MAUDE Adverse Event Report: COOK IRELAND LTD ZILVER 635 VASCULAR SELF-EXPANDING STENT; NIO STENT, ILIAC

Catalog Number ZIV6-35-125-8-60

Device Problems Inadequacy of Device Shape and/or Size (1583); Improper or Incorrect Procedure or Method (2017)

Patient Problem Occlusion (1984)

Event Date 01/09/2014

Event Type  Injury  

Event Description

The district manager was supporting a superior femoral artery procedure.The physician chose to stent the patients leg using a 6 x 140 cook zilver stent then a 6 x 120 cook zilver stent and a 6 x 120 medtronic stent.In error the district manager handed a ziv6-35-125-8-60 stent to the physician for placement.After placement of the cook 8mm stent the physician continued the procedure by placing a 6 x 60 or 40 medtronics stent.At that time it was realized that the cook 8 mm stent had been placed in error in should have been a 6 mm instead.The physician then took a picture to see if the vessels were open and it was noted that further down in the vessel, somewhere between the 2nd or 3rd stent, there appeared to be some sort of occlusion, thrombosis or plaque.The physician proceeded to place a viabahn stent to cover the occlusion.Per the physician the oversized stent could have contributed to the occlusion.Pictures were taken again showing there was a patient vessel.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

This complaint is being opened against the 8mm cook zilver stent (ziv6-35-125-8-60) as the physician believes this to be the cause of the occlusion.A viabahn stent was placed during the procedure due to the occurrence of thrombosis/occlusion.The complaint information provided indicates the physician used the incorrect size stent which may have contributed to the occlusion.A device defect has not been reported.Currently this complaint is reportable as an adverse event associated with 'user error'.Pma/510 (k) # for this device is p050017 s002 and s003.The complaint information was provided as follows: the district manager was supporting a superior femoral artery procedure.The physician chose to stent the patient's leg using a 6 x 140 cook zilver stent then a 6 x 120 cook zilver stent and a 6 x 120 medtronic stent.In error the district manager handed a ziv6-35-125-8-60 stent to the physician for placement.After placement of the cook 8mm stent the physician continued the procedure by placing a 6 x 60 or 40 medtronics stent.At that time it was realized that the cook 8 mm stent had been placed in error and it should have been a 6 mm instead.The physician then took a picture to see if the vessels were open and it was noted that further down in the vessel, somewhere between the second or third stent, there appeared to be some sort of occlusion, thrombosis or plaque.The physician proceeded to place a viabahn stent to cover the occlusion.Per the physician the oversized stent could have contributed to the occlusion.Pictures were taken again showing there was a patient vessel.As per the complaint description above the occlusion/thrombosis was noted between or third stent.Information received indicating these stents were a 6 x 120 cook zilver stent and 6 x 120 (ir 140) medtronic stent.As per the complaint information received the physician is attributing the occurrence of the occlusion/thrombosis to the ziv635-125-8-60 stent.The physician involved intended to place a 6mm stent instead of the 8mm stent that was actually placed in error.The physician involved is stating the placement of the oversized stent as the cause of the occlusion/thrombosis.Additional information received from the rep involved in this complaint indicated thrombosis was not noted earlier in the procedure but that the possibility did exit for thrombosis to be present due to the administration of anti platelet drugs prior to the procedure.The rep also confirmed that no gaps existed between the second and third stent - these stents were correctly overlapped.The thrombosis/occlusion was confirmed as occurring distal in the leg and the oversized cook stent incorrectly placed by the physician was confirmed as being placed proximally.Clinical opinion was requested to determine if the placement of an over-sized stent during the procedure could have contributed to occlusion/thrombosis occurring during the procedure.The clinical opinion received indicated that placement of an oversized stent could lead to complications however it seems unlikely it could lead to thrombosis occurring distal in the leg when the 8mm cook stent was placed proximally.Clinical opinion confirmed that even if the placement of an oversized stent did contribute to the occlusion/thrombosis this was a procedural error and not a device malfunction.From the information provided, at that time of the procedure, it was realized that the 8 mm cook zilver stent had been placed in error instead of a 6mm stent.As per the physician the oversized stent could have contributed to the occlusion of another stent.Therefore, this could be considered as a user error/procedural error and not a malfunction of the device.Images in relation to this complaint were requested but were not provided.A document based investigation was carried out as the device was not available for evaluation.There was no ziv6-35-125-8-60 device of lot c833658 in stock at the time of the investigation.The stent with gold rivets ((b)(4)) of lot ch824091 is the component involved in this complaint and undergoes fqc inspection.A review of the manufacturing records for the stent with gold rivetsa ((b)(4)) of lot ch824091 did not reveal any discrepancies which could have contributed to this complaint issue.A review of the manufacturing records for ziv6-35-125-8-60 devices of lot c833658 did not reveal any discrepancies which could have contributed to this complaint issue.Prior to distribution, zilver vascular devices are subject to visual inspection and functional checks to ensure device integrity.The physician placed a viabahn stent to cover the occlusion/thrombosis.There were no adverse effects to the patient reported as a result of this occurrence.The customer complaint was confirmed based on customer testimony.Customer quality assurance will continue to monitor complaints of this nature for potential emerging trends.

• Brand Name: ZILVER 635 VASCULAR SELF-EXPANDING STENT
• Type of Device: NIO STENT, ILIAC
• Manufacturer (Section D): COOK IRELAND LTD; limerick ; EI
• Manufacturer Contact: tracy o'sullivan, unk ; 61334440
• MDR Report Key: 3647908
• MDR Text Key: 4184409
• Report Number: 3001845648-2014-00018
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P050017 S002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/05/2015
• Device Catalogue Number: ZIV6-35-125-8-60
• Device Lot Number: C833658
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/09/2014
• Event Location: Hospital
• Date Manufacturer Received: 01/09/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/05/2012
• 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): Required Intervention