MAUDE Adverse Event Report: CORDIS CORPORATION SMART CONTROL, ILIAC 9X40; STENT, ILIAC

Catalog Number C09040SL

Device Problem Failure To Adhere Or Bond (1031)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/19/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).A review of the manufacturing documentation associated with this lot 17709064 presented no issues during the manufacturing process that can be related to the reported event.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported a smart control, iliac 9 x 40 stent was deployed in a fistula and upon deployment, it appears to have folded over on top of itself.Physician was required to place an additional stent across it to successfully complete the case.Catheter was not saved for analysis.There was no patient injury reported.The temperature exposure indicator on the pouch was checked to confirm that the black dotted pattern with a grey background is clearly visible.The product was stored and handled according to the ifu.The product was inspected and prepped according to the instructions for use.Nothing unusual was noted about the stent delivery system prior to use.The smart control locking pin was in place during advancement towards the lesion.The locking pin was removed before attempting to deploy the smart control stent.The sds was advanced past the lesion and then withdrawn back into the lesion prior to stent deployment.The ifu instructs the user to hold the handle of the smart control sds flat and straight outside the patient and this was done.There was no unusual force applied during deployment of the stent.None of the stent had been pre-maturely deployed.The tantalum markers were observed to open symmetrically.The intended procedure/target lesion was the fistula.The intended lesion was not located at the carotid bifurcation.The target lesion vessel diameter was 10mm.The diameter of the unconstrained stent size 1-2 mm was larger than the vessel diameter.The target lesion vessel length was 30mm.The lesion was not calcified.The vessel was not tortuous.The stent delivery system did not pass through any acute bends.The delivery of the sds to the lesion was ipsilateral.There was no difficulty encountered while advancing/tracking the sds towards the lesion.There was no thrombus present proximal to, at, or distal to the lesion site.The lesion was pre-dilated prior to stent implantation.No difficulty or resistance was noted while crossing the lesion with the stent.The sds did not have to pass through a previously placed stent.The user thinks that the event was related to the stent.The user does not think that the event was related to the procedure.

Manufacturer Narrative

As reported, a smart control iliac 9mm x 40mm stent was deployed in a fistula and upon deployment, it appears to have folded over on top of itself.The physician was required to place an additional stent across it to successfully complete the case.The catheter was not saved for analysis.There was no patient injury reported.The temperature exposure indicator on the pouch was checked to confirm that the black dotted pattern with a grey background is clearly visible.The product was stored and handled according to the instructions for use (ifu).The product was inspected and prepped according to the ifu.Nothing unusual was noted about the stent delivery system prior to use.The smart control locking pin was in place during advancement towards the lesion.The locking pin was removed before attempting to deploy the smart control stent.The stent delivery system (sds) was advanced past the lesion and then withdrawn back into the lesion prior to stent deployment.The ifu instructs the user to hold the handle of the smart control sds flat and straight outside the patient and this was done.There was no unusual force applied during deployment of the stent.None of the stent had been pre-maturely deployed.The tantalum markers were observed to open symmetrically.The intended procedure/target lesion was the fistula.The intended lesion was not located at the carotid bifurcation.The target lesion vessel diameter was 10mm.The diameter of the unconstrained stent size 1-2 mm was larger than the vessel diameter.The target lesion vessel length was 30mm.The lesion was not calcified.The vessel was not tortuous.The stent delivery system did not pass through any acute bends.The delivery of the sds to the lesion was ipsilateral.There was no difficulty encountered while advancing/tracking the sds towards the lesion.There was no thrombus present proximal to, at, or distal to the lesion site.The lesion was pre-dilated prior to stent implantation.No difficulty or resistance was noted while crossing the lesion with the stent.The sds did not have to pass through a previously placed stent.The user thinks that the event was related to the stent.The user does not think that the event was related to the procedure.The product was not returned for analysis.A device history record (dhr) review of lot 17709064 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.One angiographic picture was received.A guidewire is noted with two overlapping stents.Tantalum markers for both stents are noted.There is not contrast noted in the picture.The reported ¿stent-incomplete expansion¿ could not be confirmed as the product was clinically used and not returned.Limited information could be obtained from the angiographic picture received.The exact cause could not be determined.Procedural or lesion characteristics may have contributed to the event.According to the instructions for use ¿safety and effectiveness has not been demonstrated in: lesions that are either totally or densely calcified.If resistance is encountered at any time during the insertion procedure, do not force passage.Resistance may cause damage to stent or system.If resistance occurs during movement through the sheath, carefully withdraw the stent system.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.Once stent deployment has begun, the stent must be fully deployed.The system is not designed for stent repositioning or recapturing.If resistance is felt when initially retracting the outer deployment sheath, do not force deployment.Carefully withdraw the stent system without deploying the stent.Set the backer board with carrier tube on a flat surface.Remove the stent/delivery system from the carrier tube.Examine the device for damage.If it is suspected that the sterility has been compromised or the device is damaged do not use the device.Perform an arterial angiogram to verify full deployment.If incomplete expansion exists within the stent at any point along the lesion, post deployment balloon dilatation can be performed at the discretion of the physician.Neither the dhr nor the information available suggests a design or manufacturing related cause for the reported burst; therefore, no corrective/preventive action will be taken.

• Brand Name: SMART CONTROL, ILIAC 9X40
• Type of Device: STENT, ILIAC
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL 33014
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 14201 nw 60th ave; miami lakes, FL 33014
• MDR Report Key: 7182660
• MDR Text Key: 96993689
• Report Number: 9616099-2018-01772
• Device Sequence Number: 1
• Product Code: NIO
• UDI-Device Identifier: 20705032024416
• UDI-Public: 20705032024416
• 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: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 02/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2019
• Device Catalogue Number: C09040SL
• Device Lot Number: 17709064
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/11/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/22/2017
• 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; Required Intervention