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

Model Number HG-16-62-28

Device Problems Difficult to Insert (1316); Material Deformation (2976); Material Integrity Problem (2978)

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

Event Date 08/24/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Heli-fx endoanchors were being used as an accessory device in the endovascular treatment of a type i endoleak in a non mdt stent graft during the procedure it was reported that the moment the guide was bent, the applier tip could not pass forward to the vessel wall and would only pass once the guide was straightened.A new guide was used to complete the procedure without issue per the physician, the event was device related and may have been due to defective inner coating at the tip of the guide catheter no additional clinical sequalae were reported and the patient is fine.

Manufacturer Narrative

H6: rfr, fdd updated the event codes were amended, this event no longer meets reporting criteria as a result of this coding update.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.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 device decontaminated with cidex-opa pending further device testing to support the final product analysis findings.The dilator returned with the device was inserted and advanced with no issue.A bend was present to the guide catheter shaft immediately distal to the deflector knob.The guide catheter deflected with no issues.The tip deflected on rotation of the deflector knob confirming the kevlar cord was intact.Deformation was evident at the tip on the inner curve.There was no damage to the lumen with no exposed braids and no delamination.There was no damage to the kevlar.The reported insertion difficulties were not 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 ; EI
• MDR Report Key: 12369910
• MDR Text Key: 268214349
• Report Number: 9612164-2021-03308
• Device Sequence Number: 1
• Product Code: OTD
• UDI-Device Identifier: 00763000225971
• UDI-Public: 00763000225971
• 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
• Report Date: 10/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/08/2021
• Device Model Number: HG-16-62-28
• Device Catalogue Number: HG-16-62-28
• Device Lot Number: 0009960303
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2021
• Initial Date Manufacturer Received: 08/24/2021
• Initial Date FDA Received: 08/26/2021
• Supplement Dates Manufacturer Received: 09/02/2021; 09/28/2021
• Supplement Dates FDA Received: 09/03/2021; 10/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1