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

Catalog Number EVX35-07-100-080

Device Problems Malposition of Device (2616); Activation, Positioning or Separation Problem (2906); Material Deformation (2976)

Patient Problem Insufficient Information (4580)

Event Date 10/25/2022

Event Type  Injury  

Event Description

A physician was implanting an everflex self-expanding stent with the entrust delivery system for the treatment of an 80mm fibrous lesion in the proximal region of the common iliac artery.The artery was 6mm in size with mild tortuosity and calcification.A non-mdt sheath and guidewire were used.The device was prepped as per the ifu with no abnormalities found.The lock pin was removed before placement.The lesion was pre-dilated.The stent did not pass through a previously deployed stent.No resistance was encountered.It was reported that a crossover approach from the right groin region for the left iliac lesion was used.The everflex was placed in the left iliac, but due to poor deployment, only partial deployment was possible; an attempt was made to withdraw, so the stent was deformed.An attempt was made to pull it out as is to the contralateral side of the approach site, but the stent protruded into the aorta which poses a risk of thrombosis.There is also a possibility of prolonged antiplatelet therapy.It is thought that the inner wire was cut because the thumb wheel was turned forcibly to deploy it.The stent remains implanted in the aorta is across the left cia to the right cia, and the aorta section appears to be implanted with the stent extended.The physician attempted to grab and pull out the stent using biopsy forceps but gave up.The physician is concerned about stent thrombosis and prolonged two-drug antiplatelet therapy, and additional treatment will include a double-barrelled balloon-expandable covered stent and a procedure to push the stent into place.No further patient injury was reported for this event.

Manufacturer Narrative

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

Manufacturer Narrative

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

Product analysis the device was returned with the red safety tab out of the device but still attached to the device by the tube assembly the device was returned with kinks on the outer sheath, the kinks were measured distally from the strain relief at 13.8cm.82.1cm and 85.6cm.The guidewire would not advance through the device and met resistance at the site of the kinks the device handle was opened, the tube assembly did not pull out of the handle, this resulted in the tube assembly adhering to the gold isolation sheath the pullwire was broken from the device the outer sheath was skived back, no stent was 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 patient is currently under follow-up.As there are concerns about stent thrombosis in the future, gore's vbx was used, it is being considered to place c-lab or double barrels from the terminal aortic to both sides of the cia.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
• Manufacturer (Section G): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 15803455
• MDR Text Key: 303703866
• Report Number: 2183870-2022-00387
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P110023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/08/2023

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 Expiration Date: 04/14/2023
• Device Catalogue Number: EVX35-07-100-080
• Device Lot Number: B008899
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/26/2022
• Initial Date FDA Received: 11/16/2022
• Supplement Dates Manufacturer Received: 11/18/2022; 12/06/2022; 02/01/2023
• Supplement Dates FDA Received: 11/22/2022; 12/22/2022; 02/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/14/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention