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

Model Number G38490

Device Problems Failure to Advance (2524); Activation, Positioning or Separation Problem (2906); Physical Resistance/Sticking (4012)

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

Event Date 11/05/2020

Event Type  malfunction  

Manufacturer Narrative

Pma/510(k) #p100022/s014.Complaint device was returned and evaluated on 26-nov-2020.No devices defect was noted.Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.

Event Description

The end user was attempting to deploy stent and the thumbwheel felt like it was snagged so he did not feel confident to deploy the stent.Another of the same device was used to complete the procedure.Did any unintended section of the device remain inside the patient¿s body? no.Was the patient hospitalized or was there prolonged hospitalization? no.Did the patient require any additional procedures due to this occurrence? no.Did the product cause or contribute to the need for additional procedures? no.Has the complainant reported any adverse effects on the patient due to this occurrence? no.Has the complainant reported that the product caused or contributed to the adverse effects? na.Where was the access site? common fem artery.What was the patient¿s anatomy? unknown.What was the target location for the stent? sfa.Was the target location severely calcified or tortuous? unknown.Was the device flushed prior to use? yes.Were there any difficulties deploying the stent? yes.Was the stent fully deployed before removing the delivery system from the patient? na.What other devices were used in the procedure? another stent was placed prior; a zilver ptx.Were any additional procedures necessary as a result of this event? no.Can any photos, images, or reports of the procedure or device be provided? no.

Event Description

Supplemental follow-up report is being submitted due to the receipt of additional information.1.Are images of the device of procedure available? no.2.Was the approach ipsilateral or contralateral? contra.3.If contralateral, was the bifurcation angle tight? n/a.4.Was pre-dilation performed ahead of placement of the stent? yes.5.Was post-dilation performed after the placement of the stent? n/a.6.Details of the wire guide used (name, diameter, hyrdophyllic)? terumo glidewire.7.Details of the access sheath used (name, fr size, length)? terumo destination.8.Was the device flushed before the procedure, as per ifu yes.9.What was the target location for the complaint device? sfa.10.Was the patient's anatomy tortuous or calcified? no.11.Was resistance encountered when advancing the wire guide or delivery system to the target location? how did the physician deal with this resistance? no.12.Did the stent delivery system cross the target location? yes.13.Can you please confirm what is meant by "a snag in the thumbwheel"? does this mean the user felt resistance when rotating the thumbwheel? yes.14.Was the red safety lock completely depressed during attempted deployment? yes.Initial report details: the end user was attempting to deploy stent and the thumbwheel felt like it was snagged so he did not feel confident to deploy the stent.Another of the same device was used to complete the procedure.Did any unintended section of the device remain inside the patient¿s body? no.Was the patient hospitalized or was there prolonged hospitalization? no.Did the patient require any additional procedures due to this occurrence? no.Did the product cause or contribute to the need for additional procedures? no.Has the complainant reported any adverse effects on the patient due to this occurrence? no.Has the complainant reported that the product caused or contributed to the adverse effects? na.Where was the access site? common fem artery.What was the patient¿s anatomy? unknown.What was the target location for the stent? sfa.Was the target location severely calcified or tortuous? unknown.Was the device flushed prior to use? yes.Were there any difficulties deploying the stent? yes.Was the stent fully deployed before removing the delivery system from the patient? na what other devices were used in the procedure? another stent was placed prior; a zilver ptx.Were any additional procedures necessary as a result of this event? no.Can any photos, images, or reports of the procedure or device be provided? no.

Manufacturer Narrative

Pma/510(k) #(b)(4).Complaint device was returned and evaluated on 26-nov-2020.No devices defect was noted.Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.

Manufacturer Narrative

Pma/510(k) #p100022/s014.Device evaluation the zisv6-35-125-7-120-ptx device of lot number c1634163 involved in this complaint was returned for evaluation, with the original packaging.The packaging was open on receipt.With the information provided, a physical examination and document-based investigation was conducted.Lab evaluation: the device related to this occurrence underwent a laboratory evaluation on the 26th november 2020.On evaluation of the device the device flushed with no issues.A 0.035 ¿¿ wire guide passed as expected.The thumbwheel rotated with no issues and the stent deployed as expected.Document review: prior to distribution zisv6-35-125-7-120-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.A review of the manufacturing records for zisv6-35-125-7-120-ptx of lot number c1634163 did not reveal any discrepancies that could have contributed to this complaint issue.The review of relevant manufacturing records confirms the failure mode has not previously occurred with the current lot number.Based on the information available to date, there is no evidence to suggest that there are any manufacturing issues associated with lot number c1634163.It should be noted that the instructions for use (ifu0122-3) states the following: '' do not use excessive force to deploy the stent.If 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 as the circumstances of use cannot be replicated in the laboratory.A possible root cause could be attributed to difficult patient anatomy.It is possible that difficult patient anatomy may have contributed to resistance when rotating the thumbwheel which may have prevented the user deploying the stent.Summary: complaint is confirmed based on the customers testimony as the clinical setting that could impact on the functionality of the device cannot be replicated in the laboratory.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

Supplemental report being submitted due to the investigation being completed on 30-apr-2021.

Manufacturer Narrative

Pma/510(k) #p100022/s014 device evaluation the zisv6-35-125-7-120-ptx device of lot number c1634163 involved in this complaint was returned for evaluation, with the original packaging.The packaging was open on receipt.With the information provided, a physical examination and document-based investigation was conducted.Lab evaluation the device related to this occurrence underwent a laboratory evaluation on the 26th november 2020.On evaluation of the device the device flushed with no issues.A 0.035 ¿¿ wire guide passed as expected.The thumbwheel rotated with no issues and the stent deployed as expected.Document review prior to distribution zisv6-35-125-7-120-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.A review of the manufacturing records for zisv6-35-125-7-120-ptx of lot number c1634163 did not reveal any discrepancies that could have contributed to this complaint issue.The review of relevant manufacturing records confirms the failure mode has not previously occurred with the current lot number.Based on the information available to date, there is no evidence to suggest that there are any manufacturing issues associated with lot number c1634163.It should be noted that the instructions for use (ifu0122-3) states the following: '' do not use excessive force to deploy the stent.If 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 as the circumstances of use cannot be replicated in the laboratory.A possible root cause could be attributed to difficult patient anatomy.It is possible that difficult patient anatomy may have contributed to resistance when rotating the thumbwheel which may have prevented the user deploying the stent.Summary complaint is confirmed based on the customers testimony as the clinical setting that could impact on the functionality of the device cannot be replicated in the laboratory.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

Supplemental report being submitted due to updates to the imdrf coding.

• 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: 10945352
• MDR Text Key: 252274627
• Report Number: 3001845648-2020-00914
• Device Sequence Number: 1
• Product Code: NIU
• UDI-Device Identifier: 10827002384900
• UDI-Public: (01)10827002384900(17)210109(10)C1634163
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/09/2021
• Device Model Number: G38490
• Device Catalogue Number: ZISV6-35-125-7-120-PTX
• Device Lot Number: C1634163
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/26/2020
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/05/2020
• Event Location: Hospital
• Date Manufacturer Received: 11/10/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/22/2019
• 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