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 Thrombosis (2100); Thrombosis/Thrombus (4440)

Event Date 12/03/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Gouëffic et al 2019 ¿ ¿a polymer-free paclitaxel-eluting stent versus a bare-metal stent for de novo femoropopliteal lesions the battle trial¿.The misago rx, a self-expending nitinol stent with a rapid-exchange catheter, was compared with the zilver ptx, a polymer-free pes with an over-the-wire system.During the trial, available maximum lengths for misago rx and zilver ptx were 15 and 10 cm, respectively.Intervention and follow-up information is given in detail in the full protocol.Target lesion revascularisation.

Manufacturer Narrative

Pma/510(k) #: p100022/s0270.Device evaluation: the zisv6 device of unknown lot number involved in this complaint was implanted in the patient and was not available for evaluation.With the information provided, a document based investigation was conducted.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 arterial thrombosis 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.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, hyperlipidemia, diabetes, smoking, coronary artery disease (cad), renal insufficiency, obesity, history of ischemic stroke or transient ischemic attack, history of vascular surgery, history of lower limb amputation and rutherford classifications between 2 and 5.It should be noted that the ifu also lists thrombosis as a known potential adverse event.Summary: complaint is confirmed based on customer testimony.According to the initial reporter the patient required target lesion revascularisation as a result of this event.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

Supplemental report being submitted due to the investigation being completed on 16-apr-2021.Gouëffic et al 2019 ¿ ¿a polymer-free paclitaxel-eluting stent versus a bare-metal stent for de novo femoropopliteal lesions the battle trial¿.The misago rx, a self-expending nitinol stent with a rapid-exchange catheter, was compared with the zilver ptx, a polymer-free pes with an over-the-wire system.During the trial, available maximum lengths for misago rx and zilver ptx were 15 and 10 cm, respectively.Intervention and follow-up information is given in detail in the full protocol.Target lesion revascularisation.

• 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
• MDR Report Key: 9994858
• MDR Text Key: 190335959
• Report Number: 3001845648-2020-00261
• 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: company representative,health
• Type of Report: Initial,Followup
• Report Date: 04/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2020
• 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
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/03/2019
• Event Location: Hospital
• Date Manufacturer Received: 04/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention