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

Catalog Number ZISV6-35-125-6-120-PTX

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 11/14/2022

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Pt had stents placed in the right sfa via contralateral access from the left.Stents were patent post placement, and case was completed.Access was closed and patient taken off table.Patient became hypotensive and put back on table where it was determined that there was an arterial bleed on the left side.((b)(4) emdr #3001845648-2022-00874) physician accessed the contralateral side to treat the left leg where bleed was.Covered stents placed.Due to this occurrence access was maintained via sheath on the right side.Later on, it was determined that the right leg had thrombosed, ((b)(4)) and ekos was placed in the right leg via the contralateral side (left leg).Ekos left in for 48 hours and clot resolved itself.This complaint ((b)(4)) will capture the thrombosis that occurred.The following information has been received via email on 14dec2022.Sg 14dec2022 1.Lot #: i have not been able to get the lot #'s.2.Are images (e.G.Angiography, us etc.) of the device and/or procedure available? not sure if images are available.3.Was the device flushed before the procedure, as per ifu? devices were flushed per ifu.4.Were there any issues with flushing of the device? no issues were encountered when flushing the device.5.Details of the access sheath used (name, fr size,length)? 6f/45cm terumo sheath.6.Details of the wire guide used (name, diameter, hyrdophyllic)? not known.7.What approach was used to access the target site? contralateral, ipsilateral, antegrade, retrograde, other: contralateral.A.Please specify for other:null.8.If contralateral, was the bifurcation angle steep? n/a.9.What was the target location for the stent? sfa.10.What artery was the stent placed in? proximal sfa, mid sfa, distal sfa, at the ostium of the profunda, p1 (proximal popliteal), other sfa.A.Please specify for other:null.11.Was the wire guide removed from the patient prior to advancing the delivery system? no.12.If removed, was the wire guide wiped prior to advancement of the delivery system? no.13.Did the stent delivery system cross the target location? yes.14.Was pre-dilation performed ahead of placement of the stent? yes.15.Was the patient¿s anatomy difficult or altered? previous bypass, tortuous, calcified, altered, other no.A.If other, please specify: null.16.Was resistance encountered when advancing the wire guide? no.17.Was resistance encountered when advancing the delivery system to the target location? no.18.Was resistance encountered when deploying the stent? no.19.How did the physician deal with any resistance encountered? n/a.20.Was the stent fully deployed in the patient before removing the delivery system? yes.21.After deployment did the stent show signs of any of the following: compression, fracture, deformation, constraint, elongation, other: not that the rep is aware of.A.If other, please specify: null.22.Was post-dilation performed after the placement of the stent? yes 23.Did any portion of the device break off? no.A.If yes, please state what part: null.24.When did the device break? n/a, prep, advancement, deployment, withdrawal, after removal no.25.Thumbwheel only ¿ was the distal end of the stability sheath inside the access sheath? no.26.Thumbwheel only ¿ was the retraction sheet being held during deployment.No.27.Did the thumbwheel spin freely or rotate without stent release or without retracting the stent retraction sheath? no.A.If yes, was the stent partially deployed? b.If yes, was the partially deployed stent removed with the delivery system or was it deployed in the patient? n/a, removed, deployed.C.If removed, did any part of the stent fracture during removal of the delivery system? 28.Was the delivery system kinked or twisted during advancement or deployment? no.29.Please advise if and when any damage was observed on the; n/a.A.Wireguide n/a.I.Prior to use, during use, post procedure.B.Delivery system n/a, yes, no.I.Prior to use, during use, post procedure.Ii.If yes, please specify (e.G.Kinked or twisted): null.30.What intervention (if any) was required? n/a.31.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: n/a.32.Were any other defects (other than the complaint issue) observed on the delivery system prior to return (e.G.Kink)? n/a.The following information has been requested via email on 13feb2023 / 21feb2023 /02mar2023.Sg 02mar2023.1.What could have caused this thrombosis? was it an underlying condition or the procedure or device itself related? 2.Where exactly was the thrombosis - distal, proximal or within the ptx stent? the following information has been requested via email on09mar2023.Sg 09mar2023 where the clot was? ie distal proximal or within the ptx stent.The following information has been received via email on 10mar2023.Sg 10mar2023 where the clot was? ie distal proximal or within the ptx stent: according to physician it was the whole sfa and popliteal arteries.

Manufacturer Narrative

Pma 510k#p100022/s014.Device evaluation: the zisv6-35-125-6-120-ptx device evaluation could not be completed as the device involved in this complaint was not available for evaluation.With the information provided, a document-based investigation was conducted.This pr 391614 was raised to capture the thrombosis that occurred and is related to pr 381317 which was raised to capture the arterial bleed that occurred.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 the user did not follow the ifu.Instructions for use (ifu0118) also lists arterial thrombosis as a potential adverse event.Image review: an image was not returned for evaluation.Root cause review: a definitive root cause could not be determined.A possible root cause could be attributed to the procedure itself and were not related to the cook stent itself.The location of the thrombosis was stated to be the whole sfa and popliteal arteries.The doctor thought that the cause may be due to the sheaths being left in the patient for too long post procedure.This was confirmed through clinical input.As per ifu, arterial thrombosis is listed as a potential adverse event in the instructions for use.Summary: the complaint is confirmed based on customer testimony.According to the initial reporter, the physician accessed the contralateral side to treat the left leg where bleed was.Due to this occurrence access was maintained via the sheath on the right side, which later on, thrombosed.Ekos (ekosonic endovascular system) was placed in the right leg via the contralateral side (left leg).It was left in for 48 hours and the clot resolved itself.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

Complete report to be scheduled due to the completion of the investigation on 14apr2023.

• 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: 16731760
• MDR Text Key: 313207244
• Report Number: 3001845648-2023-00236
• 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,Health Professional,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/14/2023

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: ZISV6-35-125-6-120-PTX
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/14/2022
• Event Location: Hospital
• Initial Date Manufacturer Received: 03/20/2023
• Initial Date FDA Received: 04/13/2023
• Supplement Dates Manufacturer Received: 03/20/2023
• Supplement Dates FDA Received: 05/12/2023
• 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