MAUDE Adverse Event Report: COOK IRELAND LTD ZILVER PTX DRUG-ELUTING PERIPHERAL 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 Problem Restenosis (4576)

Event Type  Injury  

Manufacturer Narrative

Pma/510(k) #: p100022/s014.Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Event Description

The chief complaint was left toe ulcer (rutherford 5).(b)(6) 2014: zilver ptx 6.0x40mm was placed to treat the 90% stenosis in the left sfa.After that, follow-ups were performed on an outpatient basis.(b)(6) 2019: a fall in abi (ankle brachial pressure index) and recurrence of intermittent claudication were confirmed.Intravascular ultrasound confirmed 90% in-stent restenosis in the left sfa, so evt was performed; boston scientific¿s stent eluvia 6x120mm x 2pcs were additionally placed from the distal sfa to the ostial sfa with covering the previously placed ptx.(b)(6) 2019: gangrene of the left limb/toe was confirmed, so additional evt was performed to treat the lesion in the anterior tibial artery and dorsalis pedis artery.During the procedure, observation inside the previously placed eluvia stents in the sfa was performed with an angioscope (ovalis's zemporshe) too as follows; terumo¿s destination 6fr 45cm sheath was placed at the edge of the distal side of the eluvia stent, then both the sheath and angioscope were pulled back.Most of the stent struts were covered with a thin neointima, but a thrombus image was also confirmed.In addition, calcification protruding from through the stent struts toward the inner lumen which was suspected to be a calcified nodule was confirmed.

Manufacturer Narrative

Pma/510(k) #: p100022/s014.Device evaluation: the zisv6 device of unknown lot number involved in this complaint 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 all zisv6 devices are subject to visual a visual inspection and functional checks to ensure device integrity.These inspections and functional checks are outlined in internal procedures in place at cirl.There is no evidence to suggest that the customer did not follow the instructions for use (ifu0117-5).However, it should be noted that restenosis of the stented artery is listed as a known potential adverse event within the ifu.The japanese packaging insert c-ci1502m06 supplied with the device complies with mhlw law no.84 of 2013 which avoids including information that is not specific to the medical device or that which is basic knowledge already understood by the healthcare professional, to ensure to accurately convey all the information that is important for the user.Root cause review: a definitive root cause could not be determined from the available information.A possible root cause could be attributed to the patient¿s pre-existing conditions.From the information provided, it is known that the patient has a history of hypertension, diabetes, chronic kidney failure and thyroid (gland) cancer.Summary: the complaint is confirmed based on customer testimony.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

Complete mdr being submitted due to the completion of investigation on 07-apr-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: aisling hassett ; o halloran road; national technology park; limerick
• MDR Report Key: 11907529
• MDR Text Key: 267286210
• Report Number: 3001845648-2021-00420
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• 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
• Event Location: Hospital
• Date Manufacturer Received: 05/11/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Sex: Female