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

Model Number	EVD35-07-040-120
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/10/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Physician attempted to implant an everflex enstrust stent during a procedure.It is reported that the stent partially deployed and had to be removed.Another stent was used to compete the procedure.There was no patient injury reported.
Additional Manufacturer Narrative
Device evaluation the entrust stent delivery system, (sds), was received with the red safety tab and tube removed from the deployment handle.Neither the red safety tab nor tube were returned for evaluation.The inner guidewire lumen/pusher was exposed distally of the outer sheath, (photos 7-8), indicating that the stent had been deployed.Kinks in the catheter were noted in the exposed inner guidewire lumen and in the catheter just distal of the blue isolation sheath/strain relief.Examination of the deployment handle¿s safety tab cavity revealed no visible deformation to the inner guidewire lumen, and the pull cable is visible.The grey printed strain relief was slid distally to allow further examination of the deployment handle.The deployment handle was opened along its seams.The outer sheath is visible within the distal tip of the deployment handle.The pull cable appeared to have been properly routed through the handle, but was wrapped around the inner guidewire lumen.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 STANDARD
• Common Device Name: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• MDR Report Key: 10418765
• Report Number: 2183870-2020-00249
• Device Sequence Number: 4016120
• Product Code: NIP
• UDI-Device Identifier: 00821684051429
• UDI-Public: 00821684051429
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P110023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/19/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/10/2022
• Device Model Number: EVD35-07-040-120
• Device Catalogue Number: EVD35-07-040-120
• Device Lot Number: A945913
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2020
• Initial Date Received by Manufacturer: 08/06/2020
• Supplement Date Received by Manufacturer: 10/15/2020
• Initial Report FDA Received Date: 08/18/2020
• Supplement Report FDA Received Date: 10/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1