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); Restenosis (4576)
Date of Event	04/19/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Elegance study it was reported that a target lesion revascularization (tlr) occurred.The subject underwent treatment with the ranger paclitaxel-coated pta balloon catheters on (b)(6)2022 as a part of the elegance clinical trial.The target lesion was in the left proximal superficial femoral artery (sfa), left mid-sfa extending up to left distal-sfa with 6.0 mm proximal reference vessel diameter and 6.0 mm distal reference vessel diameter.The lesion length was 250 mm and 99% stenosis (classified as tasc ii c lesion).Prior to target lesion treatment with the study device, atherectomy was performed by using 2.1 mm x 1350 mm jetstream xc atherectomy device and pre-dilation was performed by using 5.0 mm x 200 mm mustang pta balloon.Treatment of target lesion was performed by dilation using sizes of 6.0 mm x 60 mm and 6.0 mm x 200 mm ranger paclitaxel-coated pta balloon catheter study devices.Following treatment, the final residual stenosis was noted to be 10%.On (b)(6)2022, the subject was discharged from hospital on aspirin.On (b)(6)2023, the subject noted having symptoms related to claudication.On (b)(6)2023, subject visited the hospital for left leg angiography, however it was cancelled secondary to groin rash/yeast.Hence, subject was started on oral antifungals and angiogram was rescheduled on later date, as the subject also had ongoing non-healing lower extremity ulcers and severe mixed lipedema and arterial ulcers.On (b)(6)2023, the subject revisited the hospital for planned bilateral lower extremity arteriogram.The left leg imaging revealed an occlusion in left sfa.On the same day, the subject was treated with drug-coated balloon angioplasty using 6 mm balloon followed by placement of 7 mm x 100 mm eluvia drug-eluting stent.Subsequently, left proximal sfa was treated with 6 mm balloon angioplasty.Additionally, on the same day, 60% stenosis noted in the left common femoral artery was treated with drug coated balloon angioplasty using 6 mm balloon.On (b)(6)2023, subject was discharged from hospital on dual antiplatelet therapy.
Additional Manufacturer Narrative
A1 (patient identifier): (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; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): HEMOTEQ AG; adenauerstrasse 15; wuerselen 52146 ; GM 52146
• Manufacturer Contact: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 17127026
• Report Number: 2124215-2023-30333
• Device Sequence Number: 7322481
• Product Code: ONU
• UDI-Device Identifier: 08714729976103
• UDI-Public: 08714729976103
• 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
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/14/2023

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: 03/07/2024
• Device Model Number: 1973-03
• Device Catalogue Number: 1973-03
• Device Lot Number: 02099H22
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/26/2023
• Initial Report FDA Received Date: 06/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/08/2022
• 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: 70 YR
• Patient Sex: Male
• Patient Race: White