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 Failure of Implant (1924); Obstruction/Occlusion (2422); No Information (3190)

Event Date 09/06/2018

Event Type  Injury  

Manufacturer Narrative

Pma/510(k) #p100022/s027 investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.

Event Description

Kibrik 2019 ¿a real-world experience of drug eluting and non-drug eluting stents in lower extremity peripheral arterial disease¿ a retrospective review was performed on all in patient infrainguinal lower extremity endovascular procedures between january 2014 and september 2016, which involved stent implantation.Procedures involving the common femoral artery, superficial femoral artery, and above knee popliteal artery were included.Procedures involving iliac, below knee popliteal, tibial, peroneal, and pedal arteries were excluded.The type of stent, number of stents, length of each stent, and location of stent were recorded for each procedure.Data on each patients trans-atlantic inter society consensus ii class were collected.End-points included stent thrombosis, restenosis, re-intervention, and limb loss.Post-operative arterial duplexes were obtained every three months to determine stent patency during follow-up visits.In-stent stenosis was defined as >60% narrowing on arterial duplex.Thrombosis was defined as in-stent occlusion, and limb loss involved only major amputations in the treated extremity.Bivariate analysis and students two-sample t-test were used to analyze the data.Ibm-spss ¿ 22 was used for all analyses this file was opened to capture re-intervention - 14.3% for des.

Manufacturer Narrative

Pma/510(k)#: p100022/s027.Device evaluation the unknown devices of unknown lot number involved in this complaint were implanted in the patients and were not available for evaluation.With the information provided, a document based investigation was conducted.This file was created from the journal article "40-kibrik_2019".Complaint files (b)(4) (report reference number: 3001845648-2020-00950), (b)(4) (report reference number: 3001845648-2020-00951) and (b)(4) (report reference number: 3001845648-2020-00952) were opened as a result of this paper.This file (b)(4) (report reference number: 3001845648-2020-00952) was opened to investigate re-intervention.Lab evaluation: n/a.Documents review including ifu review: as the rpn and lot number of the complaint stents are unknown, a review of the relevant manufacturing records cannot be conducted.However, prior to distribution zisv6 devices are subjected to a visual inspection and functional checks to ensure device integrity.These inspections and functional checks are outlined in internal procedures in place at cirl.The most common indications for intervention in this article were for claudication and ischemia both of which are known potential adverse event within the instructions for use (ifu0117-5).There is no evidence to suggest the user did not follow the ifu.Image review: n/a.Root cause review: a definitive root cause could not be determined from the available information.A possible root cause could be attributed to patient pre-existing/underlying conditions.From the literature article it is known that patient pre-existing conditions included coronary artery disease, hyperlipidaemia, atrial fibrillation , deep vein thrombosis critical limb threatening ischemia and diabetes.The most common indications for intervention in this article were for claudication and ischemia both of which are known potential adverse event within the instructions for use.Summary: complaint is confirmed based on customer testimony.This file was opened to capture re-intervention: 14.3% for des 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.

Event Description

Supplemental correction report is being submitted due to the file being re-opened on 18-dec-2023, from pms to update the annex e code.The risk assessment, annex c & annex d codes were also subsequently updated.

Manufacturer Narrative

Pma/510(k)#: p100022/s027.Supplemental correction report is being submitted due to the file being re-opened on 18-dec-2023, from pms to update the annex e code.The risk assessment, annex c & annex d codes were also subsequently updated.Device evaluation: the unknown devices of unknown lot number involved in this complaint were implanted in the patients and were not available for evaluation.With the information provided, a document based investigation was conducted.Lab evaluation: n/a.Documents review including ifu review: as the rpn and lot number of the complaint stents are unknown, a review of the relevant manufacturing records cannot be conducted.However, prior to distribution zisv6 devices are subjected to a visual inspection and functional checks to ensure device integrity.These inspections and functional checks are outlined in internal procedures in place at cirl.The most common indications for intervention in this article were for claudication and ischemia both of which are known potential adverse event within the instructions for use (ifu0117-5).There is no evidence to suggest the user did not follow the ifu.Image review: n/a.Root cause review: a definitive root cause could not be determined from the available information.A possible root cause could be attributed to patient pre-existing/underlying conditions.From the literature article it is known that patient pre-existing conditions included coronary artery disease, hyperlipidaemia, atrial fibrillation , deep vein thrombosis critical limb threatening ischemia and diabetes.The most common indications for intervention in this article were for claudication and ischemia both of which are known potential adverse event within the instructions for use.Summary: complaint is confirmed based on customer testimony.This file was opened to capture re-intervention - 14.3% for des 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: 11015827
• MDR Text Key: 226335992
• Report Number: 3001845648-2020-00952
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2020
• 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: 09/06/2018
• Event Location: Hospital
• Date Manufacturer Received: 12/08/2020
• 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: 73 YR