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	Obstruction/Occlusion (2422); Arteriosclerosis/ Atherosclerosis (4437); Unspecified Vascular Problem (4441)
Date of Event	04/25/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient identifier: (b)(6).
Event or Problem Description
Elegance clinical trial.It was reported that claudication and occlusion occurred.The subject underwent treatment with ranger drug coated balloons (dcb) and eluvia drug eluting stent on (b)(6) 2022 as part of the elegance clinical trial.The target lesion was located in the left distal superficial femoral artery (sfa), left proximal popliteal artery, mid popliteal artery extending to distal popliteal artery.The lesion had a proximal reference vessel diameter of 5mm, distal reference vessel diameter of 5mm, lesion length of 190mm, 100% stenosis and was classified as tasc ii c lesion.Prior to target lesion treatment, a non boston scientific (bsc) embolization protection device was used and pre dilation was performed with a 5mm x 150mm and 4mm x 40mm non-bsc balloons.Treatment of target lesion was performed by the following ranger dcb study devices: 4mm x 40mm, 5mm x 200mm and 5mm x 60mm, respectively, followed by placement of a 6mm x 60mm eluvia drug eluting study stent.Following post dilation with 5mm x 20mm nc emerge balloon, the final residual stenosis was noted to be 30%.On (b)(6) 2022, the subject visited the hospital with symptoms related to claudication.Segmental pressure and pulse volume recording (pvr) study was performed, which revealed normal right ankle brachial index (abi) of 1.13 and obstructive peripheral arterial disease of left leg with abi of 0.47.On (b)(6) 2022, subject revisited the hospital with known severe residual disease with rutherford category 3 (severe claudication) and was referred for the lower extremity angiography with possible intervention.On the same day, angiography performed in the right lower extremity revealed tortuous mild diffuse disease in the common iliac artery, external iliac artery and internal iliac artery, calcified mild diffuse disease in common femoral artery and profunda femoris artery, patent stent with mild diffuse disease in sfa and popliteal femoral artery.Angiography performed in the left lower extremity also revealed tortuous mild diffuse disease in common iliac artery, external iliac artery and internal iliac artery, patent common femoral artery and profunda femoris artery, patent stent in proximal sfa, patent mid sfa stent with mild disease, occluded distal sfa and popliteal artery, occluded tibioperoneal trunk, anterior tibial artery and ostial posterior tibial artery.On (b)(6) 2022, 16 days post index procedure, occlusion noted in the left distal sfa and left popliteal artery was treated with a 3.00mm x 150mm non-bsc balloon, 5mm x 150mm non-bsc balloon, 4mm x 40mm non-bsc balloon followed by 6mm x 150mm ranger dcb.In addition, occlusion noted in tibioperoneal trunk was treated with placement of 4mm x 32mm synergy stent, followed by post dilation with 5.0mm x 20mm nc emerge balloon with excellent angiographic results.On (b)(6) 2022, the event was considered resolved.
Additional Manufacturer Narrative
A1.Patient identifier: (b)(6).B5.Updated event description with additional information received.
Event or Problem Description
Elegance clinical trial.It was reported that claudication and occlusion occurred.The subject underwent treatment with ranger drug coated balloons (dcb) and eluvia drug eluting stent on (b)(6) 2022 as part of the elegance clinical trial.The target lesion was located in the left distal superficial femoral artery (sfa), left proximal popliteal artery, mid popliteal artery extending to distal popliteal artery.The lesion had a proximal reference vessel diameter of 5mm, distal reference vessel diameter of 5mm, lesion length of 190mm, 100% stenosis and was classified as tasc ii c lesion.Prior to target lesion treatment, a non boston scientific (bsc) embolization protection device was used and pre dilation was performed with a 5mm x 150mm and 4mm x 40mm non-bsc balloons.Treatment of target lesion was performed by the following ranger dcb study devices: 4mm x 40mm, 5mm x 200mm and 5mm x 60mm, respectively, followed by placement of a 6mm x 60mm eluvia drug eluting study stent.Following post dilation with 5mm x 20mm nc emerge balloon, the final residual stenosis was noted to be 30%.On (b)(6) 2022, the subject visited the hospital with symptoms related to claudication.Segmental pressure and pulse volume recording (pvr) study was performed, which revealed normal right ankle brachial index (abi) of 1.13 and obstructive peripheral arterial disease of left leg with abi of 0.47.On (b)(6) 2022, subject revisited the hospital with known severe residual disease with rutherford category 3 (severe claudication) and was referred for the lower extremity angiography with possible intervention.On the same day, angiography performed in the right lower extremity revealed tortuous mild diffuse disease in the common iliac artery, external iliac artery and internal iliac artery, calcified mild diffuse disease in common femoral artery and profunda femoris artery, patent stent with mild diffuse disease in sfa and popliteal femoral artery.Angiography performed in the left lower extremity also revealed tortuous mild diffuse disease in common iliac artery, external iliac artery and internal iliac artery, patent common femoral artery and profunda femoris artery, patent stent in proximal sfa, patent mid sfa stent with mild disease, occluded distal sfa and popliteal artery, occluded tibioperoneal trunk, anterior tibial artery and ostial posterior tibial artery.On (b)(6) 2022, 16 days post index procedure, occlusion noted in the left distal sfa and left popliteal artery was treated with a 3.00mm x 150mm non-bsc balloon, 5mm x 150mm non-bsc balloon, 4mm x 40mm non-bsc balloon followed by 6mm x 150mm ranger dcb.In addition, occlusion noted in tibioperoneal trunk was treated with placement of 4mm x 32mm synergy stent, followed by post dilation with 5.0mm x 20mm nc emerge balloon with excellent angiographic results.On (b)(6) 2022, the event was considered resolved.It was further reported that the patient was diagnosed with peripheral artery disease in the right leg.

• Brand Name: RANGER PACLITAXEL-COATED PTA BALLOON CATHETER
• Common Device Name: DRUG-ELUTING PERIPHERAL TRANSLUMINAL ANGIOPLASTY CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): HEMOTEQ AG; adenauerstrasse 15; wuerselen 52146 ; GM 52146
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 14639463
• Report Number: 2134265-2022-06509
• Device Sequence Number: 20263839
• Product Code: ONU
• UDI-Device Identifier: 08714729975762
• UDI-Public: 08714729975762
• Combination Product (Y/N): Y
• Initial Reporter State: NY
• 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): 07/19/2022

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: 09/13/2023
• Device Model Number: 1973-03
• Device Catalogue Number: 1973-03
• Device Lot Number: 05735H21
• 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: 05/16/2022
• Supplement Date Received by Manufacturer: 06/23/2022
• Initial Report FDA Received Date: 06/08/2022
• Supplement Report FDA Received Date: 07/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/13/2021
• 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; Hospitalization
• Patient Age: 76 YR
• Patient Sex: Female
• Patient Race: White