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

Model Number G43823

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/28/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Pma/510(k) # p050017/s002 and s003.The ziv6-35-125-6-80 device of lot number c1191075 involved in this complaint was implanted in the patient, and was not available for evaluation.With the information provided, a document based investigation was conducted.From customer testimony, it is known that images of the implanted device will not be provided.The complaint device was most likely advanced over a 0.014¿ diameter, viperwire wire guide.The customer reported that there was some compression of the stent post deployment, and a balloon was used to fully expand the stent.The patient¿s anatomy was calcified, but not tortuous.There was no resistance encountered while advancing the complaint device to the target lesion.It is not known if resistance was encountered during deployment.The physician reported that the handle was pulled towards the hub, but it cannot be confirmed whether or not the complaint device was pushed during deployment.There is no evidence to suggest that this incident did not occur.Therefore, the complaint is confirmed based on customer testimony.Possible causes for this occurrence could include the calcified patient anatomy or other unknown procedural factors.These factors could have caused or contributed to the stent foreshortening after deployment.However, as images of the implanted stent are unavailable, the complaint device is not available for evaluation, and the circumstances of use cannot be replicated in a laboratory environment, a definitive root cause cannot be determined.The following is stated in the product instruction for use: ¿for vascular introduction a.018-inch (0.46mm) wire guide is recommended for the 5.0 french (1.67mm), and a.035-inch (0.89mm) wire guide for the 6.0 french (2.0mm) introducer catheter.¿ prior to distribution all zilver 635 devices are subject to visual inspection and functional checks to ensure device integrity.A review of the relevant manufacturing records revealed no discrepancies that could have contributed to this complaint.Upon review of complaints, this failure mode has not occurred previously with this lot number.Based on the information available to date, there is no evidence to suggest that there are any manufacturing issues associated with lot number c1191075.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Another stent was placed to cover the length of the lesion.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

After deployment, the stent foreshortened.An additional stent was placed as a result.24-oct-2017: the following information was received and updated in the file."the date of procedure was the (b)(6).It was a 6x80 zilver 635.Lot # c1191075.The complaint was that it foreshortened to approximately half of its length, and that because of this an additional stent had to be used.There are angiographic images of the stent post deployment.It looks like a csi 014 viperwire was used.There was calcification, but the anatomy was not tortuous.The stent system advanced smoothly to the lesion.It looks like there was some compression on the stent post deployment and a balloon was introduced to fully expand the stent.The physician stated that he did pull handle toward the hub.Whether or not the physician pushed the delivery system during deployment cannot be confirmed.".

Event Description

This follow up report is being submitted based on the receipt of additional information.Addition of user error code to evaluation conclusion codes.Initial report details: after deployment, the stent foreshortened.An additional stent was placed as a result.24-oct-2017: the following information was received and updated in the file."the date of procedure was the (b)(6).It was a 6x80 zilver 635.Lot # c1191075.The complaint was that it foreshortened to approximately half of its length, and that because of this an additional stent had to be used.There are angiographic images of the stent post deployment.It looks like a csi 014 viperwire was used.There was calcification, but the anatomy was not tortuous.The stent system advanced smoothly to the lesion.It looks like there was some compression on the stent post deployment and a balloon was introduced to fully expand the stent.The physician stated that he did pull handle toward the hub.Whether or not the physician pushed the delivery system during deployment cannot be confirmed.".

Manufacturer Narrative

(b)(4).Exemption number: e2016031.(b)(4).Pma/510(k) # p050017/s002 and s003.This follow up report is being submitted based on the receipt of additional information.The ziv6-35-125-6-80 device of lot number c1191075 involved in this complaint was implanted in the patient, and was not available for evaluation.With the information provided, a document based investigation was conducted.From customer testimony, it is known that images of the implanted device will not be provided.The complaint device was most likely advanced over a 0.014¿ diameter, viperwire wire guide.The customer reported that there was some compression of the stent post deployment, and a balloon was used to fully expand the stent.The patient¿s anatomy was calcified, but not tortuous.There was no resistance encountered while advancing the complaint device to the target lesion.It is not known if resistance was encountered during deployment.The physician reported that the handle was pulled towards the hub, but it cannot be confirmed whether or not the complaint device was pushed during deployment.There is no evidence to suggest that this incident did not occur.Therefore, the complaint is confirmed based on customer testimony.Product development reviewed the details of the complaint, and made the following comments: "we think that the stent shortened as a result of use and not that it foreshortened due to a design or manufacturing issue." ".It sounds more like the stent was half the intended length due to compression by the delivery system or some other influence." "use of 0.014¿ wire guide could lead to inadequate support for the delivery system during deployment, possibly stretching of the flexor and partial stent deployment due to bottoming out on handle travel.We are not sure if it would lead to shortening of a fully deployed stent." possible causes for this occurrence could include the calcified patient anatomy or procedural factors.It is possible that the physician placed forward pressure on the delivery system during deployment, and the calcified anatomy could have created resistance during deployment.These factors could have caused or contributed to the stent foreshortening after deployment.However, as images of the implanted stent are unavailable, the complaint device is not available for evaluation, and the circumstances of use cannot be replicated in a laboratory environment, a definitive root cause cannot be determined.The following is stated in the product instruction for use: ¿for vascular introduction a.018-inch (0.46mm) wire guide is recommended for the 5.0 french (1.67mm), and a.035-inch (0.89mm) wire guide for the 6.0 french (2.0mm) introducer catheter.¿ "the zilver vascular stent is designed not to shorten upon deployment." prior to distribution all zilver 635 devices are subject to visual inspection and functional checks to ensure device integrity.A review of the relevant manufacturing records revealed no discrepancies that could have contributed to this complaint.Upon review of complaints, this failure mode has not occurred previously with this lot number.Based on the information available to date, there is no evidence to suggest that there are any manufacturing issues associated with lot number c1191075.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Another stent was placed to cover the length of the lesion.Complaints of this nature will continue to be monitored for potential emerging trends.

• Brand Name: ZILVER 635 VASCULAR SELF-EXPANDING STENT
• Type of Device: NIO STENT, ILIAC
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 7013934
• MDR Text Key: 91785526
• Report Number: 3001845648-2017-00537
• Device Sequence Number: 1
• Product Code: NIO
• UDI-Device Identifier: 10827002438238
• UDI-Public: (01)10827002438238(17)190118(10)C1191075
• Combination Product (y/n): N
• 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: 01/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: G43823
• Device Catalogue Number: ZIV6-35-125-6-80
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/16/2017
• Event Location: Hospital
• Date Manufacturer Received: 01/17/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention