MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RANGER PACLITAXEL-COATED PTA BALLOON CATHETER; DRUG-ELUTING PERIPHERAL TRANSLUMINAL ANGIOPLASTY CATHETER

Model Number 1973-03

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Vascular Dissection (3160)

Event Date 06/29/2023

Event Type  Injury  

Event Description

Elegance study: it was reported that a vessel dissection occurred.The subject underwent treatment with the ranger drug coated balloons on (b)(6) 2023 as a part of the elegance clinical trial.The target lesion was in the right proximal superficial femoral artery, right mid superficial femoral artery extending into right distal superficial femoral artery with 6.2 mm proximal reference vessel diameter and 6.3 mm distal reference vessel diameter with lesion length 200 mm with 100 % stenosis and was classified as tasc ii c lesion.Prior to target lesion treatment with study device, pre-dilation was performed using 5 mm x 200 mm non-boston scientific (bsc) balloon.Treatment of target lesion was performed by dilation using study devices, 6 mm x 200 mm, 6 mm x 150 mm and 6 mm x 40 mm ranger drug-coated balloons.Following treatment was performed by placement of 7 mm x 150 mm and 7 mm x 100 mm innova bare metal stents followed by dilation with 6 mm x 80 mm non-bsc balloon and the final residual stenosis was noted to be 0%.On (b)(6) 2023, on the same day of index procedure, during the treatment of the target lesion, dissection of grade b was noted in the target lesion, and the site has confirmed that the dissection was possibly due to 5 mm x 200 mm non-bsc balloon or one of the ranger drug-coated balloons and it is not clear which device led to dissection.In response to the complication, balloon dilation was performed, and stent was placed.Post treatment, the final residual stenosis was noted to be 0%.The complication of dissection was resolved.On (b)(6) 2023, the subject was discharged from the hospital.

Manufacturer Narrative

A1: patient identifier- (b)(6).

• Brand Name: RANGER PACLITAXEL-COATED PTA BALLOON CATHETER
• Type of Device: 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: 17618442
• MDR Text Key: 321919070
• Report Number: 2124215-2023-45189
• Device Sequence Number: 1
• Product Code: ONU
• UDI-Device Identifier: 08714729976202
• UDI-Public: 08714729976202
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P190019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/24/2023

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
• Device Operator: Health Professional
• Device Model Number: 1973-03
• Device Catalogue Number: 1973-03
• Device Lot Number: 09308H22
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/02/2023
• Initial Date FDA Received: 08/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/25/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 51 YR
• Patient Sex: Male
• Patient Race: Black Or African American