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); Vascular Dissection (3160); Restenosis (4576)
Date of Event	09/28/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Elegance clinical study: it was reported that restenosis 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 target lesion #001 was in the left proximal superficial femoral artery (sfa), left mid sfa extending to left distal sfa with 6.5 mm proximal reference vessel diameter and 6 mm distal reference vessel diameter with lesion length of 300 mm and 100% stenosis and was classified as tasc ii d lesion.Prior to target lesion treatment with study device, balloon angioplasty was performed with 5.0 mm x 200 mm and 6.0 mm x 220 mm sterling pta balloons.The treatment of target lesion was performed by dilatation with study device, ranger drug coated balloon of 6.0 mm x 200 mm and 6 mm x 150 mm and placement of 7 mm x 120 mm eluvia drug eluting stent.Following post dilatation with 6.0 mm x 100 mm sterling pta balloon, the final residual stenosis was noted to be 9%.On (b)(6) 2022, on the same day of index procedure, during the treatment of target lesion #001, dissection of grade c was noted in the target lesion due to ranger drug coated balloon of 6.0 mm x 150 mm.In response to the dissection noted, bailout stent was placed.On (b)(6) 2022, the subject visited the hospital with complaints of recurrent abrupt onset of left lower extremity claudication with rutherford category of iii and subsequently arterial duplex was performed which revealed in the left leg 50-74% stenosis in the common femoral artery, 75-99% stenosis in the profunda femoral artery, total occlusion of superficial femoral artery and occlusion of anterior tibial artery.Based on the above findings, the subject was scheduled for angiogram with possible intervention on later date.On (b)(6) 2022, the subject revisited the hospital for planned bilateral angiogram for recurrent claudication.On arrival, subject complaints of calf and hamstring pain after 30 seconds of ambulation and physical examination revealed 1+ femoral pulse on right and left side.Subsequently, subject was hospitalized, and lower extremity angiogram was performed which revealed in the left leg minimal luminal irregularities of vessel in common iliac artery, external iliac artery, and common femoral artery, 100% in-stent restenosis of proximal and mid superficial femoral artery, 100 stenosis in mid anterior tibial artery.On (b)(6) 2022, 182 days post index procedure, 100% stenosis noted in the left proximal sfa and mid sfa was treated with atherectomy followed balloon dilation using 7 mm x 150 mm and 6 mm x 200 mm ranger drug coated balloon and placement of 6.5 mm x 150 mm supera drug eluting stent in mid sfa.Post procedure, the final residual stenosis noted to be 0%.On (b)(6) 2022, the event was considered to be resolved.On(b)(6) 2022, the subject was discharged from the hospital on aspirin and clopidogrel.
Additional Manufacturer Narrative
(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 ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15700930
• Report Number: 2124215-2022-44520
• Device Sequence Number: 18204152
• Product Code: ONU
• UDI-Device Identifier: 08714729976189
• UDI-Public: 08714729976189
• 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
• Report Date (Section B): 10/31/2022

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: 12/21/2023
• Device Model Number: 1973-03
• Device Catalogue Number: 1973-03
• Device Lot Number: 00112H22
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/11/2022
• Initial Report FDA Received Date: 10/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/21/2021
• 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: 66 YR
• Patient Sex: Male