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

Catalog Number ZISV6-35-125-5.0-140-PTX

Device Problem Use of Device Problem (1670)

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

Event Date 07/07/2020

Event Type  malfunction  

Event Description

The sheath got detached from the handle.No further information has been provided by the sales rep."as per complaint form": the patient had a tortuous iliac arteries and when introducing the ptx it separated from the handle this file will capture the user error - incorrect size access sheath used.From the additional information, the user used a 8fr access sheath.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence 1.Was the approach ipsilateral or contralateral? contralateral.2.If contralateral, was the bifurcation angle tight? no, it was no tight.3.Was pre-dilation performed ahead of placement of the stent? no.4.Was post-dilation performed after the placement of the stent? no, they were so nervous and they leaved the stent without dilation.5.Details of the wire guide used (name, diameter, hyrdophyllic)? terumo 18fr.6.Details of the access sheath used (name, fr size, length)? no cook, short 8 fr sheath.7.Was the device flushed before the procedure, as per ifu? yes.8.What was the target location for the complaint device? sfa.9.Was the patient's anatomy tortuous or calcified? tortuous and calcified.10.Was resistance encountered when advancing the wire guide to the target location? no.10a.How did the physician deal with this resistance? no resistance.10b.Was resistance encountered when advancing the delivery system to the target location? no.10c.How did the physician deal with this resistance? 11.Did the stent delivery system cross the target location?yes.12.What artery was the stent placed in? in sfa but above the target location.13.Was the distal end of the stability sheath inside the access sheath? yes.14.Was the retraction sheath being held during deployment? no.

Manufacturer Narrative

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 zisv6-35-125-5.0-140-ptx device of lot number c1694665 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 with the device from complaint (b)(4).The device evaluation could not be completed as the device was not returned for evaluation.Photographs were received for evaluation and were evaluated under (b)(4).On review of these photographs, severe damage was noted on the device.On image 01, the outer sheath was broke/separated distal to the strain relief and the strain relief appears to be bent.On picture 02, there is curvature observed on the outer sheath.Due to poor image quality, it is not clear if there is any further damage on the remaining section of the outer sheath.As per r&d input and product manager input, the wrong size access sheath would not have caused this damage.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 for zisv6-35-125-5.0-140-ptx of lot number c1694665 did not reveal any discrepancies that could have contributed to this complaint issue.Review historical data: the review of relevant manufacturing records, confirms the failure mode has not previously occurred with the current lot number.Instructions for use and/or label it should be noted that the instructions for use (ifu0117) states the following: ¿gain access to the site using a 6 french sheath with a minimum i.D.Of 2.1 mm¿.There is evidence to suggest that the customer did not follow the instructions for use or label.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 8fr access sheath was used with the device.This is not the required access sheath required for this device.As previously noted the instructions for use (ifu0117) 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, the sheath got detached from the handle.No further information has been provided by the sales rep."as per complaint form": the patient had tortuous iliac arteries and when introducing the ptx it separated from the handle.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 8fr access sheath was used with the 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 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: 17508228
• MDR Text Key: 321242952
• Report Number: 3001845648-2023-00623
• Device Sequence Number: 1
• Product Code: NIU
• UDI-Device Identifier: 10827002352787
• UDI-Public: (01)10827002352787(17)210926(10)C1694665
• 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: Physician
• Type of Report: Initial
• Report Date: 07/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/26/2021
• Device Catalogue Number: ZISV6-35-125-5.0-140-PTX
• Device Lot Number: C1694665
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/07/2020
• Event Location: Hospital
• Date Manufacturer Received: 07/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/23/2019
• 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: 79 YR
• Patient Sex: Female