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

Model Number SG-64

Device Problems Difficult to Insert (1316); Device Contamination with Chemical or Other Material (2944)

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

Event Date 04/08/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

A heli -fx guide was used prophylactically with an endurant stent graft due to a short and angled aortic neck in an evar procedure.It was reported during the index procedure, the heli-fx guide was placed into the patient and the dilator was removed.The applier was inserted into the guide and the device was angled into place.An attempt to advance the applier to touch the outer wall of the graft was completed but the applier was unable to come out of the end of the guide.Upon examination after the device was removed from the patient, the guide was noted to have a piece of fabric stuck in the end of the device preventing the applier to be advanced through the guide.Another guide was used to complete the procedure.The guide was inspected prior to insertion as well as the anchor inspected before insertion.The piece of fabric is believed to be on the inside of the device and not from thegraft.The physician was unable to try and remove the piece of fabric with forceps so that's when it was decided to open a new one instead.It is not believed the fabric came from the main body graft that was deployed.Its thought to be from the heli-fx guide.There was no leak in the graft that was placed, this was checked so its not believed that it was a piece that ripped from the device.Per physician, the cause of the difficulty to insert was due to a piece of fabric stopping the applier to exit the guide.No additional clinical sequelae were reported and the patient is fine.

Manufacturer Narrative

Product analysis the heli-fx returned with kevlar cord protruding from the tip.Material delamination was visible inside the tip.A dilator was advanced along the guide with no resistance noted.Kevlar was visible at the tip on removal of the dilator.On rotation of the deflector knob the tip deflected.Following an audible snap, it was no longer possible to deflect the tip.Excessive delamination and exposed braid wire was visible inside the tip.Deformation was visible to the inner curve of the guide tip.An applier was advanced along the guide with strong resistance encountered 5.0mm from the tip.The handle was taken apart.The kevlar was observed loosely wound around the reel.On removal of the kevlar, it was observed that the kevlar cord had been severed.The guide was cut open along the outer curve.There was no damage or lifting evident to the spine.Excessive delamination and exposed braid wire was visible at the tip.The reported insertion difficulties could be confirmed through analysis of the returned device.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: 14285014
• MDR Text Key: 290782709
• Report Number: 9612164-2022-01656
• Device Sequence Number: 1
• Product Code: OTD
• UDI-Device Identifier: 00763000225964
• UDI-Public: 00763000225964
• 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: 11/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/17/2023
• Device Model Number: SG-64
• Device Catalogue Number: SG-64
• Device Lot Number: 0010990251
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/11/2022
• Date Device Manufactured: 12/17/2021
• 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 Age: 71 YR
• Patient Sex: Male