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

Catalog Number UNKNOWN

Device Problems Obstruction of Flow (2423); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Stenosis (2263); Insufficient Information (4580)

Event Date 05/21/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Soga et al 2019 (zilver ptx) ¿ ¿one-year late lumen loss between a polymer-coated paclitaxel-eluting stent (eluvia) and a polymer-free paclitaxel-coated stent (zilver ptx) for femoropopliteal disease¿ a 0.035, 0.018 or 0.014 inch wireguide was used to cross the lesion.After passing the wire, balloon angioplasty was performed.All lesions were dilated with an optimally sized balloon.Two types of drug-eluting stents were used: eluvia (boston scientific) n=49 and zilver ptx (cook medical) n=17.The stent size was chosen to be 1mm larger than the reference vessel diameter.The lesion has to be fully covered with eluvia or zilver ptx.Late lumen loss: the lll was defined as the difference between post-procedural and follow up mld (minimum lumen diameter).Lll was significantly lower in the eluvia group (0.12±0.6 mm) than in the zilver ptx group (1.53±1.1 mm)(p=0.009).We comparatively examined 35 cases of the eluvia group and 10 of the zilver ptx group in which follow-up angiography could be performed one year later.After 12 months, mld was still significantly larger in the eluvia group (4.2±1.0 mm) than in the zilver ptx group (3.2±0.6 mm) (p= 0.0047), and lll was significantly lower in the eluvia group (0.60±0.80 mm) than in the zilver ptx group (1.74±0.89 mm) (p=0.0003).

Manufacturer Narrative

Device evaluation the zisv6 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.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.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, smoking, coronary artery disease (cad), history of ischemic stroke or transient ischemic attack, obesity and rutherford classifications between 2 and 4.Complaint is confirmed based on customer testimony.The patient outcome is unknown.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: 10762006
• MDR Text Key: 216681419
• Report Number: 3001845648-2020-00824
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): Y
• 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: 12/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2020
• 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: 05/21/2019
• Event Location: Hospital
• Date Manufacturer Received: 10/01/2020
• 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: 76 YR
• Patient Sex: Male