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

Catalog Number UNKNOWN

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Activation Failure (3270)

Patient Problems Obstruction/Occlusion (2422); Restenosis (4576)

Event Date 08/03/2022

Event Type  Injury  

Event Description

Massoni 2022, ¿ real-world outcomes of cook zilver ptx in femoro-popliteal district from multicenter experience collected data from four units were retrospectively joined and analyzed considering zilver ptx deployed from august 2009 according to the instruction for use.Patient demographics, preoperative comorbidities, rutherford classification, arterial characteristics and stent data were considered.Target lesion revascularization (tlr) was defined as reintervention performed for =50% diameter stenosis after recurrent clinical symptoms.Primary outcome was the freedom from tlr (fftlr) and its risk factors.Secondary outcomes were primary patency (pp) of the stent, amputation-free survival (afs) and their risk factors.The primary patency was 85.6±5.0%, 74.2±7.6% and 72.7±8.2%, respectively.Require intervention/additional procedures to prevent permanent impairment/damage.Patient info: mena age 73.5 years.Gender: male 66.5% (135)/female 33.5% (68).

Manufacturer Narrative

Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Manufacturer Narrative

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 complaint is related to pr 384001 and was raised from the attached article.This complaint will conservatively capture (b)(4)% of patients that had loss of patency (0.273 x 203 = 55.41 patients) lab evaluation the device lab 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 drug-eluting peripheral stent 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.It should be noted that occlusion and restenosis of the stented artery are both listed as potential adverse events in the ifu0117.There is no evidence to suggest the user did not follow the ifu.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 have likely been attributed to patients¿ pre-existing condition.From the information available, the patients pre existing conditions included arterial hypertension, diabetes mellitus, dyslipidaemia, smoke habit, chronic renal failure, coronary artery disease and obesity could all lend to the occlusion and/or restenosis of the stented artery.Occlusion and restenosis of the stented artery are both listed as potential events within the ifu and are a common adverse event of endovascular procedures.Summary the complaint is confirmed based on customer testimony.The complaint was raised from the attached journal article.According to the initial reporter, 55 patients experienced a loss of patency over the 3 year period of the study.All patients required intervention/additional procedures to prevent permanent impairment/damage.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

This report is being submitted due to completion of the investigation on the 26-apr-2023.

• Brand Name: ZILVER PTX DRUG ELUTING PERIPHERAL 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: 16200274
• MDR Text Key: 307661741
• Report Number: 3001845648-2023-00046
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): Y
• Reporter Country Code: IT
• PMA/PMN Number: P100022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/26/2023

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?: 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?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/03/2022
• Event Location: Hospital
• Initial Date Manufacturer Received: 12/21/2022
• Initial Date FDA Received: 01/18/2023
• Supplement Dates Manufacturer Received: 12/21/2022
• Supplement Dates FDA Received: 05/25/2023
• 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