MAUDE Adverse Event Report: COOK IRELAND LTD ZILVER VENA VENOUS SELF-EXPANDING STENT

Model Number G57449

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/14/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The tech who scrubbed the case showed me an image of the zilver vena post deployment in the patient¿s right common iliac vein.As it was being deployed, the stent stretched out.Picture attached.The tech believes it was due to the way the physician was deploying.Instead of pinning one hand and pulling with the other, she believes he pulled with both and did not have his one hand pinned properly causing the stent to stretch out as deploying.No replacement needs to be sent did any unintended section of the device remain inside the patient¿s body? -no if yes, please describe.Was the patient hospitalized or was there prolonged hospitalization? -no did the patient require any additional procedures due to this occurrence? -no if yes, please describe.Did the product cause or contribute to the need for additional procedures? -no if yes, please specify additional procedures and provide details.Has the complainant reported any adverse effects on the patient due to this occurrence? -no has the complainant reported that the product caused or contributed to the adverse effects? -no please specify adverse effects and provide details.The rep has been asked to provide the answers to the following questions.(b)(6).(b)(6) 2021.Prefix zvt7 3.94 are images of the device or procedure available? n/a,yes,no yes 3.95 did the patient have pre-existing conditions? n/a, yes, no yes ¿ if yes, please specify: (b)(6) 3.96 please describe the native state of the vessel (i.E.Was the anatomy tortuous? was the vessel fibrotic?) n/a, tortuous, calcified, fibrotic, other ¿ if other, please specify: unknown 3.97 was a stent previously placed during previous procedures? n/a, yes, no no 3.98 was the device used percutaneously? n/a,yes,no yes 3.99 where on the patient was the percutaneous access site? left popliteal vein 3.100 was the access site jugular or femoral? n/a, jugular, femoral other ¿ if other, please specify: popliteal 3.101 what disease pathology was being treated? may thurner, acute or chronic obstruction, restenosis, other? may thurner ¿ if other, please specify 3.102 was the lesion approached via contralateral or ipsilateral? n/a, contralateral, ipsilateral ipsilateral 3.103 was pre-dilation performed ahead of placement of the stent? n/a, yes, no 3.104 what was the target location for the stent? iliac vein 3.105 details of access sheath used (name, fr size, length)? 13fr, 15cm, inari clot triever sheath 3.106 was the device flushed through both flushing ports before the procedure, as per ifu? n/a,yes,no yes 3.107 details of the wire guide used (name, diameter, hydrophylic)? amplatz wire 3.108 was resistance encountered when advancing the wire guide to the target location? n/a, yes, no no 3.109 was resistance encountered when advancing the delivery system to the target location? n/a, yes, no no 3.110 if resistance was met, how did the physician address this? 3.111 did the tip of the delivery system cross the target location? n/a,yes,no yes 3.112 did the user pull the handle towards the hub during deployment, per ifu? n/a,yes,no yes 3.113 did the user push the hub during deployment? n/a, yes, no unknown 3.114 did the user remove slack in the delivery system before deployment, per ifu? n/a, yes, no yes 3.115 was the stent deployed smoothly / without resistance? n/a, yes, no no 3.116 was the stent fully deployed in the patient? n/a, yes, no yes 3.117 was the stent fully deployed before removing the delivery system from the patient? n/a, yes, no yes 3.118 was post dilation performed after the placement of the stent? n/a, yes, no yes 3.119 was the delivery system damaged/kinked/twisted during deployment? n/a, yes, no no 3.120 what intervention (if any) was required? n/a 3.121 was the secondary intervention performed during the same procedure as the device failure or was it scheduled for another day? n/a, same procedure, another day n/a 3.122 were any other defects (other than the complaint issue) observed on the delivery system prior to return (e.G.Kink)? n/a, yes, no ¿ please specify if yes.No.

Manufacturer Narrative

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

Event Description

Supplemental mdr being submitted due to completion of imaging review on 01-oct-21:.

Manufacturer Narrative

Product code: qan 510(k) number: (b)(4).Device evaluation the zvt7-35-80-16-140 device of lot number c1832094 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 zvt7-35-80-16-140 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 zvt7-35-80-16-140 of lot number c1832094 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 c1832094.It should be noted that the instructions for use ifu0091-7 states the following: ¿continue deployment of stent by sliding the handle toward the hub in a slow, smooth and consistent fashion¿.There is evidence to suggest the user did not follow the ifu.Image review images were provided to support the complaint investigation.They were reviewed through cook research inc.(cri) and the following comments were provided by the independent reviewer: impression 1.The complaint of stretched stent implantation is confirmed.2.The stretched segment was at least 11.5cm long.The full length of the stretched segment cannot be determined because the superior end of the stent was not included on the image.3.The introducer tip location was well inferior to the expected location of the left civ ivc confluence.This supports the complaint report¿s suggestion that the hub and handle were retracted during deployment.The stretch would have been fluoroscopically evident during deployment.Either fluoroscopic observation as not performed during deployment or the stent was deployed too rapidly for the stretch to be addressed a definitive root cause of user error was identified from the available information.The ifu states that (ifu0091-7): ¿continue deployment of stent by sliding the handle toward the hub in a slow, smooth and consistent fashion¿.According to the complaint, the hub and handle were retracted during deployment of the stent.The user did not use the pin and pull method for deployment.As a result of this incorrect/improper technique, the stent stretched out as the user deployed the stent.Complaint is confirmed as the failure was verified in the image(s).The stretching of the stent was observed in the imaging review.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.The patient did not require any additional procedures as a result of the occurrence.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

Final mdr being submitted due to completion of the investigation on (b)(6) 21.

• Brand Name: ZILVER VENA VENOUS SELF-EXPANDING STENT
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• Manufacturer (Section G): COOK IRELAND LTD; o halloran road; national technology park; limerick
• Manufacturer Contact: aisling hassett ; o halloran road; national technology park; limerick
• MDR Report Key: 12317450
• MDR Text Key: 280818605
• Report Number: 3001845648-2021-00613
• Device Sequence Number: 1
• Product Code: QAN
• UDI-Device Identifier: 10827002574493
• UDI-Public: (01)10827002574493(17)240521(10)C1832094
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G57449
• Device Catalogue Number: ZVT7-35-80-16-140
• Device Lot Number: C1832094
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/14/2021
• Event Location: Hospital
• Date Manufacturer Received: 07/26/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/21/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 81 YR
• Patient Sex: Female