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

Model Number G38463

Device Problems Failure to Advance (2524); Activation, Positioning or Separation Problem (2906)

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

Event Date 09/18/2022

Event Type  malfunction  

Manufacturer Narrative

Pma/510(k)#: p100022/s014.

Event Description

Per email from (b)(6): the stent would not deploy, another stent was used, patient was unharmed, no further treatment was required.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? n/a the following information has been requested via email on 19sep022: (b)(6) 19sep2022.What was the date of the occurrence? on what date were you notified? is the facility going to be reporting to the fda? can you provide any patient information? what type of procedure was being performed? are images (e.G.Angiography, us etc.) of the device and/or procedure available? n/a, yes, no was the device flushed before the procedure, as per ifu? n/a, yes, no were there any issues with flushing of the device? n/a, yes, no details of the access sheath used (name, fr size,length)? details of the wire guide used (name, diameter, hyrdophyllic)? what approach was used to access the target site? contralateral, ipsilateral, antegrade, retrograde, other please specify for other: if contralateral, was the bifurcation angle steep? n/a, yes, no what was the target location for the stent? what artery was the stent placed in? proximal sfa, mid sfa, distal sfa, at the ostium of the profunda, p1 (proximal popliteal), other please specify for other: was the wire guide removed from the patient prior to advancing the delivery system? n/a, yes, no if removed, was the wire guide wiped prior to advancement of the delivery system? n/a, yes, no did the stent delivery system cross the target location? n/a, yes, no was pre-dilation performed ahead of placement of the stent? n/a, yes, no was the patient¿s anatomy difficult or altered? previous bypass, tortuous, calcified, altered, other if other, please specify: was resistance encountered when advancing the wire guide? n/a, yes, no was resistance encountered when advancing the delivery system to the target location? n/a, yes, no was resistance encountered when deploying the stent? n/a, yes, no how did the physician deal with any resistance encountered?.

Manufacturer Narrative

Pma/510(k) # (b)(4).Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Event Description

Supplemental report is being submitted due to confirmation of the date of event and submissions of answers to additional questions.Date of event: (b)(6) 2022.The following information has been received via email on 27oct2022.Sg 27oct2022.6.Are images (e.G.Angiography, us etc.) of the device and/or procedure available? no images were provided.7.Was the device flushed before the procedure, as per ifu? yes.8.Were there any issues with flushing of the device? no.9.Details of the access sheath used (name, fr size,length)?no detail provided by customer.10.Details of the wire guide used (name, diameter, hydrophylic)?no detail provided by customer.11.What approach was used to access the target site? contralateral, ipsilateral, antegrade, retrograde, other.A.Please specify for other: no detail provided by customer.B.If contralateral, was the bifurcation angle steep? 12.What was the target location for the stent?sfa.13.What artery was the stent placed in? proximal sfa, mid sfa, distal sfa, at the ostium of the profunda, p1 (proximal popliteal), other stent was never placed in patients body.A.Please specify for other: 14.Was the wire guide removed from the patient prior to advancing the delivery system? no detail provided by customer.15.If removed, was the wire guide wiped prior to advancement of the delivery system? 16.Did the stent delivery system cross the target location? no.17.Was pre-dilation performed ahead of placement of the stent? no detail provided by customer.18.Was the patient¿s anatomy difficult or altered? previous bypass, tortuous, calcified, altered, other.A.If other, please specify: no detail provided by customer.19.Was resistance encountered when advancing the wire guide? no detail provided by customer.

Manufacturer Narrative

Pma/510(k) # p100022/s014.Device evaluation: the zisv6-35-125-6-40-ptx device of lot number c1951091 involved in this complaint was not available for evaluation.With the information provided, a document-based investigation was conducted.Lab evaluation: the device lab evaluation could not be completed as the device, or photographic evidence of the device, was not returned for evaluation.Document review: prior to distribution all devices are subjected to a visual inspection and functional inspection to ensure device integrity.A review of the manufacturing records did not reveal any discrepancies that could have contributed to this complaint issue.Historical data review: the review of relevant manufacturing records confirms the failure mode has not previously occurred for this work order.Ifu & label review: there is no evidence to suggest that the customer did not follow the instructions for use.Instructions for use ifu0118 state 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.Image review: an image was not returned for evaluation.Root cause review: a definitive root cause could not be determined from the available information.A possible root cause could be attributed to a possible difficult patient anatomy.It is possible that difficult patient anatomy may have caused and/or contributed to resistance during advancement and/or attempted deployment.It is possible that this resistance resulted in the inability to deploy the stent.However, as no additional information was received after numerous requests and as the device was not returned for evaluation, a definitive root cause cannot be determined.Should more information become available at a future date, the file will be re-opened and updated accordingly.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 and the procedure was successfully completed with another device.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

Supplemental report is being submitted due to the completion of the investigation on 06-feb-23.

• 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: 15615204
• MDR Text Key: 307070269
• Report Number: 3001845648-2022-00702
• Device Sequence Number: 1
• Product Code: NIU
• UDI-Device Identifier: 10827002384634
• UDI-Public: (01)10827002384634(17)240503(10)C1951091
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/06/2023

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 Expiration Date: 05/03/2024
• Device Model Number: G38463
• Device Catalogue Number: ZISV6-35-125-6-40-PTX
• Device Lot Number: C1951091
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/18/2022
• Event Location: Hospital
• Initial Date Manufacturer Received: 09/19/2022
• Initial Date FDA Received: 10/17/2022
• Supplement Dates Manufacturer Received: 09/19/2022; 09/19/2022
• Supplement Dates FDA Received: 11/24/2022; 03/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/10/2022
• 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