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); Arteriosclerosis/ Atherosclerosis (4437); Thrombosis/Thrombus (4440); Restenosis (4576)
Date of Event	07/28/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
Elegance study.It was reported that the patient experienced claudication related to worsening ischemia of the target vessel.The subject underwent treatment with three ranger drug coated balloons on (b)(6) 2021 as a part of the elegance clinical trial.The target lesion was in the left proximal common femoral artery and femoral-anterior tibial bypass with proximal reference vessel diameter of 10 mm and distal reference vessel diameter of 5 mm.The lesion was classified as tasc ii d, with a length of 360 mm and 90% stenosis.Prior to target lesion treatment, balloon dilatation was performed using 3.0 mm x 40 mm sterling pta balloon.The treatment of target lesion was performed by dilatation using study devices 5 mm x 40 mm, 6 mm x 100 mm and 6 mm x 200 mm ranger drug coated balloons.Following post dilatation was performed with 7.0 mm x 220 mm sterling pta balloon and the final residual stenosis was noted to be 10%.On (b)(6) 2022, subject was noted with the claudication symptoms related to worsening ischemia noted in bilateral lower extremity.On the same day, subject underwent left lower extremity duplex which revealed that the left external iliac artery was patent, common femoral artery had mural thrombus, femoral-anterior tibial bypass graft proximal anastomotic site was 50-99% stenosis, and the proximal anterior tibial artery was patent.On (b)(6) 2022, 255 days post index procedure, 80% stenosis noted at the proximal anastomosis and proximal bypass graft were treated by balloon angioplasty using 5 mm x 150 mm ranger drug coated balloons.Post intervention, the final residual stenosis was noted to be 20%.

• 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): BOSTON SCIENTIFIC CORPORATION; 500 commander shea boulevard; quincy MA 02171
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15506397
• Report Number: 2124215-2022-35047
• Device Sequence Number: 7848032
• Product Code: ONU
• UDI-Device Identifier: 08714729976141
• UDI-Public: 08714729976141
• Combination Product (Y/N): Y
• Initial Reporter State: OH
• 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
• Report Date (Section B): 09/28/2022

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: 05/29/2022
• Device Model Number: 1973-03
• Device Catalogue Number: 1973-03
• Device Lot Number: 0027490714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/07/2022
• Initial Report FDA Received Date: 09/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/29/2020
• 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: 55 YR
• Patient Sex: Male
• Patient Race: White