MAUDE Adverse Event Report: CORDIS US. CORP UNKNOWN SMART RADIANZ; STENT, SUPERFICIAL FEMORAL ARTERY

Model Number UNK-SMARTRADIANZ

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

Patient Problem Vascular Dissection (3160)

Event Date 02/10/2023

Event Type  Injury  

Event Description

As reported in the radiancy study, there was an amputation of the left lower limb.Failure of revascularization, extensive dissection upstream and downstream of the stent in the proximal third of the superficial femoral artery with slowed flow, which is due to the fragility of the patient's artery.The amputation is not related to the study devices used.The lesion to be treated was in the sfa and/or ppa.The radial artery was palpable and was measured to be 2.5mm.The lesion was noted to have a stenosis greater than 50%.There were no stents previously placed.The vessel did not have any tortuosity.There was no perforation at the target site.It was noted that there was not a chronic total occlusion (cto).There was no thrombus noted prior to crossing the lesion.Pta treatment was not successful at the target lesion.Approximately 9 days post procedure, the patient had rectal hemorrhage with sever polyps and bleeding.The device will not be returned for evaluation.

Manufacturer Narrative

As reported in the radiancy study, there was an amputation of the left lower limb, unrelated to the study devices.Failure of revascularization, extensive dissection upstream and downstream of the stent in the proximal third of the superficial femoral artery with slowed flow, which is due to the fragility of the patient's artery.The lesion to be treated was in the superficial femoral artery (sfa) and/or popliteal artery (ppa).The radial artery was palpable and was measured to be 2.5mm.The lesion was noted to have a stenosis greater than 50%.There were no stents previously placed.The vessel did not have any tortuosity.There was no perforation at the target site.It was noted that there was not a chronic total occlusion (cto).There was no thrombus noted prior to crossing the lesion.Pta treatment was not successful at the target lesion.Approximately 9 days post procedure, the patient had rectal hemorrhage with sever polyps and bleeding.The device was not returned for analysis and the sterile lot number is unknown therefore a product history review could not be performed.The cordis s.M.A.R.T.Radianz¿ vascular stent system is designed to deliver a self-expanding stent to the iliac arteries and/or superficial femoral arteries and/or proximal popliteal arteries using a 6f (2.0 mm) sheathed delivery system delivered through the radial artery.The stent is a flexible, fine mesh tubular prosthesis that expands upon deployment to appose the vessel wall.Upon deployment, the stent imparts an outward radial force on the luminal surface of the vessel to establish patency.The s.M.A.R.T.Radianz¿ vascular stent system is indicated for use to improve luminal diameter in the treatment of patients with de novo or restenotic native lesion(s) of the superficial femoral artery and/or proximal popliteal artery with total length up to 150 mm and a reference vessel diameter ranging from 4 mm to 7 mm, while for iliac arteries a total length up to 100 mm with a vessel diameter of 4 to 9mm.Without images available for review the reported ¿arterial dissection¿ could not be confirmed or further clarified nor a definitive cause determined.Vessel dissection is a known adverse event associated with vascular angioplasty and stent placement, is well documented and is listed as such in the instructions for use (ifu).According to the ifu which is not intended as a mitigation of risk the use of the device is contraindicated in patients with highly calcified lesions resistant to pta.The ifu also states that the device is not recommended for use in lesions that are either totally or densely calcified.The lesion was noted to be a chronic total occlusion and according to the study the event was due to the fragility of the patient's artery.There is nothing in the information provided to suggest that the event is related to the design or manufacturing of the device, as such no corrective action will be taken.

• Brand Name: UNKNOWN SMART RADIANZ
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): CORDIS US. CORP; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer (Section G): CORDIS US. CORP; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 14201 nw 60 avenue; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 16554160
• MDR Text Key: 311411136
• Report Number: 9616099-2023-06353
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNK-SMARTRADIANZ
• Device Catalogue Number: UNK-SMARTRADIANZ
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/24/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Other
• Patient Age: 86 YR
• Patient Sex: Male
• Patient Weight: 64 KG