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

Catalog Number UNKNOWN

Device Problems Activation, Positioning or Separation Problem (2906); No Apparent Adverse Event (3189); Migration (4003)

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

Event Type  malfunction  

Event Description

Wooster 2016, zilver ptx, early post-registry experience with drug-eluting stents in the superficial femoral artery.Standard procedural techniques were used for lesion crossing and device deployment.Postoperatively, patients were all initiated on dual antiplatelet therapy with aspirin 81 mg and plavix 75 mg daily unless contraindicated (ie, intolerance to antiplatelet agents, alternative anticoagulation required by comorbidities).Surveillance protocol included ankle-brachial indices (abis) and toe pressure (tp) measurements immediately postprocedure as well as duplex surveillance with repeat abi/tps at 6 weeks, 3 months, 6 months, 1 year, and annually thereafter unless abnormality was noted prompting more frequent surveillance intervals.Further, early experience and discussion with other specialists using the stent even more extensively revealed a learning curve to manage the tendency of the device to ¿¿jump¿¿ on deployment leading to inaccurate placement mandating additional device use to obtain complete lesion coverage.This file captures the device jumping on deployment leading to inaccurate placement.

Manufacturer Narrative

Pma # - p100022/s027.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 the completion of the investigation.

Manufacturer Narrative

Pma # - p100022/s027.Problem statement this report comes via a literature file; ¿early post-registry experience with drug-eluting stents in the superficial femoral artery.¿ wooster 2016 as reported: standard procedural techniques were used for lesion crossing and device deployment.Postoperatively, patients were all initiated on dual antiplatelet therapy with aspirin 81 mg and plavix 75 mg daily unless contraindicated (i.E.Intolerance to antiplatelet agents, alternative anticoagulation required by comorbidities).Surveillance protocol included ankle-brachial indices (abis) and toe pressure (tp) measurements immediately postprocedure as well as duplex surveillance with repeat abi/tps at 6 weeks, 3 months, 6 months, 1 year, and annually thereafter unless abnormality was noted prompting more frequent surveillance intervals.Further, early experience and discussion with other specialists using the stent even more extensively revealed a learning curve to manage the tendency of the device to ¿¿jump¿¿ on deployment leading to inaccurate placement mandating additional device use to obtain complete lesion coverage.***this file captures the device jumping on deployment leading to inaccurate placement*** the zisv6 ptx devices of unknown lot number involved in this complaint were implanted in the patients and were not available for evaluation.With the information provided, a document-based investigation was conducted.Device evaluation the device 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.Manufacturing records review could not be completed as the lot number is unknown.Historical data was not reviewed as the lot number is unknown.There is no evidence to suggest that the customer did not follow the instructions for use.Root cause review a definitive root cause of negative feedback was identified from the available information.As per complaints description, ¿¿further, early experience and discussion with other specialists using the stent even more extensively revealed a learning curve to manage the tendency of the device to ¿¿jump¿¿ on deployment leading to inaccurate placement mandating additional device use to obtain complete lesion coverage.¿ as per clinical input ¿this is a complaint but not a specific case in this study¿.Summary this complaint/negative feedback is confirmed based on customer testimony.For complaints involving negative/positive feedback, since there is no verifiable failure mode or failure effect or harm, these complaints will not be assessed for risk.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

Supplemental report is being submitted due to the updates made to the investigation on 05-apr-2023.

Manufacturer Narrative

This complaint was raised from attached literature article ¿early post-registry experience with drug-eluting stents in the superficial femoral artery.¿ wooster 2016 and was raised to capture the device jumping on deployment leading to inaccurate placement.Device evaluation the zisv6 ptx devices of unknown lot number involved in this complaint were implanted in the patients and were not available for evaluation.With the information provided, a document-based investigation was conducted.Lab evaluation the device 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 zilver ptx 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.Historical data was not reviewed as the lot number is unknown.There is no evidence to suggest that the customer did not follow the instructions for use.It should be noted the instructions for use ifu0118 list stent migration as a possible adverse event.Image review an image was not returned for evaluation root cause review a definitive root cause could not be determined from the information available.Stents jumping on deployment can be possibly root caused to a number of reasons eg.Patients pre existing conditions, difficult patient anatomy, product handling.Zilver ptx devices are used for improving luminal diameter for the treatment of de novo or restenotic symptomatic lesions in native vascular disease of the above the knee femoropopliteal arteries.It is known from the article that the patients pre existing conditions included sfa or popliteal disease.Patients most likely have an anatomy that could possibly present resistance when attempting to deploy the stent, which would require extra force to be used, thus causing it to ¿jump¿ out.There could be tension built up in the device due to a patients anatomy which could cause the stents to jump.This tension could have been caused by the delivery system becoming compressed longitudinally, which then, in turn, could cause the stents to jump.Product handling and user technique could also be a possible root cause for stents jumping on deployment.Another possible way that stents can get compressed or jump during deployment is if the user pushes or twists the delivery system.Also, if the stability sheath is not inside the access sheath, it can also lead to stents jumping on deployment.Summary complaint is confirmed based on customer testimony.This complaint was raised from attached literature article ¿early post-registry experience with drug-eluting stents in the superficial femoral artery.¿ wooster 2016 and was raised to capture the device jumping on deployment leading to inaccurate placement.As per complaints description, ¿¿further, early experience and discussion with other specialists using the stent even more extensively revealed a learning curve to manage the tendency of the device to ¿¿jump¿¿ on deployment leading to inaccurate placement mandating additional device use to obtain complete lesion coverage.¿ there is no specific patient outcome given in the article other than need for an additional device to obtain complete lesion coverage.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: 13448990
• MDR Text Key: 296130517
• Report Number: 3001845648-2022-00065
• Device Sequence Number: 1
• Product Code: NIU
• 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: Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• 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
• Event Location: Hospital
• Date Manufacturer Received: 01/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 65 YR
• Patient Sex: Male