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

Model Number EVD35-06-150-120

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/02/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Physician used an everflex entrust self-expanding stent along with non-medtronic 6fr sheath and 0.035" guidewire during procedure to treat a severely calcified plaque lesion in the mid superficial femoral artery to popliteal artery with 55% stenosis.The vessel diameter and lesion length are 5.5mm and 150mm respectively.The vessel was moderately tortuous.There was no damage noted to packaging.There was no issue noted when removing device from hoop/tray.Ifu was followed.It was reported that device stopped deploying halfway through deployment, thumbwheel stopped working.Physician was able to crack open the stent external to the body, to complete full deployment of stent inside of body.Partial deployment occurred.The thumbscrew/lock-pin checked for securement prior to procedure.The lock-pin was removed before stent deployment.The lesion was pre dilated using 6x150 device.The device did not pass through a previously deployed stent.There was no resistance encountered when advancing the device.The stent handle was cracked open to pull on the string/wire to force deployment of the rest of stent (inside body).The stent was being deployed in the superficial femoral artery/popliteal and about halfway through deployment, the thumbwheel seemingly got stuck.When attempted to spin the thumbwheel, it fully disengaged.Physician cracked open stent handle and manually deployed the remainder of the stent via pulling on the wire attached to thumbwheel.Physician successfully deployed remainder stent with no adverse effects to the patient.There was no patient injury reported.

Manufacturer Narrative

Image review four photographic images were received for analysis.The first image is of the pouch label for the entrust stent delivery system and is consistent with the reported event description.The second image is of a cine image of the targeted vessel anatomy prior to treatment.The third image is of a cine image of the everflex stent implanted in the targeted vessel anatomy.A support catheter with radiopaque markers is positioned within the implanted stent.Due to the quality and clarity of the images individual stent struct cell rows cannot be easily identified.In the proximal section, (closest to the heart), of the stent some of the stent strut cell rows exhibit elongation.The fifth photographic image shows the entrust stent delivery handle split opened and the pull cable remains attached between the thumbwheel to the outer sheath.Images 5 and 6 are examples of self-expanding stents exhibiting offsets and elongation.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: 10828122
• MDR Text Key: 216139154
• Report Number: 2183870-2020-00383
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 00821684051399
• UDI-Public: 00821684051399
• 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
• Report Date: 01/14/2021

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: 11/03/2022
• Device Model Number: EVD35-06-150-120
• Device Catalogue Number: EVD35-06-150-120
• Device Lot Number: A926133
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/02/2020
• Initial Date FDA Received: 11/12/2020
• Supplement Dates Manufacturer Received: 01/12/2021
• Supplement Dates FDA Received: 01/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 84 YR
• Patient Weight: 63