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

Catalog Number ZISV6-35-125-6-100-PTX

Device Problems Fracture (1260); Structural Problem (2506)

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

Event Date 01/06/2022

Event Type  Injury  

Event Description

Per rep - 07jan2022 - the implant date was sometime in the week of (b)(6) 2021.The problem with the device was discovered yesterday (b)(6) 2022.The stent was fractured inside the vessel.They had to put another stent (not a cook device) inside that stent.The initial stent (complaint device) was placed without issue to increase flow to the future bypass area.The bypass had not yet been performed.There were no problems with the stent before the bypass procedure.The patient went to have the bypass after the stent was deployed.The interventional radiologist believes that the stent fractured during the bypass procedure.The problem was discovered during post-bypass follow up.Did any unintended section of the device remain inside the patient¿s body? no.If yes, please describe.Was the patient hospitalized or was there prolonged hospitalization due to this occurrence? the patient had to be in the hospital for the additional stenting.Did the patient require any additional procedures due to this occurrence? yes.If yes, please describe.Additional stenting.Did the product cause or contribute to the need for additional procedures? yes.If yes, please specify additional procedures and provide details.Additional stenting.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? no.Please specify adverse effects and provide details.Ziv5/ziv6/zfv6 are images of the device or procedure available? n/a, yes, no.Yes at what stage of the procedure did the complaint occur? unpacking or preparation of the device, insertion, stent placement, removing the introducer.After placement.Details of access sheath used (name, fr size, length)? unkr.What was the target location for the stent? proximal popliteal artery.Was the product inspected for kinks or damage before use? n/a, yes, no -unkr - rep not present.Was the device used percutaneously? n/a, yes, no.Yes.Was the device flushed through both flushing port before the procedure, as per ifu? n/a, yes, no.Unkr.Was pre-dilation performed ahead of placement of the stent? n/a, yes, no.Unkr.Was post-dilation performed after the placement of the stent? n/a, yes, no.Unkr.Details of the wire guide used (name, diameter, hyrdophyllic)? unkr.Did the patient exhibit difficult or altered anatomy (if altered please specify how it is altered)? n/a, tortuous, calcified, altered -total occlusion.Was resistance encountered when advancing the wire guide to the target location? n/a, yes, no.Yes.Was resistance encountered when advancing the delivery system to the target location? n/a, yes, no.Unkr.How did the physician deal with this resistance? unkr.Was the approach ipsilateral or contralateral? n/a, ipsilateral, contralateral -up an over.If contralateral, was the bifurcation angle steep? n/a, yes, no.Did the tip of the delivery system cross the target location? n/a, yes, no.Yes.Was the delivery system tracked around a tight angle in the patient anatomy? n/a, yes, no.Unkr.Was the delivery system damaged/kinked/twisted during deployment? n/a, yes, no -unkr.Was the handle pulled towards the hub during deployment? n/a, yes, no -no.Was the delivery system pushed during deployment? n/a, yes, no -no.Was the stent deployed smoothly / without resistance? n/a, yes, no -unkr.If no, please detail any difficulty experienced during deployment: what artery was the stent placed in? -distal sfa proximal popliteal.Was the stent fully deployed from the delivery system prior to removal of the delivery system? n/a, yes, no -yes.Did the patient have any pre-existing conditions? n/a, yes, no -see pt outcome.If yes, please specify: did the patient require any additional procedures as a result of this event? n/a, yes, no -yes.What intervention (if any) was required? -realignment.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 -another day.Were any other defects (other than the complaint issue) observed on the delivery system prior to return (e.G.Kink)? n/a, yes, no -no.Please specify if yes.

Manufacturer Narrative

Pma/510(k) #p100022/s014.The investigation is in progress and a follow up mdr will be submitted.

Manufacturer Narrative

Pma/510(k) #p100022/s014.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 imaging review received on 29-jan-2022.

Manufacturer Narrative

Pma 510k #p100022/s014; device evaluation; the device evaluation could not be completed as the zisv6-35-125-6-100-ptx device was not returned for evaluation.Manufacturing records; 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.Review historical data.Historical data was not reviewed as the lot number is unknown.Instructions for use and/label.It should be noted that the instructions for use (ifu0118) states the following: ¿do not use excessive force to deploy the stent¿.There is no evidence to suggest that the customer did not follow the instructions for use.Image review.Images were provided to support the complaint investigation.They were reviewed through cook research inc.(cri) and the following comments were provided by the independent reviewer: 1.The complaint of stent fracture is confirmed.The fracture was a type iii fracture.2.The less than one month interval between fracture discovery and implantation and the bedridden clinical status exclude mechanical fatigue as a fracture mechanism.3.The normal post implantation appearance excludes stretch and or twist as fracture risk factors.The interval bypass supports the implanting physician¿s impression that the fracture occurred during the bypass procedure.The surgical clips and the occlusion location indicate that the fracture location was a likely location of arterial mobilization and or clamping during the bypass procedure.Root cause analysis.A definitive root cause could not be determined from the available information.As per clinical input the imaging review confirms that the stent fracture likely occurred during the bypass procedure i.E.When the artery was mobilised or potentially clamped down on.It is unlikely that the stent would have been able to withstand this type of external compression and would certainly not be designed to do so.Confirmation of complaint.Complaint is confirmed based on visual and/or functional inspection.Summary of investigation.According to the customer the stent was fractured inside the vessel.Confirmed quantity of 1 device, confirmed used.Investigation findings conclude a definitive root cause could not be determined from the available information.As per clinical input the imaging review confirms that the stent fracture likely occurred during the bypass procedure i.E.When the artery was mobilised or potentially clamped down on.It is unlikely that the stent would have been able to withstand this type of external compression and would certainly not be designed to do so.According to the initial reporter, additional stenting was required as a result of this event.Complaint confirmed based on visual and/or functional inspection.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 25-nov-2022.

Event Description

This supplemental report is being submitted due an updated to the a code on the completed investigation on 12-apr-2023.

Manufacturer Narrative

Pma 510k #p100022/s014.Device evaluation: the device evaluation could not be completed as the zisv6-35-125-6-100-ptx device was not returned for evaluation.Manufacturing records: 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.Review historical data historical data was not reviewed as the lot number is unknown.Instructions for use and/label it should be noted that the instructions for use states the following: ¿do not use excessive force to deploy the stent¿.There is no evidence to suggest that the customer did not follow the instructions for use.Image review: images were provided to support the complaint investigation.They were reviewed through cook research inc.(cri) and the following comments were provided by the independent reviewer.The complaint of stent fracture is confirmed.The fracture was a type iii fracture.The less than one month interval between fracture discovery and implantation and the bedridden clinical status exclude mechanical fatigue as a fracture mechanism.The normal post implantation appearance excludes stretch and or twist as fracture risk factors.The interval bypass supports the implanting physician¿s impression that the fracture occurred during the bypass procedure.The surgical clips and the occlusion location indicate that the fracture location was a likely location of arterial mobilization and or clamping during the bypass procedure.Root cause analysis: a definitive root cause could not be determined from the available information.As per clinical input the imaging review confirms that the stent fracture likely occurred during the bypass procedure i.E.When the artery was mobilised or potentially clamped down on.It is unlikely that the stent would have been able to withstand this type of external compression and would certainly not be designed to do so.Confirmation of complaint is confirmed based on visual and/or functional inspection.Summary of investigation according to the customer the stent was fractured inside the vessel.Confirmed quantity of 1 device, confirmed used.Investigation findings conclude a definitive root cause could not be determined from the available information.As per clinical input the imaging review confirms that the stent fracture likely occurred during the bypass procedure i.E.When the artery was mobilised or potentially clamped down on.It is unlikely that the stent would have been able to withstand this type of external compression and would certainly not be designed to do so.According to the initial reporter, additional stenting was required as a result of this event.Complaint confirmed based on visual and/or functional inspection.Complaints of this nature will continue to be monitored for potential emerging trends.

• 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: 13422242
• MDR Text Key: 289457410
• Report Number: 3001845648-2022-00051
• 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: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ZISV6-35-125-6-100-PTX
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/06/2022
• 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 Outcome(s): Required Intervention
• Patient Sex: Male