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)

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

Event Date 04/20/2023

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

Event Description

A physician was treating a patient for a 200mm calcified lesion with chronic total occlusion in the proximal region of the popliteal artery.The artery was 4.5mm with moderate calcification and mild tortuosity.A 7fr non medtronic sheath and a 0.035" non medtronic guidewire was used.Embolic protection was used with the hawkone device.A hawkone was used and then a 4x250 inpact balloon for pre-dilation.Physician noticed a dissection in the popliteal area. as a result of the dissection a 5x150mm viabahn stent was attempted to be deployed but it was getting caught by a dissection flap.The physician was able to cross a 018 4x200 terumo balloon which inflated just fine.The physician tried the viabahn stent again and it still wouldn¿t deploy.The physician then swapped out the wire using 035 trailblazer, placed 035 glidewire advantage, and deployed a 6x100mm everflex to the popliteal with no issues.More stenting was required and a 6x150mm everflex was chosen.The stent was prepped as per the ifu with no issues identified.The physician overlapped more than what is required by ifu because the room to do so was there.The stent began to deploy but it stopped deploying even though the physician was still spinning the thumb wheel.When the physician was deploying the 6x150mm stent, deployment felt normal, but then a "pop" was heard and the thumbwheel spun almost too easily.The stent had fractured during deployment and part of the stent was stuck in the delivery system.  the delivery system was removed with part of the stent still intact on the delivery catheter.No difficulty in removing the delivery system.No vessel damage reported.A 035 trailblazer was advanced to the tibials and exchanged the wire for a 018 glidewire advantage.A 5x150mm viabahn covered stent was successfully deployed to trap the fractured stent.No resistance was encountered during advancement of the device and the device passed through a previously deployed stent.

Manufacturer Narrative

Product analysis the device was returned with the red safety tab removed.The device was returned with three kinks observed to the gold isolation sheath, a kink was observed on the gold isolation sheath at approx.13.6cm, 15.3cm and 21cm when measured from the distally from the strain relief, the device was returned with approx.3mm of the stent exposed, when measured, approx.117mm of the stent was observed in the device the handle was dismantled and the pull wire was observed to be broken away from the device no functional testing could be carried out due to the condition of the returned device.Image analysis the customer returned 3 still images and 2 cine images.Upon review of the information provided, the reported dissection of a calcified chronic total occlusion in the popliteal artery reportedly occurred following the atherectomy with the hawkone and pre-dilation with the in.Pact balloon.The fluoroscopic images provided confirm the vessel dissection at the popliteal artery and subsequently the resolution of blood flow following the implant of the stents.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.

• 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: 16902439
• MDR Text Key: 314908068
• Report Number: 2183870-2023-00152
• 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,Followup
• Report Date: 06/30/2023

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: B340090
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/20/2023
• Initial Date FDA Received: 05/10/2023
• Supplement Dates Manufacturer Received: 06/14/2023
• Supplement Dates FDA Received: 06/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/17/2022
• 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: 85 YR
• Patient Sex: Male