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

Catalog Number EVX35-05-150-120

Device Problem Activation, Positioning or Separation Problem (2906)

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

Event Date 02/15/2024

Event Type  malfunction  

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 was attempting to use an everflex entrust self-expanding stent during treatment of a plaque lesion in the patients right mid superficial femoral artery (sfa).No vessel tortuosity and moderate vessel calcification are reported.Lesion exhibited 80% 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 6mm x 150 cm evercross balloon.The device did not pass through a previously-deployed stent.No resistance was encountered when advancing the device.Partial deployment of the stent was reported.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 before deployment.The defective stent was removed and a replacement stent was used to complete procedure.No patient injury reported.

Manufacturer Narrative

Additional information: no intervention was required to remove the stent from the patient, the handle was deliberately cracked to help aid with attempted deployment.No vessel damage was noted.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.Medtronic will submit a supplemental report if additional relevant information becomes known.

Manufacturer Narrative

Image analysis one video clip was returned by the customer for evaluation.Video 1: in this clip the hcp is observed with the everflex entrust device in his hands.The handle of the device is dismantled, the red locking pin and the deployment wheel can be seen out of the device.The gold inner sheath can be seen with a guidewire protruding from the back hub / luer.Product analysis the device was returned dismantled, with an unknown introducer which has a syringe attached to it, adhered to the everflex entrust device.There was a guidewire stuck in the device and a portion of the stent was exposed from the device the device was identified by the strain relief, approx 25mm of stent was exposed from the unknown introducer, the radiopaque markers were not present on the device, the pull cable was still attached to the deployment wheel and to the device, the stent was deployed by using the manual deployment method and measured approx.147mm, the guidewire was measured and measured as 0.014¿, 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.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: 18807439
• MDR Text Key: 336879902
• Report Number: 2183870-2024-00069
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: TC
• PMA/PMN Number: P110023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/10/2024

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: EVX35-05-150-120
• Device Lot Number: B380858
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/16/2024
• Initial Date FDA Received: 02/29/2024
• Supplement Dates Manufacturer Received: 03/15/2024; 05/02/2024
• Supplement Dates FDA Received: 04/10/2024; 05/10/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/07/2022
• 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