MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RANGER; CATHETER, PERCUTANEOUS

Model Number 1177-01

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

Patient Problems Arteriosclerosis/ Atherosclerosis (4437); Restenosis (4576); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/25/2024

Event Type  Injury  

Manufacturer Narrative

Patient id: (b)(6).Patient age 83 years old at time of enrollment.

Event Description

Elegance clinical study it was reported that restenosis occurred, requiring hospitalization and intervention.On 11-jan-2024, the subject underwent treatment with two ranger drug coated balloons and an eluvia drug-eluting stent as a part of the elegance clinical trial.The target lesion was in the right proximal superficial femoral artery (sfa), right mid-sfa, extending up to the right distal sfa, with 5 mm proximal reference vessel diameter, and 5 mm distal reference vessel diameter, with lesion length of 90 mm, and 90% stenosis, and was classified as transatlantic intersociety consensus (tasc) ii c lesion.Prior to target lesion treatment with the study devices, lithotripsy and atherectomy were performed using non-boston scientific devices.Pre-dilation was performed by using a non-boston scientific cutting balloon and percutaneous transluminal angioplasty (pta) balloon.Treatment of the target lesion was then performed by dilation using study devices 5 mm x 80 mm and 5 mm x 120 mm ranger drug-coated balloons, followed by the placement of eluvia drug-eluting vascular stent system 6x100, 130 cm study device.Post treatment dilation was performed by using a non-boston scientific pta balloon, and the final residual stenosis was noted to be 20%.On (b)(6) 2024, the subject was discharged from the hospital on clopidogrel.On (b)(6) 2024, the subject was noted with symptoms related to restenosis in the right sfa and was hospitalized on the same day for further evaluation and treatment.The subject received medications at that time.Restenosis was noted in the right sfa and was treated by lithotripsy and was revascularized using drug coated balloon.The event was ongoing, and the subject was still hospitalized.

Manufacturer Narrative

A1: patient id: (b)(6).A2: patient age 83 years old at time of enrollment.

Event Description

Elegance clinical study: it was reported that restenosis occurred, requiring hospitalization and intervention.On (b)(6) 2024, the subject underwent treatment with two ranger drug coated balloons and an eluvia drug-eluting stent as a part of the elegance clinical trial.The target lesion was in the right proximal superficial femoral artery (sfa), right mid-sfa, extending up to the right distal sfa, with 5 mm proximal reference vessel diameter, and 5 mm distal reference vessel diameter, with lesion length of 90 mm, and 90% stenosis, and was classified as transatlantic intersociety consensus (tasc) ii c lesion.Prior to target lesion treatment with the study devices, lithotripsy and atherectomy were performed using non-boston scientific devices.Pre-dilation was performed by using a non-boston scientific cutting balloon and percutaneous transluminal angioplasty (pta) balloon.Treatment of the target lesion was then performed by dilation using study devices 5 mm x 80 mm and 5 mm x 120 mm ranger drug-coated balloons, followed by the placement of eluvia drug-eluting vascular stent system 6x100, 130 cm study device.Post treatment dilation was performed by using a non-boston scientific pta balloon, and the final residual stenosis was noted to be 20%.On (b)(6) 2024, the subject was discharged from the hospital on clopidogrel.On (b)(6) 2024, the subject was noted with symptoms related to restenosis in the right sfa and was hospitalized on the same day for further evaluation and treatment.The subject received medications at that time.Restenosis was noted in the right sfa and was treated by lithotripsy and was revascularized using drug coated balloon.The event was ongoing, and the subject was still hospitalized.It was further reported that the restenosis was not related to the study devices.

• Brand Name: RANGER
• Type of Device: CATHETER, PERCUTANEOUS
• 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: 19135004
• MDR Text Key: 340506561
• Report Number: 2124215-2024-19507
• Device Sequence Number: 1
• Product Code: ONU
• Combination Product (y/n): Y
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/15/2024

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 Model Number: 1177-01
• Device Catalogue Number: 1177-01
• Device Lot Number: 07634H23
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/27/2024
• Initial Date FDA Received: 04/18/2024
• Supplement Dates Manufacturer Received: 04/26/2024
• Supplement Dates FDA Received: 05/15/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/18/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: RANGER BALLOON, ELUVIA STENT; RANGER BALLOON, ELUVIA STENT
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Male
• Patient Race: White