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

Catalog Number ZVT7-35-80-14-6.0

Device Problems Premature Activation (1484); Device Damaged Prior to Use (2284)

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

Event Date 12/03/2020

Event Type  malfunction  

Manufacturer Narrative

Pma/510(k) #: p200023.Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Event Description

The proximal strut of14mm x6cm zilver vena was dropped out before deployment (red safety lock is still on the deployment handle.No additional information on this complaint event received to date.

Manufacturer Narrative

Pma/510(k) #: p200023.Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Event Description

Supplemental follow-up report is being submitted due to the receipt of additional information received on 04-jan-21, 08-jan-21 and 19-jan-21 reviewed.Additional information received 04-jan-21: 1.Are images of the device or procedure available? yes, attached the image of the defected product.2.Did the patient have pre-existing conditions? no.3.If yes, please specify : 4.Please describe the native state of the vessel (i.E.Was the anatomy tortuous? was the vessel fibrotic?) n/a.5.If other, please specify: 6.Was a stent previously placed during previous procedures? no.7.Was the device used percutaneously? yes.8.Where on the patient was the percutaneous access site? n/a.9.Was the access site jugular or femoral? n/a.If other, please specify: 10.What disease pathology was being treated? chronic obstruction.If other, please specify: 11.Was the lesion approached via contralateral or ipsilateral? n/a.12.Was pre-dilation performed ahead of placement of the stent? n/a.13.What was the target location for the stent? n/a.14.Details of access sheath used (name, fr size, length)? 7fr brite tip - cordis.15.Was the device flushed through both flushing ports before the procedure, as per ifu? yes.16.Details of the wire guide used (name, diameter, hyrdophyllic)? g02246.17.Was resistance encountered when advancing the wire guide to the target location? n/a.18.Was resistance encountered when advancing the delivery system to the target location? n/a.19.If resistance was met, how did the physician address this? 20.Did the tip of the delivery system cross the target location? n/a.21.Did the user pull the handle towards the hub during deployment, per ifu? n/a.22.Did the user push the hub during deployment? n/a.23.Did the user remove slack in the delivery system before deployment, per ifu? n/a.24.Was the stent deployed smoothly / without resistance? n/a.25.Was the stent fully deployed in the patient? n/a.26.Was the stent fully deployed before removing the delivery system from the patient? n/a.27.Was post dilation performed after the placement of the stent? n/a.28.Was the delivery system damaged/kinked/twisted during deployment? n/a.29.Did the patient require any additional procedures as a result of this event? no.30.What intervention (if any) was required? 31.Was the secondary intervention performed during the same procedure as the device failure or was it scheduled for another day? n/a.32.Were any other defects (other than the complaint issue) observed on the delivery system prior to return (e.G.Kink)? n/a.33.Please specify if yes.34.Could we please confirm the complaint issue.Does this mean the stent partially prematurely deployed from the distal end of the sheath? see attachment.Additional information received 04-jan-21: 1.Where on the patient was the access site (i.E.From where was the device advanced)? none report.2.Where was the stent intended to be placed (i.E.Where was the target location for the device)? none report.3.What size wire guide was use with the device? 0.035¿¿.4.Did the stent partially prematurely deploy as the device was advanced through the patient's anatomy or at a different point during the procedure? the proximal strut of14mm x6cm zilver vena was dropped out before deployment.This is the condition of the device while opened from the sterilized packaging and the defects was discovered on table.The device have no contact with the patient yet.5.If it deployed prematurely at another point please state at what point this occurred.N/a.Additional information received 19-jan-21: previously it was confirmed that the stent strut had deployed prior to patient contact and that this was how the device was presented on the table.Could i please confirm the following: 1.Was the stent observed to be protruding from the device after it had been removed from the packaging? yes.2.Had the device been flushed prior to this observation? none report.3.Was the stent strut protruding from the distal end of the device (i.E.From the distal white tip)? yes stent strut was protruded from the distal white tip.Initial report details: the proximal strut of14mm x6cm zilver vena was dropped out before deployment (red safety lock is still on the deployment handle.No additional information on this complaint event received to date.

Manufacturer Narrative

Pma/510(k) #: p200023.Component code (annex g): g04122 ¿ stent.The zvt7-35-80-14-6.0 device of lot number c1620238 involved in this complaint was not available for evaluation.With the information provided, a document-based investigation was conducted.Prior to distribution zvt7-35-80-14-6.0 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 zvt7-35-80-14-6.0 of lot number c1620238 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 c1620238.It should be noted that the instructions for use states the following: ¿carefully inspect the sterile package and stent system prior to use to verify that neither has been damaged during shipment.¿ ¿upon removal from the package, inspect the product to ensure no damage has occurred.¿ there is no evidence to suggest the user did not follow the ifu.A definitive root cause could not be determined from the available information.A possible root cause could be attributed to damage during transport or storage and/or excessive pressure on the outer sheath as the device was removed from the tray.The complaint is confirmed based on customer testimony.According to the initial reporter, the device did not make patient contact.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

Supplemental follow-up report is being submitted as a cancellation report.The investigation into this complaint has now been completed and it has been determined that this event no longer meets the criteria of an fda ¿serious injury¿ report or ¿malfunction¿ report as per fda guidelines ¿medical device reporting for manufacturers (2016)¿.The device made no contact with the patient and no adverse effects to the patient was reported as occurring.No reporting malfunction precedence exists for this complaint event for this product family.Low risk of failure mode indicates no potential for serious injury if the malfunction were to recur.Initial report details.The proximal strut of 14mm x6cm zilver vena was dropped out before deployment (red safety lock is still on the deployment handle.No additional information on this complaint event received to date.Additional information received 04-jan-21: 1.Are images of the device or procedure available? yes, attached the image of the defected product.2.Did the patient have pre-existing conditions? no.3.If yes, please specify : 4.Please describe the native state of the vessel (i.E.Was the anatomy tortuous? was the vessel fibrotic?) n/a.5.If other, please specify: 6.Was a stent previously placed during previous procedures? no.7.Was the device used percutaneously? yes.8.Where on the patient was the percutaneous access site? n/a.9.Was the access site jugular or femoral? n/a.If other, please specify: 10.What disease pathology was being treated? chronic obstruction if other, please specify.11.Was the lesion approached via contralateral or ipsilateral? n/a.12.Was pre-dilation performed ahead of placement of the stent? n/a.13.What was the target location for the stent? n/a.14.Details of access sheath used (name, fr size, length)? 7fr brite tip - cordis.15.Was the device flushed through both flushing ports before the procedure, as per ifu? yes.16.Details of the wire guide used (name, diameter, hyrdophyllic)? g02246.17.Was resistance encountered when advancing the wire guide to the target location? n/a.18.Was resistance encountered when advancing the delivery system to the target location? n/a.19.If resistance was met, how did the physician address this? 20.Did the tip of the delivery system cross the target location? n/a.21.Did the user pull the handle towards the hub during deployment, per ifu? n/a.22.Did the user push the hub during deployment? n/a.23.Did the user remove slack in the delivery system before deployment, per ifu? n/a.24.Was the stent deployed smoothly / without resistance? n/a.25.Was the stent fully deployed in the patient? n/a.26.Was the stent fully deployed before removing the delivery system from the patient? n/a.27.Was post dilation performed after the placement of the stent? n/a.28.Was the delivery system damaged/kinked/twisted during deployment? n/a.29.Did the patient require any additional procedures as a result of this event? no.30.What intervention (if any) was required? 31.Was the secondary intervention performed during the same procedure as the device failure or was it scheduled for another day? n/a.32.Were any other defects (other than the complaint issue) observed on the delivery system prior to return (e.G.Kink)? n/a.33.Please specify if yes.34.Could we please confirm the complaint issue.Does this mean the stent partially prematurely deployed from the distal end of the sheath? see attachment.Additional information received 04-jan-21: 1.Where on the patient was the access site (i.E.From where was the device advanced)? none report.2.Where was the stent intended to be placed (i.E.Where was the target location for the device)? none report.3.What size wire guide was use with the device? 0.035¿¿.4.Did the stent partially prematurely deploy as the device was advanced through the patient's anatomy or at a different point during the procedure? the proximal strut of14mm x6cm zilver vena was dropped out before deployment.This is the condition of the device while opened from the sterilized packaging and the defects was discovered on table.The device have no contact with the patient yet.5.If it deployed prematurely at another point please state at what point this occurred.N/a.Additional information received 19-jan-21: previously it was confirmed that the stent strut had deployed prior to patient contact and that this was how the device was presented on the table.Could i please confirm the following: 1.Was the stent observed to be protruding from the device after it had been removed from the packaging? yes.2.Had the device been flushed prior to this observation? none report.3.Was the stent strut protruding from the distal end of the device (i.E.From the distal white tip)? yes stent strut was protruded from the distal white tip.

• Brand Name: ZILVER VENA VENOUS SELF-EXPANDING STENT
• Type of Device: NIO STENT, ILIAC
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 11055794
• MDR Text Key: 244418290
• Report Number: 3001845648-2020-00983
• Device Sequence Number: 1
• Product Code: NIO
• UDI-Device Identifier: 10827002520223
• UDI-Public: (01)10827002520223(17)220606(10)C1620238
• 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: 04/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/06/2022
• Device Catalogue Number: ZVT7-35-80-14-6.0
• Device Lot Number: C1620238
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/03/2020
• Event Location: Hospital
• Date Manufacturer Received: 12/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1