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); Movement Disorder (4412); Arteriosclerosis/ Atherosclerosis (4437)
Date of Event	07/18/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Elegance clinical trial.It was reported that re-occlusion occurred.The subject underwent treatment with the ranger drug coated balloon and eluvia drug eluting stent on (b)(6) 2022 as a part of the elegance clinical trial.The first target lesion was in the right proximal popliteal artery, right mid popliteal artery extending to right distal popliteal artery with proximal reference vessel diameter of 5.0 mm and distal reference vessel diameter of 5.0 mm with lesion length of 90 mm and 100 % stenosis.Prior to target lesion treatment with study device, pre dilation was performed using 5.0 mm x 240 mm and 3.0 mmx 240 mm non-boston scientific pta balloons.Treatment of target lesion was performed by dilation with study device, ranger drug coated balloon of 5.0 mm x 100 mm.Following treatment, the final residual stenosis was noted to be 10%.The second target lesion was in the right proximal superficial femoral artery (sfa), right mid sfa extending to right distal sfa with proximal reference vessel diameter of 6.0 mm and distal reference vessel diameter of 6.0 mm with lesion length of 370 mm and 100 % stenosis.Prior to target lesion treatment with study device, pre dilation was performed using 5.0 mm x 240 mm non-boston scientific pta balloon and endoprosthesis was performed using non-boston scientific stent graft of 6.0 mm x 250 mm.Treatment of target lesion was performed by placement of study device, eluvia drug eluting stent of 6.0 mm x 120 mm.Post target lesion treatment, post dilation was performed with 6.0 mm x 240 mm non-boston scientific pta balloon.Following treatment, the final residual stenosis was noted to be 0%.On (b)(6) 2022, the subject was discharged from the hospital on clopidogrel and aspirin.On (b)(6) 2022, the subject was noted with the symptoms related to right sfa and popliteal occlusion.On (b)(6) 2022, subject was hospitalized for further medical evaluation and treatment.Occlusion noted in the right sfa and popliteal artery was treated with thrombolysis.
Additional Manufacturer Narrative
(b)(6).
Additional Manufacturer Narrative
A1: patient identifier: (b)(6).E1: initial reporter phone: (b)(6).Correction: b5 describe event or problem: corrected date of index procedure.
Event or Problem Description
Elegance clinical trial.It was reported that re-occlusion occurred.The subject underwent treatment with the ranger drug coated balloon and eluvia drug eluting stent on (b)(6) 2022 as a part of the elegance clinical trial.The first target lesion was in the right proximal popliteal artery, right mid popliteal artery extending to right distal popliteal artery with proximal reference vessel diameter of 5.0 mm and distal reference vessel diameter of 5.0 mm with lesion length of 90 mm and 100 % stenosis.Prior to target lesion treatment with study device, pre dilation was performed using 5.0 mm x 240 mm and 3.0 mmx 240 mm non-boston scientific pta balloons.Treatment of target lesion was performed by dilation with study device, ranger drug coated balloon of 5.0 mm x 100 mm.Following treatment, the final residual stenosis was noted to be 10%.The second target lesion was in the right proximal superficial femoral artery (sfa), right mid sfa extending to right distal sfa with proximal reference vessel diameter of 6.0 mm and distal reference vessel diameter of 6.0 mm with lesion length of 370 mm and 100 % stenosis.Prior to target lesion treatment with study device, pre dilation was performed using 5.0 mm x 240 mm non-boston scientific pta balloon and endoprosthesis was performed using non-boston scientific stent graft of 6.0 mm x 250 mm.Treatment of target lesion was performed by placement of study device, eluvia drug eluting stent of 6.0 mm x 120 mm.Post target lesion treatment, post dilation was performed with 6.0 mm x 240 mm non-boston scientific pta balloon.Following treatment, the final residual stenosis was noted to be 0%.On (b)(6) 2022, the subject was discharged from the hospital on clopidogrel and aspirin.On (b)(6) 2022, the subject was noted with the symptoms related to right sfa and popliteal occlusion.On (b)(6) 2022, subject was hospitalized for further medical evaluation and treatment.Occlusion noted in the right sfa and popliteal artery was treated with thrombolysis.It was further corrected that the subject underwent treatment with the ranger drug coated balloon and eluvia drug eluting stent on (b)(6) 2022 as a part of the elegance clinical trial.It was further reported that on (b)(6) 2022, the subject visited hospital with complaints of difficulty in walking due to claudication in the right leg.On examination, subject was noted with rutherford category 5 on the right leg, with a great toe wound and a right abi of 0.27.No action was taken at that point of time and right leg angiogram was recommended next week.On (b)(6) 2022, subject visited the hospital for scheduled right lower extremity angiogram and was hospitalized for further medical evaluation and treatment.On the same day, the subject underwent lower extremity angiogram which revealed the 30-40% narrowing of right common femoral artery, patent right profunda femoris, occlusion of the stent from the ostium of sfa to the p2 section of the right popliteal artery, occlusion noted in the of stent extending from tibial peroneal trunk to posterior tibial artery.On (b)(6) 2022, 139 days post index procedure, thrombotic occlusions of the right sfa, and right popliteal artery was treated with serial inflations of 5 mm x 220 mm sterling balloon.In addition, thrombotic occlusion noted in the proximal segment of the posterior tibial artery and tibial peroneal trunk was treated with balloon angioplasty using 3.5 mm x 80 mm sterling balloon.Post procedure, posterior tibial artery remained occluded hence, overnight thrombolysis was recommended.A non-boston scientific infusion catheter was placed in the tibial peroneal trunk and 4 mg of tpa was administered and 1mg/hr tpa infusion was started via infusion catheter.Subject was transferred for ccu for overnight thrombolysis therapy.On (b)(6) 2022, post thrombolysis therapy, the subject also underwent lower extremity angiogram which revealed that both the right common femoral artery and the profunda femoris are patent.A stent extends from the proximal portion of the right superficial femoral artery to the p1 segment of the right popliteal artery which was widely patent and with no evidence of a thrombus.The popliteal artery was widely patent distal to the stent.A stent runs from the tibial peroneal trunk to the posterior tibial artery and was widely patent as well however, mid segment of posterior tibial artery had 70% narrowing with no thrombus and the anterior tibial artery was occluded in the proximal segment.Based on these findings, chronic total occlusion of the right proximal anterior tibial artery was treated with pre-dilation using coyote balloon of size 3.5 mm x 150 mm followed by placement of 3.5 mm x 48 mm synergy drug-eluting stent.Post dilation with 3.0 mm x 150 mm balloon, the final residual stenosis was 0%.In addition, 70% stenosis noted in the proximal to mid posterior tibial artery was treated with balloon angioplasty using 3.0 mm x 150 mm balloon.Following treatment, the final residual stenosis was noted to be 10%.On (b)(6) 2022, the event was considered resolved and on the same day subject was discharged from the hospital.

• 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: 15336938
• Report Number: 2134265-2022-08712
• Device Sequence Number: 6843220
• Product Code: ONU
• UDI-Device Identifier: 08714729975984
• UDI-Public: 08714729975984
• Combination Product (Y/N): Y
• Initial Reporter State: NC
• 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): 11/07/2022

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: 11/29/2023
• Device Model Number: 1973-03
• Device Catalogue Number: 1973-03
• Device Lot Number: 07630H21
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/08/2022
• Supplement Date Received by Manufacturer: 10/13/2022
• Initial Report FDA Received Date: 09/01/2022
• Supplement Report FDA Received Date: 11/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/29/2021
• 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: 58 YR
• Patient Sex: Female
• Patient Race: White