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); Restenosis (4576)
Date of Event	11/13/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A1 - patient identifier: (b)(6).A2 - age at time of event: 74 years old at the time of enrollment.
Event or Problem Description
Elegance clinical trial.It was reported ischemia occurred.The subject underwent treatment with the ranger drug-coated balloon and eluvia drug-eluting stents on (b)(6) 2023 as a part of the elegance clinical trial.The target lesion was located in the left external iliac artery with 6mm proximal reference vessel diameter and 6.5mm distal reference vessel diameter with lesion length of 60mm with 70% stenosis and was classified as tasc ii a lesion.Treatment of target lesion was performed by dilation using 7mm x 60mm ranger drug-coated balloon study device.Following post-treatment was performed by placement of 9mm x 60mm epic vascular self-expanding stent and the final residual stenosis was noted to be 30%.On (b)(6) 2023, the subject was discharged from the hospital on dual antiplatelet therapy.On (b)(6) 2023, the subject visited the hospital, computed tomography angiography runoff showed significant stenosis in the left distal external iliac artery (eia) stent.However, no action was taken at that point of time.On (b)(6) 2023, the subject was admitted to the hospital for reintervention of left lower extremity peripheral arterial occlusive disease.The subject was diagnosed with left lower extremity chronic limb threatening ischemia with minor tissue loss, with prior hybrid intervention.Subsequently, during the operative procedure, subject underwent angiography which revealed severe stenosis in left distal external iliac artery stent and new severe stenosis of the left proximal superficial femoral artery.Patency noted in bilateral renal arteries, common iliac arteries, internal iliac artery, common femoral artery, profunda femoral artery and 3 vessel runoffs to the foot.On the same day, 165 days post index procedure, severe stenosis noted in the left distal external iliac artery was treated by performing intravascular lithotripsy using 8mm x 30mm non-boston scientific balloon, followed by placement of 9mm x 40mm epic self-expanding stent which was post dilated using 8mm x 40mm sterling balloon.Subsequently, severe restenosis in the left proximal superficial femoral artery was treated by pre-dilation using 4.5mm x 40mm sterling balloon followed by drug coated balloon angioplasty using 6mm x 40mm ranger drug coated balloon.Post treatment, the final residual stenosis was noted to be 0% with no evidence of dissection and preserved runoff to the left foot.On the next day, the subject was discharged from the hospital as subject was deemed medically stable for discharge.The outcome of the event is considered to be ongoing.
Additional Manufacturer Narrative
A1 - patient identifier: (b)(6).A2 - age at time of event: 74 years old at the time of enrollment.
Event or Problem Description
Elegance clinical trial it was reported ischemia occurred.The subject underwent treatment with the ranger drug-coated balloon and eluvia drug-eluting stents on (b)(6) 2023 as a part of the elegance clinical trial.The target lesion was located in the left external iliac artery with 6mm proximal reference vessel diameter and 6.5mm distal reference vessel diameter with lesion length of 60mm with 70% stenosis and was classified as tasc ii a lesion.Treatment of target lesion was performed by dilation using 7mm x 60mm ranger drug-coated balloon study device.Following post-treatment was performed by placement of 9mm x 60mm epic vascular self-expanding stent and the final residual stenosis was noted to be 30%.On the third day of (b)(6) 2023, the subject was discharged from the hospital on dual antiplatelet therapy.On (b)(6) 2023, the subject visited the hospital, computed tomography angiography runoff showed significant stenosis in the left distal external iliac artery (eia) stent.However, no action was taken at that point of time.On (b)(6) 2023, the subject was admitted to the hospital for reintervention of left lower extremity peripheral arterial occlusive disease.The subject was diagnosed with left lower extremity chronic limb threatening ischemia with minor tissue loss, with prior hybrid intervention.Subsequently, during the operative procedure, subject underwent angiography which revealed severe stenosis in left distal external iliac artery stent and new severe stenosis of the left proximal superficial femoral artery.Patency noted in bilateral renal arteries, common iliac arteries, internal iliac artery, common femoral artery, profunda femoral artery and 3 vessel runoffs to the foot.On the same day, 165 days post index procedure, severe stenosis noted in the left distal external iliac artery was treated by performing intravascular lithotripsy using 8mm x 30mm non-boston scientific balloon, followed by placement of 9mm x 40mm epic self-expanding stent which was post dilated using 8mm x 40mm sterling balloon.Subsequently, severe restenosis in the left proximal superficial femoral artery was treated by pre-dilation using 4.5mm x 40mm sterling balloon followed by drug coated balloon angioplasty using 6mm x 40mm ranger drug coated balloon.Post treatment, the final residual stenosis was noted to be 0% with no evidence of dissection and preserved runoff to the left foot.On the next day, the subject was discharged from the hospital as subject was deemed medically stable for discharge.The outcome of the event is considered to be ongoing.It was further reported that on (b)(6) 2023 post treatment, the final residual stenosis was noted to be 0%.Subsequently, 80% severe restenosis in the left proximal superficial femoral artery (sfa).Post treatment, the final residual stenosis was noted to be 30%.On (b)(6) 2023, the event was considered to be resolved and the subject was discharged from the hospital as subject was deemed medically stable for discharge.
Event or Problem Description
Elegance clinical trial it was reported ischemia occurred.The subject underwent treatment with the ranger drug-coated balloon and eluvia drug-eluting stents on (b)(6) 2023 as a part of the elegance clinical trial.The target lesion was located in the left external iliac artery with 6mm proximal reference vessel diameter and 6.5mm distal reference vessel diameter with lesion length of 60mm with 70% stenosis and was classified as tasc ii a lesion.Treatment of target lesion was performed by dilation using 7mm x 60mm ranger drug-coated balloon study device.Following post-treatment was performed by placement of 9mm x 60mm epic vascular self-expanding stent and the final residual stenosis was noted to be 30%.On the third day of (b)(6) 2023, the subject was discharged from the hospital on dual antiplatelet therapy.On (b)(6) 2023, the subject visited the hospital, computed tomography angiography runoff showed significant stenosis in the left distal external iliac artery (eia) stent.However, no action was taken at that point of time.On (b)(6) 2023, the subject was admitted to the hospital for reintervention of left lower extremity peripheral arterial occlusive disease.The subject was diagnosed with left lower extremity chronic limb threatening ischemia with minor tissue loss, with prior hybrid intervention.Subsequently, during the operative procedure, subject underwent angiography which revealed severe stenosis in left distal external iliac artery stent and new severe stenosis of the left proximal superficial femoral artery.Patency noted in bilateral renal arteries, common iliac arteries, internal iliac artery, common femoral artery, profunda femoral artery and 3 vessel runoffs to the foot.On the same day, 165 days post index procedure, severe stenosis noted in the left distal external iliac artery was treated by performing intravascular lithotripsy using 8mm x 30mm non-boston scientific balloon, followed by placement of 9mm x 40mm epic self-expanding stent which was post dilated using 8mm x 40mm sterling balloon.Subsequently, severe restenosis in the left proximal superficial femoral artery was treated by pre-dilation using 4.5mm x 40mm sterling balloon followed by drug coated balloon angioplasty using 6mm x 40mm ranger drug coated balloon.Post treatment, the final residual stenosis was noted to be 0% with no evidence of dissection and preserved runoff to the left foot.On the next day, the subject was discharged from the hospital as subject was deemed medically stable for discharge.The outcome of the event is considered to be ongoing.It was further reported that on (b)(6) 2023 post treatment, the final residual stenosis was noted to be 0%.Subsequently, 80% severe restenosis in the left proximal superficial femoral artery (sfa).Post treatment, the final residual stenosis was noted to be 30%.On (b)(6) 2023, the event was considered to be resolved and the subject was discharged from the hospital as subject was deemed medically stable for discharge.It was further reported that the subject was diagnosed with restenosis in the left iliofemoral artery (001).
Additional Manufacturer Narrative
A1 - patient identifier: (b)(6).A2 - age at time of event: 74 years old at the time of enrollment.

• 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: 18378679
• Report Number: 2124215-2023-71937
• Device Sequence Number: 7797633
• Product Code: ONU
• UDI-Device Identifier: 08714729976264
• UDI-Public: 08714729976264
• Combination Product (Y/N): Y
• Initial Reporter State: PA
• 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,Followup
• Report Date (Section B): 07/24/2024

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: 10/10/2024
• Device Model Number: 1973-03
• Device Catalogue Number: 1973-03
• Device Lot Number: 08423H22
• 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: Not provided
• Supplement Date Received by Manufacturer: 02/20/2024; 07/01/2024
• Initial Report FDA Received Date: 12/21/2023
• Supplement Report FDA Received Date: 03/13/2024; 07/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/11/2022
• 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: Required Intervention
• Patient Sex: Female
• Patient Race: Black Or African American