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

Model Number G38483

Device Problems Use of Device Problem (1670); Physical Resistance/Sticking (4012)

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

Event Date 06/21/2023

Event Type  malfunction  

Event Description

Reported by the dm via phone call - the thumbwheel was able to be clicked on the device but it did not unsheath the stent.The delivery system and stent were able to be removed and they were able to successfully deploy two new stents of the same type to complete procedure.No photos of the complaint device can be provided inside the body.No harm done to the patient per dm via phone call.3.60 are images (e.G.Angiography, us etc.) of the device and/or procedure available? not the complaint device.Yes, to part of the procedure.3.61 was the device flushed before the procedure, as per ifu? unknown.3.62 were there any issues with flushing of the device? unknown.3.63 details of the access sheath used (name, fr size,length)? unknown.3.64 details of the wire guide used (name, diameter, hydrophillic)? unknown.3.65 what approach was used to access the target site? based on the imaging- controlateral.If contralateral, was the bifurcation angle steep? no.3.66 what was the target location for the stent? sfa.3.67 what artery was the stent placed in? sfa.3.68 was the wire guide removed from the patient prior to advancing the delivery system? unknown.3.69 if removed, was the wire guide wiped prior to advancement of the delivery system? unknown.3.70 did the stent delivery system cross the target location? unknown.3.71 was pre-dilation performed ahead of placement of the stent? it was not.3.72 was the patient¿s anatomy difficult or altered? calcified.If other, please specify: 3.73 was resistance encountered when advancing the wire guide? unknown.3.74 was resistance encountered when advancing the delivery system to the target location? unknown.3.75 was resistance encountered when deploying the stent? yes, the stent would not deploy.3.76 how did the physician deal with any resistance encountered? they realized something was wrong and that's when they called the sales rep and by the time the sales rep got there the delivery system had already been removed with the device.3.77 was the stent fully deployed in the patient before removing the delivery system? no the device never deployed.3.78 after deployment did the stent show signs of any of the following: compression, fracture, deformation, constraint, elongation, other.N/a.If other, please specify: stent did not deploy.3.79 was post-dilation performed after the placement of the stent? n/a.3.80 did any portion of the device break off? no.If yes, please state what part: 3.81 when did the device break? during deployment.3.82 thumbwheel only ¿ was the distal end of the stability sheath inside the access sheath? yes because it was up and over.3.83 thumbwheel only ¿ was the retraction sheet being held during deployment.Unknown.3.84 did the thumbwheel spin freely or rotate without stent release or without retracting the stent retraction sheath? yes.If yes, was the stent partially deployed? the customer is saying no because it never flowered.If yes, was the partially deployed stent removed with the delivery system or was it deployed in the patient? n/a.3.85 if removed, did any part of the stent fracture during removal of the delivery system? no.3.86 was the delivery system kinked or twisted during advancement or deployment? unknown.3.87 please advise if and when any damage was observed on the; 3.87.1 wireguide- unknown.3.87.2 delivery system- unknown.3.88 what intervention (if any) was required? none.3.89 was the secondary intervention performed during the same procedure as the device failure or was it scheduled for another day? n/a, same procedure, another day.3.90 were any other defects (other than the complaint issue) observed on the delivery system prior to return (e.G.Kink)? no.

Manufacturer Narrative

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

Manufacturer Narrative

Pma/510(k) # p100022/s026 cancellation report is being submitted due to additional information received on 19-feb-2024.Fda mdr reporting not required.No reporting malfunction precedence exists for this complaint event for this product family.No risk/ low risk of failure mode indicates no potential for serious injury if the malfunction were to recur.Device evaluation the zisv6-35-125-6-140-ptx device of lot number c2050500 involved in this complaint was returned for evaluation, without the original packaging.With the information provided, a physical examination and document-based investigation was conducted.The device related to this occurrence underwent a laboratory evaluation on the 18th july 2023 and a lab re-evaluation on the 02 aug 2023.On evaluation of the device on the 18th july 2023, the following was noted: visual inspection ¿ delivery system returned with access sheath still attached.¿ fraying observed on the braiding of outer sheath approx 17.5cm from distal tip.¿ red safety tab is depressed on return.¿ unable to remove access sheath from delivery system due to fraying on outer sheath.Functional inspection ¿ thumbwheel rotated but unable to retract retraction sheath.On the 02 aug 2023, the device underwent a lab re-evaluation with engineering present.The following was noted: visual inspection ¿ crinkling observed on distal blue tip of access sheath ¿ access sheath moved from outer catheter and biological matter present ¿ outer sheath separated 17cm from distal end of device ¿ distal white tip observed retracted into catheter functional inspection ¿ stent deployed manually intact on the 23 jan 2024, an additional lab re-evaluation took place to measure the access sheath (brand unknown) that was returned with the device which measured at an outer diameter of approximately 2.64mm.The measurements cannot confirm the access sheath size returned with the device as the access sheath could have become deformed through the initial use of the cook device with the reported incorrect size 5fr access sheath.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 zisv6-35-125-6-140-ptx of lot number c2050500 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 (ifu0118) 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 5fr access sheath was used with the device.This is not the required access sheath required for this device.Fraying and crinkling observed during the lab evaluation, likely occurred as the device struggled to be advanced through the smaller size access sheath.This fraying and crinkling then caused the device to become stuck in the access sheath.This would have then resulted in a need for force to be used while advancing/attempting deployment which could have caused the outer sheath separation seen in the lab evaluation.It is also known the patients anatomy was calcified.Calcification is where calcium builds up in body tissue, causing the tissue to harden.Advancing the device through a calcified anatomy could have also caused difficulty and could have required excess force to be used while advancing the device to the target location or while attempting deployment.This excessive force could have caused the outer sheath separation.As seen in the lab re-evaluation, the stent was able to be manually deployed intact.This calcified anatomy coupled with the incorrect size access sheath, could have caused/contributed to the damage to the device as seen in the lab evaluation.Force was also likely required when removing the device which resulted in the distal white tip been retracted into the catheter as seen in the lab evaluation.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 2.1 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 visual/functional inspection.Corrective action/correction: complaints of this nature will continue to be monitored for potential emerging trends.Summary of investigation according to the initial reporter, the thumbwheel was able to be clicked on the device but it did not unsheath the stent.The delivery system and stent were able to be removed and they were able to successfully deploy two new stents of the same type to complete procedure.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.A 6fr size access sheath was reportedly used with the successful replacement devices.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 5fr 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.

Event Description

Cancellation report is being submitted due to the completion of the investigation on 19-feb-2024.Fda mdr reporting not required.No reporting malfunction precedence exists for this complaint event for this product family.No risk/ low risk of failure mode indicates no potential for serious injury if the malfunction were to recur.

• 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: 17360937
• MDR Text Key: 320243827
• Report Number: 3001845648-2023-00563
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): Y
• Reporter Country Code: US
• 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: 02/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G38483
• Device Catalogue Number: ZISV6-35-125-6-140-PTX
• Device Lot Number: C2050500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/21/2023
• Event Location: Hospital
• Date Manufacturer Received: 06/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/05/2023
• 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 Sex: Female