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

Catalog Number EVD35-07-120-120

Device Problems Fracture (1260); Activation, Positioning or Separation Problem (2906); Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)

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

Event Date 01/30/2024

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 was attempting to use an everflex entrust self-expanding stent with a 5f non-medtronic sheath and a 035 non-medtronic guidewire during treatment of a calcified lesion in the patients left distal external iliac/common femoral artery.No vessel tortuosity and moderate vessel calcification were reported.Lesion exhibited 75% 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.A 5mm evercross was used for pre-dilation.No resistance was encountered when advancing the device.The device did not pass through a previously deployed stent.The thumbscrew/lock-pin was checked for securement prior to procedure.The lock-pin broke.It was reported the stent was unable to deploy.Stent dislodgement occurred during removal following failed delivery.The stent broke in half and was partially explanted.A second 7x80 everflex entrust stent was successfully placed through the broken implanted stent.The other half of the stent was still in the delivery system and successfully removed.No patient injury reported.

Manufacturer Narrative

Image analysis image 1: this is a procedural image.The image shows the patients left distal external illiac/common femoral artery, one set of radiopaque markers from the implanted stent can be visualised.Image 2: this images shows 2 red lock pins, one has the lock tube still attached to the lock pin, while the second does not have the lock tube attached to the pin.Product analysis the device was returned with the red safety tab out of the device with the recovered portion of the stent out of the device, the device was identified by the strain relief approx 60cm of the stent was returned, the red lock tube could be observed through the handle of the device and the lock pin was returned with no portion of the red lock tube attached, the device handle was opened, the tube assembly was observed to be adhered to the gold isolation sheath and the pull cable was still intact.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: 18710274
• MDR Text Key: 335413820
• Report Number: 2183870-2024-00044
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 00821684051467
• UDI-Public: 00821684051467
• 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
• 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: EVD35-07-120-120
• Device Lot Number: B367772
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/30/2024
• Initial Date FDA Received: 02/15/2024
• Supplement Dates Manufacturer Received: 05/02/2024
• Supplement Dates FDA Received: 05/10/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/12/2022
• 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