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); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/17/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Elegance study.It was reported that occlusion occurred.The subject underwent treatment with the ranger drug coated balloon on (b)(6) 2022 as a part of the elegance clinical trial.The first target lesion was in the right peroneal artery with proximal reference vessel diameter of 4.0 mm and distal reference vessel diameter of 4.0 mm with lesion length of 60 mm and 100% stenosis.Prior to target lesion treatment, pre dilation was performed using 3.5 mm x 100 mm and 4.0 mm x 120 mm sterling pta balloon.Treatment of first target lesion was performed by dilation with study device, ranger drug coated balloon 4.0 mmx 60 mm.Following treatment, the final residual stenosis was noted to be 0%.The second target lesion was in the right proximal popliteal artery with proximal reference vessel diameter of 5.2 mm and distal reference vessel diameter of 5.2 mm with lesion length of 100 mm and 100% stenosis.Prior to target lesion treatment pre dilation was performed using 3.5 mm x 100 mm and 4.0 mm x 120 mm sterling pta balloon.Treatment of second target lesion was performed by dilation of study device, ranger drug coated balloon 5.00 mm x 80 mm.Post target lesion treatment, 6 mm x 80 mm non-boston scientific bare metal stent was implanted.Following post dilation with 6 mm x 40 mm sterling balloon, the final residual stenosis was noted to be 0%.On the same day, the subject was discharged from the hospital on clopidogrel and aspirin.On (b)(6) 2022, the subject visited the hospital for study specific 6 month follow up with the complaints of recurrent right calf claudication from past 7 to 10 days without any rest pain.However, the subject physical examination was not consistent with acute limb ischemia.Additionally, during the time of the event, subject suffered from benign essential hypertension, critical lower limb ischemia and peripheral arteria disease.On (b)(6) 2022, the subject revisited the hospital with the symptoms of worsening right calf claudication and subsequently right lower extremity angiography was performed which revealed occlusion of distal superficial femoral artery (sfa), popliteal artery, tibioperoneal trunk, anterior tibial artery, posterior tibial artery and the peroneal artery is filled by collaterals and reaches the foot.On (b)(6) 2022, 112 days post index procedure, occlusion noted in right distal sfa was treated with rotational atherectomy and thrombectomy through a previously stented segment with return of a large amount of thrombotic material and the entire occluded segment including the right popliteal artery, tibioperoneal trunk was dilated with 4 mm balloon.Following, there was focal filling defect noted in distal popliteal artery suggestive of thrombus with possible superimposed dissection which was treated with balloon dilation using 4 mm x 60 mm balloon and placement of 5 mm x 60 mm non-boston scientific stent overlapping the previous stent.Following post dilation with 5 mm balloon, brisk flow with inline flow to the peroneal stent was noted and post dilation of distal sfa stent with 6 mm balloon, the residual stenosis in the proximal to sfa stent was noted to be 25%.On (b)(6) 2022, the event was considered resolved and was recommended to continue xarelto 2.5 mg twice daily, plavix 75 mg and aspirin 81 mg daily for 2-4 weeks.
Additional Manufacturer Narrative
Patient identifier: (b)(6).Age at time of event: 71 years.(b)(6).
Event or Problem Description
Elegance study.It was reported that occlusion occurred.The subject underwent treatment with the ranger drug coated balloon on (b)(6) 2022 as a part of the elegance clinical trial.The first target lesion was in the right peroneal artery with proximal reference vessel diameter of 4.0 mm and distal reference vessel diameter of 4.0 mm with lesion length of 60 mm and 100% stenosis.Prior to target lesion treatment, pre dilation was performed using 3.5 mm x 100 mm and 4.0 mm x 120 mm sterling pta balloon.Treatment of first target lesion was performed by dilation with study device, ranger drug coated balloon 4.0 mmx 60 mm.Following treatment, the final residual stenosis was noted to be 0%.The second target lesion was in the right proximal popliteal artery with proximal reference vessel diameter of 5.2 mm and distal reference vessel diameter of 5.2 mm with lesion length of 100 mm and 100% stenosis.Prior to target lesion treatment pre dilation was performed using 3.5 mm x 100 mm and 4.0 mm x 120 mm sterling pta balloon.Treatment of second target lesion was performed by dilation of study device, ranger drug coated balloon 5.00 mm x 80 mm.Post target lesion treatment, 6 mm x 80 mm non-boston scientific bare metal stent was implanted.Following post dilation with 6 mm x 40 mm sterling balloon, the final residual stenosis was noted to be 0%.On the same day, the subject was discharged from the hospital on clopidogrel and aspirin.On (b)(6) 2022, the subject visited the hospital for study specific 6 month follow up with the complaints of recurrent right calf claudication from past 7 to 10 days without any rest pain.However, the subject physical examination was not consistent with acute limb ischemia.Additionally, during the time of the event, subject suffered from benign essential hypertension, critical lower limb ischemia and peripheral arteria disease.On (b)(6) 2022, the subject revisited the hospital with the symptoms of worsening right calf claudication and subsequently right lower extremity angiography was performed which revealed occlusion of distal superficial femoral artery (sfa), popliteal artery, tibioperoneal trunk, anterior tibial artery, posterior tibial artery and the peroneal artery is filled by collaterals and reaches the foot.On (b)(6) 2022, 112 days post index procedure, occlusion noted in right distal sfa was treated with rotational atherectomy and thrombectomy through a previously stented segment with return of a large amount of thrombotic material and the entire occluded segment including the right popliteal artery, tibioperoneal trunk was dilated with 4 mm balloon.Following, there was focal filling defect noted in distal popliteal artery suggestive of thrombus with possible superimposed dissection which was treated with balloon dilation using 4 mm x 60 mm balloon and placement of 5 mm x 60 mm non-boston scientific stent overlapping the previous stent.Following post dilation with 5 mm balloon, brisk flow with inline flow to the peroneal stent was noted and post dilation of distal sfa stent with 6 mm balloon, the residual stenosis in the proximal to sfa stent was noted to be 25%.On (b)(6) 2022, the event was considered resolved and was recommended to continue xarelto 2.5 mg twice daily, plavix 75 mg and aspirin 81 mg daily for 2-4 weeks.It was further reported that the event of the occlusion was caused by the study device, ranger drug coated balloon 4.0 mmx 60 mm.Causality of the ranger drug coated balloon 5.00 mm x 80 mm has been downgraded.
Additional Manufacturer Narrative
A1 - patient identifier: (b)(6).A2 - age at time of event: 71 years.E1 - initial reporter facility name: (b)(6).

• 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 johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 14646708
• Report Number: 2134265-2022-06530
• Device Sequence Number: 14876343
• Product Code: ONU
• UDI-Device Identifier: 08714729975809
• UDI-Public: 08714729975809
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• 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): 08/05/2022

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: 08/29/2022
• Device Model Number: 1973-03
• Device Catalogue Number: 1973-03
• Device Lot Number: 01746H21
• 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: 05/19/2022
• Supplement Date Received by Manufacturer: 07/11/2022
• Initial Report FDA Received Date: 06/09/2022
• Supplement Report FDA Received Date: 08/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/02/2021
• 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
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Race: Black Or African American