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

Catalog Number ZISV6-35-125-6.0-80-PTX-C-CI

Device Problem Obstruction of Flow (2423)

Patient Problems Stenosis (2263); No Code Available (3191)

Event Date 10/24/2018

Event Type  Injury  

Manufacturer Narrative

Per the initial reporter, the device will not be returned.Common name & product code = unavailable as the device lot number is unknown.Pma/510(k) number = unavailable as the device lot number is unknown.(b)(4).This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.

Event Description

It has been reported that restenosis occurred after placement of a zilver paclitaxel-eluting peripheral stent involved in a clinical study.Three study stents were placed during an index procedure on (b)(6) 2018.The study lesion was in the left proximal superficial femoral artery (sfa), measuring 140 mm in length.There was 99 % stenosis in the study lesion noted on baseline angiography.The proximal reference vessel diameter (rvd) was 4.0 mm, the distal rvd was 5.0 mm.Pre-stent dilatation was performed and the three study stents were placed without difficulty.Post-stent dilatation was performed with four balloon inflations of a 80 mm x 120 mm balloon.Final angiography measurements revealed 12% diameter stenosis in the study lesion.The patient was discharged on (b)(6) 2018.Discharge medications included aspirin and clopidogrel.On (b)(6) 2018 (209 days post-procedure), the patient was diagnosed with a 50-99% occlusion/restenosis within the study lesion, requiring intervention.Clinical signs and symptoms included worsening claudication and imaging results (angiography).Treatment included bare balloon angioplasty.The intervention was successful with residual stenosis of <50%.

Manufacturer Narrative

Additional information: during the supplier's review of the clinical imaging review document on 27feb2019, an additional failure mode was noted in one of the study stents."the review states that a fracture occurred in the stent as a result of it being stretched at implantation." this report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.

Event Description

Additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

Event Description

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

Manufacturer Narrative

Investigation - evaluation: a review of the complaint history, device history record, documentation, instructions for use (ifu), manufacturing instructions, quality control, and other documentation of the device was conducted during the investigation.No issues were found related to the reported complaint.The zisv6-35-125-6.0-80-ptx-c-ci and zisv6-35-125-6.0-60-ptx-c-ci devices of lot numbers cf1313206 and cf1310775 involved in this complaint were implanted in the patient, and were not available for evaluation; therefore, no physical examination could be performed.Prior to distribution zisv6-35-125-6.0-80-ptx-c-ci and zisv6-35-125-6.0-60-ptx-c-ci devices are subjected to a visual inspection and functional checks to ensure device integrity.A document-based investigation was performed.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 confirms the failure mode has previously occurred with the current lot numbers.However, there is no requirement to take immediate action as restenosis is listed as a known potential adverse event within the instructions for use (ifu) and it is known that 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) or patient factors (pre-existing conditions, etc.).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.In addition to the document review, images provided were reviewed during the complaint investigation.The following comments were provided by the independent reviewer: 1.Neointimal hyperplasia (nih) beginning before three months progressed to severe in-stent stenosis in both zisv6-35-125-6.0-80-ptx-c-ci stents by six months.The zisv6-35-125-6.0-60-ptx-c-ci was free of significant nih.Nih inhibition was challenged by significant untreated inflow and outflow stenoses.2.The mid-section of the distal zisv6-35-125-6.0-80-ptx-c-ci was stretched at implantation.This segment developed a type ii fracture by six months.Although severe nih developed at the fracture site, the development of severe nih elsewhere through intact stent suggests that the type ii fracture was not responsible for the severe nih.The ifu lists potential adverse events associated with the device, which include restenosis of the stented artery, stent strut fracture, and worsened claudication/rest pain.Based on the information provided, no product returned, and the results of our investigation, it has been concluded a definitive cause for the event could not be established.Monitoring will continue to be performed for similar complaints.The appropriate personnel have been notified.Per the [quality engineering] risk assessment, no further action is required.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 INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8222287
• MDR Text Key: 132244061
• Report Number: 1820334-2019-00049
• 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: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 04/17/2019

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ZISV6-35-125-6.0-80-PTX-C-CI
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/20/2018
• Initial Date FDA Received: 01/07/2019
• Supplement Dates Manufacturer Received: 02/27/2019; 03/28/2019
• Supplement Dates FDA Received: 02/28/2019; 04/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN MANUFACTURER'S BALLOON DEVICE; UNKNOWN MANUFACTURER'S BALLOON DEVICE
• Patient Outcome(s): Required Intervention
• Patient Age: 79 YR
• Patient Weight: 70