MAUDE Adverse Event Report: COOK IRELAND LTD ZILVER PTX 35 DRUG-ELUTING STENT; NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING

Catalog Number ZISV6-35-125-7-100-PTX

Device Problems Failure to Advance (2524); Activation, Positioning or Separation Problem (2906)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/09/2020

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

As reported to customer relations via email "this morning during an angio case we had a defective stent (ref: g38489) that did not deploy and became stuck.Dr.Liu was able to remove it.".

Event Description

Supplemental report is being submitted due to the completion of the investigation.

Manufacturer Narrative

Pma/510(k) #: p100022/s027.Device evaluation: the zisv6-35-125-7-100-ptx device of unknown lot number involved in this complaint was not available for evaluation.With the information provided, a document-based investigation was conducted.Three attempts have been made to obtain additional information regarding this event, however at the time of the investigation no additional information was provided by the user.If any additional information is received in the future the file will be updated.Document review: as the lot number of the complaint stent is unknown, a review of the relevant manufacturing records cannot be conducted.However, prior to distribution zisv6-35-125-7-100-ptx devices are subjected to a visual inspection and functional checks to ensure device integrity.These inspections and functional checks are outlined in internal procedures in place at cirl d00059766 [qsi0943] rev063, it should be noted that the instructions for use (ifu0118-6) states the following: do not use excessive force to deploy the stent.If the 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 the user did not follow the ifu.Root cause review: a definitive root cause could not be determined from the available information.A possible root cause could be attributed to difficult patient anatomy or kink on the outer sheath.Difficult patient anatomy may have caused resistance during advancement which may have contributed to the formation of a kink out the outer sheath which may have prevented the user deploying the stent.Summary the 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.

• Brand Name: ZILVER PTX 35 DRUG-ELUTING STENT
• Type of Device: NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 11131613
• MDR Text Key: 246699904
• Report Number: 3001845648-2021-00001
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ZISV6-35-125-7-100-PTX
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/09/2020
• Event Location: Hospital
• Date Manufacturer Received: 12/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1