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

Catalog Number	ZISV6-35-125-6-80-PTX
Medical Device Problem Codes	Collapse (1099); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Obstruction/Occlusion (2422); Vascular Dissection (3160)
Date of Event	08/17/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the initial reporter, "procedure was yesterday 17aug2023, physician called this afternoon stating the stent had shut down and that there was going to be another surgery today to see what was going on.The stent deployed successfully during the 1st procedure; post stent angiogram looked successful.Will find out today if the stent failed or something else might have caused the occurrence." the following information has been received via phone call on 18aug2023.Sg: 18aug2023.1.Did any unintended section of the device remain inside the patient¿s body? no.2.Was the patient hospitalized or was there prolonged hospitalization? yes possibly, waiting for confirmation, having a procedure @ 4pm (b)(6) 2023.3.Did the patient require any additional procedures due to this occurrence? yes possibly, waiting for confirmation, having a procedure @ 4pm (b)(6) 2023.4.Did the product cause or contribute to the need for additional procedures? yes possibly, waiting for confirmation, having a procedure @ 4pm (b)(6) 2023.5.Has the complainant reported any adverse effects on the patient due to this occurrence? no 6.Has the complainant reported that the product caused or contributed to the adverse effects? no the following information has been received via email on 25aug2023.Sg 28aug2023 6.Was the patient hospitalized or was there prolonged hospitalization? pt stayed overnight.7.Did the patient require any additional procedures due to this occurrence? pt was brought back to the lab and had another left leg angiogram with placement of 6x150 viabahn across occluded zptx stent.8.Did the product cause or contribute to the need for additional procedures? once 2nd left leg angiogram was done, occluded stent was visualized.Occluded stent was crossed with wire/catheter and viabahn was placed.9.Has the complainant reported any adverse effects on the patient due to this occurrence? pt had a secondary procedure the following day.10.Has the complainant reported that the product caused or contributed to the adverse effects? it is not known if the product caused or contributed to the adverse effect.The following information has been received via phone call on 18aug2023.Sg 18aug2023 3.60 are images (e.G.Angiography, us etc.) of the device and/or procedure available? will ask when attending 2nd procedure.3.61 was the device flushed before the procedure, as per ifu? yes.3.62 were there any issues with flushing of the device? no.3.63 details of the access sheath used (name, fr size,length)? terumo 6fr, 45cm 3.64 details of the wire guide used (name, diameter, hyrdophyllic)? unknown.3.65 what approach was used to access the target site? contralateral.If contralateral, was the bifurcation angle steep? unknown.3.66 what was the target location for the stent? mid to distal sfa.3.67 what artery was the stent placed in? mid to distal sfa.3.68 was the wire guide removed from the patient prior to advancing the delivery system? no, tracked over wire.3.69 if removed, was the wire guide wiped prior to advancement of the delivery system? n/a.3.70 did the stent delivery system cross the target location? unknown.3.71 was pre-dilation performed ahead of placement of the stent? yes, medtronic impact dcb.3.72 was the patient¿s anatomy difficult or altered? no.3.73 was resistance encountered when advancing the wire guide? unknown.3.74 was resistance encountered when advancing the delivery system to the target location? no.3.75 was resistance encountered when deploying the stent? no.3.76 how did the physician deal with any resistance encountered? n/a.3.77 was the stent fully deployed in the patient before removing the delivery system? yes.3.78 after deployment did the stent show signs of any of the following: compression, fracture, deformation, constraint, elongation, other : no.3.79 was post-dilation performed after the placement of the stent? unknown.3.80 did any portion of the device break off? no.3.81 when did the device break? n/a.3.82 thumbwheel only ¿ was the distal end of the stability sheath inside the access sheath? unknown.3.83 thumbwheel only ¿ was the retraction sheet being held during deployment.No.3.84 did the thumbwheel spin freely or rotate without stent release or without retracting the stent retraction sheath? unknown.¿ if yes, was the stent partially deployed? ¿ if yes, was the partially deployed stent removed with the delivery system or was it deployed in the patient? n/a, removed, deployed.3.85 if removed, did any part of the stent fracture during removal of the delivery system? no.3.86 was the delivery system kinked or twisted during advancement or deployment? no 3.87 please advise if and when any damage was observed on the;.3.87.1 wireguide -no.3.87.2 delivery system - no.3.88 what intervention (if any) was required? yes possibly, waiting for confirmation, having a procedure @ 4pm 18aug2023, unknown if it is a device failure or something that else.3.89 was the secondary intervention performed during the same procedure as the device failure or was it scheduled for another day? today 18aug2023.3.90 were any other defects (other than the complaint issue) observed on the delivery system prior to return (e.G.Kink)? no.The following information has been received via email on 25aug2023.Sg 28aug2023.3.64 details of the wire guide used (name, diameter, hyrdophyllic)? nitrex 035 wire was used.3.65 what approach was used to access the target site? contralateral access if contralateral, was the bifurcation angle steep? unknown.3.70 did the stent delivery system cross the target location? yes.3.73 was resistance encountered when advancing the wire guide? not aware of any resistance being encountered.3.79 was post-dilation performed after the placement of the stent? post dilation was not done after placement of stent.3.82 thumbwheel only ¿ was the distal end of the stability sheath inside the access sheath? uknown.3.84 did the thumbwheel spin freely or rotate without stent release or without retracting the stent retraction sheath? uknown.¿ if yes, was the stent partially deployed? ¿ if yes, was the partially deployed stent removed with the delivery system or was it deployed in the patient? n/a, removed, deployed.3.88 what intervention (if any) was required? (yes possibly, waiting for confirmation, having a procedure @ 4pm 18aug2023, unknown if it is a device failure or something that else).Additional information: i was told by the customer that the patient received plavix post-procedure at 12.
Additional Manufacturer Narrative
Pma/510(k) #: p100022/s014.Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.
Additional Manufacturer Narrative
Pma/510(k) # p100022/s014.Device evaluation: the zisv6-35-125-6-80-ptx device of lot number c2062357 involved in this complaint was implanted in the patient and was not available for evaluation.The device evaluation could not be completed as the device or photographic evidence of the device was not returned for evaluation.With the information provided, a document-based investigation was conducted.Manufacturing records review: prior to distribution all zilver ptx 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.Instructions for use and label: there is no evidence to suggest that the customer did not follow the instructions for use.It should be noted that the instructions for use (ifu0118) lists the following as potential adverse events: dissection, occlusion.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.A zilver ptx was used to treat atherosclerotic disease in the left sfa.A pre-treatment angiogram was not submitted for review to determine the degree of stenosis/occlusion prior to stent placement.2.The stent appears to have deployed uneventfully as the immediate post deployment video demonstrates good opacification of the stent lumen and good flow through the stent.Of note, there are no subtraction artifacts just proximal to the stent on the initial angiogram.3.There was no comment on initiation or continuation of dual anti-platelet therapy after stent placement, which is considered standard of care and decreases the risk of stent thrombosis.4.The follow up angiogram demonstrates no flow through a long segment of the sfa, including the segment containing the stent.There is now a very subtle subtraction artifact located just proximal to the stent, this was not present on the first angiogram.This artifact could either be a subtle dissection, or piece of calcium/calcified embolic material.Either of these possibilities could have altered the flow through this region causing the acute thrombotic event.This area was treated with a viabahn covered stent, suggesting there may have been something the physician was trying to exclude from the lumen of the artery.However, there was no discussion as to the potential reason the stent went down by the provider.5.If the physician did not place the patient on dual anti-platelet therapy, and or there was a flow limiting dissection or embolized material to the stent, these could have all resulted in the acute thrombosis of the stent.None of these events would have been caused by the stent.Root cause analysis a definitive root cause could not be determined from the available information.Following imaging review and clinical input, it was determined that the adverse events described would not have been caused by the stent and could be attributed to the patient pre-existing conditions i.E.,subtle dissection or piece of calcium/calcified embolic material that occluded the vessel.It should also be noted that dissection and occlusion are listed as known potential adverse events within the instructions for use.As per imagining review ¿if the physician did not place the patient on dual anti-platelet therapy, and or there was a flow limiting dissection or embolized material to the stent, these could have all resulted in the acute thrombosis of the stent.None of these events would have been caused by the stent.¿ corrective action/correction: complaints of this nature will continue to be monitored for potential similar events.Confirmation of complaint: complaint is confirmed based on customer testimony and/or rep testimony.Summary of investigation: according to the initial reporter, the physician called stating the stent had shut down and that there was going to be another surgery today to see what was going on.The stent deployed successfully during the 1st procedure; post stent angiogram looked successful.Patient had another left leg angiogram with placement of 6x150 viabahn across occluded zptx stent.Confirmed quantity of 01 device, confirmed used.According to the initial reporter, the occluded stent was crossed with wire/catheter and viabahn stent was placed in a secondary procedure the following day.Investigation findings conclude a possible root cause of the patients pre-existing conditions.As previously noted, dissection is listed as a potential adverse event in the instructions for use.Complaints of this nature will continue to be monitored for potential similar events.
Event or Problem Description
Supplemental report is being submitted due to the completion of the investigation on 26-apr-2024.

• Brand Name: ZILVER PTX 35 DRUG-ELUTING STENT
• Common Device Name: 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: 17754557
• Report Number: 3001845648-2023-00717
• Device Sequence Number: 6653952
• Product Code: NIU
• UDI-Device Identifier: 10827002384801
• UDI-Public: (01)10827002384801(17)250330(10)C2062357
• Combination Product (Y/N): Y
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: P100022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/30/2025
• Device Catalogue Number: ZISV6-35-125-6-80-PTX
• Device Lot Number: C2062357
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/17/2023
• Event Location: Hospital
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/18/2023
• Supplement Date Received by Manufacturer: 08/18/2023
• Initial Report FDA Received Date: 09/15/2023
• Supplement Report FDA Received Date: 05/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/13/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 79 YR
• Patient Sex: Male