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 Code	Vascular Dissection (3160)
Date of Event	02/20/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A1: patient identifier- (b)(6).A2: age at time of enrollment- 68 years old.
Event or Problem Description
It was reported that there was a vessel dissection.An additional device was required to treat the dissection.The subject underwent treatment with the eluvia drug-eluting stents and ranger drug-coated balloons on (b)(6) 2023 as a part of the elegance clinical trial.The target lesion was in the left proximal superficial femoral artery, left mid superficial femoral artery, left distal superficial femoral artery, left proximal popliteal artery and left mid popliteal artery with 6.5 mm proximal reference vessel diameter and 6 mm distal reference vessel diameter with lesion length of 480 mm and 100% stenosis and was classified as tasc ii d lesion.Prior to target lesion treatment with study devices, laser atherectomy was performed using 1.5 mm non-boston scientific otw device, pre-dilation was performed using 3 mm x 100 mm and 6 mm x 240 mm non-boston scientific otw pta balloon and two 6 mm x 60 mm mustang pta balloons.Treatment of target lesion was performed by the placement of study devices of size 7 mm x 120 mm and 7 mm x 150 mm eluvia drug eluting stents and dilation using study devices, two 6 mm x 200 mm and one 6 mm x 40 mm of ranger drug-coated balloons.Post treatment of target lesions with study device, shockwave lithotripsy was performed using 6 mm x 60 mm non-boston scientific lithotripsy device and following post dilation with 6 mm x 60 mm mustang pta balloon, the final residual stenosis was noted to be 40%.On (b)(6) 2023, on the same day of index procedure, during the treatment of the target lesion, dissection of grade b was noted due to ranger drug-coated balloon.Which specific ranger drug-coated balloon led to dissection was unknown.In response to the complication, a bailout stent was placed.Post treatment, the final residual stenosis was noted to be 40%.The complication of dissection was resolved on the same day, and the subject was discharged on aspirin.

• 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: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 17397715
• Report Number: 2124215-2023-37896
• Device Sequence Number: 14966039
• Product Code: ONU
• UDI-Device Identifier: 08714729976080
• UDI-Public: 08714729976080
• 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
• Report Date (Section B): 07/26/2023

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: 07/06/2024
• Device Model Number: 1973-03
• Device Catalogue Number: 1973-03
• Device Lot Number: 05447H22
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/28/2023
• Initial Report FDA Received Date: 07/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/07/2022
• 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 Sex: Male
• Patient Race: White