MAUDE Adverse Event Report: CORDIS CORPORATION SMART CONTROL, ILIAC 7X100ML; STENT, ILIAC

Model Number C07100ML

Device Problem Difficult or Delayed Positioning (1157)

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

Event Date 02/17/2023

Event Type  malfunction  

Manufacturer Narrative

The product history record review is anticipated; however, it has not yet been finalized.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, a smart control iliac 7x100 self-expanding stent did not deploy properly.The physician pulled the pin and partially deployed the stent using the thumb wheel.After the stent started to oppose the vessel wall the physician converted to the slide but the stent did not deploy smoothly but folded in on itself and then continued to deploy.There was no reported patient injury.The intended procedure was reported to be a right leg angiogram; recanalization of right superficial femoral artery (sfa).The target lesion was the right sfa.Lesion characteristics included moderate lesion calcification with no vessel tortuosity and eighty percent stenosis.The device was not used for a chronic total occlusion.The temperature exposure indicator on the pouch was checked to confirm that the black dotted pattern with a grey background was clearly visible.The product was stored and handled according to the instructions for use (ifu).There was no damage noticed prior to opening the package.There was no difficulty removing the device from the sterile packaging.The device prepped per the ifu without difficulty.The stent was still constrained within the outer member/sheath when removed from the tray.A stopcock was not connected to the y-connector of the tuohy borst valve.There was no difficulty encountered flushing the sds.No unusual force was used at any time during the procedure.The stent delivery system did not pass through any acute bends.The diameter of the unconstrained stent was sized 1-2 mm larger than the vessel diameter.There was no difficulty or resistance noted while crossing the lesion with the stent nor difficulty encountered while advancing/tracking the sds towards the lesion.The catheter was never in an acute bend.The sds was removed and the stent was post dilated.The stent was implanted and the sds was removed from the patient.The device was discarded; therefore, it will not be returned for evaluation.

Manufacturer Narrative

As reported, a smart control iliac 7x100 self-expanding stent did not deploy properly.The physician pulled the pin and partially deployed the stent using the thumb wheel.After the stent started to oppose the vessel wall the physician converted to the slide but the stent did not deploy smoothly but folded in on itself and then continued to deploy.The intended procedure was reported to be a right leg angiogram; recanalization of right superficial femoral artery (sfa).The target lesion was the right sfa.Lesion characteristics included moderate lesion calcification with no vessel tortuosity and eighty percent stenosis.The device was not used for a chronic total occlusion.The temperature exposure indicator on the pouch was checked to confirm that the black dotted pattern with a grey background was clearly visible.The product was stored and handled according to the instructions for use (ifu).There was no damage noticed prior to opening the package.There was no difficulty removing the device from the sterile packaging.The device prepped per the ifu without difficulty.The stent was still constrained within the outer member/sheath when removed from the tray.A stopcock was not connected to the y-connector of the tuohy borst valve.There was no difficulty encountered flushing the sds.No unusual force was used at any time during the procedure.The stent delivery system did not pass through any acute bends.The diameter of the unconstrained stent was sized 1-2 mm larger than the vessel diameter.There was no difficulty or resistance noted while crossing the lesion with the stent nor difficulty encountered while advancing/tracking the sds towards the lesion.The catheter was never in an acute bend.The sds was removed, and the stent was post dilated.The stent was implanted and the sds was removed from the patient.There was no reported patient injury.The product was not returned for analysis.A product history record (phr) review of lot 18029794 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿stent delivery system (sds)-ses~ deployment difficulty¿ and ¿stent-ses~ incomplete expansion¿ were not confirmed.The device was not returned for analysis, and neither were procedural film/images.Vessel characteristics of moderate calcification and procedural factors such as the user¿s interaction with the device during use likely contributed to the reported events.However, without the return of the device for analysis, it is difficult to draw a clinical conclusion between the device and the events reported.According to the instructions for use (ifu) ¿advance the device over the guidewire and through the introducer to the target site.If resistance is met during delivery system introduction, the system should be withdrawn and another system used.If resistance is felt during retraction of the outer sheath do not force deployment.Carefully withdraw the stent system without deploying the stent.¿ additionally, slack removal: advance the stent delivery system past the lesion site, pull back the stent delivery system until the radiopaque stent markers (leading and trailing ends) move in position so that they are proximal and distal to the lesion site.Ensure that the stent delivery system outside the patient remains flat and straight.Caution: slack in the catheter shaft either outside or inside the patient may result in deploying the stent beyond the lesion site.Note: failure to maintain a fixed handle position or constraining the catheter shaft during deployment may result in stent compression (shortening) or elongation.Stent deployment is complete when the proximal markers appose to the vessel wall and the outer sheath radiopaque marker is proximal to the inner shaft stent stop.¿ 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 CONTROL, ILIAC 7X100ML
• Type of Device: STENT, ILIAC
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL 33014 2802
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL 33014 2802
• Manufacturer Contact: karla castro ; 14201 nw 60th avenue; miami lakes, FL 33014-2802 ; 7863138372
• MDR Report Key: 16519268
• MDR Text Key: 311560266
• Report Number: 9616099-2023-06312
• Device Sequence Number: 1
• Product Code: NIO
• UDI-Device Identifier: 20705032023921
• UDI-Public: 20705032023921
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P020036
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2023
• Device Model Number: C07100ML
• Device Catalogue Number: C07100ML
• Device Lot Number: 18029794
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/14/2021
• 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 Sex: Male