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

Model Number EVD35-07-150-120

Device Problems Activation, Positioning or Separation Problem (2906); Device Dislodged or Dislocated (2923)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 04/18/2022

Event Type  Injury  

Manufacturer Narrative

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 with a non-medtronic 6fr.Sheath and non-medtronic 0.014 guidewire during treatment of an 8-10cm plaque lesion in the patient's mid right superficial femoral artery (sfa) of diameter 6mm.No tortuosity and moderate calcification reported.Embolic protection was not used.Pre-dilation was not performed.There was no damage noted to packaging (i.E.Shelf carton, hoop/tray).No issues were noted when removing the device from the hoop/tray.The device was prepped with no issues identified.The thumbscrew/lock-pin was checked for securement prior to procedure and removed prior to deployment attempt.The device was passed through a previously deployed stent with no resistance encountered during advancement.Deployment difficulties are reported.Physician used the thumbwheel for deployment but the stent was not fully deployed, approximately 50mm deployed.During the physician's attempt to remove the partially deployed stent, stent dislodgement occurred.Partial explant of the stent was completed with the stent removed from the patient with the markers dislodged.A new stent was implanted to complete the procedure.No patient injury reported.

Manufacturer Narrative

Additional information: stent placement was not adjusted after initial flowering of stent, as stent stopped flowering mid deployment.The handle of the delivery system was cracked open during deployment attempt to aid stent deployment as a last option.The delivery system was safely removed from the patient.The stent was removed over the wire, pulled through sheath.There were no attempts made to remove the marker-bands as physician did not think it was necessary.There was no vessel damage noted.Patient's age, weight and medical history provided.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.

Manufacturer Narrative

Product analysis the device was returned in a partial state, with no handle and two sections of broken stent the strain relief shows it is a 150mm stent the 2 sections of stent measure approx.110mm, with one piece measuring approx.17mm and the other measuring approx.93mm the silver retractable outer sheath was torn at approx.20mm the gold isolation sheath was severely kinked for approx.60mm the pull wire on the deployment wheel was broken the guidewire returned with the device and tangled up with it was a 0.014¿ guidewire, which was measured on the micrometer.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

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
• 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: 14414690
• MDR Text Key: 291856280
• Report Number: 2183870-2022-00178
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 00821684051474
• UDI-Public: 00821684051474
• 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,Followup
• Report Date: 11/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EVD35-07-150-120
• Device Catalogue Number: EVD35-07-150-120
• Device Lot Number: B338652
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/18/2022
• Initial Date FDA Received: 05/17/2022
• Supplement Dates Manufacturer Received: 05/17/2022; 09/21/2022; 09/21/2022
• Supplement Dates FDA Received: 05/20/2022; 09/22/2022; 11/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/14/2022
• 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 Age: 81 YR
• Patient Sex: Male
• Patient Weight: 95 KG