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

Model Number	G38488
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.
Event or Problem Description
"device bunched up in the center during deployment.User was able to fully deploy it and didn't notice issue until after deployment.They were able to balloon it to re-expand it (in diameter), but may have to bring patient back to check it and possibly extend it as it is still shortened (looks like about a 60 instead of an 80).Long occlusion of the sfa.Pictures available." patient outcome: did any unintended section of the device remain inside the patient¿s body? not at this time, possibly in the future.If yes, please describe.Was the patient hospitalized or was there prolonged hospitalization due to this occurrence? not at this time, possibly in the future.If yes, please describe.Did the patient require any additional procedures due to this occurrence? not at this time, possibly in the future.If yes, please describe.Did the product cause or contribute to the need for additional procedures? not at this time, possibly in the future.If yes, please specify additional procedures and provide details.Has the complainant reported any adverse effects on the patient due to this occurrence? not at this time, possibly in the future.Has the complainant reported that the product caused or contributed to the adverse effects? not at this time, possibly in the future.Please specify adverse effects and provide details.Additional information provided by (b)(6) on 16jun2021: "please provide whatever video/imagery is available of the device and/or procedure.Images will be sent separately.Was the device flushed before the procedure, as per ifu? n/a, yes, no: yes.Were there any issues with flushing of the device? n/a, yes, no: no.Details of the access sheath used (name, fr size,length)? 6/45 ansel g44154.Details of the wire guide used (name, diameter, hyrdophyllic)? hydro st g52939.What approach was used to access the target site? contralateral, ipsilateral, antegrade, retrograde, other: contralateral.Please specify for other: if contralateral, was the bifurcation angle steep? n/a, yes, no: no.What was the target location for the stent? mid sfa.What artery was the stent placed in? proximal sfa, mid sfa, distal sfa, at the ostium of the profunda, p1 (proximal popliteal), other: mid sfa.Please specify for other: was the wire guide removed from the patient prior to advancing the delivery system? n/a, yes, no: no.If removed, was the wire guide wiped prior to advancement of the delivery system? n/a, yes, no: did the stent delivery system cross the target location? n/a, yes, no: yes.Was pre-dilation performed ahead of placement of the stent? n/a, yes, no: yes.Was the patient¿s anatomy difficult or altered? previous bypass, tortuous, calcified, altered, other: calcified.If other, please specify: was resistance encountered when advancing the wire guide? n/a, yes, no: no.Was resistance encountered when advancing the delivery system to the target location? n/a, yes, no: no.Was resistance encountered when deploying the stent? n/a, yes, no: yes.How did the physician deal with any resistance encountered? continued to deploy.Was the stent fully deployed in the patient before removing the delivery system? n/a, yes, no: yes.After deployment did the stent show signs of any of the following: compression, fracture, deformation, constraint, elongation, other: compression.If other, please specify: was post-dilation performed after the placement of the stent? n/a, yes, no: yes.Did any portion of the device break off? n/a, yes, no: no.If yes, please state what part: when did the device break? n/a, prep, advancement, deployment, withdrawal, after removal: n/a.Thumbwheel only ¿ was the distal end of the stability sheath inside the access sheath? n/a, yes, no: unsure.Thumbwheel only ¿ was the retraction sheet being held during deployment.N/a, yes, no: possibly.Did the thumbwheel spin freely or rotate without stent release or without retracting the stent retraction sheath? n/a, yes, no: no.
Event or Problem Description
This supplemental report is being submitted due to completion of the investigation on the 07-apr-2023.
Additional Manufacturer Narrative
Pma/510(k) #p100022/s014.Device evaluation: user/use related complaints is considered foreseen misuse.It is unknown how the device will perform outside of instructions for use and/or labelling requirements.The user has not complied with the requirements of the ifu and/label.Trending will monitor if any future investigation is required the device evaluation for zisv6-35-125-7-80-ptx device of lot number c1815683 could not be completed as the device or photographic evidence of the 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.A review of the manufacturing records of lot number c1815683 did not reveal any discrepancies that could have contributed to this complaint issue.Review historical data: the review of relevant manufacturing records of lot number c1815683 confirms the failure mode has not previously occurred for this work order.Instructions for use/and label it should be noted that the instructions for use (ifu0118) states the following ¿a 0.035 inch(0.89mm) diameter wire guide should be used during tracking, deployment, and removal in order to ensure adequate support of the system.¿ there is evidence to 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: the provided image confirms concertinaed deployment of the zisv6-35-125-7-80-ptx.Root cause review: a definitive root cause was established.From the available information it is known a 0.14-inch guide was used.The user has not complied with the requirements of the ifu/label.As per ifu it in known that a 0.035'' wire guide is required for use with this device.It is possible that use of a non-recommended wire guide provided insufficient support to the device during use causing the stent to compress upon deployment.Confirmation of complaint: complaint is confirmed based on visual inspection.Summary of investigation: according to the customer the device bunched up in the centre during deployment.Confirmed quantity of 1 device, confirmed used.According to the initial report, the patient did not experience any adverse effects due to this occurrence.The customer was able to expand the stent in diameter using a balloon, but may have to bring patient back to check it and possibly extend it as it is still shortened.Investigation findings conclude a definitive root cause was established.From the available information it is known a 0.14-inch guide was used.It is possible that use of a non-recommended wire guide provided insufficient support causing the stent to compress upon deployment.Complaint is confirmed based on visual inspection.Complaints of this nature will continue to be monitored for potential emerging trends.

• 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: 12133733
• Report Number: 3001845648-2021-00546
• Device Sequence Number: 4601440
• Product Code: NIU
• UDI-Device Identifier: 10827002384887
• UDI-Public: (01)10827002384887(17)230209(10)C1815683
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• 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): 04/07/2023

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/09/2023
• Device Model Number: G38488
• Device Catalogue Number: ZISV6-35-125-7-80-PTX
• Device Lot Number: C1815683
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/09/2021
• Event Location: Hospital
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/09/2021
• Supplement Date Received by Manufacturer: 06/09/2021
• Initial Report FDA Received Date: 07/08/2021
• Supplement Report FDA Received Date: 05/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/31/2021
• 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: 71 YR
• Patient Sex: Unknown