MAUDE Adverse Event Report: CORDIS CORPORATION SES SMART CONTROL 8X40 120; STENT, ILIAC

Model Number C08040MV

Device Problem Defective Component (2292)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/13/2020

Event Type  Injury  

Manufacturer Narrative

A review of the manufacturing documentation associated with this lot presented no issues during the manufacturing process that can be related to the reported complaint.It is unknown if the device will be returned for testing and evaluation.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, after the 8mm x 40mm x 120cm smart control self-expanding stent (ses) system was placed, it was found that the stent had shortened.There was no reported patient injury.The product was stored properly per the instructions for use (ifu).There was no reported difficulty removing the product from the packaging.There was no damage noted on the device before or after the procedure.There were no anomalies nor difficulties noted while using the smart stent.The target lesion for the procedure was the femoral artery.A femoral approach was used for the procedure.There was no unusual force used at any time during the procedure.A 6f cordis sheath introducer was used.A guiding catheter was used.The diameter of the unconstrained stent size was 1-2 mm larger than the vessel diameter.The stent was not thought to be too short due to compression (after deployment in the patient).An additional stent was implanted in the patient due to the reported product issue.The procedure was completed successfully without patient injury.The device will be returned for analysis.

Manufacturer Narrative

Complaint conclusion: after the smart control 8mm x 40mm x 120cm self-expanding stent (ses) system was placed, it was found that the stent had shortened.The product was stored properly per the instructions for use (ifu).There was no reported difficulty removing the product from the packaging.There was no damage noted on the device before or after the procedure.There were no anomalies nor difficulties noted while using the smart stent.The target lesion for the procedure was the femoral artery.A femoral approach was used for the procedure.There was no unusual force used at any time during the procedure.A 6f cordis sheath introducer was used.A guiding catheter was used.The diameter of the unconstrained stent size was 1-2 mm larger than the vessel diameter.The stent was not thought to be too short due to compression (after deployment in the patient).An additional stent was implanted in the patient due to the reported product issue.The procedure was completed successfully without patient injury.There was no reported patient injury.The device was not returned for analysis.A product history record (phr) review of lot 17901050 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 (although unknown) 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: SES SMART CONTROL 8X40 120
• Type of Device: STENT, ILIAC
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• MDR Report Key: 10809854
• MDR Text Key: 215309689
• Report Number: 9616099-2020-04040
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• PMA/PMN Number: P020036
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 11/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2021
• Device Model Number: C08040MV
• Device Catalogue Number: C08040MV
• Device Lot Number: 17901050
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention