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

Model Number G57445

Device Problem Improper or Incorrect Procedure or Method (2017)

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

Event Date 02/18/2022

Event Type  malfunction  

Event Description

Per rep on (b)(6) 2022: they had access with a boston scientific amplatz wire (.035, 260 cm).They had a cordis sheath 11 fr in.They flushed the device and wire.They tried to advance the cook stent over the wire and it got stuck after about 30 cm of going over the wire.They removed the stent device from wire and flushed it again.They tried again to go over wire and the same thing happened but the tip of the stent also became loose at this point due to friction with the wire.The stent device did not go through the sheath at any point.They removed this stent device and successfully completed the procedure with another device of the same type.Per rep on (b)(6) 2022: i was in this procedure and as i recall, this device was not inspected before or after the procedure for any damage.File required to capture user error as not inspected before use.Patient outcome: did any unintended section of the device remain inside the patient¿s body? no.Was the patient hospitalized or was there prolonged hospitalization due to this occurrence? no.Did the patient require any additional procedures due to this occurrence? no.Did the product cause or contribute to the need for additional procedures? 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.Patient/event info- notes: prefix zvt7.Are images of the device or procedure available? video of device post-procedure.Did the patient have pre-existing conditions? unkr.Was a stent previously placed during previous procedures? no.Was the device used percutaneously? they wanted to, but it did not make pt contact.Where on the patient was the percutaneous access site? unkr.Was the access site jugular or femoral? n/a, jugular, femoral other unkr.What disease pathology was being treated? may thurner, acute or chronic obstruction, restenosis, other? n/a.Was the lesion approached via contralateral or ipsilateral? n/a.Was pre-dilation performed ahead of placement of the stent? n/a.What was the target location for the stent? iliofemoral.Details of access sheath used (name, fr size, length)? cordis sheath 11 fr was the device flushed through both flushing ports before the procedure, as per ifu? yes.Details of the wire guide used (name, diameter, hyrdophyllic)? boston scientific amplatz wire (.035, 260 cm).Was resistance encountered when advancing the wire guide to the target location? unkr.Was resistance encountered when advancing the delivery system to the target location? no patient contact.If resistance was met, how did the physician address this? n/a.Did the tip of the delivery system cross the target location? no.Did the user pull the handle towards the hub during deployment, per ifu? did not attempt to deploy.Did the user push the hub during deployment? n/a.Did the user remove slack in the delivery system before deployment, per ifu? n/a.Was the stent deployed smoothly / without resistance? n/a.Was the stent fully deployed in the patient? no.Was the stent fully deployed before removing the delivery system from the patient? n/a.Was post dilation performed after the placement of the stent? n/a.Was the delivery system damaged/kinked/twisted during deployment? no.What intervention (if any) was required? none.Was the secondary intervention performed during the same procedure as the device failure or was it scheduled for another day? none.Were any other defects (other than the complaint issue) observed on the delivery system prior to return (e.G., kink)? no.

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 zvt7-35-80-14-100 device of lot number c1851672 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 on evaluation of the device the following was noted: visual inspection ¿ a kink is observed on the outer sheath approx.13cm from the handle.Functional inspection -0.035 inch wire guide would not pass through the kink the device flushed with no issue stent deployed with no issue 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: ¿inspect the product to ensure no damage has occurred¿.There is evidence to suggest that the customer did not follow the instructions for use in relation to inspecting the product before use.As per rep ¿ 02 nov 2022 ¿i was in this procedure and as i recall, this device was not inspected before or after the procedure for any damage.¿ also, it should be noted that the instructions for use (ifu0091) states the following: ¿if excessive resistance is felt when beginning deployment, do not force deployment.Remove the delivery system without deploying the stent and replace with new device.¿ based on the information provided it is known that as the user experienced difficulty when advancing the stent over the wire, the user removed the device from the body, flushed the device and then re-advanced the device into the patients body.Image review an image was not returned for evaluation root cause review a definitive root cause of user error is confirmed based on customer testimony.The instructions for use states that the product is to be inspected before use for any damage.Had the product being inspected, damage may have been noted and the device would not have been used.Furthermore, had the damage being noted upon inspection, the device would not have been used and re-flushed which is also against the ifu.The user has not complied with the requirements of the ifu with respect to the intended use of the device summary complaint is confirmed based on the customers 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 on 22feb2023.

• 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: 15893484
• MDR Text Key: 308463390
• Report Number: 3001845648-2022-00821
• Device Sequence Number: 1
• Product Code: QAN
• UDI-Device Identifier: 10827002574455
• UDI-Public: (01)10827002574455(17)240720(10)C1851672
• 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: 02/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G57445
• Device Catalogue Number: ZVT7-35-80-14-100
• Device Lot Number: C1851672
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/18/2023
• Event Location: Hospital
• Date Manufacturer Received: 11/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/20/2021
• 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