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

Catalog Number UNKNOWN

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

Patient Problems Stenosis (2263); Obstruction/Occlusion (2422)

Event Date 01/01/2023

Event Type  Injury  

Manufacturer Narrative

Possible pma/510(k) # p100022/s014, p100022/s026, p100022/s027.Investigation is still pending, a follow-up mdr report will be submitted to include the investigation conclusions.

Event Description

Shibata et al 2023 - one year outcomes of zilver ptx versus eluvia for femoropopliteal disease in real-world practice: realdes study.Endovascular procedure: under local anaesthesia, vascular access was obtained through ipsilateral or contralateral puncture of the common femoral artery.After placing a 6 french sheath, an intra-arterial bolus of heparin (70¿100 u/kg) was administered.Furthermore, the target lesion was passed through a 0.018 inch or 0.014 inch guidewire and a support catheter.Occlusive lesions with failed transluminal recanalization were recanalized using a subintimal approach with re-entry into the true lumen.A retro-grade approach was used when required.The des selection was determined by each operator.To ensure msa, optimal vessel preparation was performed as follows: pre-dilatation was routinely performed with a diameter similar to the reference vessel diameter.The des diameter was selected to be 1 mm larger than that of the reference vessel.A minimum over-lap of 10 mm was obtained for lesions requiring more than one des.After des use, post-dilatation was routinely per-formed with the same diameter as the reference vessel.This file will capture 11 cases of restenosis (occlusive + non occlusive).Note: as per medical affairs confirmation, ¿i believe more than one device had been used in one patient.Lesion lengths in the zilver ptx group was 85.7±92.0mm.The longest ptx stent is 140mm, which means some patients had more than one stent implanted.So the ¿n¿ number refers to patient quantity, not device quantity.The actual amount of device being used is unclear.) require intervention / additional procedures s=4.

Manufacturer Narrative

Possible pma/510(k) #: p100022/s014, p100022/s026, p100022/s027.Device 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.This file was created from the literature paper ¿shibata et al 2023 - one year outcomes of zilver ptx versus eluvia for femoropopliteal disease in real-world practice: realdes study¿.It is related to pr 403163, pr 403164 and 403165 and captures 11 cases of restenosis (occlusive + non occlusive).Manufacturing records 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.Instructions for use and label: the japanese packaging insert c-ci1502m06 supplied with the device complies with mhlw law no.84 of 2013 which avoids including information that is not specific to the medical device or that which is basic knowledge already understood by the healthcare professional, to ensure to accurately convey all the information that is important for the user.This states the following: potential defects and adverse events that may occur in use of this device include restenosis or occlusion of the stented artery.There is no evidence to suggest the user did not follow the japanese packaging insert.Image review: an image was not returned for evaluation.Root cause analysis: a definitive root cause could not be determined from the available information.A possible root cause could be attributed to the patients pre existing conditions/characteristics.From the article it is known that the patients included in the study, had baseline characteristics which included hypertension, coronary artery disease, smoking and diabetes mellitus.These are all known predictors of restenosis.There is no evidence within the journal article to suggest any device malfunction or deterioration in device characteristics.As previously noted, restenosis of a stented artery and occlusion are listed as known potential adverse events within the japanese packaging insert.Confirmation of complaint: complaint is confirmed based on customer testimony and/or rep testimony.Summary of investigation: the complaint was raised from literature paper shibata et al 2023 - one year outcomes of zilver ptx versus eluvia for femoropopliteal disease in real-world practice: realdes study and captures 11 cases of restenosis (occlusive + non occlusive).Confirmed quantity of 11 patients, confirmed used.According to the medical input, the patients would have required intervention/additional procedures due to these occurrences.Investigation findings conclude a possible root cause could be attributed to the patients pre existing conditions/characteristics.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

Supplemental report is being submitted due to the completion of the investigation on 18-dec-2023.

• 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: 17350282
• MDR Text Key: 319551730
• Report Number: 3001845648-2023-00561
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): Y
• Reporter Country Code: JA
• PMA/PMN Number: P100022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/01/2023
• Event Location: Hospital
• Date Manufacturer Received: 06/21/2023
• 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
• Patient Age: 75 YR
• Patient Sex: Male