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

Model Number	SG-64
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/25/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
A heli-fx endoanchoring system was used prophylactically with an endurant stent graft system during an evar procedure.It was reported during the index procedure, after opening the sg-64 there was no dilator included in the packaging.The physician decided to use the sg-64 without the dilator by introducing a 16fr non-mdt sheath high up in the endurant body of the stent graft, to prevent any damage of the arterial wall or stent graft.9 endoanchors were successfully placed.Per the physician the cause was deemed product related.  no additional clinical sequalae was provided and the patient is fine.
Additional Manufacturer Narrative
Product analysis conclusion :two photos were provided by the account for review.The photos show the helifx guide complaint device and product tray at the account.The device and product tray have both been removed from the sterile packaging.The dilator for the complaint device is not visible in the photos.The reported ¿component missing¿ cannot be confirmed through analysis of the images provided.B5; additional information received : it was confirmed that the sterile barrier of the packaging was intact and there was no damage noted to the packaging.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
• Common Device Name: 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: 13367112
• Report Number: 9612164-2022-00387
• Device Sequence Number: 20165401
• Product Code: OTD
• UDI-Device Identifier: 00763000225964
• UDI-Public: 00763000225964
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K140036
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/09/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/15/2023
• Device Model Number: SG-64
• Device Catalogue Number: SG-64
• Device Lot Number: 0010939525
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/25/2022
• Supplement Date Received by Manufacturer: 02/14/2022
• Initial Report FDA Received Date: 01/27/2022
• Supplement Report FDA Received Date: 03/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/15/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Sex: Male