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

Catalog Number EVD35-06-100-120

Device Problems Fracture (1260); Activation, Positioning or Separation Problem (2906); Material Deformation (2976)

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

Event Date 02/05/2024

Event Type  Injury  

Event Description

Physician was attempting to use an everflex entrust self-expanding stent along with a 45cm 5fr sheath during treatment of a plaque lesion in the patients right mid distal superficial femoral artery (sfa).No vessel tortuosity and moderate vessel calcification were reported.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 4mm evercross balloon was used for pre-dilation.The device did not pass through a previously-deployed stent.No resistance was encountered when advancing the device.The surgeon placed the stent over wire and to the target lesion area and pulled the red locking pin off the device.The surgeon began to deploy the stent by using the rotating thumb wheel and the stent began to deploy and stopped deploying mid-way.The rotating thumb wheel would not move and was stuck.The stent was only half deployed, so the surgeon broke the handle into 2 pieces, once the handle was broken, parts of the red locking pin were visible inside the stent tri-axial system.The surgeon used a hemostat to remove remaining red locking pieces.The surgeon pulled the string and the string broke.The stent was still only half deployed, so the surgeon used a scalpel to break apart tri-axial system.Once the surgeon dissected the device down past the blue sheath the stent finally finished deploying.Stent was deployed at the target lesion.The stent appeared to be elongated and possibly fractured once deployed on the live fluoroscopy image.Surgeon decided to re-align the stent with a new stent.Lesion was then open and image appeared normal.No patient injury reported.

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 #706237378:analysis the device was returned dismantled with damage noted to different parts of the device, most notably; the pull cable was still attached to the deployment wheel but not to the rest of the device.The red locking pin was damaged, and the lock tube had broken, also there were parts of the silver sheath cut and separate to the device, the device was identified by the strain relief, a kink and a series of what appeared like ¿chatter marks¿ were observed on the gold inner sheath from approx.12cm to 15cm from the back luer, the silver sheath was observed damaged and cut at the distal end of the blue outer sheath the red lock pin, red lock tube, a section of gold inner sheath with red lock tubing attached to it and cut pieces of silver sheath were also returned out of the device and with damage, the red lock pin was observed with a small piece of red lock tube protruding for the pin at the point of the break, 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.

Manufacturer Narrative

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: 18798621
• MDR Text Key: 336456188
• Report Number: 2183870-2024-00068
• Device Sequence Number: 1
• Product Code: NIP
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 04/26/2024

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: EVD35-06-100-120
• Device Lot Number: B636938
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/06/2024
• Initial Date FDA Received: 02/28/2024
• Supplement Dates Manufacturer Received: 04/25/2024; 04/25/2024
• Supplement Dates FDA Received: 04/26/2024; 04/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/09/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-1644-2022
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female