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

Catalog Number ZISV6-35-125-6-140-PTX

Device Problems Dent in Material (2526); Physical Resistance/Sticking (4012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/29/2023

Event Type  malfunction  

Event Description

Upon deployment, the stent delivery system was met with significant resistance trying to move the thumbwheel to the point where full deployment was not possible.Physician was able to manipulate the device to eventually have the stent deploy and successfully remove the delivery system with no harm to the patient.During a call on 05july2023, dm stated that the handle is opened where the user attempted to either see what was going wrong or investigate the device after the case.Ar 05jul2023 did any unintended section of the device remain inside the patient¿s body? no was the patient hospitalized or was there prolonged hospitalization? no did the patient require any additional procedures due to this occurrence? no did the product cause or contribute to the need for additional procedures? no has the complainant reported any adverse effects on the patient due to this occurrence? no has the complainant reported that the product caused or contributed to the adverse effects? na.

Manufacturer Narrative

Pma/510(k) #p100022/s026 investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Manufacturer Narrative

Pma/510(k) #p100022/s026#.Device evaluation the zisv6-35-125-6-140-ptx device of lot number c2045252 involved in this complaint was returned for evaluation without the original packaging.With the information provided, a physical examination and document-based investigation was conducted.The device related to this occurrence underwent a laboratory evaluation on the 15th aug 2023.Refer to the returned product-notes field for lab attendance and lab evaluation notes.The returned device lab examination findings and observations can be referred through attached photos.On evaluation of the device the following was noted: visual inspection: device returned disassembled.Handle opened and all the inner components returned separately.Multiple kinks and crinkling observed on the delivery system.Proximal inner broken.Retraction wire broken and blue plastic fragment observed on the retraction wire.Functional inspection: unable to complete functional inspection as the device was returned disassembled.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 did not reveal any discrepancies that could have contributed to this complaint issue.Review historical data: the review of relevant manufacturing records confirms the failure mode has not previously occurred for this work order.Instructions for use/label: instructions for use (ifu0118) states the following: ¿if high resistance is felt on the thumbwheel prior to stent deployment, do not force deployment¿ and "recapature or re-sheathing of the zilver ptx drug-eluting peripheral stent is not possible because the stent retraction sheath cannot be re-advanced".There is no evidence to suggest that the customer did not follow the instructions for use (ifu0118).Image review: an image was not returned for evaluation.Root cause review: a definitive root cause could not be concluded from the limited information available.A possible root cause may be attributed to a possible difficult patient anatomy.If the patients anatomy was calcified or tortuous, this could have caused and/or contributed to resistance during advancement and/or deployment exerting excessive force on the device.This may have caused kinks to form on the delivery system which would have resulted in a need for greater force to be used when attempting deployment.A high deployment force used during the deployment may have resulted in extra pressure being applied to the retraction wire (possibly due to kinks occurring on the proximal end of the proximal inner catheter either prior to advancement or during advancement).Significant damage was seen here in the lab evaluation, and this could have resulted in the significant resistance the user felt when attempting deployment.As the user has stated that the system was met with resistant to the point where full deployment was not possible, it is assumed that the stent had being partially deployed.Other possible root causes might be attributed to misuse or device handling technique.It is known the user was able to manipulate the device to eventually have the stent deploy and the handle was returned disassembled.We are unable to tell how much damage was caused by the device malfunctioning or if the damage to the device occurred during/after the removal from the patient when the user disassembled the handle.Very limited information was provided by the user to assist with identifying the complaint.Three attempts were made to obtain more information relevant to this complaint but were unsuccessful in doing so.No further information could be obtained.Should more information regarding this complaint become available at a later date, the file can be re-opened and re-assessed accordingly.Confirmation of complaint: complaint is confirmed based on customer and/or rep testimony.Corrective action/correction: complaints of this nature will continue to be monitored for potential emerging trends.Summary: according to the initial reporter, upon deployment, the stent delivery system was met with significant resistance trying to move the thumbwheel to the point where full deployment was not possible.Physician was able to manipulate the device to eventually have the stent deploy and successfully remove the delivery system with no harm to the patient.During a call on (b)(6) 2023, dm stated that the handle is opened where the user attempted to either see what was going wrong or investigate the device after the case.Confirmed quantity of 01 device, confirmed used.According to the initial reporter, the physician was able to manipulate the device to eventually have the stent deploy and successfully remove the delivery system with no harm to the patient.Investigation findings conclude a definitive root cause could not be determined due to the limited information available.Possible root causes might be attributed to a possible patient anatomy, misuse or device handling technique.

Event Description

Supplemental report is being submitted due to the completion of the investigation on 19-jan-2024.

• 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: 17412444
• MDR Text Key: 319923640
• Report Number: 3001845648-2023-00588
• Device Sequence Number: 1
• Product Code: NIU
• UDI-Device Identifier: 10827002384832
• UDI-Public: (01)10827002384832(17)250228(10)C2045252
• Combination Product (y/n): Y
• Reporter Country Code: US
• 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: 01/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ZISV6-35-125-6-140-PTX
• Device Lot Number: C2045252
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/29/2023
• Event Location: Hospital
• Initial Date Manufacturer Received: 07/05/2023
• Initial Date FDA Received: 07/28/2023
• Supplement Dates Manufacturer Received: 07/05/2023
• Supplement Dates FDA Received: 01/30/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/20/2023
• 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