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

Catalog Number ZIV6-125-6-8.0

Device Problem Off-Label Use (1494)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/15/2021

Event Type  malfunction  

Event Description

During the procedure,the first ziv stent was released along the stiffened wire guide wire successfully.Because the length of the covered lesion was insufficient, a second ziv stent was needed.In vitro examination, the user found that there was a slight crease about 20cm before the second stent placed.But the user thought that the stent had been opened, they try to advance it, but the result was unsuccessful.Finally, one of bard's stent was replaced and successfully placed in the patient.The second ziv stent was returned (the sent was still in the delivery system and not deployed) a kink was observed on the outer sheath prior to use but the user proceeded to advance the kinked device and attempt to deploy it in the patient.This file related to (b)(4).Note:this file is related to pr 318799 that it is opened to capture off-label use of the first placed zilver stent as it was placed in the superior mesenteric artery a section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.1.Are images of the device or procedure available? no 2.At what stage of the procedure did the complaint occur? visual examination process of device preparation 3.Details of access sheath used (name, fr size, length)? ksaw-6.0-18/38-55-rb-anl2-hc 4.What was the target location for the stent? superior mesenteric artery 5.Was the product inspected for kinks or damage before use? yes,slight kink was observed at the sheath near the end 20cm 6.Was the device used percutaneously? yes 7.Was the device flushed through both flushing port before the procedure, as per ifu? yes,the user had rich experience in use stent.8.Was pre-dilation performed ahead of placement of the stent? no,no required.9.Was post-dilation performed after the placement of the stent? no, as the stent placed failed.10.Details of the wire guide used (name, diameter, hyrdophyllic)? thsf-35-260-aus1 11.Did the patient exhibit difficult or altered anatomy (if altered please specify how it is altered)? tortuous 12.Was resistance encountered when advancing the wire guide to the target location? no, the wire guide was advanced through catheter with no resistance.13.Was resistance encountered when advancing the delivery system to the target location? yes, with too big resistance to advance the delivery system.14.How did the physician deal with this resistance? removed the stent and replaced with bard¿s stent 15.Was the approach ipsilateral or contralateral? ipsilateral approach from femoral artery and reach into abdominal aorta and then to the superior mesenteric artery 16.If contralateral, was the bifurcation angle steep? n/a 17.Did the tip of the delivery system cross the target location? no 18.Was the delivery system tracked around a tight angle in the patient anatomy? no 19.Was the delivery system damaged/kinked/twisted during deployment? unsure, the stent removed once met resistance.20.Was the handle pulled towards the hub during deployment? n/a 21.Was the delivery system pushed during deployment? n/a 22.Was the stent deployed smoothly / without resistance? n/a 23.If no, please detail any difficulty experienced during deployment: __________________ 24.What artery was the stent placed in? superior mesenteric artery(sma) 25.Was the stent fully deployed from the delivery system prior to removal of the delivery system? no 26.Did the patient have any pre-existing conditions? yes 27.If yes, please specify: __ (sma dissection))__________________ 28.Did the patient require any additional procedures as a result of this event? no 29.What intervention (if any) was required?n/a 30.Was the secondary intervention performed during the same procedure as the device failure or was it scheduled for another day? n/a 31.Were any other defects (other than the complaint issue) observed on the delivery system prior to return (e.G.Kink)? no 32.The user reported a "crease 20cm before the second stent" does this mean a kink on the delivery system or does it mean something else? if it means something else could you please clarify what is meant by crease and where on the device it was observed? yes, during the flushing stage, the user found the delivery system also observed a slightly uneven, but the first ziv stent passed.

Manufacturer Narrative

Pma/510(k) #: p050017/s002 and s003.Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Manufacturer Narrative

Pma/510(k) #: p050017/s002 and s003.Annex g: g04122 - stent.Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Event Description

Supplemental report being submitted as lot number and rpn confirmed on 25-feb-2021.During the procedure,the first ziv stent was released along the stiffened wire guide wire successfully.Because the length of the covered lesion was insufficient, a second ziv stent was needed.In vitro examination, the user found that there was a slight crease about 20cm before the second stent placed.But the user thought that the stent had been opened, they try to advance it, but the result was unsuccessful.Finally, one of bard's stent was replaced and successfully placed in the patient.The second ziv stent was returned (the sent was still in the delivery system and not deployed) a kink was observed on the outer sheath prior to use but the user proceeded to advance the kinked device and attempt to deploy it in the patient.This file related to (b)(4) note:this file is related to (b)(4) that it is opened to capture off-label use of the first placed zilver stent as it was placed in the superior mesenteric artery a section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.1.Are images of the device or procedure available? no 2.At what stage of the procedure did the complaint occur? visual examination process of device preparation 3.Details of access sheath used (name, fr size, length)? ksaw-6.0-18/38-55-rb-anl2-hc 4.What was the target location for the stent? superior mesenteric artery 5.Was the product inspected for kinks or damage before use? yes,slight kink was observed at the sheath near the end 20cm 6.Was the device used percutaneously? yes 7.Was the device flushed through both flushing port before the procedure, as per ifu? yes,the user had rich experience in use stent.8.Was pre-dilation performed ahead of placement of the stent? no,no required.9.Was post-dilation performed after the placement of the stent? no, as the stent placed failed.10.Details of the wire guide used (name, diameter, hyrdophyllic)? thsf-35-260-aus1 11.Did the patient exhibit difficult or altered anatomy (if altered please specify how it is altered)? tortuous 12.Was resistance encountered when advancing the wire guide to the target location? no, the wire guide was advanced through catheter with no resistance.13.Was resistance encountered when advancing the delivery system to the target location? yes, with too big resistance to advance the delivery system.14.How did the physician deal with this resistance? removed the stent and replaced with bard¿s stent 15.Was the approach ipsilateral or contralateral? ipsilateral approach from femoral artery and reach into abdominal aorta and then to the superior mesenteric artery 16.If contralateral, was the bifurcation angle steep? n/a 17.Did the tip of the delivery system cross the target location? no 18.Was the delivery system tracked around a tight angle in the patient anatomy? no 19.Was the delivery system damaged/kinked/twisted during deployment? unsure, the stent removed once met resistance.20.Was the handle pulled towards the hub during deployment? n/a 21.Was the delivery system pushed during deployment? n/a 22.Was the stent deployed smoothly / without resistance? n/a 23.If no, please detail any difficulty experienced during deployment: 24.What artery was the stent placed in? superior mesenteric artery(sma) 25.Was the stent fully deployed from the delivery system prior to removal of the delivery system? no 26.Did the patient have any pre-existing conditions? yes 27.If yes, please specify: (sma dissection)) 28.Did the patient require any additional procedures as a result of this event? no 29.What intervention (if any) was required?n/a 30.Was the secondary intervention performed during the same procedure as the device failure or was it scheduled for another day? n/a 31.Were any other defects (other than the complaint issue) observed on the delivery system prior to return (e.G.Kink)? no 32.The user reported a "crease 20cm before the second stent" does this mean a kink on the delivery system or does it mean something else? if it means something else could you please clarify what is meant by crease and where on the device it was observed? yes, during the flushing stage, the user found the delivery system also observed a slightly uneven, but the first ziv stent passed.

Event Description

Supplemental report being submitted due to the investigation being completed on 16-apr-2021.During the procedure,the first ziv stent was released along the stiffened wire guide wire successfully.Because the length of the covered lesion was insufficient, a second ziv stent was needed.In vitro examination, the user found that there was a slight crease about 20cm before the second stent placed.But the user thought that the stent had been opened, they try to advance it, but the result was unsuccessful.Finally, one of bard's stent was replaced and successfully placed in the patient.The second ziv stent was returned (the sent was still in the delivery system and not deployed) a kink was observed on the outer sheath prior to use but the user proceeded to advance the kinked device and attempt to deploy it in the patient.This file related to (b)(4).Note:this file is related to (b)(4) that it is opened to capture off-label use of the first placed zilver stent as it was placed in the superior mesenteric artery.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.1.Are images of the device or procedure available? no.2.At what stage of the procedure did the complaint occur? visual examination process of device preparation.3.Details of access sheath used (name, fr size, length)? ksaw-6.0-18/38-55-rb-anl2-hc.4.What was the target location for the stent? superior mesenteric artery.5.Was the product inspected for kinks or damage before use? yes,slight kink was observed at the sheath near the end 20cm.6.Was the device used percutaneously? yes.7.Was the device flushed through both flushing port before the procedure, as per ifu? yes,the user had rich experience in use stent.8.Was pre-dilation performed ahead of placement of the stent? no,no required.9.Was post-dilation performed after the placement of the stent? no, as the stent placed failed.10.Details of the wire guide used (name, diameter, hyrdophyllic)? thsf-35-260-aus1.11.Did the patient exhibit difficult or altered anatomy (if altered please specify how it is altered)? tortuous.12.Was resistance encountered when advancing the wire guide to the target location? no, the wire guide was advanced through catheter with no resistance.13.Was resistance encountered when advancing the delivery system to the target location? yes, with too big resistance to advance the delivery system.14.How did the physician deal with this resistance? removed the stent and replaced with bard¿s stent.15.Was the approach ipsilateral or contralateral? ipsilateral approach from femoral artery and reach into abdominal aorta and then to the superior mesenteric artery.16.If contralateral, was the bifurcation angle steep? n/a.17.Did the tip of the delivery system cross the target location? no.18.Was the delivery system tracked around a tight angle in the patient anatomy? no.19.Was the delivery system damaged/kinked/twisted during deployment? unsure, the stent removed once met resistance.20.Was the handle pulled towards the hub during deployment? n/a.21.Was the delivery system pushed during deployment? n/a.22.Was the stent deployed smoothly / without resistance? n/a.23.If no, please detail any difficulty experienced during deployment: 24.What artery was the stent placed in? superior mesenteric artery(sma).25.Was the stent fully deployed from the delivery system prior to removal of the delivery system? no.26.Did the patient have any pre-existing conditions? yes.27.If yes, please specify: (sma dissection)).28.Did the patient require any additional procedures as a result of this event? no.29.What intervention (if any) was required? n/a.30.Was the secondary intervention performed during the same procedure as the device failure or was it scheduled for another day? n/a.31.Were any other defects (other than the complaint issue) observed on the delivery system prior to return (e.G.Kink)? no.32.The user reported a "crease 20cm before the second stent" does this mean a kink on the delivery system or does it mean something else? if it means something else could you please clarify what is meant by crease and where on the device it was observed? yes, during the flushing stage, the user found the delivery system also observed a slightly uneven, but the first ziv stent passed.

Manufacturer Narrative

Pma/510(k) #: p050017/s002 and s003.Annex g: g04122 - stent.Device evaluation: this complaint is related to the following files: (b)(4).This file investigates the reported event whereby ¿off label use of the the first placed zilver stent¿.For details of the other investigations please refer to (b)(4).The ziv6-125-6-6.0 device of lot number c1656504 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.Document review: prior to distribution ziv6-125-6-6.0 devices are subjected to a visual inspection and functional checks to ensure device integrity.These inspections and functional checks are outlined in internal procedures in place at cirl.A review of the manufacturing records for ziv6-125-6-6.0 of lot number ¿c1656504 did not reveal any discrepancies that could have contributed to this complaint issue.The review of relevant manufacturing records confirms the failure mode has not previously occurred with the current 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 c1656504.It should be noted that the instructions for use (ifu0041-7) states the following: ¿intended use.The product is intended for use in the iliac arteries for the following treatments: ateriosclerotic stenosis.Total occlusions that have been recanalizated.¿ there is evidence to suggest the user did not follow the instructions for use as the device was placed in the superior mesenteric artery.Root cause review: a definitive root cause of off-label use was identified from the available information.It is known that the device was used in the superior mesenteric artery.As per the instructions for use, the device is intended for use in the iliac arteries.It is not possible to state how the device will perform when used outside of its validated state.Summary: complaint is confirmed based on customer testimony.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.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: 11380274
• MDR Text Key: 280446895
• Report Number: 3001845648-2021-00148
• Device Sequence Number: 1
• Product Code: NIO
• 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,Followup
• Report Date: 04/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/11/2023
• Device Catalogue Number: ZIV6-125-6-8.0
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 02/10/2021
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/15/2021
• Event Location: Hospital
• Initial Date Manufacturer Received: 02/19/2021
• Initial Date FDA Received: 02/25/2021
• Supplement Dates Manufacturer Received: 02/19/2021; 02/19/2021
• Supplement Dates FDA Received: 03/26/2021; 04/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 46 YR