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

Model Number G57446

Device Problems Off-Label Use (1494); Deformation Due to Compressive Stress (2889)

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

Event Date 05/13/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

As reported to customer relations via phone conversation "when the stent was deployed - it seemed shorter than it should be.Therefore, ivus was used to measure the device.Ivus confirmed that the stent was approximately 2mm's shorter than it should have been.The procedure was completed successfully with the stent (even though it was shorter than expected)." "did any unintended section of the device remain inside the patient¿s body?" no."did the patient experience a delay or require any additional procedure due to this occurrence?" no."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."are images of the device or procedure available?" yes."did the patient have pre-existing conditions?" see above.Please describe the native state of the vessel (i.E.Was the anatomy tortuous? - no was the vessel fibrotic?) n/a, tortuous, calcified, fibrotic, other.If other, please specify: no."was a stent previously placed during previous procedures?" yes."was the device used percutaneously?" yes."where on the patient was the percutaneous access site?" polpiteal vein."what disease pathology was being treated? may thurner, acute or chronic obstruction, restenosis, other?" acute to chronice."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?" the right iliac vein."details of access sheath used (name, fr size, length)?" 8fr bright tip (manufacture - cordis)."was the device flushed through both flushing ports before the procedure, as per ifu?" flushed throught the back due to time constraints regardin gthe procedure."details of the wire guide used (name, diameter, hydrophilic)?" amplatz."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."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."were any other defects (other than the complaint issue) observed on the delivery system prior to return (e.G.Kink)?" no and not being returned.

Manufacturer Narrative

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

Event Description

Supplemental report is being submitted due to the completion of imaging review on 11-june-2022: impression: 1.The complaint that the stent was 2cm shorter than labeled is not confirmed.Based on the ivus catheter, the implanted stent length was no less than 12.8cm.Additional stent length was present as the ivus catheter took a straighter course through lumen.2.Stent implantation alongside and inside of preexisting stents can affect deployment length.As per clniical input receievd on 20-june-2022: the stents are not designed to be used alongside another stent so this would be off label.

Manufacturer Narrative

Common name - qan, pma/510(k) # p200023.Device evaluation: the device evaluation of zvt7-35-80-14-140 device, lot number c1853550 could not be completed as the device or photographic evidence of the device was not returned for evaluation.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 for zvt7-35-80-14-140 device of lot number c1853550 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 c1853550.There is evidence to suggest that the customer did not follow the instructions for use.As per medical advisor, it is expected that a small amount of contact between two stents would occur when two stents are placed bilaterally in the iliac arteries ie.¿kissing¿ stents but there is no instruction that they should be placed side by side in another stent.Here two stents were placed bilaterally and are lying side by side in another bigger stent in the ivc.The stents are not designed to be used alongside another stent.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 that the stent was 2cm shorter than labelled is not confirmed.Based on the ivus catheter, the implanted stent length was no less than 12.8cm.Additional stent length was present as the ivus catheter took a straighter course through lumen.2.Stent implantation alongside and inside of pre-existing stents can affect deployment length.Root cause review: a definitive root cause of off label use was established from the available information.The user has not complied with the requirements of the ifu with respect to the intended use of the device.As per image review, the implanted stent length was no less than 12.8cm.Additional stent length was present as the ivus catheter took a straighter course through lumen.Also, stent implantation alongside and inside of preexisting stents can affect deployment length.As per medical advisor, these stents are not designed to be used alongside another stent.It should be noted that, as the device was used outside of their validated state it is not possible to predict how the devices will perform or function.Summary: the complaint of the stent seeming to be shorted than intended, is not confirmed as the defect could not be verified in the image(s).As per image review, the implanted stent length was no less than 12.8cm.Additional stent length was present as the ivus catheter took a straighter course through lumen.Also, stent implantation alongside and inside of preexisting stents can affect deployment length.As per medical advisor, these stents are not designed to be used alongside another stent.According to the initial reporter, the procedure was completed successfully.The patient suffered no 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 on 14-oct-2022.

• 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; holstein campus kiel; arnold- keller str- 3; limerick
• Manufacturer Contact: sinead o'leary ; holstein campus kiel; arnold- keller str- 3; limerick
• MDR Report Key: 14643674
• MDR Text Key: 302070104
• Report Number: 3001845648-2022-00351
• Device Sequence Number: 1
• Product Code: QAN
• UDI-Device Identifier: 10827002574462
• UDI-Public: (01)10827002574462(17)240728(10)C1853550
• 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,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G57446
• Device Catalogue Number: ZVT7-35-80-14-140
• Device Lot Number: C1853550
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/13/2022
• Event Location: Hospital
• Date Manufacturer Received: 05/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/28/2021
• 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