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 Problems Migration or Expulsion of Device (1395); Activation, Positioning or Separation Problem (2906)

Patient Problem Insufficient Information (4580)

Event Date 03/30/2023

Event Type  Injury  

Event Description

It was reported that an attempt was made to treat a calcified lesion in the right proximal superficial femoral artery with an everflex entrust self-expanding stent.No degree of tortuosity.Moderate degree of calcification.Unknown degree of stenosis.5fr 45cm, non medtronic sheath was used.035 glide advantage, and a non medtronic guide wire was used.Embolic protection was not used.Device prepped per ifu.It was reported that deployment issues occurred (partial deployment).There was no damage to the deployment mechanisms or device handle prior to deployment issue.Thumbscrew/lock-pin was checked for securement prior to procedure.Lock-pin was removed after stent catheter was in place, right before deployment.The lesion was predilated with a 5mm pre-dilation device.The device did not pass through a previously deployed stent.Resistance was not encountered when advancing the device.Excessive force was not used.After only partial deployment, the physician continued to try to deploy with wheel, the tech then removed strain relief and opened the handle to manually deploy.The string on wheel was severed and all tangled up.They attempted to pull copper catheter and it finally released and deployed with much difficulty.Profunda artery became jailed, procedure was aborted and patient was admitted to hospital for removal of stent.No further patient injury reported for this event.

Manufacturer Narrative

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
• Manufacturer (Section G): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 16712999
• MDR Text Key: 313042279
• Report Number: 2183870-2023-00128
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 00821684051399
• UDI-Public: 00821684051399
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P110023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EVD35-06-150-120
• Device Catalogue Number: EVD35-06-150-120
• Device Lot Number: B421734
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/03/2023
• Initial Date FDA Received: 04/11/2023
• Date Device Manufactured: 07/26/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR
• Patient Sex: Female