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 Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Stenosis (2263); Restenosis (4576)

Event Date 12/04/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Yong-joon lee (2020 unpublished) (zilver ptx) - "drug eluting stent vs.Drug coated balloon for native femoropopliteal artery disease: a two centre experience." under local anaesthesia, vascular access was obtained by ipsilateral or contralateral puncture of the common femoral artery.After placement of a 6e7 fr sheath, an intra-arterial bolus of heparin (70e100 u/kg) was administered.The target lesion was passed with a 0.035 or 0.018 inch guidewire, and a supporting 4e5 fr multipurpose catheter (cook medical) or 0.018 inch cxi support catheter (cook medical) was applied to cross the occlusive lesion.Generally, lesions with moderate or severe calcification were treated with a des or atherectomy plus a dcb.A des was preferred in the presence of arterial dissection after pre-dilation with a plain balloon.In lesions requiring more than one des or dcb, a minimum overlap of 10 mm was obtained.After the use of a des or dcb, post-dilation using an additional larger diameter balloon than the drug eluting device or same diameter non-compliant balloon with high pressure was performed to achieve residual stenosis < 30%.Among patients who experienced loss of primary clinical patency during the two year follow up, 66.2% (45/68) received repeat revascularisation.

Manufacturer Narrative

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, hyperlipidemia, diabetes, smoking, coronary artery disease (cad), renal insufficiency, obesity, history of ischemic stroke or transient ischemic attack, history of vascular surgery and a history of lower limb amputation.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 patients received repeat 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: 11065093
• MDR Text Key: 223394144
• Report Number: 3001845648-2020-00985
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): Y
• Reporter Country Code: KR
• 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: 12/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue 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: 10/18/2020
• Event Location: Hospital
• Date Manufacturer Received: 12/04/2020
• 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: 71 YR
• Patient Sex: Male