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

Catalog Number EVD35-08-150-120

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

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/11/2024

Event Type  Injury  

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.

Event Description

Physician attempted to use an everflex entrust self-expanding stent along with a 6fr sheath and during treatment of an 80mm calcified lesion in the patients left mid distal superficial femoral artery (sfa).Little vessel tortuosity and severe vessel calcification were reported.Artery diameter reported as 6mm.Lesion exhibited cto (chronic total occlusion-100%) stenosis.There were no abnormalities reported in relation to anatomy.Embolic protection was not used.There was no damage noted to packaging (i.E.Shelf carton, hoop/tray).There were no issues noted when removing the device from the hoop/tray.The device was prepped per the ifu with no issues identified.The lesion was pre-dilated with a 5mm evercross pta balloon.The device did not pass through a previously-deployed stent.No resistance was encountered when advancing the device.It was reported upon deployment the physician stated the thumbwheel stopped working.There was no damage to the deployment mechanisms or device handle prior to deployment issue.The thumbscrew/lock-pin was checked for securement prior to procedure.The lock-pin was removed prior to deployment.Physician had forgotten how to manually deploy the stent, so he tried to pull the delivery system off the wire.This resulted in elongation of the stent outside of the in tended target zone proximal.Physician deployed two protege gps stents inside the elongated entrust stent and finished the case to his satisfaction.No patient injury occurred.

Manufacturer Narrative

Correction to regulatory rep #: 2183870-2024-00026.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

Image analysis the customer returned two images for evaluation.Both images appear to depict the left mid distal superficial femoral artery where a stent can be visualised, the stent appears to be elongated.Product analysis the device was returned with the red safety tab out of the device, the stent was deployed.The device was confirmed from the strain relief as 150mm, no stent was in the device and the stent pusher was visible at approx.33cm, the device was returned with kinks to the outer shaft at approx.14.5cm and 37.5cm distal to the strain relief and at approx.45.5cm from the distal end of the device, the handle was dismantled, and the pull cable was found to be broken away from the device, medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• 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: 18580699
• MDR Text Key: 333737657
• Report Number: 2183870-2024-00026
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 00821684051559
• UDI-Public: 00821684051559
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P110023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/08/2024

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 Catalogue Number: EVD35-08-150-120
• Device Lot Number: B404232
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/11/2024
• Initial Date FDA Received: 01/25/2024
• Supplement Dates Manufacturer Received: 01/11/2024; 04/04/2024
• Supplement Dates FDA Received: 02/08/2024; 04/08/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/22/2022
• 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
• Patient Sex: Male
• Patient Weight: 71 KG