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

Catalog Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Obstruction/Occlusion (2422); Restenosis (4576)

Event Type  Injury  

Manufacturer Narrative

Pma # - p100022/s027.Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.

Event Description

Wooster 2016, zilver ptx, early post-registry experience with drug-eluting stents in the superficial femoral artery.Standard procedural techniques were used for lesion crossing and device deployment.Postoperatively, patients were all initiated on dual antiplatelet therapy with aspirin 81 mg and plavix 75 mg daily unless contraindicated (ie, intolerance to antiplatelet agents, alternative anticoagulation required by comorbidities).Surveillance protocol included ankle-brachial indices (abis) and toe pressure (tp) measurements immediately postprocedure as well as duplex surveillance with repeat abi/tps at 6 weeks, 3 months, 6 months, 1 year, and annually thereafter unless abnormality was noted prompting more frequent surveillance intervals.Over a mean 62-week follow-up, 2 occlusions were noted (mean 27 weeks) for primary patency of 92.3% and secondary patency of 96.2%.One occlusion was treated with surgical bypass and the other with endovascular salvage.Review of completion angiograms from the index procedures demonstrated severely compromised outflow in the patient later treated with a fem-distal bypass.A residual stenosis just distal to the stent was noted in the second, which was salvaged with a repeat angioplasty and additional stent placement.Capturing restenosis and occlusion and intervention one with surgical bypass and other with additional stent placement.

Manufacturer Narrative

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 restenosis of the stented artery and occlusion are listed as a known potential adverse events within 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 patient pre-existing/underlying conditions.From the literature article it is known that patient pre-existing conditions included hypertension, hyperlipidemia, diabetes, smoking, pulmonary disease, renal insufficiency, and critical limb 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.Occlusion 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 obstruction to the vessel (e.G.During percutaneous transluminal angioplasty (pta) and/or stenting).Summary: complaint is confirmed based on customer testimony.From the literature article is known that one occlusion was treated with surgical bypass and the other with endovascular salvage additional stent placement.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

Final mdr being submitted due to competion of investigation on 23-may-2022.

• Brand Name: ZILVER PTX DRUG-ELUTING PERIPHERAL 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: 13450843
• MDR Text Key: 289273851
• Report Number: 3001845648-2022-00068
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): Y
• Reporter Country Code: US
• 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: 05/23/2022

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 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
• Event Location: Hospital
• Initial Date Manufacturer Received: 01/07/2022
• Initial Date FDA Received: 02/04/2022
• Supplement Dates Manufacturer Received: 01/27/2022
• Supplement Dates FDA Received: 06/20/2022
• 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: 64 YR
• Patient Sex: Male