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 04/11/2022

Event Type  Injury  

Event Description

Elegance study it was reported that a dissection occurred, requiring an additional device.The subject underwent treatment with the ranger drug coated balloons and eluvia drug eluting stent on (b)(6) 2022 as a part of the elegance clinical trial.The target lesion was in the left proximal superficial femoral artery, left mid superficial femoral artery extending up to left distal superficial femoral artery 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, and pre-dilation was performed by using 5 mm x 200 mm sterling pta balloon.Treatment of target lesion was performed by dilation using 6 mm x 200 mm and 6 mm x 150 mm ranger drug-coated balloons study devices followed by the placement of 7 mm x 120 mm eluvia drug eluting stent study device.Following post treatment, dilation was performed by using 6 mm x 100 mm sterling pta balloon, and the final residual stenosis was noted to be 0%.On 11-apr-2022, during the treatment of target lesion, occlusion noted in the left superficial femoral artery was pre-dilated using 5 mm x 200 mm and 6 mm x 220 mm sterling pta balloon followed by drug coated balloon angioplasty was performed using 6 mmx 200 mm and 6 mm x 150 mm ranger drug coated balloon.Subsequently, repeat ivus performed revealed dissection of grade c in the proximal superficial femoral artery.In response to dissection, 7 mmx 120 mm eluvia drug eluting stent was placed.Post treatment, the final residual stenosis was noted to be 0%.On the same day, the complication of dissection was resolved.On (b)(6) 2022, the subject was discharged from the hospital on dual antiplatelet therapy.

Manufacturer Narrative

Patient identifier- (b)(6).Patient age at time of enrollment- 66 years old.

• 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: 19209848
• MDR Text Key: 341357659
• Report Number: 2124215-2024-24285
• Device Sequence Number: 1
• Product Code: ONU
• UDI-Device Identifier: 08714729976202
• UDI-Public: 08714729976202
• Combination Product (y/n): Y
• 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: 04/29/2024

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 Expiration Date: 12/21/2023
• Device Model Number: 1973-03
• Device Catalogue Number: 1973-03
• Device Lot Number: 00107H22
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/02/2024
• Initial Date FDA Received: 04/29/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/21/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male
• Patient Race: White