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

Catalog Number ZISV6-35-125-5-100-PTX

Device Problems Fracture (1260); Structural Problem (2506)

Patient Problem Pain (1994)

Event Date 03/19/2015

Event Type  Injury  

Event Description

Oberto et al 2015 ¿ comparison of sfa lesion treatment with zilver ptx in diabetics vs.Non-diabetics: 2-year clinical and functional results.¿ background: prospective single-arm study, aimed at evaluating safety and effectiveness at 12 and 24 months of the paclitaxel-eluting nitinol stent (zilver ptx), and focused in particular on the treatment of complex lesions and/or diabetic patients.Between may 2010 and march 2012, 67 patients (78% males) were treated by zilver ptx, because of stenosis or occlusions of the superficial femoral artery in one of two centers.Stage renal disease).One hundred-two stents were used (1.7±0.9 per patients); median 1 (range 1-4).All patients had successful stent placement.The des evaluated in the study was the zilver ptx nitinol stent (cook medical, bloomington, in, usa), which incorporates a self-expanding, flexible nitinol stent platform with a 3 ¿g/mm2 polymer-free coating of paclitaxel on its outer surface.Thirty-two of 67 (48%) were diabetics, 14 (21%) active smokers and 11 (14.6%) had chronic renal failure (end stage renal disease).The average length of lesions was 104±60 mm.Occlusion was complete in 46.3% of cases, whereas severely calcified lesions were present in 30% of patients (18.8% in diabetics and 31.4% in non-diabetics).Twenty-six patients (39%) had type c or d lesions according to tasc 2.Stents were placed at least 1 cm below the sfaorigin and above the medial femoral epicondyle to fully cover the target lesion(s).Pre-dilatation and post dilatation were at the physician¿s discretion, with residual stenosis <30% required for procedural success.The same antiplatelet regimen was recommended for all patients.This complaint was opened to capture stent fracture and stent migration- there was only one patient who had fracture and stent migration (1.5%), determining sudden pain occurrence because of vascular occlusion.As per figure 5.¿angiogram showing post-operative stent fracture.The patient, a (b)(6), non-diabetic male, had a 210-mm sfa obstruction.The lesion was treated with 3 ptx-coated stent (two 5×100 mm, and one 6×100 mm).Four months after endovascular surgery, there was a fracture of the proximal 5×100-mm stent, detected because of sudden pain and vascular occlusion and shown in the angiogram.Require intervention/additional procedures to prevent permanent impairment/damage.

Manufacturer Narrative

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

Event Description

Supplemental mdr being submitted due to completion of investigation on 18-may-2022.

Manufacturer Narrative

Device evaluation: the zisv6 device of unknown lot number involved in this complaint was not available for evaluation.With the information provided, a document-based investigation was conducted.Document review: as the lot number of the complaint stent is unknown, a review of the relevant manufacturing records cannot be conducted.However, prior to distribution all zisv6 devices are subject to visual a visual inspection and functional checks to ensure device integrity.These inspections and functional checks are outlined in internal procedures in place at cirl.It should be noted that stent migration and stent strut fracture are known potential adverse events listed in the instructions for use (ifu0117).There is no evidence to suggest the user did not follow the ifu.Root cause review: a definitive root cause could not be determined from the available information.A possible root cause could be attributed to the very long lesion length which would be an increased risk factor for stent fracture.Since the fracture was detected due to a sudden pain, this may have been due to a sudden torsional stress that the stent could not withstand.Summary: complaint is confirmed as the failure was verified in the image.Stent fracture and stent migration was observed in the image in the literature paper.The patient required intervention/additional procedure to prevent permanent impairment/damage.

• 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: 13416341
• MDR Text Key: 285149501
• Report Number: 3001845648-2022-00048
• 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: 05/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ZISV6-35-125-5-100-PTX
• 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: 03/19/2015
• Event Location: Hospital
• Date Manufacturer Received: 01/07/2022
• 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: 76 YR
• Patient Sex: Male