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 Ischemia (1942); Post Operative Wound Infection (2446)

Event Date 02/16/2023

Event Type  Injury  

Manufacturer Narrative

A1 - patient identifier: (b)(6).A2 - age at time of event: the patient was 45 years old at the time of study enrollment.

Event Description

It was reported that the subject experienced acute limb ischemia and infection of the right leg.The subject underwent treatment with ranger drug-coated balloon on (b)(6) 2022 as a part of the elegance clinical trial.The target lesion #001 was in the right common femoral artery, right external iliac artery and right proximal superficial femoral artery.The target lesion had a 6 mm proximal reference vessel diameter, 6 mm distal reference vessel diameter, and a lesion length of 60 mm.The lesion was 50% stenosed and was classified as tasc ii b lesion.Prior to target lesion treatment with study device, pre-dilation was performed using 6 mm x 40 mm mustang pta balloon.Treatment of target lesion was performed by study device, 6 mm x 80 mm ranger drug-coated balloon.Post treatment was performed by implanting 5 mm x 40 mm innova bare metal stent in the proximal sfa and 6 mm x 40 mm non-boston scientific bare metal stent in the external iliac artery.Following treatment, final residual stenosis was noted to be 0%.On (b)(6) 2022, the subject was discharged on aspirin and clopidogrel.On (b)(6) 2022, the subject underwent ct angiography which revealed in-stent stenosis of the right external iliac artery, and occlusion of the right external iliac artery, right common femoral artery, and right superficial femoral artery.On (b)(6) 2022, 115 days post index procedure, 100% stenosis noted in right proximal superficial femoral artery and right external iliac artery were treated by placing bypass graft from right external iliac artery to right superficial artery.Post procedure, the final residual stenosis was noted to be 0%.This intervention was previously reported under report number 2124215-2023-00510.On (b)(6) 2023, due to persistent impaired wound healing and continued suspicion of existing graft infection, resection of ptfe (polytetraflouroethylene) graft was performed using small pericardial tube grafts between the left external iliac artery and the right superficial femoral artery was replaced via retroperitoneal access.On (b)(6) 2023, plastic surgery was performed to cover the wound by means of an autologous skin transplant with split skin and the removal site was on the ipsilateral thigh at a size of approximately 5 x 15 cm.Subject was started on therapeutic anticoagulation with unfractionated heparin which was switched to rivaroxaban along with aspirin upon discharge to rehabilitation clinic on (b)(6) 2023 with assistance of physiotherapy which resulted in adequate wound healing.

• 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; wurselen 52146 ; GM 52146
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 17860713
• MDR Text Key: 324797765
• Report Number: 2124215-2023-54198
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/03/2023

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: 1177-01
• Device Catalogue Number: 1177-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/08/2023
• Initial Date FDA Received: 10/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 5 MM X 40 MM INNOVA.; 6 MM X 40 MM MUSTANG PTA BALLOON.
• Patient Outcome(s): Required Intervention
• Patient Sex: Female
• Patient Race: White