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 Problems Hemorrhage/Bleeding (1888); Thrombosis/Thrombus (4440)

Event Date 11/14/2022

Event Type  Injury  

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.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, and ekos was placed in the right leg via the contralateral side (left leg).Ekos left in for 48 hours and clot resolved itself.Did any unintended section of the device remain inside the patient¿s body? no.Was the patient hospitalized or was there prolonged hospitalization? yes.Did the patient require any additional procedures due to this occurrence? not known.Did the product cause or contribute to the need for additional procedures? not known.Has the complainant reported any adverse effects on the patient due to this occurrence? not known.Has the complainant reported that the product caused or contributed to the adverse effects? unsure.Please specify adverse effects and provide details.The following information has been received via email on (b)(6) 2022.(b)(6) 2022.1.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: 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: 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: 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: 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: 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): 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.

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 confirmation from medical affairs 16-mar-2023 that arterial bleed and thrombosis are two different harms.As a result, (b)(4) has been updated to include arterial bleed only and a new (b)(4) will capture thrombosis.Updates made to brief description, description of events and annex e and to capture the completion of the investigation on 11-apr-2023.

Manufacturer Narrative

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 (b)(4) was raised to capture the arterial bleed that occurred and is related to pr 391614 which was raised to capture the thrombosis 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 vessel perforation or rupture 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 was not related to the cook stent itself.The bleeding could possibly have occurred due to the sheaths being left in place in the patient post procedure for too long.As per ifu, vessel perforation or rupture 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 and covered stents were placed.Patient outcome since is unknown.Should this information become available at a later date, the file can be re-opened and update accordingly.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: 15995078
• MDR Text Key: 305592055
• Report Number: 3001845648-2022-00874
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 03/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2022
• 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
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/14/2022
• Event Location: Hospital
• Date Manufacturer Received: 11/28/2022
• 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