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

Catalog Number EVX35-06-150-120

Device Problems Malposition of Device (2616); Activation, Positioning or Separation Problem (2906)

Patient Problem Death (1802)

Event Date 07/03/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The physician attempted to use an everflex entrust self-expanding stent on the sfa dex.The lesion was highly calcified with fibrocalcific plaque and had 60% lesion stenosis.The degree of tortuosity is reported to cross over reach of the right femoral artery.There were abnormalities reported in relation to anatomy.The device was prepped per the ifu, with no issues identified.There was no damage noted to the device packaging.There was no issues noted when removing the device from the hoop/tray.There was no resistance encountered during delivery to the lesion and no excessive force was used.The physician did not have to crack the handle of the delivery system.The device did not pass through a previously deployed stent.It was reported thumbwheel issues were encountered and that the device was unable to deploy.The thumbscrew/lock-pin was checked for securement prior to procedure.The lock-pin was removed before releasing stent at location.The stent was deployed, but since the delivery mechanism was broken, it led to a nonstandard deployment of the stent, with prolongation of the straps.The device was safely removed from the patient.The procedure was completed by deploying another stent through the first one.The patient is reported to have expired, however it was reported by the physician that the death of the patient was not device related.The cause of death was heart and lung related.

Manufacturer Narrative

Device evaluation: the entrust sds was received with the red safety tab and tube removed from the deployment handle, (photo 6).The red safety tab and tube were not returned with device.The safety tab cavity of the handle was examined; no deformation of the inner guidewire lumen and the pull cable was not visible, (photo 7).The absence of seeing the pull cable in the safety tab cavity of the handle indicates that either the pull cable broke and the pull cable to outer sheath bond broke during the attempted deployment.The distal end of the silver colored outer sheath was back lighted to determine the location of the distal end of the inner guidewire lumen/pusher.The distal end of the pusher is approximately 23cm proximal of the distal end of the outer sheath.This indicates that the outer sheath has been pulled distally after the release of the stent.The kinks in the sds catheter most likely happened post procedure given how the device was packaged for return.The printed strain relief of the sds deployment handle was slid distally to allow further examination of the deployment handle.The deployment handle was split opened along its seams.The pull cable was wrapped around the thumbwheel.The pull cable pathway within the handle was examined and no unusual wear/witness marks were present to indicate that the pull cable was not properly routed through the handle.Two zones of accordion compression of the inner guidewire lumen was noted; this indicates the inner guidewire lumen was under compression forces within the handle.The proximal hub luer lock was removed from the inner guidewire lumen to allow further examination of the catheter.The blue isolation sheath was slid proximally off the inner guidewire lumen.The gold colored isolation sheath was slid proximally over the inner guidewire lumen, but progress stopped at the distal zone of accordion folding of the inner guidewire lumen.The inner guidewire lumen was cut to allow further examination of the catheter.The gold colored isolation sheath was slid proximally off the inner guidewire lumen.The proximal end of the outer sheath was examined; the pull cable had been pulled out of its weaved bond to the outer sheath.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: 10475881
• MDR Text Key: 205120982
• Report Number: 2183870-2020-00275
• 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
• Report Date: 10/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/14/2023
• Device Catalogue Number: EVX35-06-150-120
• Device Lot Number: B008800
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2020
• Date Manufacturer Received: 08/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 84 YR
• Patient Weight: 71