MAUDE Adverse Event Report: COOK IRELAND LTD ZILVER VENA VENOUS SELF-EXPANDING STENT; Stent, iliac vein

Model Number G57447

Device Problems Improper or Incorrect Procedure or Method (2017); Migration (4003)

Patient Problems Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/29/2022

Event Type  Injury  

Event Description

As initially reported to customer relations via phone: a male patient of unspecified age underwent an iliac vein stenting procedure in which the zilver vena venous self-expanding stent, g57447, was used.Prior to stent placement the physician used an inari medical device and was able to pull out a lot of the clot.The physician deployed the stent in the iliac and when went to do an ultrasound it was noted the stent had pushed up or traveled up to the ivc.A wire was used to go up through and hook onto the stent and the physician was then able to pull the stent back down to the external iliac.A boston scientific wall stent was then deployed inside of the zilver.Prefix zvt7.Are images of the device or procedure available? requested from district manager.Did the patient have pre-existing conditions? none specified by end user.If yes, please specify: please describe the native state of the vessel (i.E.Was the anatomy tortuous? thrombosed.Was the vessel fibrotic?) n/a, tortuous, calcified, fibrotic, other.If other, please specify: was a stent previously placed during previous procedures? no, this is the only procedure to date.Was the device used percutaneously? yes.Where on the patient was the percutaneous access site? right femoral vein.Was the access site jugular or femoral? femoral- leg.If other, please specify: what disease pathology was being treated? may thurner, acute or chronic obstruction, restenosis, other? chronic obstruction and compression.If other, please specify.Was the lesion approached via contralateral or ipsilateral? ipsilateral.Was pre-dilation performed ahead of placement of the stent? no.What was the target location for the stent? right common iliac.Details of access sheath used (name, fr size, length)? 12fr sheath by inari.Was the device flushed through both flushing ports before the procedure, as per ifu? yes.Details of the wire guide used (name, diameter, hydrophylic)? glidewire.035 advantage.Was resistance encountered when advancing the wire guide to the target location? no.Was resistance encountered when advancing the delivery system to the target location? no.If resistance was met, how did the physician address this? n/a.Did the tip of the delivery system cross the target location? yes.Did the user pull the handle towards the hub during deployment, per ifu? yes.Did the user push the hub during deployment? no.Did the user remove slack in the delivery system before deployment, per ifu? yes.Was the stent deployed smoothly / without resistance? yes.Was the stent fully deployed in the patient? yes.Was the stent fully deployed before removing the delivery system from the patient? yes.Was post dilation performed after the placement of the stent? yes.Was the delivery system damaged/kinked/twisted during deployment? no.What intervention (if any) was required? see event description.Was the secondary intervention performed during the same procedure as the device failure or was it scheduled for another day? no.Were any other defects (other than the complaint issue) observed on the deliverysystem prior to return (e.G.Kink)? no.¿ please specify if yes.

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.

Manufacturer Narrative

Pma/510(k) # p200023.Product code - qan.Device evaluation: the device evaluation of zvt7-35-80-16-60 device of lot number c1864908 involved in this complaint was not available for evaluation.With the information provided, a document-based investigation was conducted.Document review: prior to distribution all devices are subjected to a visual inspection and functional inspection to ensure device integrity.A review of the manufacturing records 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 for this work order.It should be noted that the instructions for use (ifu0091) states the following: ¿selection of inappropriate stent diameter and length based on lesion and vessel characteristics could lead to stent migration.It is important to select the appropriate stent size after a complete diagnostic evaluation¿.There is evidence to suggest that the customer did not follow the instructions for use.From the information received, it states that ¿he now believes that the vein was not fully perfused when he passed the ivus up and the vein was probably much bigger¿.Root cause review: a definitive root cause is attributed to user error as there is evidence to suggest that the physician does not complete a diagnostic evaluation and selects diameter of stent incorrectly.This leads to the stent being undersized which resulted in stent migration as per clinical advisor.Summary: this pr was raised as the stent implanted migrated to the patients ivc.Through this investigation and from the information available, a definitive root cause could be attributed to the physician not performing a diagnostic evaluation and selecting the wrong stent size.From the ifu, it is known that stent migration can occur from inappropriate stent size selection.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.

Event Description

Supplemental report is being submitted due to the completion of the investigation and receipt of additional information.The vein was totally occluded and inari was performed to clear the clot.Once the vein was open again, ivus was passed through and the measurements were about 15mm x 13mm.He chose a 16mm x 60.He now believes that the vein was not fully perfused when he passed the ivus up and the vein was probably much bigger.

• Brand Name: ZILVER VENA VENOUS SELF-EXPANDING STENT
• Type of Device: Stent, iliac vein
• 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: sinead o'leary ; o halloran road; national technology park; limerick
• MDR Report Key: 14204722
• MDR Text Key: 290055729
• Report Number: 3001845648-2022-00252
• Device Sequence Number: 1
• Product Code: QAN
• UDI-Device Identifier: 10827002574479
• UDI-Public: (01)10827002574479(17)240906(10)C1864908
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/16/2022

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 Model Number: G57447
• Device Catalogue Number: ZVT7-35-80-16-60
• Device Lot Number: C1864908
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/29/2022
• Event Location: Hospital
• Initial Date Manufacturer Received: 03/30/2022
• Initial Date FDA Received: 04/26/2022
• Supplement Dates Manufacturer Received: 03/30/2022
• Supplement Dates FDA Received: 12/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/06/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male