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 Activation, Positioning or Separation Problem (2906); Detachment of Device or Device Component (2907); Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/16/2023

Event Type  Injury  

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.

Event Description

A physician was attempting to implant an everflex entrust for the treatment of a 120mm calcified lesion with chronic total occlusion in the distal region of the superficial femoral artery.  the artery diameter was 5mm with mild tortuosity and severe calcification.The device was prepped as per the ifu with no issues identified.  a 6fr non medtronic sheath and a 260cm non medtronic j wire were used.  embolic protection was not used.  the vessel was predilated with a 4mm pre-dilation device.The stent was prepped per ifu and delivered to target lesion.The device did not pass through a previously deployed stent.Distal part of stent deployed with no issue.The length of the deployed stent in the vessel was approximately 60mm.Resistance was felt on thumbwheel halfway through deployment.Cable snapped.Handle was dismantled per instructions to complete deployment.When attempting to manually deploy it was noted that the cable broke on the distal end.It appeared that the constraining sheath was separated on the distal end as well.Stent deformation was noted.After minor manipulation the proximal half of the stent completely separated from the distal end.The entire delivery system and remaining portion of the stent was carefully retracted into the sheath and removed.Physician rewired the implanted p ortion of the stent and confirmed it  was not wired through a stent strut.The physician performed angioplasty and delivered a non medtronic stent inside the existing stent and completed the procedure with no remaining complications.

Manufacturer Narrative

Product analysis the device was returned dismantled, the device was confirmed from the strain relief as 150mm, the device was returned with approx.10mm of stent exposed from the distal end of the device, the pull cable was found to be broken away from the device, the device was returned with several kinks along the silver outer sheath, when measured at approx.10.8cm, 20.3cm, 41cm, 44.5cm and 63.9cm from the distal tip, the stent would not release manually so the device was skived back, and the stent was released, approx.105mm of stent remained, image analysis the customer returned 2 cine clips and 2 procedural images clip 1: sound only but indistinguishable clip 2: sound only but indistinguishable image 1: image one confirms the stent implant in the femoral artery.The distal end of the stent appears to be deployed for the reported 60mm and then elongated/deformed and fractured at the proximal end of the stent.Image 2: image two shows the implanted distal end of the fractured stent with a guidewire proximal in the femoral artery.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: 17254673
• MDR Text Key: 318364069
• Report Number: 2183870-2023-00245
• Device Sequence Number: 1
• Product Code: NIP
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 08/31/2023

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: B526531
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/16/2023
• Initial Date FDA Received: 07/05/2023
• Supplement Dates Manufacturer Received: 08/30/2023
• Supplement Dates FDA Received: 08/31/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/02/2023
• 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: Male
• Patient Weight: 82 KG