MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RANGER PACLITAXEL-COATED PTA BALLOON CATHETER; DRUG-ELUTING PERIPHERAL TRANSLUMINAL ANGIOPLASTY CATHETER

Model Number	1973-03
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Arteriosclerosis/ Atherosclerosis (4437); Restenosis (4576)
Date of Event	03/27/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
Elegance study.It was reported that a target lesion revascularization (tlr) occurred.The subject underwent treatment with the ranger paclitaxel-coated pta balloon catheter on (b)(6) 2023 as a part of the elegance clinical trial.The target lesion was in the right proximal superficial femoral artery (sfa), right mid-sfa extending up to right distal-sfa with 5.0 mm proximal reference vessel diameter and 5.0 mm distal reference vessel diameter.The lesion length of 60 mm and 100% stenosis (classified as tasc ii a lesion).Prior to target lesion treatment with study device, pre-dilation was performed using 4 mm x 80 mm armada 35 otw pta balloon.Treatment of target lesion was performed by dilation using study device of size 4 mm x 80 mm ranger paclitaxel-coated pta balloon catheter.Following treatment, the final residual stenosis was noted to be 10%.On the same day, the subject was discharged from hospital on antiplatelet therapy.On (b)(6) 2023, the subject presented to the hospital with symptoms of intermittent claudication.On the same day, right lower extremity angiography revealed occlusion of the right proximal-sfa, mid-sfa and distal-sfa.Additional treatment as performed with balloon angioplasty using 4 mm x 100 mm charger balloon followed by placement of 4.5 mm x 40 mm supera stent.Post-dilation with 4 mm x 100 mm charger balloon, the final residual stenosis was noted to be 0%.
Additional Manufacturer Narrative
A1: (b)(6).
Event or Problem Description
Elegance study it was reported that a target lesion revascularization (tlr) occurred.The subject underwent treatment with the ranger paclitaxel-coated pta balloon catheter on (b)(6) 2023 as a part of the elegance clinical trial.The target lesion was in the right proximal superficial femoral artery (sfa), right mid-sfa extending up to right distal-sfa with 5.0 mm proximal reference vessel diameter and 5.0 mm distal reference vessel diameter.The lesion length of 60 mm and 100% stenosis (classified as tasc ii a lesion).Prior to target lesion treatment with study device, pre-dilation was performed using 4 mm x 80 mm armada 35 otw pta balloon.Treatment of target lesion was performed by dilation using study device of size 4 mm x 80 mm ranger paclitaxel-coated pta balloon catheter.Following treatment, the final residual stenosis was noted to be 10%.On the same day, the subject was discharged from hospital on antiplatelet therapy.On (b)(6) 2023, the subject presented to the hospital with symptoms of intermittent claudication.On the same day, right lower extremity angiography revealed occlusion of the right proximal-sfa, mid-sfa and distal-sfa.Additional treatment as performed with balloon angioplasty using 4 mm x 100 mm charger balloon followed by placement of 4.5 mm x 40 mm supera stent.Post-dilation with 4 mm x 100 mm charger balloon, the final residual stenosis was noted to be 0%.Additional information was received that changed the target location.The right proximal/distal sfa was removed, and the right proximal/mid/distal popliteal artery was added.
Additional Manufacturer Narrative
A1: (b)(6).
Event or Problem Description
Elegance study: it was reported that a target lesion revascularization (tlr) occurred.The subject underwent treatment with the ranger paclitaxel-coated pta balloon catheter on (b)(6) 2023 as a part of the elegance clinical trial.The target lesion was in the right proximal superficial femoral artery (sfa), right mid-sfa extending up to right distal-sfa with 5.0 mm proximal reference vessel diameter and 5.0 mm distal reference vessel diameter.The lesion length of 60 mm and 100% stenosis (classified as tasc ii a lesion).Prior to target lesion treatment with study device, pre-dilation was performed using 4 mm x 80 mm armada 35 otw pta balloon.Treatment of target lesion was performed by dilation using study device of size 4 mm x 80 mm ranger paclitaxel-coated pta balloon catheter.Following treatment, the final residual stenosis was noted to be 10%.On the same day, the subject was discharged from hospital on antiplatelet therapy.On (b)(6) 2023, the subject presented to the hospital with symptoms of intermittent claudication.On the same day, right lower extremity angiography revealed occlusion of the right proximal-sfa, mid-sfa and distal-sfa.Additional treatment as performed with balloon angioplasty using 4 mm x 100 mm charger balloon followed by placement of 4.5 mm x 40 mm supera stent.Post-dilation with 4 mm x 100 mm charger balloon, the final residual stenosis was noted to be 0%.Additional information was received that changed the target location.The right proximal/distal sfa was removed, and the right proximal/mid/distal popliteal artery was added.Additional information was received that updated the onset date to (b)(6) 2023, as the subject had presented previous to (b)(6) 2023 with persistent right lower extremity claudication and no change in symptoms.Subject underwent duplex ultrasound which revealed loss of normal triphasic wave form and greater than 50% stenosis from right distal sfa to the popliteal artery without focal velocity elevation.Based on the underlying symptomatic condition and diagnostic results, subject was scheduled to undergo repeat angiography with possible intervention at a later date.

• Brand Name: RANGER PACLITAXEL-COATED PTA BALLOON CATHETER
• Common Device Name: 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: 17034993
• Report Number: 2124215-2023-27535
• Device Sequence Number: 15051266
• Product Code: ONU
• UDI-Device Identifier: 08714729975809
• UDI-Public: 08714729975809
• Combination Product (Y/N): Y
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P190019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/21/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/07/2024
• Device Model Number: 1973-03
• Device Catalogue Number: 1973-03
• Device Lot Number: 02090H22
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/09/2023
• Supplement Date Received by Manufacturer: 09/26/2023; 02/12/2024
• Initial Report FDA Received Date: 05/31/2023
• Supplement Report FDA Received Date: 10/18/2023; 02/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/08/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 55 YR
• Patient Sex: Female
• Patient Race: White