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

Model Number	SA-85
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/07/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
An endurant iis stent graft system was implanted during the endovascular treatment of a ruptured 100mm abdominal aortic aneurysm on (b)(6) 2023.It was reported during the index procedure after the stents were deployed, on the final angiogram a type ia endoleak was observed.The physician elected to implant 8 endoanchors however a slight endoleak was still seen and the procedure was completed.The next day a ct scan showed the type ia endoleak.The physician decided to complete further intervention that day.A 5 vessel laser fenestration to extend the endograft up to get to healthy tissue was performed.The celiac, sma, right renal and both left renal arteries were pre-stented with non mdt stents.A valiant vamf3030c100tu (30818855) was placed over the visceral vessels.All the visceral vessels were lasered and a covered stent placed in each vessel.A non mdt stent was used in the sma and non mdt stents were used in the celiac, right renal, and both left renal arteries.The right limb of the endurant was also extended down to the right hypogastric with a etew1313c82e lot v30472973.The final angiogram showed the proximal type i endoleak had resolved.Per the physician the cause of the endoleak was anatomy related and noted that the patient presented with no proximal landing zone.No additional clinical sequelae were reported and the patient is fine.

• 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: 16129113
• Report Number: 9612164-2023-00110
• Device Sequence Number: 16943849
• Product Code: OTD
• UDI-Device Identifier: 00763000225933
• UDI-Public: 00763000225933
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/10/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/17/2024
• Device Model Number: SA-85
• Device Catalogue Number: SA-85
• Device Lot Number: 0011314916
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/07/2023
• Initial Report FDA Received Date: 01/10/2023
• Date Device Manufactured: 07/18/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 78 YR
• Patient Sex: Male