MAUDE Adverse Event Report: COOK IRELAND LTD ZILVER PTX DRUG-ELUTING PERIPHERAL STENT; NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING

Catalog Number ZISV6-35-80-5.0-80-PTX

Device Problems Break (1069); Material Separation (1562)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Pma/510(k) # p100022/s027.Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Event Description

This report is being submitted due to the completion of the lab evaluation on the (b)(6)2023.

Manufacturer Narrative

Pma 510k #p100022/s027.Device evaluation the zisv6-35-80-5.0-80-ptx device of lot number c1883759 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 the device related to this occurrence underwent a laboratory evaluation.On evaluation of the device the following was noted: visual inspection: outer sheath assembly (including strain relief and flushing port) returned separately from handle.Cog and metal bar (knurl pin) returned separately.Protective tubing present on outer sheath red safety button returned depressed.Handle returned open.Retraction wire protruding from the handle.Kink observed on outer sheath approx.82cm & 83cm from the distal white tip.Damaged observed on the distal inner.Functional inspection.Thumbwheel rotating freely.Unable to flush device.Unable to insert wire guide.Unable to deploy the stent.Handle was opened fully.Retraction wire separation observed.Lab re-evaluation on the 21st august 2023, to confirm the presence of the stent in the delivery system.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.Review historical data: historical data was not reviewed as the failure mode is unknown.Instructions for use/label: instructions for use (ifu0117) states the following: ¿do not use excessive force to deploy the stent.If excessive resistance is felt when beginning deployment, remove the delivery system without deploying the stent and replace with a new device¿.There is no evidence to suggest that the customer did not follow the instructions for use (ifu0117).Image review: an image was not returned for evaluation.Root cause review: a definitive root cause could not be concluded from the limited information available.A possible root cause may be attributed to a possible difficult patient anatomy.If the patients anatomy was calcified or tortuous, this could have caused and/or contributed to resistance during advancement and/or deployment exerting excessive force on the outer sheath of the device.This may have caused kinks to form on the delivery system which would have resulted in a need for greater force to be used when attempting deployment.As the red safety button was returned depressed, it is the assumption that the user reached the target site and attempted deployment.A high deployment force used during the attempted deployment may have resulted in extra pressure being applied to the retraction wire which could have resulted in the separation of the retraction wire from the stent retraction sheath (srs).Other possible root causes might be attributed to misuse or device handling technique.As the handle was returned open, it is the presumption that the user manually opened the handle which also could have caused/contributed to the observed damage.We do not know any patient information, at what stage the device malfunctioned or how it malfunctioned.We are unable to tell how much damage was caused by the device malfunctioning or if the damage to the device occurred during/after the removal from the patient.No information was provided by the customer to assist with identifying the complaint.Three attempts were made to obtain more information relevant to this complaint but were unsuccessful in doing so.The file was then cancelled on the basis that no information was available.The product was then returned and the file re-opened and updated when the lab evaluation was complete.Multiple device defects were observed during the lab evaluation.03 more attempts to obtain any information relating to this complaint were made again but no further information was provided.The original point of contact has ceased employment with cook and the rep that took over the case has stated that they have very little information regarding this complaint and that the surgeon was reluctant to answer questions.No further information could be obtained.Should more information regarding this complaint become available at a later date, the file can be re-opened and re-assessed accordingly.Confirmation of complaint: complaint is confirmed based on visual and/or functional inspection.Corrective action/correction: a capa has been implemented to document and track the actions taken to investigate the stent retraction wire/stent retraction sheath joint separation.The capa owner has been notified that this file may possibly be linked.However based on the fact that we have been unable to gather any information relating to the device despite numerous attempts, a definitive root caused cannot be established.Possible root causes could be attributed to misuse, technique or patient anatomy so at this time, this complaint cannot be definitively related to the capa.Should information become available at a later stage, the file can be re-assessed and the capa owner to be notified.Summary: according to the initial reporter, all that was stated was that they were waiting on more information from the rep.Numerous attempts were made to obtain more information relevant to this complaint but were unsuccessful in doing so.Confirmed quantity of 01 device, confirmed used.From the initial reporter, we do not know the patient outcome nor if the patient experienced any adverse effect of this occurrence.Investigation findings conclude a definitive root cause could not be determined due to the limited information available.Possible root causes might be attributed to a possible patient anatomy, misuse or device handling technique.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

This report is being submitted due to the completion of the investigation on 20-oct-2023 the stent retraction wire/stent retraction sheath joint separation.

• Brand Name: ZILVER PTX DRUG-ELUTING PERIPHERAL STENT
• Type of Device: NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING
• 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: 17204205
• MDR Text Key: 318031074
• Report Number: 3001845648-2023-00502
• Device Sequence Number: 1
• Product Code: NIU
• UDI-Device Identifier: 10827002353043
• UDI-Public: (01)10827002353043(17)230601(10)C1883759
• Combination Product (y/n): Y
• PMA/PMN Number: P100022
• 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: 10/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2023
• Device Catalogue Number: ZISV6-35-80-5.0-80-PTX
• Device Lot Number: C1883759
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Date Manufacturer Received: 05/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/03/2021
• 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