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); Restenosis (4576)

Event Date 01/16/2020

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

Miki 2020, zilver ptx.-"impact of ivus-derived vessel size on midterm outcomes after stent implantation in femoropopliteal lesions".Purpose: to identify intravascular ultrasound (ivus) findings that predict midterm stent patency in femoropopliteal (fp) lesions.This was a retrospective review of prospectively collected data from a single center on all consecutive patients who underwent ivus examination during angioplasty and stenting of isolated de novo fp lesions between january 2010 and december 2015.Evt with primary stenting was performed via an ipsilateral or contralateral femoral approach through 6-f sheaths.Following successful navigation of a 0.014- or 0.018-inch guidewire across the target site, the lesion was predilated using a balloon with a diameter equal to the reference vessel diameter (rvd) according to visual angiographic estimation.Balloon inflation was maintained at a pressure of 4 to 10 atmospheres for 30 to 60 seconds and repeated routinely 2 to 4 times at the same segment.Subsequently, self-expanding bns [innova (boston scientific marlborough, ma, usa); misago (terumo corp, tokyo, japan); s.M.A.R.T.Control (cordis, miami lakes, fl, usa); or zilver (cook medical, bloomington, in, usa)] or drug-eluting stents(zilver ptx; cook medical) with diameters that were 1 to 2 mm larger than the rvd were deployed.Postdilation was performed routinely in all lesions with a balloon corresponding to the rvd at a pressure of 14 atmospheres.Dual antiplatelet therapy (aspirin 100 mg/d + cilostazol 100 mg/d, ticlopidine 200 mg/d, or clopidogrel 75 mg/d) was started at least 1 week prior to evt and continued for at least 6 months following stent implantation.Initial success was defined as a residual stenosis <30% and the absence of a flow-limiting dissection on angiography.This file will capture 42 cases of restenosis requiring target limb revascularisation.

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.Lab evaluation ¿ n/a.Document 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.It should be noted that restenosis of the stented artery is listed as a 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 hypertension, dyslipidaemia, diabetes, renal insufficiency and chronic limb-threating ischemia.Restenosis of the stented artery is also listed as a known potential adverse event within the ifu and is a common adverse event of endovascular procedures that can be caused by injury to the vessel (e.G.During percutaneous transluminal angioplasty (pta) and/or stenting).Vessel injury provokes an inflammatory response that leads to or amplifies the restenosis process.It may be noted that the surface of the zilver ptx stent is coated with the drug paclitaxel to help prevent subsequent restenosis of the artery.Summary: complaint is confirmed based on customer testimony.The (b)(4) patients required target limb revascularisation.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.

• 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: aisling hassett ; o halloran road; national technology park; limerick
• MDR Report Key: 10993107
• MDR Text Key: 220968299
• Report Number: 3001845648-2020-00940
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/27/2022

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?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/16/2020
• Event Location: Hospital
• Initial Date Manufacturer Received: 11/13/2020
• Initial Date FDA Received: 12/11/2020
• Supplement Dates Manufacturer Received: 11/13/2020
• Supplement Dates FDA Received: 02/22/2022
• 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: 72 YR
• Patient Sex: Male