MAUDE Adverse Event Report: COVIDIEN EVERFLEX SELF-EXPANDING PERIPHERAL STENT WITH ENTRUST DELIVERY SYSTEM LONG; STENT, SUPERFICIAL FEMORAL ARTERY

Catalog Number EVD35-06-150-120

Device Problem Activation Problem (4042)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/07/2019

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the physician intended was using an everflex entrust rx stent to treat a severely calcified, moderately tortuous, chronic total occlusion(cto, 100%) stenotic lesion in the superficial femoral artery.There was no damage noted to the packaging and no issues noted when removing the device from the tray.The device was prepped per ifu without issue.A 6fr non-medtronic sheath and a non-medtronic guidewire were used for the procedure with no embolic protection.The device did not pass through a previously deployed stent and no resistance was encountered nor excessive force was applied during delivery of the device to the lesion.The thumbscrew was checked for securement prior to the procedure and the lock-pin was removed prior to deployment.The lesion was pre-dilated with a 4mm device.It was reported that the stent was difficult to deploy.It was reported that the stent partially deployed and the thumb wheel continued to turn but the stent would not deploy.The physician opened up the handle and finished deploying the stent.There was no patient injury reported.

Manufacturer Narrative

Product analysis: the everflex entrust was returned.No ancillary devices were included.The everflex entrust was inspected and observed the handle assembly was broken apart.It was observed the clear proximal luer was positioned forward within the grey strain relief.It was noted the pull cable was detached from the silver outer.The distal end of the pull cable was frayed.The distal tip of the catheter shaft was inspected under microscope and found the stent was not loaded and dried blood was observed on the exterior and inner lumen of the catheter.With direct lighting applied to the catheter shaft, it was observed the pusher was located approximately 13 cm from the distal tip of the catheter shaft.The stent was not returned.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

The physician opened up the handle and fully deployed the stent at the target lesion.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: EVERFLEX SELF-EXPANDING PERIPHERAL STENT WITH ENTRUST DELIVERY SYSTEM LONG
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• MDR Report Key: 8690865
• MDR Text Key: 148292526
• Report Number: 2183870-2019-00329
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 00821684051399
• UDI-Public: 00821684051399
• Combination Product (y/n): N
• PMA/PMN Number: P110023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 08/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/18/2021
• Device Catalogue Number: EVD35-06-150-120
• Device Lot Number: A710112
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2019
• Initial Date Manufacturer Received: 06/07/2019
• Initial Date FDA Received: 06/12/2019
• Supplement Dates Manufacturer Received: 06/20/2019; 08/23/2019
• Supplement Dates FDA Received: 07/02/2019; 08/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1