MAUDE Adverse Event Report: COOK IRELAND LTD ZILVER PACLITAXEL-ELUTING PERIPHERAL STENT

Catalog Number ZISV6-35-125-6.0-60-PTX-C-CI

Device Problem Occlusion Within Device (1423)

Patient Problem Occlusion (1984)

Event Date 01/15/2018

Event Type  Injury  

Manufacturer Narrative

Common name = stent, superficial femoral artery, drug-eluting; product code = niu.Per the initial reporter, the device will not be returned.(b)(4).Pma/510(k) number = p100022.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.

Event Description

It was reported that during an endovascular index procedure, two zilver paclitaxel-eluting peripheral stents were placed.One stent(zisv6-35-125-6.0-60-ptx-c-ci) in the right distal superficial femoral artery(sfa) and one stent (zisv6-35-125-6.0-60-ptx-c-ci) in the popliteal artery lesion.The baseline lesion morphology showed mild, calcified, de novo lesion.There was presence of thrombus which was successfully treated.The inflow tract was patent.There were two patent run-off vessels present.The study lesion was 90 millimeters (mm) in length.The proximal reference vessel was 5.5 mm and the distal reference vessel diameter was 5.0 mm.The percentage diameter stenosis was 80%.There were no difficulties using the stents or the delivery system.The patient had both a pre-and post-dilatation performed.The post-dilatation left a percent diameter stenosis in the study lesion of 0%.Post-stent dilatation was performed with two inflations.Three days post-procedure, the study leg ankle-brachial index (abi) was measured to be 0.9.Twenty-eight days post-procedure, the one month clinical assessment showed a study leg rutherford classification of 1 and no problems on the walking impairment questionnaire.The abi was 1.1.Fifty-nine days post-procedure, an ultrasound showed a thrombic occlusion within the ¿femoro-popliteo-crural¿ study stent and distal to the study lesion.The patient had symptoms of rest pain and rutherford class was 4.The patient was hospitalized from (b)(6) 2018 to (b)(6) 2018.A secondary intervention was performed on (b)(6) 2018.The patient was treated percutaneously with a drug-eluting balloon, a drug-eluting stent and a thrombectomy.A thrombus was retrieved from the lesion and the secondary intervention was considered successful with residual stenosis <50%.The patient remains in the study.Additional information regarding patient outcome has been requested, but is not available at this time.

Manufacturer Narrative

Outcomes attributed to adverse events: hospitalization, required intervention.The patient's hospital stay was from (b)(6) 2018 to (b)(6) 2018, for a total of four days.Additional information regarding the patient's status was received from the customer.The patient's status following their january discharge was reportedly fine, and a new follow up visit is planned for the end of (b)(6).This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Manufacturer Narrative

Investigation: evaluation.A review of the complaint history, device history record, instructions for use (ifu), manufacturing instructions, and trends of the device was conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, a document based investigation evaluation was performed.Based on the information available to date, there is no evidence to suggest that there are any manufacturing issues associated with the lot number of the complaint product.Based on the information provided, no product returned and the results of our investigation, a definitive root cause could not be determined.We will continue to monitor for similar complaints.Per the design failure mode and effect analysis, no further action is required.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

• Brand Name: ZILVER PACLITAXEL-ELUTING PERIPHERAL STENT
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick IN 47404
• MDR Report Key: 7404193
• MDR Text Key: 104661537
• Report Number: 1820334-2018-00734
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup,Followup
• Report Date: 06/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: ZISV6-35-125-6.0-60-PTX-C-CI
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/07/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 77 YR
• Patient Weight: 53