MAUDE Adverse Event Report: COOK IRELAND LTD ZILVER FLEX 35 VASCULAR SELF-EXPANDING STENT; NIO STENT, ILIAC

Catalog Number ZFV6-125-7-10.0

Device Problem Device Damaged Prior to Use (2284)

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

Event Date 07/26/2023

Event Type  malfunction  

Event Description

The patient underwent arteriosclerosis occlusion of lower extremity, the doctor prepared to implant vascular stent zfv6-125-7-10.0 after opening the occlusional lesion through a wire guide and catheter.When the stent packaging was opened, it was found that part of the stent was released outside the delivery system, and then a new stent zfv6-125-7-12.0 was replaced to successfully complete the procedure.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

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

Manufacturer Narrative

Pma/510(k) # p050017/s006.Cancellation report is being submitted due to the completion of the investigation on 29-apr-2024.Overall risk assessed as category iia (low risk).No reporting malfunction precedence exists for this complaint event for this product family.No risk/ low risk of failure mode indicates no potential for serious injury if the malfunction were to recur.No adverse effect to the patient was reported as occurring.Device evaluation: the zfv6-125-7-10.0 device of lot number c2040497 involved in this complaint was returned for evaluation, without the original packaging.With the information provided, a physical and a document-based investigation was conducted.The device related to this occurrence underwent a laboratory evaluation on the 15th aug 2023.On evaluation of the device the following was noted: visual inspection: red safety tab returned in place.Stent partially deployed on return.No other defects observed.Functional inspection: device flushed with no issue.0.35 inch wire guide passed with no issue.This is the required wire guide for this device red safety tab removed, stent deployed without issue.Device functioned as intended.Photographs were also submitted with the complaint.The first photograph showed a picture of the catheter on a cook packaging box.The second photograph shows the stent partially deployed out of the device.Manufacturing records: 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.Throughout the manufacturing process, all products undergo numerous quality checks to ensure product quality and conformance.These checks are outlined in quality procedure qsi0975.These checks are performed at: production, final quality control, packaging, packaging qc , post sterilisation qc, post sterilisation services, foil packaging qc and post sterilisation services.These checks include: complete a 100% visual inspection of a unit while held at a comfortable arm¿s length from the unaided eye at normal lighting conditions for all units in a reasonable amount of time.An initial 100% visual inspection of any individual component or combination of components (e.G., product, pouch, tray, label, ifu,instruction leaflet, implant card, etc.) should be completed prior to commencing the relevant packaging instruction.Complete a 100% visual inspection of the packaged unit while held at a comfortable arm¿s length from the unaided eye at normal lighting conditions.Therefore it is highly unlikely that the device left the manufacturing plant, with the stent partially deployed inside the packaging.Historical data review: the review of relevant manufacturing records confirms the failure mode has not previously occurred for this work order.Instructions for use/label: there is no evidence to suggest that the customer did not follow the instructions for use.It should be noted that the instructions for use (ifu0058) states the following: ¿upon removal from the package, inspect the product to ensure no damage has occurred¿.¿ensure that the safety lock is not inadvertently removed prior to stent release¿.Image review: an image was not returned for evaluation.Root cause analysis a definitive root cause could not be determined.A possible root cause may be attributed to transport or storage of the device prior to use.If an unpredicted external force like a sudden or forceful movement, was applied to the packaged device, this may have caused the red safety tab to loosen and may have caused the stent to partially deploy.Another possible root cause could be attributed to device handling while removing the device from the packaging.The stent was found to be partially deployed when the user was unpacking the device.It was observed in the lab evaluation that the red safety tab was present on the device.Its possible that during the unpackaging and removal of the device, that the device may have gotten jostled, loosening the red safety tab and partially deploying the stent.Confirmation of complaint: complaint is confirmed based on complaint is confirmed based on visual and/or functional inspection.Corrective action/correction: complaints of this nature will continue to be monitored for similar events.Summary: according to the initial reporter, the patient underwent arteriosclerosis occlusion of lower extremity, the doctor prepared to implant vascular stent zfv6-125-7-10.0 after opening the occlusional lesion through a wire guide and catheter.When the stent packaging was opened, it was found that part of the stent was released outside the delivery system, and then a new stent zfv6-125-7-12.0 was replaced to successfully complete the procedure.Confirmed quantity of 01 device, confirmed prior to use.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.The partially deployed stent was discovered prior to patient contact.A new stent was used to carry out the procedure successfully.Investigation findings conclude a definitive root cause could not be established.Possible root causes include transport and device handling/removal from the packaging.

Event Description

Cancellation report is being submitted due to the completion of the investigation on 29-apr-2024.Overall risk assessed as category iia (low risk).No reporting malfunction precedence exists for this complaint event for this product family.No risk/ low risk of failure mode indicates no potential for serious injury if the malfunction were to recur.No adverse effect to the patient was reported as occurring.

• Brand Name: ZILVER FLEX 35 VASCULAR SELF-EXPANDING STENT
• Type of Device: NIO STENT, ILIAC
• 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: 17595420
• MDR Text Key: 321644256
• Report Number: 3001845648-2023-00644
• Device Sequence Number: 1
• Product Code: NIO
• UDI-Device Identifier: 10827002519043
• UDI-Public: (01)10827002519043(17)260407(10)C2040497
• Combination Product (y/n): N
• 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: 04/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ZFV6-125-7-10.0
• Device Lot Number: C2040497
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/26/2023
• Event Location: Hospital
• Initial Date Manufacturer Received: 07/28/2023
• Initial Date FDA Received: 08/22/2023
• Supplement Dates Manufacturer Received: 07/28/2023
• Supplement Dates FDA Received: 05/16/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/07/2023
• 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 Age: 83 YR
• Patient Sex: Male