MAUDE Adverse Event Report: CORDIS CASHEL SMART CONTROL, ILIAC 8X100; STENT, ILIAC

Catalog Number C08100SL

Device Problems Detachment Of Device Component (1104); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Stenosis (2263)

Event Date 05/30/2017

Event Type  Injury  

Manufacturer Narrative

A review of the manufacturing documentation associated with lot (17617766) 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

During an interventional endovascular procedure for an occlusion of a left superficial femoral artery (sfa) and the external iliac artery, two smart stents were placed (c06100sl and c08100sl).The smart stent (c06100sl) was placed into the left sfa, it was confirmed that there was no distal embolus to the distal side and the procedure was completed without any problems.The tip of the non-cordis sheath used with contralateral approach was withdrawn to the right external iliac artery, and started treatment of the left external iliac artery.After pre dilatation of the lesion, the complaint smart stent (c08100sl) was advanced to the lesion so that it could overlap with a non-cordis stent which has previously been implanted in the right common iliac artery.The distal tip of the smart stent hit the previous stent and it was difficult positioning the smart stent.Finally the smart stent was placed overlapping the previous stent, and the smart stent was deployed.Then angiography was done only in the iliac artery with the smart stent and the right peripheral vessel(s) were not checked by the angiography.The procedure was completed.Approximately six months after the index procedure, the stenosis in the right superficial femoral artery became worse.The lesion was treated by making a contralateral approach from the left femoral artery.During this procedure, the distal tip of the smart stent which has been implanted during index procedure was confirmed to be floating in the right popliteal artery.Therefore, it was removed by a snare catheter.The treatment was successful.The doctor mentioned that the distal tip of the smart stent was caught by the previous stent when there was difficulty in delivery.There is no reported patient injury and no thrombosis was adhered on the removed distal tip.

Manufacturer Narrative

After further review of additional information received the sections have been updated accordingly.Additional information received indicates that the product that was fractured inside patient was the distal tip of the delivery system catheter.The separated tip was left inside the patient during the index procedure and another procedure was performed because the lesion became worse (not related to the separated tip).Then the residual tip was confirmed and it was removed by a catheter for removing foreign substances.A smart stent (c06100sl) was implanted in the right superficial femoral artery and another smart stent (c08100sl) was implanted in the right external iliac artery.The smart stent (c06100sl) was delivered through a non-cordis catheter and no issue confirmed in delivery.However, when the smart stent (c08100sl) was inserted, the non-cordis catheter was retracted and there was resistance with a previous non-cordis stent.Hence it seems that the distal tip of the smart stent (c08100sl) was separated.It seems the tip is from the smart stent (c08100sl) in the right external iliac artery.During an interventional endovascular procedure for a right superficial femoral occlusion and for the right external iliac artery, two smart stents (c06100sl and c08100sl) was placed.A contralateral approach was made from the left femoral artery.The smart stent (c06100sl) was placed in the right superficial femoral artery.It was confirmed that there was no distal embolus to the distal side and the procedure was completed without any problems.The tip of the non-cordis sheath used with contralateral approach was withdrawn to the right common iliac artery, and started treatment of narrowing of right external iliac artery.After pre-dilatation, the smart stent (c08100sl) was advanced to the lesion so that it could overlap with the distal part of a non-cordis stent (which had previously been implanted in the right common iliac artery).However, the distal tip of the smart stent hit the previous stent and it was difficult positioning the smart stent.The smart stent was placed overlapping the previous stent, and the smart stent was deployed.Then angiography was done only in the iliac artery with the smart stent and the right peripheral vessel(s) were not checked by the angiography.The procedure was then completed.Approximately on or about six months after index procedure, the stenosis in the right superficial femoral artery became worse.Therefore, a treatment was made by making a contralateral approach from the left femoral artery.During this procedure, the distal tip of the smart stent which has been implanted during the index procedure was confirmed to be floating in the right popliteal artery.Therefore, it was removed by a snare catheter.The treatment was successfully made.Per additional information received, the performing doctor mentioned that during the index procedure, the distal tip of the smart stent (c08100sl) was caught by the previous stent when there was difficulty in delivery.Hence it seems that the distal tip of the c08100sl was separated during the procedure.There is no reported patient injury and no thrombosis was adhered on the removed distal tip.One non-sterile separated tip of a smart control catheter unit was received for analysis inside a plastic bag.Per microscopic analysis, the tip was inspected under vision system and it was observed that the separated sections of the tip presented elongations and frayed edges.These characteristics are clear evidence of an application of a tension force that induced the separation.No other issues were noted during analysis.Review of lot 17617766 revealed no anomalies during the manufacturing and inspection processes that can be associated with the reported complaint.Without medical records and procedural films available for review, the reported event of ¿superficial femoral arterial stenosis¿ could not be confirmed.Stenosis is a narrowing of the vessel.Stenosis of a vessel does not represent a device malfunction.Clinical factors that may have influenced the event include patient, pharmacological and lesion characteristics.The event reported by the customer as¿ catheter tip- separated - in patient¿ was confirmed due to the elongated and frayed edges separated condition of the tip as received.However, the exact cause of the separated condition of the tip from the unit could not be conclusively determined during the product analysis.Handling and/or procedural factors may have contributed to the event reported.It is also possible that the operator's interaction with the sds may have contributed to the reported event if the deployment steps as listed in the ifu were not followed correctly.According to the instructions for use ¿recrossing a partially or fully deployed stent with adjunct devices must be performed with caution.Evaluate the distal end of the catheter to ensure that the stent is contained within the outer sheath.Do not use if the stent is partially deployed.If a gap between the catheter tip and outer sheath tip exists, open the tuohy borst valve and gently pull the inner shaft in a proximal direction until the gap is closed.Lock the tuohy borst valve after the adjustment by rotating the proximal valve end in a clockwise direction.Advance the device over the guidewire to the lesion site.Note: if resistance is met during delivery system introduction, the system should be withdrawn and another system should be used.Initiate stent deployment by retracting the outer sheath while holding the inner shaft in a fixed position.While using fluoroscopy, maintain position of the radiopaque stent markers relative to the targeted lesion site.Watch for the distal radiopaque markers to begin separating.Separation of the distal stent markers signals that the stent is unsheathed.Continue deploying the stent until the distal end of the stent obtains full apposition with the vessel wall.Continue deploying the stent until the proximal end of the stent obtains full apposition with the vessel wall.While using fluoroscopy, advance the outer sheath until the outer sheath marker contacts the catheter tip and withdraw the entire delivery system as one unit, over the guidewire and out of the sheath introducer.Remove the delivery device from the guidewire.¿ neither the dhr nor the information available suggests a design or manufacturing related cause for the reported event; therefore, no corrective/preventive action will be taken at this time.Corrected data: (b)(4).This is one of two products involved with the reported event and the associated manufacturer report numbers are 9616099-2017-01709.

• Brand Name: SMART CONTROL, ILIAC 8X100
• Type of Device: STENT, ILIAC
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co. tipperary; EI
• Manufacturer (Section G): CORDIS CASHEL; cahir road; cashel, co. tipperary; EI
• Manufacturer Contact: karla castro ; 14201 nw 60th ave; miami lakes, FL 33014
• MDR Report Key: 7139961
• MDR Text Key: 95587141
• Report Number: 9616099-2017-01708
• Device Sequence Number: 1
• Product Code: NIO
• UDI-Device Identifier: 20705032024256
• UDI-Public: 20705032024256
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P020036
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2018
• Device Catalogue Number: C08100SL
• Device Lot Number: 17617766
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/21/2017
• Initial Date FDA Received: 12/21/2017
• Supplement Dates Manufacturer Received: 01/31/2018
• Supplement Dates FDA Received: 02/08/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/12/2016
• 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): Hospitalization; Life Threatening; Required Intervention; Disability