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

Model Number G38480

Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)

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

Event Date 02/08/2023

Event Type  malfunction  

Manufacturer Narrative

Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Event Description

As initially reported to customer relations: a patient of undisclosed gender and age underwent a stenting of the sfa procedure in which the zilver ptx 35 drug-eluting stent, g38480, was to be used.While the device was on the back table the physician flushed the device as per the ifu (district manager confirmed it was done correctly as they were present during the case).Then when physician tried to place the wire down the catheter the wire would not go through.The physician noted a kink about half way up the catheter.The physician noted there was no damage to the marketing box nor the device packaging.Another zilver was used to continue and complete the procedure with no further complications.7fr x 45cm ansel access sheath used on replacement device.Complaint opened to capture the use of a wrong size access sheath.3.60 are images (e.G.Angiography, us etc.) of the device and/or procedure available? no.3.61 was the device flushed before the procedure, as per ifu? yes.3.62 were there any issues with flushing of the device? no, just the wire that would not go through.3.63 details of the access sheath used (name, fr size,length)? 7fr x 45cm ansel.3.64 details of the wire guide used (name, diameter, hyrdophyllic)? did not get this far.The remaining questions not applicable as this occurred prior to patient contact.(b)(4) (b)(6) 2023.Requested 16mar2023; district manager replied 17mar2023.(b)(4) 17mar2023.Please confirm that the same 7fr access sheath was used with the replacement device or if another access sheath was used? and if so, what size? the same 7ft access sheath was used with the replacement.

Manufacturer Narrative

Investigation is still pending, a follow-up mdr report will be submitted to include the investigation conclusions.

Event Description

Supplemental follow-up mdr correction report is being submitted due to the update to rpn and lot number to unknown on 15 may 2023.

Event Description

Supplemental report being submitted due to the completion of the investigation on 19-jun-2023.

Manufacturer Narrative

Pma 510k #p100022/s027.Device evaluation: user/use related complaints is considered foreseen misuse.It is unknown how the device will perform outside of instructions for use and/or labelling requirements.The user has not complied with the requirements of the ifu and/label.Trending will monitor if any future investigation is required the unknown ptx device of lot number unknown 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.This file was raised as an additional complaint to capture the user error of using an incorrect size access sheath on the replacement device from complaint (b)(4) (emdr number 3001845648-2023-00233).The device evaluation could not be completed as the device or photographic evidence of the device was not returned for evaluation.Manufacturing records: prior to distribution all devices are subjected to a visual inspection and functional inspection to ensure device integrity.Manufacturing records review could not be completed as the lot number is unknown.Review historical data: historical data was not reviewed as the lot number is unknown.Instructions for use and/or label: it should be noted that the instructions for use (ifu0118) states the following: ¿gain access to the site using a 6 french sheath with a minimum i.D.Of 2.0 mm¿.There is evidence to suggest that the customer did not follow the instructions for use or label.As per additional information received, it is known that the user used a 7fr ansel sheath.This is not the required access sheath required for this device.Image review: an image was not returned for evaluation.Root cause analysis: a definitive root cause of the user not reading or following the instructions for use has been determined.From the additional questions it is known that a 7fr access sheath was used with the replacement device.This is not the required access sheath required for this device.As previously noted the instructions for use (ifu0118) states the following: ¿gain access to the site using a 6 french sheath with a minimum i.D.Of 2.0 mm¿.The user has not complied with the requirements of the ifu with respect to the intended use of the device.User/use error complaints are considered foreseen misuse.It should be noted that, as the device was used outside of their validated state and/or against the instructions provided in the ifu, it is not possible to predict how the devices will perform or function confirmation of complaint: the complaint is confirmed based on customer and/or rep testimony.Summary of investigation: according to the initial reporter a patient underwent a stenting of the sfa procedure in which the zilver ptx 35 drug-eluting stent, g38480, was to be used.While the device was on the back table the physician flushed the device as per the ifu.Then when physician tried to place the wire down the catheter the wire would not go through.Another device was used and a 7fr x 45cm ansel access sheath used on the replacement device.Confirmed quantity of 01 device, confirmed used.According to the initial reporter, the patient did not experience any adverse effects as a result of this occurrence.Investigation findings conclude a definitive root cause was established.The user has not complied with the requirements of the ifu.It is known that a 7fr access sheath was used with the replacement device.This is not the required access sheath required for this device.As previously noted the instructions for use states to use a 6fr sheath.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
• 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: 16731762
• MDR Text Key: 313711010
• Report Number: 3001845648-2023-00235
• Device Sequence Number: 1
• Product Code: NIU
• UDI-Device Identifier: 10827002384801
• UDI-Public: (01)10827002384801(17)240906(10)C1987540
• Combination Product (y/n): Y
• Reporter Country Code: US
• 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: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 06/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G38480
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/08/2023
• Event Location: Hospital
• Date Manufacturer Received: 03/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/11/2022
• 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