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 Discomfort (2330); Obstruction/Occlusion (2422); Arteriosclerosis/ Atherosclerosis (4437)

Event Date 03/13/2023

Event Type  Injury  

Event Description

Elegance clinical study it was reported that the subject had re-occlusion of the left superficial femoral artery and left popliteal artery, requiring intervention.The subject was enrolled in the elegance clinical study on (b)(6) 2022.Baseline rutherford classification assessment was performed on the same day and revealed category 4 ischemic rest pain.The index procedure was also performed on the same day.The target lesion was located in the left proximal superficial femoral artery (sfa), left mid-sfa, left distal sfa, left proximal popliteal artery extending up to the left mid-popliteal artery, with 5.0 mm proximal reference vessel diameter and 5.0 mm distal reference vessel diameter with lesion length 470 mm with 100% stenosis, and was classified as transatlantic intersociety consensus (tasc) ii d lesion.Prior to treatment of the target lesion with the study devices, dilation was performed using a non-boston scientific percutaneous transluminal angioplasty balloon, and laser treatment with a non-boston scientific laser device.Then treatment of the target lesion was performed using three ranger paclitaxel-coated pta balloon catheters: sizes 5 mm x 200 mm, 5 mm x 200 mm and 5 mm x 80 mm.Following treatment, the final residual stenosis was noted to be 10%.The subject was discharged on aspirin and clopidogrel.On (b)(6) 2023, the subject presented with worsening symptoms related to peripheral arterial disease.On (b)(6) 2023, occlusion was noted in the left sfa and left popliteal artery.This was treated with atherectomy and balloon dilation using a drug coated balloon and percutaneous transluminal angioplasty balloon.Post treatment, the final residual stenosis was noted to be at 10%.

Manufacturer Narrative

A1 patient identifier: (b)(6).A2 patient age: 74 years old at time of enrollment.

Event Description

Elegance clinical study it was reported that the subject had re-occlusion of the left superficial femoral artery and left popliteal artery, requiring intervention.The subject was enrolled in the elegance clinical study on (b)(6) 2022.Baseline rutherford classification assessment was performed on the same day and revealed category 4 ischemic rest pain.The index procedure was also performed on the same day.The target lesion was located in the left proximal superficial femoral artery (sfa), left mid-sfa, left distal sfa, left proximal popliteal artery extending up to the left mid-popliteal artery, with 5.0 mm proximal reference vessel diameter and 5.0 mm distal reference vessel diameter with lesion length 470 mm with 100% stenosis, and was classified as transatlantic intersociety consensus (tasc) ii d lesion.Prior to treatment of the target lesion with the study devices, dilation was performed using a non-boston scientific percutaneous transluminal angioplasty balloon, and laser treatment with a non-boston scientific laser device.Then treatment of the target lesion was performed using three ranger paclitaxel-coated pta balloon catheters: sizes 5 mm x 200 mm, 5 mm x 200 mm and 5 mm x 80 mm.Following treatment, the final residual stenosis was noted to be 10%.The subject was discharged on aspirin and clopidogrel.On (b)(6) 2023, the subject presented with worsening symptoms related to peripheral arterial disease.On (b)(6) 2023, occlusion was noted in the left sfa and left popliteal artery.This was treated with atherectomy and balloon dilation using a drug coated balloon and percutaneous transluminal angioplasty balloon.Post treatment, the final residual stenosis was noted to be at 10%.It was further reported that on (b)(6) 2023, the subject presented for a 6 month follow up visit and complained of worsening claudication of the left lower extremity.On the same day, bilateral lower extremity arterial duplex was performed in the left lower extremity.This revealed elevated velocity (319 cm/sec) at the origin of the sfa within the target lesion, suggestive of less than 50% stenosis; occluded distal sfa with distal reconstitution at the popliteal artery; occluded proximal and mid-posterior tibial artery with distal reconstitution from collateralization; and diffuse calcification.On the same day, left ankle brachial index was noted to be 0.58, indicative of moderate arterial disease.The rutherford classification was 3.On (b)(6) 2023, the subject experienced recurrent symptoms of claudication of the left lower extremity and was hospitalized for further treatment and evaluation.On the same day, selective angiography of the left lower extremity showed a patent left common femoral artery and left deep femoral artery, proximally occluded left sfa, occluded left popliteal artery with reconstituted collaterals in the distal p3 segment of the left popliteal artery, occluded left femoral-popliteal artery bypass graft, left posterior tibial artery, left anterior tibial artery, and left tibio-peroneal trunk was patent with diffuse moderate disease.On the same day, the occlusion that was noted in the left sfa and occluded proximal to mid-segments of the left popliteal artery were treated with laser atherectomy, followed by balloon dilation using 4 mm x 250 mm percutaneous transluminal angioplasty balloon.In addition, drug coated balloon angioplasty was performed using a 5 mm x 250 mm balloon in the left sfa, and 3 to 3.5 mm x 210 mm balloon in the left popliteal artery as definitive therapy.Post treatment, the final angiogram revealed residual stenosis of 5 to 10% with brisk flow to the distal vessels.On the same day, the subject was discharged from the hospital in stable condition on clopidogrel medication.

Manufacturer Narrative

A1 patient identifier: (b)(6) a2 patient age: (b)(6) years old at time of enrollment.

• 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: 17619351
• MDR Text Key: 321918857
• Report Number: 2124215-2023-41258
• 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,Followup
• Report Date: 12/12/2023

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: 03/15/2024
• Device Model Number: 1973-03
• Device Catalogue Number: 1973-03
• Device Lot Number: 02428H22
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/24/2023
• Supplement Dates Manufacturer Received: 12/05/2023
• Supplement Dates FDA Received: 12/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/16/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Race: Black Or African American