MAUDE Adverse Event Report: CORDIS CORPORATION SMART RADIANZ; STENT, ILIAC

Catalog Number UNKSMARTRADIANZ

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

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Type  Injury  

Manufacturer Narrative

This is one of two products involved with the reported event and the associated manufacturer report numbers is: 9616099-2024-00084.The event date is currently unknown.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, after implantation of two unknown smart radianz self-expanding stents (ses) within the iliac veins, the patient suffered malaise, fatigue, flushing, and palpitations due to what was confirmed as a nickel allergy.The devices will be returned for evaluation.

Event Description

As reported, after implantation of two unknown smart radianz self-expanding stents (ses) within the iliac veins, the patient suffered malaise, fatigue, flushing, and palpitations due to what was confirmed as a nickel allergy.Additional information was requested but was not provided.The devices were not returned as expected.

Manufacturer Narrative

This is one of two products involved with the reported event and the associated manufacturer report number is: 9616099 2024 00084 complaint conclusion: as reported, after implantation of two unknown smart radianz self-expanding stents (ses) within the iliac veins, the patient suffered malaise, fatigue, flushing, and palpitations due to what was confirmed as a nickel allergy.Additional information was requested but was not provided.The devices were not returned as expected.The reported ¿hypersensitivity¿ cannot be confirmed due to the nature of the reported event as this is an adverse event.Despite requests for additional information, none was provided.The safety information in the instructions for use for smart radianz warns that individuals with nickel titanium (nitinol) allergies may experience adverse reactions to the implant.Specifically, the device is contraindicated for patients with known hypersensitivity to nickel titanium (nitinol).This case underscores the importance of thorough patient evaluation for allergies and highlights the necessity for adherence to safety warnings during medical device selection.According to the warnings in the safety information in the instructions for use for smart radianz, ¿persons with allergic reactions to nickel titanium (nitinol) may suffer an allergic response to this implant.Contraindications: patients with a known hypersensitivity to nickel titanium (nitinol).This device contains the following substance defined as cmr 1a and/or cmr 1b and/or endocrine disrupting substances in a concentration above 0.1% weight by weight: cobalt; cas no.(b)(4) ; ec no.231-158-0.¿ the information available does not suggest a design or manufacturing related cause for the reported event.Therefore, no corrective or preventive action will be taken at this time.

• Brand Name: SMART RADIANZ
• Type of Device: STENT, ILIAC
• Manufacturer (Section D): CORDIS CORPORATION; 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 ; santiago troncoso 808; juarez, chihuahua ; 7863138372
• MDR Report Key: 18978735
• MDR Text Key: 338599647
• Report Number: 9616099-2024-00085
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Catalogue Number: UNKSMARTRADIANZ
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/01/2024
• Was Device Evaluated by Manufacturer?: No
• 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): Other
• Patient Sex: Female