MAUDE Adverse Event Report: CORDIS US. CORP SMART RADIANZ; STENT, ILIAC

Catalog Number SR08060XL

Device Problem Defective Component (2292)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/10/2023

Event Type  malfunction  

Manufacturer Narrative

Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, the 8x60 smart radianz stent foreshortened while deploying into the common/external iliac.The stent was inserted distal to the vessel then pulled into place.With all the shaft strait the roller was engaged flowering the stent in perfect position distally and as the stent was deployed it began to foreshorten.Before stent deployment the proximal portion of the stent was approximately 10mm above the internal iliac artery and after deployment it was below the artery.The length of the lesion was 40mm.The diameter of the vessel was 7mm.The blockage covered about 60% of the vessel.The stent had good wall apposition.A second stent was not needed.There was no reported injury to the patient.The device was stored and prepped correctly.The device will not be returned for evaluation.

Event Description

As reported, the 8x60 smart radianz stent foreshortened while deploying into the common/external iliac.The stent was inserted distal to the vessel then pulled into place.With all the shaft strait the roller was engaged flowering the stent in perfect position distally and as the stent was deployed it began to foreshorten.Before stent deployment the proximal portion of the stent was approximately 10mm above the internal iliac artery and after deployment it was below the artery.The length of the lesion was 40mm.The diameter of the vessel was 7mm.The blockage covered about 60% of the vessel.The stent had good wall apposition.A second stent was not needed.There was no reported injury to the patient.The device was stored and prepped correctly.The device will not be returned for evaluation.

Manufacturer Narrative

After further review of additional information received the following sections have been updated accordingly: b5, d4, g3, h1, h2, h3 and h6 the 8x60 smart radianz stent foreshortened while deploying into the common/external iliac.The stent was inserted distal to the vessel then pulled into place.With all the shaft strait the roller was engaged flowering the stent in perfect position distally and as the stent was deployed it began to foreshorten.Before stent deployment the proximal portion of the stent was approximately 10mm above the internal iliac artery and after deployment it was below the artery.The length of the lesion was 40mm.The diameter of the vessel was 7mm.The blockage covered about 60% of the vessel.The stent had good wall apposition.A second stent was not needed.The device was stored and prepped correctly.There was no reported injury to the patient.The device was not returned for analysis.A product history record (phr) review of lot 18147047 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.Without the return of the device for analysis and based on the information provided, the reported ¿stent-ses~ incorrect length - too short¿ could not be confirmed and the exact root cause could not be determined.Handling and procedural factors such as vessel characteristics and or the user¿s interaction with the device may have led to the reported event.The instructions for use (ifu) advises that during placement, it is imperative that the treating physician holds the deployment handle in a fixed position during the entire deployment.If the handle is moved forward or backward after the stent has achieved initial wall apposition, then segments of compression or expansion can be created.This can result in stent lengths which are longer or shorter than expected.Neither the phr review nor the information available suggests a design or manufacturing related cause could be related to the manufacturing process of the unit.Therefore, no corrective or preventive actions will be taken.

• Brand Name: SMART RADIANZ
• Type of Device: STENT, ILIAC
• Manufacturer (Section D): CORDIS US. CORP; 14201 nw 60 avenue; miami lakes, florida 33014
• Manufacturer (Section G): CORDIS US CORP.; 14201 nw 60 avenue; miami lakes, florida 33014
• Manufacturer Contact: karla castro ; santiago troncoso 808; juarez, chihuahua ; 7863138372
• MDR Report Key: 16876879
• MDR Text Key: 314643164
• Report Number: 9616099-2023-06484
• Device Sequence Number: 1
• Product Code: NIO
• UDI-Device Identifier: 20705032062485
• UDI-Public: (01)20705032062485(17)230831(10)18147047
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: SR08060XL
• Device Lot Number: 18147047
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/02/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/20/2022
• 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
• Treatment: UNK.
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic