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

Catalog Number UNKNOWN

Device Problem Off-Label Use (1494)

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

Event Type  malfunction  

Manufacturer Narrative

Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Event Description

I was notified today of a product complaint involving one of our zilver ptx stents.Dr (b)(6), a vascular surgeon from (b)(6), called me regarding a finding she made while doing an angiogram of her patient¿s left leg.She found that a zilver ptx stent that she placed in (b)(6) 2016 had fractured and possibly caused a pseudoaneurysm in the left sfa.Patient had no complaints, pain, or discomfort, but dr (b)(6) will now need to do an additional surgery or endo procedure to repair the artery.Additional information provided by fsm on (b)(6) 2020: if the patient has surgery it may be possible to return the fractured stent.(b)(6) 2016: date of zilver stent placement.Percutaneous transluminal balloon angioplasty of left femoral to popliteal bypass graft at anastomotic site between polytetrafluoroethylene and saphenous vein graft in proximal thigh utilizing 5 mm x 2 cm, 5 mm x 4 cm, and 6 mm x 2 cm cook advance angioplasty balloons) with stent deployment x2 (overlapping) at this site (cook zilver 6 mm x 6 cm and cook zilver 6 mm x 4 cm stents).Off-label use: used in bypass vessel (non-native vessel).User statement forwarded from fsm on (b)(6) 2020: "two overlapping stents proximal stent: cook zilver 6 mm x 4 cm, distal fractured stent: cook zilver 6 mm x 6 cm, stents are within a gore ptfe graft.At some point, i plan to surgically intervene on this problem ¿ likely will be graft and stent removal with graft reconstruction intraop it may determined that with scarring, best be to bypass around the problem and leave the stent in place.If i remove stent, i believe it can be sent back to cook".This file has been opened to capture the off-label use of the second zilver ptx, used in bypass vessel (non-native vessel).Additional information provided by initial reporter on 30sep2020: "can it be determined if the cook device was a contributing factor to the fracture? undeterminable can it be determined if the cook device was a contributing factor to the pseudoaneurysm? undeterminable".General questions for complaint occurring during use, request the following: where was the access site? what was the patient¿s anatomy? i.E.Scarred, tortuous, calcified, etc.Undeterminable what was the target location for the stent? undeterminable was the target location severely calcified or tortuous? undeterminable was the device flushed prior to use? were there any difficulties deploying the stent? undeterminable was the stent fully deployed before removing the delivery system from the patient? undeterminable what other devices were used in the procedure? 5 mm x 2 cm, 5 mm x 4 cm, and 6 mm x 2 cm cook advance angioplasty balloons) with stent deployment x2 (overlapping) at this site (cook zilver 6 mm x 6 cm and cook zilver 6 mm x 4 cm stents).Please provide manufacturer, model, brand, and size if possible.Patient outcome: did any unintended section of the device remain inside the patient¿s body? if yes, please describe.Was the patient hospitalized or was there prolonged hospitalization due to this occurrence? if yes, please describe.Did the patient require any additional procedures due to this occurrence? "dr (b)(6) will now need to do an additional surgery or endo procedure to repair the artery." if yes, please describe.Did the product cause or contribute to the need for additional procedures? "dr (b)(6) will now need to do an additional surgery or endo procedure to repair the artery." if yes, please specify additional procedures and provide details.Has the complainant reported any adverse effects on the patient due to this occurrence? "possibly caused a pseudoaneurysm in the left sfa.Patient had no complaints, pain, or discomfort": has the complainant reported that the product caused or contributed to the adverse effects? "possibly caused a pseudoaneurysm in the left sfa.Patient had no complaints, pain, or discomfort": please specify adverse effects and provide details.Did any unintended section of the device remain inside the patient¿s body? if yes, please describe.Was the patient hospitalized or was there prolonged hospitalization due to this occurrence? if yes, please describe.Did the patient require any additional procedures due to this occurrence? "dr (b)(6) will now need to do an additional surgery or endo procedure to repair the artery." if yes, please describe.Did the product cause or contribute to the need for additional procedures? "dr (b)(6) will now need to do an additional surgery or endo procedure to repair the artery." if yes, please specify additional procedures and provide details.Has the complainant reported any adverse effects on the patient due to this occurrence? "possibly caused a pseudoaneurysm in the left sfa.Patient had no complaints, pain, or discomfort": has the complainant reported that the product caused or contributed to the adverse effects? "possibly caused a pseudoaneurysm in the left sfa.Patient had no complaints, pain, or discomfort": please specify adverse effects and provide details.

Event Description

Supplemental follow-up report is being submitted due to the receipt of image review.

Manufacturer Narrative

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

Manufacturer Narrative

Pma/510(k) # p100022/s027.Device evaluation : the device of unknown rpn and lot number for this complaint has not yet been returned for evaluation.With the information provided, a document-based investigation was conducted.The investigation will be updated once the device has been returned and evaluated.Lab evaluation : the device related to this occurrence underwent a laboratory evaluation on the 19 march 2021.Only part of the fractured stent (two pieces of approximately 2.0cm in total) was returned.One of the pieces measured approximately 1.5cm.This piece had 4 gold rivets on one end and was heavily calcified/soiled.The other piece was approximately 0.5cm in length.This consisted of only a few struts which looked to be fractured.Document review: as the rpn and lot number of the complaint stents are unknown, a review of the relevant manufacturing records cannot be conducted.However, prior to distribution all zilver ptx devices are subject to visual a visual inspection and functional checks to ensure device integrity.These inspections and functional checks are outlined in internal procedures in place at cirl.It should be noted that the intended use (ifu0118-6) states the following: ¿¿ the zilver ptx drug-eluting peripheral stent is indicated for improving luminal diameter for the treatment of den-novo or restenosis symptomatic lesions in native vascular disease of the above the knee femoropopliteal arteries having reference vessel diameter from 4mm to 7mm and total lesion length up to 300mm per patient.There is evidence suggest the user did not follow the ifu.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: impression: 1.The complaint of zisv6-35-125-6-60-ptx fracture and pseudoaneurysm formation is confirmed.The pseudoaneurysm likely involved the proximal svg.2.The pseudoaneurysm was more likely the result rather than the cause of the fracture.Ptfe graft is stiffer than vein.The stent overlap added additional stiffness.This would have shifted bending and twisting forces from hip flexion towards the svg.Consequently, repetitive bending and twisting would have been focused at the stent and svg immediately downstream the overlap.Over the course of years, the stent fractured and progressively fragmented.The pseudoaneurysm was the result of motion against the fracture fragments.3.Although it is possible that the pseudoaneurysm preceded stent fracture, this is less likely because it assumes either an unreported svg rupture at implantation or drug induced change.Drug induced change is unlikely because it should have involved the entire length svg exposed to the stent.Root cause review: a definitive root cause of off- label use was identified from the available information.From the description it is known that the stent was placed in a bypass graft this is considered a non-native vessel.As per the ifu this is considered off- label use and possibly contributed to the stent fracture.From clinical input received it is known that the pseudoaneurysm was a cascading effect of the stent fracture.Summary: the complaint is confirmed based on customer testimony as the failure was verified in the images.According to the initial reporter, the physician will now need to do an additional surgery or endo procedure to repair the artery.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.

• 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: aisling hassett ; o halloran road; national technology park; limerick
• MDR Report Key: 10725852
• MDR Text Key: 212998369
• Report Number: 3001845648-2020-00817
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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: 09/28/2020
• 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: 56 YR
• Patient Sex: Female