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); Activation, Positioning or Separation Problem (2906)

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

Event Date 09/15/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The stent partly deployed in advance during the process of the stent being advanced along the deliver system to the iliac vein, the stent was slightly withdrawn due to resistance, but the safety valve of the stent had not yet been pull out.It was found on the screen that the end of the stent had begun to be released partly.Then the physician immediately withdraw the stent into the sheath and removed the stent with the sheath together from the patient's body, and replace another stent to complete the procedure.Was pre-dilation performed ahead of placement of the stent? no.Was post-dilation performed after the placement of the stent? no.Was the device used percutaneously? yes.Where on the patient was the percutaneous access site? femoral vein.Details of access sheath used (name, fr size, length)? cook¿s¿8f sheath, 55cm.What was the target location for the stent? deep femoral vein.Was the approach contralateral, ipsilateral or jugular? contralateral.What disease mode was being treated e.G may thurner, acute or chronic thrombosis? acute deep veinous thrombosis.Was the device flushed through both flushing ports before the procedure, as per ifu? yes.Details of the wire guide used (name, diameter, hydrophylic)? boston science¿s wire guide,.035mm with hydrophillic.Was the patient's anatomy tortuous or calcified? no.Was resistance encountered when advancing the wire guide or delivery system to the target location? how did the physician deal with this resistance? yes, no resistance.Did the tip of the delivery system cross the target location? yes.Are images of the device of procedure available? no.Did the user pull the handle towards the hub during deployment, per ifu? no, the stent has not deployed.Did the user push the hub during deployment? no.Did the user remove slack in the delivery system before deployment, per ifu? no.Is the patient known to be covid-19 positive? no covid-19 positive.

Manufacturer Narrative

Pma/510(k) #: p050017/s006.Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Event Description

Supplemental report being submitted due to the device being evaluated in the lab at cirl on (b)(6) 2020.The stent partly deployed in advance during the process of the stent being advanced along the deliver system to the iliac vein, the stent was slightly withdrawn due to resistance, but the safety valve of the stent had not yet been pull out.It was found on the screen that the end of the stent had begun to be released partly.Then the physician immediately withdraw the stent into the sheath and removed the stent with the sheath together from the patient's body, and replace another stent to complete the procedure.1.Was pre-dilation performed ahead of placement of the stent? no.2.Was post-dilation performed after the placement of the stent? no.3.Was the device used percutaneously? yes.4.Where on the patient was the percutaneous access site? femoral vein.5.Details of access sheath used (name, fr size, length)?cook¿s¿8f sheath, 55cm.6.What was the target location for the stent? deep femoral vein.7.Was the approach contralateral, ipsilateral or jugular? contralateral.8.What disease mode was being treated e.G may thurner, acute or chronic thrombosis? acute deep venious thrombosis.9.Was the device flushed through both flushing ports before the procedure, as per ifu? yes 10.Details of the wire guide used (name, diameter, hyrdophyllic)?boston science¿s wire guide ,.035mm with hyrdophyllic.11.Was the patient's anatomy tortuous or calcified? no.12.Was resistance encountered when advancing the wire guide or delivery system to the target location? how did the physician deal with this resistance? yes,no resistance 13.Did the tip of the delivery system cross the target location? yes.14.Are images of the device of procedure available? no.15.Did the user pull the handle towards the hub during deployment, per ifu? no, the stent has not deployed.16.Did the user push the hub during deployment? no.17.Did the user remove slack in the delivery system before deployment, per ifu? no.18.Is the patient known to be covid-19 positive? no covid-19 positive.

Event Description

Supplemental report being submitted due to completion of the investigation on 25-mar-2021 and to update the report type from malfunction to serious injury.

Manufacturer Narrative

Annex g: g04063 - handpiece.Pma/510(k) #: p200023.Product code: qan.Device evaluation: the zvt7-35-80-14-6.0 device of lot number c1641876 involved in this complaint was returned for evaluation, with the original packaging.The packaging was open on receipt.With the information provided, a physical examination and document-based investigation was conducted.Lab evaluation: the device related to this occurrence underwent a laboratory evaluation on the 06 november 2020.On evaluation of the device the stent was observed to be partially deployed from the access sheath but fully removed from the delivery system on return.No damage was observed on the stent.The device flushed as expected and a 0.035¿ wire guide passed with no issues.The red safety lock was in place on return of the device.Document review: 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 c1641876 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 c1641876.It should be noted that the instructions for use (ifu0047-5) states the following: ¿do not attempt to remove the stent from the delivery system before use.¿ ¿ensure that the red safety lock is not inadvertently removed prior to stent release.¿ there is no evidence to suggest the user did not follow the ifu.Root cause review: a definitive root cause could not be determined as the circumstances of use cannot be replicated in the laboratory.A possible root cause could be attributed to resistance during advancement.From the available information it is known that the user encountered slight resistance whilst advancing the device.It is possible that this resistance resulted in the user applying inadvertent forward pressure on the handle of the device which may have contributed to the stent partially deploying from the outer sheath during the procedure.Summary: the 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 VENA VENOUS SELF-EXPANDING STENT
• Type of Device: NIO STENT, ILIAC
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 10853919
• MDR Text Key: 254713519
• Report Number: 3001845648-2020-00874
• Device Sequence Number: 1
• Product Code: NIO
• UDI-Device Identifier: 10827002520223
• UDI-Public: (01)10827002520223(17)220816(10)C1641876
• 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: 03/25/2021

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: 08/16/2022
• Device Catalogue Number: ZVT7-35-80-14-6.0
• Device Lot Number: C1641876
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2020
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/15/2020
• Event Location: Hospital
• Initial Date Manufacturer Received: 09/23/2020
• Initial Date FDA Received: 11/17/2020
• Supplement Dates Manufacturer Received: 09/23/2020; 09/23/2020
• Supplement Dates FDA Received: 12/04/2020; 04/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR
• Patient Weight: 70