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 Code	Restenosis (4576)
Date of Event	05/17/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A1 - patient identifier: (b)(6).
Event or Problem Description
Elegance clinical trial.It was reported that restenosis occurred.The subject underwent treatment with the ranger drug coated balloon on (b)(6) 2023 as a part of the elegance clinical trial.The target lesion was in the right proximal superficial femoral artery extending up to right mid superficial femoral artery with 6.0 mm proximal reference vessel diameter and 6.0 mm distal reference vessel diameter with lesion length 150 mm with 90% stenosis and was classified as tasc ii b lesion.Prior to the target lesion treatment with the study device, atherectomy was performed by using 4.0 mm x 120 mm non-boston scientific (bsc) atherectomy device and pre-dilation was performed by using 5.0 mm x 100 mm sterling pta balloon.Treatment of target lesion was performed by dilation using study device, 6.0 mm x 150 mm ranger drug-coated balloon.Following treatment, the final residual stenosis was noted to be 5%.On the same day, the subject was discharged on aspirin and clopidogrel.On 17-may-2023, subject was noted with worsening symptoms related to peripheral artery disease in the right leg.On 07-jun-2023, 120 days post index procedure, 70% stenosis noted in the right proximal superficial femoral artery and right mid superficial femoral artery were treated by atherectomy and percutaneous transluminal angioplasty.The outcome of the event is unknown.
Additional Manufacturer Narrative
A1 - patient identifier: (b)(6).
Event or Problem Description
Elegance clinical trial.It was reported that restenosis occurred.The subject underwent treatment with the ranger drug coated balloon on (b)(6) 2023 as a part of the elegance clinical trial.The target lesion was in the right proximal superficial femoral artery extending up to right mid superficial femoral artery with 6.0 mm proximal reference vessel diameter and 6.0 mm distal reference vessel diameter with lesion length 150 mm with 90% stenosis and was classified as tasc ii b lesion.Prior to the target lesion treatment with the study device, atherectomy was performed by using 4.0 mm x 120 mm non-boston scientific (bsc) atherectomy device and pre-dilation was performed by using 5.0 mm x 100 mm sterling pta balloon.Treatment of target lesion was performed by dilation using study device, 6.0 mm x 150 mm ranger drug-coated balloon.Following treatment, the final residual stenosis was noted to be 5%.On the same day, the subject was discharged on aspirin and clopidogrel.On (b)(6) 2023, subject was noted with worsening symptoms related to peripheral artery disease in the right leg.On (b)(6) 2023, 120 days post index procedure, 70% stenosis noted in the right proximal superficial femoral artery and right mid superficial femoral artery were treated by atherectomy and percutaneous transluminal angioplasty.The outcome of the event is unknown.It was further reported that on (b)(6) 2023, the patient visited the hospital with the complaints of new onset of pain and numbness in the lower extremities and was advised to have a right leg angiogram on later date.On (b)(6) 2023, subject visited the hospital for scheduled right lower extremity angiogram with possible intervention.On the same day, duplex ultrasonography performed revealed presence of occlusive disease with heavy calcification in bilateral femoral-popliteal artery and tibial vessels.Subsequently, right lower extremity angiography was performed which revealed: patent aortoiliac segment, common femoral artery, profunda femoris artery, more than 65 to 70% of stenosis in the proximal and mid portions of the superficial femoral artery which was closer to 75% on the ivus, calcific however patent popliteal artery with less than 10% stenosis, severely calcified anterior tibial artery, severely diseased tibial peroneal trunk with up to 95% stenosis, distally occluded posterior tibial artery 75% stenosis at proximal segment of peroneal artery.On (b)(6) 2023, 120 days post index procedure, 70% stenosis noted in the right superficial femoral artery were treated by orbital atherectomy followed by balloon angioplasty using 6 mm x 240 mm non-bsc balloon.In addition, during the revascularization procedure, 95% stenosis noted in right tibio-peroneal trunk and 75% stenosis noted in right peroneal artery were treated by orbital atherectomy and percutaneous transluminal angioplasty using 3 mm balloon and 4 mm balloon.The subject tolerated the procedure well and there were no immediate post-procedure complications.The outcome of the event is unknown.On (b)(6) 2023, right leg arterial duplex was performed which revealed multiphasic arterial waveforms were detected in the right common femoral artery, deep femoral artery, superficial femoral artery, and popliteal arteries.Monophasic waveforms are seen in the peroneal, anterior tibial, and dorsalis pedis arteries with occlusion of posterior tibial artery.

• 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: 18545080
• Report Number: 2124215-2023-74204
• Device Sequence Number: 15398691
• Product Code: ONU
• UDI-Device Identifier: 08714729976189
• UDI-Public: 08714729976189
• Combination Product (Y/N): Y
• Initial Reporter State: DC
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/03/2024

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: 03/14/2024
• Device Model Number: 1973-03
• Device Catalogue Number: 1973-03
• Device Lot Number: 02410H22
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/26/2023
• Supplement Date Received by Manufacturer: 04/15/2024
• Initial Report FDA Received Date: 01/19/2024
• Supplement Report FDA Received Date: 05/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/15/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 61 YR
• Patient Sex: Male
• Patient Race: White