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

Catalog Number EVX35-05-100-120

Device Problems Entrapment of Device (1212); Activation, Positioning or Separation Problem (2906); Physical Resistance/Sticking (4012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/09/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Physician was attempting to use an everflex entrust self-expanding stent along with a non medtronic 6fr sheath and an 0.035" guide wire during procedure to treat a severely calcified lesion in the left distal sfa with chronic total occlusion (cto).The vessel is none tortuous and treated lesion length of 7mm.There was no damage noted to packaging and no issues noted when removing device from hoop/tray.The device was prepped per ifu with no issued identified.There was resistance encountered during delivery to lesion with force applied.The device did not pass through a previously deployed stent.The lesion was pre dilated using a non medtronic pta balloon.It was reported that it was not possible to release the stent because the release mechanism did not work.Physician decided to retrieve the stent, but it was not possible.The stent remains in the middle of the lesion.The sent is lodged in the proximal end of the vessel.The delivery system could be salvaged.The dislodged stent was dilated with a balloon.A non medtronic stent was implanted to complete the procedure.Abnormalities reported in relation to patient anatomy is minor wall irregularities in the major pelvic and massive kinking.There was no patient injury reported.

Manufacturer Narrative

Product analysis: the everflex entrust was returned to medtronic investigation lab and a 0.032" guidewire was loaded in the catheter shaft.The everflex entrust was inspected and found the stent was not loaded on the catheter shaft.A 0.032" guide wire was loaded on the catheter and was stuck.Approximately 13cm of the guide wire was exposed outside of the distal rim of the everflex entrust catheter shaft.The pusher was located approximately 7 cm proximal to the distal end of the catheter shaft.It should be noted the red locking pin was not loaded on the handle assembly.Dried blood was observed through out the deployment system.The thumb switch could not be rotated.Resistance was encountered.The handle assembly was cracked open and observed the inner was buckled at the distal edge of the clear luer.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: embolic protection was not used.The thumbscrew/lock-pin was checked for securement prior to procedure.During procedure lock-pin was removed.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: 9581205
• MDR Text Key: 194545316
• Report Number: 2183870-2020-00015
• 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
• Report Date: 03/05/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 09/24/2022
• Device Catalogue Number: EVX35-05-100-120
• Device Lot Number: A904058
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2020
• Initial Date Manufacturer Received: 01/09/2020
• Initial Date FDA Received: 01/13/2020
• Supplement Dates Manufacturer Received: 01/15/2020; 03/03/2020
• Supplement Dates FDA Received: 01/17/2020; 03/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Weight: 67