MAUDE Adverse Event Report: MEDTRONIC IRELAND ENDO ANCHOR SYSTEM - HELI-FX AAA; ENDOVASCULAR SUTURING SYSTEM

Model Number SA-85

Device Problems Leak/Splash (1354); Device Dislodged or Dislocated (2923)

Patient Problem Insufficient Information (4580)

Event Date 01/27/2023

Event Type  Injury  

Event Description

An endurant iis stent graft system and heli-fx endoanchors were implanted during the endovascular treatment of a 55mm abdominal aortic aneurysm.It was reported approximately 5 years post the index procedure, follow up ct identified a type ia endoleak.The physician believed it was due to the presence of a large plaque in the neck.On (b)(6) 2023 intervention was completed.Imaging during the intervention showed 1 of the endoanchors could be clearly seen 2cms below the others in a vertical position.The physician believed the endoanchor became dislodged as all the endoanchors (6) were implanted at same level during the index procedure.The physician resolved both issues the by snorkeling/chimney the left renal and used a 36x49 endurant cuff deployed up to the right renal which was the higher of the two.This same cuff also covered the displaced endoanchor sandwiching it between the old graft and the cuff.The procedure was completed with both issues resolved and the patient reported as doing fine.Per the physician the cause of the dislodgement is undetermined.No additional clinical sequelae were reported and the patient is fine.

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.

Manufacturer Narrative

Product analysis conclusion: the reported proximal endoleak and endoanchor dislodgement were confirmed; however, the exact cause of the events could not be deter mined from the films provided.Lack of pre-implant ct¿s did not allow for a thorough assessment of the pre-implant anatomy.Endoleak interrogation via selective angiograms (injecting from different levels within the stent graft) to help determine the source and rule out other potential endoleak sources was not seen.Procedural angiogram showing the endoanchor deployment were also not provided.Although the cause of the endoleak cannot be fully determined, it is it is likely that the presence of neck calcification may have been a factor.It is possible that implanting an endoanchor within a calcified aortic neck may compromise endoanchor penetration or fixation and could have contributed to the dislodgement of the endoanchor.A likely type ii endoleak from a patent collateral vessel was also present along the reported endoleak.Analysis of the returned films did not reveal any obvious stent graft integrity issues.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: ENDO ANCHOR SYSTEM - HELI-FX AAA
• Type of Device: ENDOVASCULAR SUTURING SYSTEM
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 16425760
• MDR Text Key: 310043172
• Report Number: 9612164-2023-00817
• Device Sequence Number: 1
• Product Code: OTD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140036
• 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: 04/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SA-85
• Device Catalogue Number: SA-85
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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: 91 YR
• Patient Sex: Male