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

Catalog Number EVX35-05-100-120

Device Problems Premature Activation (1484); Activation, Positioning or Separation Problem (2906); Material Deformation (2976)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/19/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Physician was using an everflex entrust self-expanding stent along with a non-medtronic 5fr 90cm sheath during procedure to treat a severely calcified lesion in the distal superficial femoral artery to popliteal artery.The vessel diameter and lesion length are 5mm and 100mm respectively.The vessel was severely tortuous.There was no damage noted to packaging.There was no issue noted when removing device from hoop/tray.The device was prepped per ifu with no issues identified.Deployment issue occurred with partial deployment.It was reported that the first few clicks went well but suddenly the deployment stopped and the handle could not be rotated any further.Physician planned to retrieve the whole stent with the non-medtronic sheath but when physician pulled back the stent it jumped out and suddenly it was fully deployed.Then it was elongated from its normal length of 100mm to about 140mm and it did not cover the target lesion anymore.Physician implanted another stent more distal to fully cover the lesion.It resulted in good blood flow inside the vessel.The thumbscrew/lock-pin was checked for securement prior to procedure.The lock-pin was removed before stent deployment.The lesion was pre dilated.The device did not pass through a previously deployed stent.There was resistance encounte red when advancing the device.Excessive force was used during delivery.Physician implanted another stent more distal to fully cover the lesion to complete the procedure.The patient is alive with no injuries and with good blood flow in the target vessel.

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

Additional information: the delivery system was fully removed.There was no vessel damage noted.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 entrust sds was received with the red safety tab and tube removed from the deployment handle.The guidewire lumen and pull cable were visible within the safety tab cavity of the deployment handle.Backlighting of the distal end of the outer sheath revealed that the 100mm length stent had been deployed.The deployment handle was split opened to reveal that the pull cable was properly routed through the handle and remained bonded to the outer sheath.Image review four photographs of procedural cine images were received for analysis.The first two images are prior to the placement of the stent and show the tortuosity of the vessel being treated; left leg distal superficial femoral artery and popliteal artery.A guidewire of unknown size and model is in both images.The third image both stents have been implanted and a 40mm length 5mm diameter pta catheter is position within the stents in a non-inflated state at the distal end stents.Based on the pta radiopaque marker band spacing the two stents cover approximately 80mm in length of the treated vessel.There does appear to be highly elongated stent cells proximal, (closer to the heart), of the proximal end of the 80mm length stent marker hoops.How far the other stent is elongated cannot be determined by the contents of the image.The proximal stent proximal marker hoops are not in any of the images provided.Based on a comparison of the marker hoop diameter, to the guidewire diameter the guidewire appears to be 0.035¿ compatible.The fourth image is of the 40mm length 5mm diameter pta catheter dilating the proximal end of the 80mm length stent.Due to the quality and clarity of the image it is not possible to identify individual strut cell row proximal of the 80mm length stent.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: 10711308
• MDR Text Key: 212286809
• Report Number: 2183870-2020-00344
• Device Sequence Number: 1
• Product Code: NIP
• 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,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/16/2023
• Device Catalogue Number: EVX35-05-100-120
• Device Lot Number: B086899
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2020
• Date Manufacturer Received: 01/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1