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	Ischemia (1942); Obstruction/Occlusion (2422)
Date of Event	05/23/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient identifier: (b)(6).
Event or Problem Description
Elegance clinical trial.It was reported that the patient developed acute ischemia and bilateral common femoral occlusions.The subject underwent treatment with the ranger drug coated balloons on (b)(6) 2022 as a part of the elegance clinical trial.The first target lesion was in the right profunda femoral artery with proximal reference vessel diameter of 4 mm and distal reference vessel diameter of 4 mm with lesion length of 40 mm and 80% stenosis.Pre-dilatation in the target lesion was performed with a 4 mm x 135 mm lithotripsy device.Treatment of target lesion was performed by dilation with study device, ranger drug coated balloon of 4 mm x 40 mm.Post treatment, the final residual stenosis was noted to be 10%.The second target lesion was in the right common femoral artery with proximal reference vessel diameter of 5 mm and distal reference vessel diameter of 5 mm with lesion length of 60 mm and 70% stenosis.Pre-dilatation in the target lesion was performed with a 5 mm x 110 mm lithotripsy device.Treatment of target lesion was performed by dilation with study device, ranger drug coated balloon of 5 mm x 60 mm.Post treatment, the final residual stenosis was noted to be 25%.The third target lesion was in the left profunda femoral artery with proximal reference vessel diameter of 4 mm and distal reference vessel diameter of 4 mm with lesion length of 40 mm and 80% stenosis.Pre-dilatation in the target lesion was performed with a 4 mm x 135 mm lithotripsy device.Treatment of target lesion was performed by dilation with study device, ranger drug coated balloon of 4 mm x 40 mm.Post treatment, the final residual stenosis was noted to be 10%.The fourth target lesion was in the left common femoral artery with proximal reference vessel diameter of 5 mm and distal reference vessel diameter of 5 mm with lesion length of 80 mm and 80% stenosis.Pre-dilatation in the target lesion was performed with a 5 mm x 110 mm lithotripsy device.Treatment of target lesion was performed by dilation with study device, ranger drug coated balloon of 5 mm x 60 mm.Post treatment, the final residual stenosis was noted to be 25%.On (b)(6) 2022, subject developed acute ischemia in the right lower extremity, hence, emergent bilateral cta was performed which revealed bilateral common femoral artery occlusions with extension into the sfa and profunda femoral arteries.On (b)(6) 2022, 3 days post index procedure, arteriotomy was performed from right external iliac artery to the profunda femoral artery and the occlusion noted in the right common femoral artery was treated with endarterectomy followed by profundoplasty.In addition, arteriotomy was performed from left external iliac artery to the profunda femoral artery and the occlusion noted in the left common femoral artery was treated with eversion endarterectomy followed by profundoplasty.Doppler signals in the right sfa were diminished hence, angiogram was performed which revealed widely patent right common femoral artery, profunda femoral artery and proximal sfa.Subsequently, bilateral bovine pericardial patch angioplasty was used to close the arteriotomy with sureclose dressing and was taken to cvicu in stable condition.On the same day, the event was considered resolved.During the hospital course, electrophysiology service was consulted, and icd was implanted successfully for low ejection fraction and non-sustained ventricular tachycardia.On (b)(6) 2022, the subject was discharged from the hospital on anticoagulants.
Event or Problem Description
It was reported that the patient developed acute ischemia and bilateral common femoral occlusions.The subject underwent treatment with the ranger drug coated balloons on (b)(6) 2022 as a part of a clinical trial.The first target lesion was in the right profunda femoral artery with proximal reference vessel diameter of 4 mm and distal reference vessel diameter of 4 mm with lesion length of 40 mm and 95% stenosis.Pre-dilatation in the target lesion was performed with a 4 mm x 40 mm lithotripsy device.Treatment of target lesion was performed by dilation with study device, ranger drug coated balloon of 4 mm x 40 mm.Post treatment, the final residual stenosis was noted to be 10%.The second target lesion was in the right common femoral artery with proximal reference vessel diameter of 5 mm and distal reference vessel diameter of 5 mm with lesion length of 60 mm and 70% stenosis.Pre-dilatation in the target lesion was performed with a 5 mm x 60 mm lithotripsy device.Treatment of target lesion was performed by dilation with study device, ranger drug coated balloon of 5 mm x 60 mm.Post treatment, the final residual stenosis was noted to be 25%.The third target lesion was in the left profunda femoral artery with proximal reference vessel diameter of 4 mm and distal reference vessel diameter of 4 mm with lesion length of 40 mm and 80% stenosis.Pre-dilatation in the target lesion was performed with a 4 mm x 40 mm lithotripsy device.Treatment of target lesion was performed by dilation with study device, ranger drug coated balloon of 4 mm x 40 mm.Post treatment, the final residual stenosis was noted to be 10%.The fourth target lesion was in the left common femoral artery with proximal reference vessel diameter of 5 mm and distal reference vessel diameter of 5 mm with lesion length of 60 mm and 80% stenosis.Pre-dilatation in the target lesion was performed with a 5 mm x 60 mm lithotripsy device.Treatment of target lesion was performed by dilation with study device, ranger drug coated balloon of 5 mm x 60 mm.Post treatment, the final residual stenosis was noted to be 25%.On (b)(6) 2022, subject developed acute ischemia in the right lower extremity, hence, emergent bilateral cta was performed which revealed bilateral common femoral artery occlusions with extension into the sfa and profunda femoral arteries.On (b)(6) 2022, 3 days post index procedure, arteriotomy was performed from right external iliac artery to the profunda femoral artery and the occlusion noted in the right common femoral artery was treated with endarterectomy followed by profundoplasty.In addition, arteriotomy was performed from left external iliac artery to the profunda femoral artery and the occlusion noted in the left common femoral artery was treated with eversion endarterectomy followed by profundoplasty.Doppler signals in the right sfa were diminished hence, angiogram was performed which revealed widely patent right common femoral artery, profunda femoral artery and proximal sfa.Subsequently, bilateral bovine pericardial patch angioplasty was used to close the arteriotomy with sureclose dressing and was taken to cvicu in stable condition.On the same day, the event was considered resolved.During the hospital course, electrophysiology service was consulted, and icd was implanted successfully for low ejection fraction and non-sustained ventricular tachycardia.On (b)(6) 2022, the subject was discharged from the hospital on anticoagulants.It was further reported that on (b)(6) 2022, in response to the bilateral common femoral artery occlusions, the subject received medication or regimen was adjusted.

• 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: 15179963
• Report Number: 2134265-2022-08346
• Device Sequence Number: 15020139
• Product Code: ONU
• UDI-Device Identifier: 08714729975762
• UDI-Public: 08714729975762
• Combination Product (Y/N): Y
• Initial Reporter State: OH
• 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): 06/03/2025

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: 02/16/2024
• Device Model Number: 1973-03
• Device Catalogue Number: 1973-03
• Device Lot Number: 01514H22
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/11/2022
• Supplement Date Received by Manufacturer: 05/06/2025
• Initial Report FDA Received Date: 08/05/2022
• Supplement Report FDA Received Date: 06/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/16/2022
• 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
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Race: White