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

Catalog Number UNKNOWN

Device Problem Use of Device Problem (1670)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/05/2019

Event Type  malfunction  

Manufacturer Narrative

Pma/510(k) #: p100022 (exact rpn unknown- zilver ptx).Device evaluation: the zilver ptx device of unknown lot number involved in this complaint was implanted in the patient, and was not available for evaluation.With the information provided, a document based investigation was conducted.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 zilver 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 cook (b)(4).It should be noted that the instructions for use (ifu0118-4) state the following: ¿do not use stent after the ¿use by¿ date specified on the package.¿ there is sufficient information to suggest the instructions for use were not followed.Root cause review: a definitive root cause could not be determined as the circumstances of use cannot be replicated in the laboratory.A possible root cause could be attributed to the user misreading the use by date or not checking the use by date of the device prior to implantation.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.

Event Description

As reported by dm via phone: expired stent was placed in patient.

Event Description

As reported by dm via phone: expired stent was placed in patient.This report is being submitted as a cancellation report as the risk associated with this event has been determined as low.No reporting malfunction precedence exists for this complaint event for this product family and no injury to the patient has occurred.

Manufacturer Narrative

Pma/510(k) #: p100022 (exact rpn unknown- zilver ptx).This file no longer meets the criteria of a malfunction report as no mdr precedence has been established for this event and the overall risk is low.This is a correction cancellation report.Device evaluation: the zilver ptx device of unknown lot number involved in this complaint was implanted in the patient, and was not available for evaluation.With the information provided, a document based investigation was conducted.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 zilver 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.It should be noted that the instructions for use (ifu0118-4) state the following: ¿do not use stent after the ¿use by¿ date specified on the package.¿ there is sufficient information to suggest the instructions for use were not followed.Root cause review: a definitive root cause could not be determined as the circumstances of use cannot be replicated in the laboratory.A possible root cause could be attributed to the user misreading the use by date or not checking the use by date of the device prior to implantation.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 DRUG ELUTING PERIPHERAL STENT
• Type of Device: NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 9150178
• MDR Text Key: 191130351
• Report Number: 3001845648-2019-00508
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): N
• PMA/PMN Number: P100022
• 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: 06/03/2020

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: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/05/2019
• Event Location: Hospital
• Initial Date Manufacturer Received: 09/06/2019
• Initial Date FDA Received: 10/03/2019
• Supplement Dates Manufacturer Received: 09/06/2019
• Supplement Dates FDA Received: 07/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1