in the left superficial femoral artery and was hospitalized on the same day for further evaluation and treatment.Occlusion noted in left proximal superficial femoral artery, left mid superficial femoral artery, and left distal superficial femoral was treated by placement of drug eluting stent.Post procedure, the final residual stenosis was noted to be 0%.On the same day, the event was considered to be resolved.It was further reported that the on 02-mar-2023, the subject was noted with symptoms related to gangrene on the 1st and 2nd toes of left leg, and not related to stenosis in the left sfa as previously reported, and was hospitalized for further evaluation and treatment.On (b)(6) 2023, the subject was discharged from the hospital.

Manufacturer Narrative

A1 - patient identifier: (b)(6).H6 - patient codes: removed restenosis, added necrosis.

Event Description

(b)(4) clinical trial.It was reported that restenosis occurred requiring additional intervention.The subject underwent treatment with the ranger drug-coated balloons on (b)(6) 2022 as a part of the elegance clinical trial.The target lesion was in the left proximal superficial femoral artery, left mid superficial femoral artery extending up to left distal superficial femoral artery with 5 mm proximal reference vessel diameter and 5 mm distal reference vessel diameter with lesion length 380 mm with 100% stenosis and was classified as tasc ii d lesion.Prior to the target lesion treatment with the study device, atherectomy was performed using a non-boston scientific (bsc) exchangeable system 1.50 solid atherectomy device and pre-dilation was performed using 4 mm x 300 mm non-bsc 014 pta balloon.Treatment of target lesion was performed by dilation using two 5 mm x 200 mm ranger drug-coated balloons study devices.Following treatment, the final residual stenosis was noted to be 0%.On the same day, the subject was discharged from the hospital.On (b)(6) 2023, 287 days post index procedure, the subject was noted with symptoms related to stenosis in the left superficial femoral artery and was hospitalized on the same day for further evaluation and treatment.Occlusion noted in left proximal superficial femoral artery, left mid superficial femoral artery, and left distal superficial femoral was treated by placement of drug eluting stent.Post procedure, the final residual stenosis was noted to be 0%.On the same day, the event was considered to be resolved.It was further reported that the on (b)(6) 2023, the subject was noted with symptoms related to gangrene on the 1st and 2nd toes of left leg, and not related to stenosis in the left sfa as previously reported, and was hospitalized for further evaluation and treatment.On (b)(6) 2023, the subject was discharged from the hospital.It was further reported that on (b)(6) 2023, the subject visited the hospital with gangrene on the first and second left toes and was recommended for emergent angiogram along with endovascular intervention.On the same day, peripheral angiography was performed which revealed: the distal aorta, bilateral common iliac, and external iliac were within normal limits, clinically non-significant calcium at left common femoral artery, patent, non-diseased profunda, occluded proximal superficial femoral artery and reconstitution of above-knee popliteal artery via the profunda with patent below-knee popliteal artery, occluded distal anterior tibial artery and chronically occluded tibioperoneal trunk and the peroneal artery.On the same day, 287 days post index procedure, occlusion was noted in left proximal superficial femoral artery, left mid superficial femoral artery, left distal superficial femoral and popliteal artery were treated by balloon angioplasty using 3 mm and 5 mm balloon.Repeat angiogram demonstrated segmental residual stenosis along the entire length of the left superficial femoral artery and popliteal artery.Hence, 5 mm x 10 mm non-boston scientific (bsc) stent was deployed from the distal above left knee popliteal to the adductor canal which was post dilated using 5mm balloon.Subsequently, 6 mm x 150 mm drug-coated stent was deployed proximally which was post dilated using 5 mm balloon following which 6 mm x 100 mm drug-coated stent was deployed in overlapping manner and was post dilatated using 6 mm balloon.Based on final angiogram, 7 mm x 150 mm drug coated stent was placed at left proximal superficial femoral artery followed by post dilatation with a 6 mm balloon.Post procedural angiogram of the left superficial femoral artery and popliteal demonstrated no residual stenosis.In addition, on the same day, during revascularization procedure, occlusion noted in the left anterior tibial artery was treated using 2.5 mm balloon and dorsalis pedis was treated by balloon angioplasty using 1.5 mm balloon.Completion angiogram demonstrated inline flow.During the end of the procedure, the subject had a sudden onset of hemoptysis and was hospitalized.On the same day, the event was considered resolved.

Manufacturer Narrative

A1 - patient identifier: (b)(6).H6 - patient codes: removed restenosis, added necrosis.

• 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: 18388472
• MDR Text Key: 331283411
• Report Number: 2124215-2023-69455
• Device Sequence Number: 1
• Product Code: ONU
• UDI-Device Identifier: 08714729976042
• UDI-Public: 08714729976042
• 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,Followup
• Report Date: 03/29/2024

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: 02/11/2024
• Device Model Number: 1973-03
• Device Catalogue Number: 1973-03
• Device Lot Number: 01296H22
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/01/2023
• Initial Date FDA Received: 12/22/2023
• Supplement Dates Manufacturer Received: 03/04/2024
• Supplement Dates FDA Received: 03/29/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/11/2022
• 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): Other
• Patient Age: 81 YR
• Patient Sex: Female
• Patient Race: Black Or African American