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 09/13/2017

Event Type  Injury  

Manufacturer Narrative

Per the initial reporter, the device will not be returned.Common name = stent, superficial femoral artery, drug-eluting; product code = niu pma/510(k) number = p100022.(b)(4).Investigation - evaluation: a preliminary review of the complaint history, device history record, documentation, instructions for use (ifu), manufacturing instructions, and specifications was conducted during the investigation.The complaint device was not returned; therefore no physical examination could be performed.However, a document-based investigation was performed.There is no evidence to suggest the finished product was not made to specifications.Review of the device history record of the finished product shows no nonconforming events that could contribute to this failure mode.A complaint history search revealed that there were no other reported complaints for this lot number.Restenosis is a common adverse event of endovascular procedures and 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.The surface of the device is coated with the drug paclitaxel to help prevent subsequent restenosis of the artery.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 in the patient's left distal superficial femoral artery (sfa) lesion.One stent (zisv6-35-125-6.0-60-ptx-c-ci) was placed proximal to the lesion, and the other distal (zisv6-35-125-6.0-80-ptx-c-ci).The baseline lesion morphology showed mild calcification and a patent inflow tract.A total of three patent runoff vessels were noted.The study lesion was 120 millimeters (mm) in length, and the proximal and distal reference vessel diameter was 5.5 mm.The percentage diameter stenosis was 100%.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%.Two days post-procedure, the study leg ankle-brachial index (abi) was measured to be 0.6, and either one or both of zilver paclitaxel-eluting peripheral stents were observed to be completely occluded.No treatment was performed; the patient remained in the study.Additional information regarding event details, which stent(s) was/were occluded, and patient outcome was unable to be requested as customer contact information is unavailable.

Manufacturer Narrative

Investigation - evaluation: a review of the complaint history, device history record, documentation, and specifications was conducted during the investigation.The complaint devices were not returned; therefore no physical examination could be performed.However, both a document-based investigation and medical assessment was performed.Per the document based investigation: there is no evidence to suggest the finished product was not made to specifications.Review of the device history record of the finished product shows no nonconforming events that could contribute to this failure mode.A complaint history search revealed that there were no other reported complaints for this lot number.Per the medical assessment: implant angiography was reviewed; however, neither imaging nor a report documenting post implantation stent angioplasty was provided.Since the imaging of the occlusion was not provided, the occlusion¿s cause cannot be confirmed.However, based upon angiography review, time elapsed during implantation of final stent, and pre-existing circumstances thrombosis is overwhelmingly favored over restenosis.As per the product instruction for use, arterial thrombosis is listed under potential adverse effects.Based on the information provided and the results of our investigation, a definitive root cause could not be determined.Per the [quality engineering] risk assessment, no further action is required.Monitoring will continue to be performed for similar complaints.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.

• Brand Name: ZILVER PACLITAXEL-ELUTING PERIPHERAL STENT
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 7270824
• MDR Text Key: 100115176
• Report Number: 1820334-2018-00381
• 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
• Report Date: 04/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2018
• Is this an Adverse Event Report?: No
• 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: 04/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 55 YR
• Patient Weight: 125