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

Model Number E

Device Problems Entrapment of Device (1212); Fracture (1260); Detachment of Device or Device Component (2907)

Patient Problems No Consequences Or Impact To Patient (2199); Device Embedded In Tissue or Plaque (3165)

Event Date 10/02/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the physician intended to use an everflex self-expanding peripheral stent as part of a procedure to treat the superficial femoral artery (sfa).The artery was reported to be moderately calcified artery and moderately tortuous.A 5fr sheath was used.There was no embolic protection used.The ifu was followed during preparation and procedure.The lesion was pre-dilated with a 4 fr device.It was reported that the physician noticed an issue when removing the device from the hoop/tray.During the procedure it is reported the device was unable to be removed from the guidewire.It was alleged that the catheter broke apart and the detached portion remains in the patient.The procedure was not completed.There was no reported patient injury.

Manufacturer Narrative

Image review: ten photographs of the stent delivery system and support catheter were provided for evaluation.The first photograph is of a procedure note written in spanish.The second image is of the deployment handle.The device appears to be loaded onto a 0.035¿ compliant guidewire.The inner guidewire lumen is protruding from the safety tab cavity of the deployment handle.A portion of the pull cable is protruding from a seam at the proximal end of the handle.Photographs three through five are of the deployment handle at different angles showing the inner guidewire protruding from the safety tab cavity and the pull cable protruding from a seam in the handle.Photographs six through nine are of a support introducer sheath and the protégé everflex stent.In photographs six through eight the proximal end of the stent with its radiopaque marker hoops is visible protruding from the hemostatic valve of the support introducer sheath.In photograph nine the fracture face of the stent is protruding from the distal end of the support introducer sheath.The distal end of the introducer sheath exhibits compression damage and flaring.Photograph ten is of the device¿s labelled shelf carton.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

Code update in h.2.Additional information: a 0.035 non-medtronic guidewire was used.Balloon pre-dilation was carried using a 2mm and 5mm balloon.Upon deployment attempt, the lock pin was removed and the stent partially deployed.It was reported that the guidewire locked up on the delivery system.The physician attempted to trace the delivery system and a fracture was noted in the handle.Physician tried to force stent deployment but the stent got caught in the introducer.The stent delivery system and guidewire were removed in tandem but 20% of the stent fractured in the subcutaneous tissue.Attempts were made to remove the fractured portion of the stent but it got caught in the femoral access.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

Additional information: the fracture occurred in the distal portion of the stent.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.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

Correction to h10: it should read: ¿the fractured part of the stent remains in the subintimal tissue without any involvement¿ and not the fractured part of the catheter remains in the subintimal tissue without any involvement.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

Additional information: the fractured portion of the stent was attempted to be removed once through the same introducer.The physician experienced withdrawal difficulty and left the fractured stent inside the patient.The fractured part of the catheter remains in the subintimal tissue without any involvement.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
• MDR Report Key: 9184447
• MDR Text Key: 194827722
• Report Number: 2183870-2019-00496
• Device Sequence Number: 1
• Product Code: NIP
• 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,foreig
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 12/19/2019

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 Expiration Date: 10/10/2020
• Device Model Number: E
• Device Catalogue Number: EVX35-05-100-120
• Device Lot Number: A537366
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/09/2019
• Initial Date FDA Received: 10/14/2019
• Supplement Dates Manufacturer Received: 10/15/2019; 11/08/2019; 11/18/2019; 11/18/2019; 12/18/2019
• Supplement Dates FDA Received: 10/24/2019; 11/11/2019; 11/20/2019; 11/20/2019; 12/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 65 YR