MAUDE Adverse Event Report: COVIDIEN PROTEGE EVERFLEX SELF-EXPANDING STENT SYSTEM STANDARD; STENT, ILIAC

Model Number PRB35-08-040-120

Device Problems Fracture (1260); Device Dislodged or Dislocated (2923)

Patient Problems Injury (2348); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/16/2020

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Physician placed a protégé rx self-expanding stent during treatment of a calcified lesion in the patient¿s proximal, mid, and distal left common iliac artery.Moderate vessel calcification and slight tortuosity are reported.Lesion exhibited 80% stenosis.No damage was noted to the product packaging prior to use.No issues were noted when removing the device from the packaging.Ifu was followed and the device was prepped without issue.Pre-dilation was performed with a 6x40 pre-dilation device.The device was not passed through a previously deployed stent.No resistance was noted during advancement.No issues reported during deployment of the protégé everflex.During post-dilation of the protégé everflex stent, the balloon is reported to have become caught on stent causing the stent to facture.The stent is reported to have slid proximally into the distal aorta.The physician gained access on the other side and deployed bi-lateral visi-pro stents utilizing a "kissing" stent technique at the bifurcation to stabilize the protégé everflex stent.A good result is reported to have been achieved.No further injury reported.No issue reported for the visipro stents deployed.

Manufacturer Narrative

Additional information: the patient has not been given any additional treatment and there are no plans to remove the fractured protégé everflex.The patient is currently doing well.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

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: PROTEGE EVERFLEX SELF-EXPANDING STENT SYSTEM STANDARD
• Type of Device: STENT, ILIAC
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• MDR Report Key: 10704453
• MDR Text Key: 212100266
• Report Number: 2183870-2020-00341
• Device Sequence Number: 1
• Product Code: NIO
• UDI-Device Identifier: 00821684060223
• UDI-Public: 00821684060223
• Combination Product (y/n): N
• PMA/PMN Number: P110023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 02/25/2021

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 Expiration Date: 01/18/2023
• Device Model Number: PRB35-08-040-120
• Device Catalogue Number: PRB35-08-040-120
• Device Lot Number: B056508
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/16/2020
• Initial Date FDA Received: 10/20/2020
• Supplement Dates Manufacturer Received: 11/02/2020; 02/24/2021
• Supplement Dates FDA Received: 11/12/2020; 02/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention