MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RANGER; CATHETER, PERCUTANEOUS

Model Number 1177-01

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

Patient Problems Arteriosclerosis/ Atherosclerosis (4437); Restenosis (4576)

Event Date 01/25/2024

Event Type  Injury  

Manufacturer Narrative

(b)(6).

Event Description

Elegance clinical study.It was reported that restenosis occurred.On (b)(6) 2023, the subject underwent treatment with the ranger drug coated balloon as a part of the elegance clinical trial.The target lesion #001 was in the right mid popliteal artery with 4.8 mm proximal reference vessel diameter and 4.8 mm distal reference vessel diameter with lesion length of 20 mm and 60% stenosis and was classified as tasc ii a lesion.Treatment of target lesion was performed by dilation using 5 mm x 40 mm ranger drug-coated balloon study device.Following post treatment, dilation was performed by using 5 mm x 40 mm sterling pta balloon, and the final residual stenosis was noted to be 10%.The target lesion #002 was in the right distal superficial femoral artery extending up to right proximal popliteal artery with 5.4 mm proximal reference vessel diameter and 5.4 mm distal reference vessel diameter with lesion length of 50 mm and 90% stenosis and was classified as tasc ii a lesion.Treatment of target lesion was performed by dilation using 6 mm x 60 mm ranger drug-coated balloon study device.The final residual stenosis was noted to be 10%.On the same day, the patient was discharged from hospital on dual antiplatelet therapy.On (b)(6) 2024, 269 days post the initial procedure, the patient presented with symptoms related to stenosis noted in the right distal superficial femoral artery.The stenosis was treated by percutaneous transluminal angioplasty, drug coated balloon, and followed by placement of stent.In addition, right proximal superficial femoral artery was also treated.On (b)(6) 2024, the event was considered resolved.There were no further patient complications reported.

Manufacturer Narrative

E1 - initial reporter phone: (b)(6).

Event Description

Elegance clinical study.It was reported that restenosis occurred.On (b)(6) 2023, the subject underwent treatment with the ranger drug coated balloon as a part of the elegance clinical trial.The target lesion #001 was in the right mid popliteal artery with 4.8 mm proximal reference vessel diameter and 4.8 mm distal reference vessel diameter with lesion length of 20 mm and 60% stenosis and was classified as tasc ii a lesion.Treatment of target lesion was performed by dilation using 5 mm x 40 mm ranger drug-coated balloon study device.Following post treatment, dilation was performed by using 5 mm x 40 mm sterling pta balloon, and the final residual stenosis was noted to be 10%.The target lesion #002 was in the right distal superficial femoral artery extending up to right proximal popliteal artery with 5.4 mm proximal reference vessel diameter and 5.4 mm distal reference vessel diameter with lesion length of 50 mm and 90% stenosis and was classified as tasc ii a lesion.Treatment of target lesion was performed by dilation using 6 mm x 60 mm ranger drug-coated balloon study device.The final residual stenosis was noted to be 10%.On the same day, the patient was discharged from hospital on dual antiplatelet therapy.On (b)(6) 2024, 269 days post the initial procedure, the patient presented with symptoms related to stenosis noted in the right distal superficial femoral artery.The stenosis was treated by percutaneous transluminal angioplasty, drug coated balloon, and followed by placement of stent.In addition, right proximal superficial femoral artery was also treated.On (b)(6) 2024, the event was considered resolved.There were no further patient complications reported.It was further reported that on (b)(6) 2024, the angiography of right lower extremity revealed, 95 % severe focal stenosis on the right adductor duct, 50-60% stenosis in the proximal superficial femoral artery (sfa), 20mm from origin of sfa, 90 % severe stenosis noted few centimeters below the prior lesion, and approximately 70-80 mm lower, short stenosis of 75% was noted.In addition, moderate non-significant stenosis was noted in the right mid popliteal artery, right peroneal artery and anterior tibial artery, and occlusion was noted on proximal half of right posterior tibial artery.In addition, 50-60 % stenosis noted in right proximal sfa was treated by pre-dilation and drug coated balloon angioplasty using 5 mm x 200 mm ranger drug coated balloon.Post different dilations, persistent significant stenosis was noted in the right mid sfa which was treated by placement of 6 mm x 40 mm eluvia drug eluting stent.

• Brand Name: RANGER
• Type of Device: CATHETER, PERCUTANEOUS
• 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: 18907345
• MDR Text Key: 337702517
• Report Number: 2124215-2024-15109
• Device Sequence Number: 1
• Product Code: ONU
• Combination Product (y/n): Y
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/05/2024

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 Model Number: 1177-01
• Device Catalogue Number: 1177-01
• Device Lot Number: 09854H22
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/21/2024
• Initial Date FDA Received: 03/14/2024
• Supplement Dates Manufacturer Received: 03/12/2024
• Supplement Dates FDA Received: 04/05/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/25/2022
• 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): Required Intervention
• Patient Age: 77 YR
• Patient Sex: Female
• Patient Race: White