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

Model Number SA-85

Device Problem Fracture (1260)

Patient Problems No Consequences Or Impact To Patient (2199); Device Embedded In Tissue or Plaque (3165)

Event Date 07/22/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

An heli-fx endoanchor system was used in an endovascular treatment of a patient.It was reported that during the index procedure, during the second stage of deployment, it was noted the endoanchor was damaged / broken and only the distal part was found in the patient's body.After removing the heli-fx applier from the patient's body, the other part of the broken endoanchor was found in the applier which was then removed and the operation continued.During a visual examination outside the patient's body, the next implant was loaded into the applier and visual defect of the endoanchor was noted.The physician then decided to stop further use of the heli-fx endoanchor system.As per the physician, cause of the event is unknown.No additional clinical sequelae were reported and the patient will be monitored.

Manufacturer Narrative

Additional information received: it was reported the endoanchors were implanted as a prophylactic treatment and there was no type ia endoleak observed in the endurant stent graft.During the index procedure after the endoanchor broke during deployment the proximal part of the endoanchor remained screwed into the graft/aorta and the distal part remained in the applier.Upon inspection it appeared that the tip on the endoanchors appeared to differ from each other.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 endoanchor fracture and deformity were confirmed on the image provided; however, the cause of the event could not be fully determined.Lack of pre-implant ct¿s did not allow for a thorough assessment of the pre-implant anatomy.Levels of calcification cannot be assessed and the patient¿s aortic neck does not appear to be excessively angulated.It is possible that implantation in the area of another implanted endoanchor may have contributed to fracture and deformity of the endoanchor.Only a single imaging view point (a-p) was observed in the films provided; thereby, making determination of the aortic neck angulation and endoanchors location difficult.Possible anatomical causes of the anchor fracture include implanting into areas of calcification, thrombus, and highly angulated anatomy.In addition, improper apposition, excessive catheter torque build-up and excessive unsupported applier may have also contributed to the anchor fracture.A device issue cannot be ruled out as a potential cause.The device is pending return for analysis and the results will be summarized in a separate report.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: the applier was returned without the section of fractured endoanchor.There no deformation observed to the applier housing or catheter.The reported fracture of the endoanchor could be confirmed through analysis.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
• MDR Report Key: 10349241
• MDR Text Key: 201332436
• Report Number: 9612164-2020-02836
• Device Sequence Number: 1
• Product Code: OTD
• Combination Product (y/n): N
• PMA/PMN Number: K140036
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/30/2020

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 Expiration Date: 12/18/2021
• Device Model Number: SA-85
• Device Catalogue Number: SA-85
• Device Lot Number: 0010068542
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2020
• Initial Date Manufacturer Received: 07/23/2020
• Initial Date FDA Received: 07/31/2020
• Supplement Dates Manufacturer Received: 07/23/2020; 08/31/2020; 10/30/2020
• Supplement Dates FDA Received: 08/20/2020; 09/28/2020; 10/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other