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 Problems Pain (1994); Restenosis (4576)

Event Date 04/13/2023

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Elegance study.It was reported that a target lesion revascularization (tlr) occurred.The subject underwent treatment with the ranger paclitaxel-coated pta balloon catheter and eluvia drug-eluting stent on (b)(6) 2022 as a part of the elegance clinical trial.The target lesion was in right proximal superficial femoral artery (sfa), right mid superficial femoral artery extending up to right distal superficial femoral artery with 6.0 mm proximal reference vessel diameter and 6.0 mm distal reference vessel diameter with lesion length of 250 mm.The lesion had 90 percent stenosis and was classified as tasc ii c lesion.Prior to target lesion treatment with the study device, pre-dilation was performed using 5 mm x 200 mm saber balloon.Treatment of target lesion was performed by dilation using study device, 6 mm x 200 mm ranger paclitaxel-coated pta balloon catheter followed by placement of study stent, 6 mm x 40 mm, eluvia drug-eluting stent.Post-treatment, the final residual stenosis was noted to be 10 percent.On the same day, during the treatment of target lesion, dissection of grade c was noted in the proximal sfa due to the ranger treatment.In response, an eluvia drug-eluting stent was placed, and the complication was resolved on the same day.On the same day, the subject was discharged from the hospital on dual antiplatelet therapy.On (b)(6) 2023, the subject underwent angiogram and right leg intervention was recommended on later date.On (b)(6) 2023, subject visited the hospital for the scheduled angiogram with possible intervention for right lower extremity pain after walking for less than 200 meters.On examination, rutherford classification assessed revealed category 3, severe claudication.On the same day, selective angiography of right lower extremity performed revealed 80 percent in-stent stenosis of right sfa, widely patent right common femoral artery, profunda femoris artery, popliteal artery and 3-vessel run-off to the foot.On the same day, the right proximal superficial femoral artery was treated with a 2.0 laser atherectomy followed by drug-coated balloon angioplasty using 6 mm x 200 mm stellarex.Post treatment, the final residual stenosis was noted to be 20 percent.

• 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: 18160964
• MDR Text Key: 328415938
• Report Number: 2124215-2023-62391
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/17/2023

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 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: 10/27/2023
• Initial Date FDA Received: 11/17/2023
• 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 Age: 68 YR
• Patient Sex: Male
• Patient Race: White