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	No Consequences Or Impact To Patient (2199)
Date of Event	05/15/2019
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
An endurant ii aui stent graft system was implanted in a patient for the endovascular treatment of a 59 mm abdominal aortic aneurysm.The proximal aortic neck diameter measures 26-32 mm and 10 mm in length.The proximal neck was noted as short wide and conical with moderate calcification and thrombus present.It was reported during the index procedure, after the aui stent was implanted a completion angiogram identified a type ia endoleak.There appeared to be approximately 5-8 mm of proximal neck that could be gained with a proximal extension so the physician elected to deploy a proximal aortic extension just below renal arteries.A second angiogram demonstrated the type ia endoleak remained.4 helix-fx endoanchors were then placed in the proximal seal zone.A final completion angiogram was performed demonstrating a reduced and delayed type ia endoleak.The physician decided to end the procedure.Per the physician the cause of the event is undetermined.No additional clinical sequelae were reported and the patient will be monitored.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Film evaluation summary: the cause of the proximal type i endoleak reported during implant could not be determined from the pre-implant films provided.Films during implant were not available for review and the reported event could not be assessed.Pre-implant films revealed that the patient had a challenging anatomy which most likely contributed to the type ia endoleak; short, calcified, thrombus filled, and conical-shaped proximal neck.Since the site reported an additional 5-8mm of available proximal neck above the implanted bifurcate, it is possible that the bifurcate may have been implanted lower than intended within the 10mm length neck, which also may have been a factor.The likely target of the endoanchors was in a calcified location within the proximal neck, which also may have contributed to incomplete resolution of the endoleak post-anchor implant.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
• MDR Report Key: 8646027
• Report Number: 9612164-2019-02041
• Device Sequence Number: 13957395
• Product Code: OTD
• UDI-Device Identifier: 00763000006617
• UDI-Public: 00763000006617
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K140036
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/09/2019

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: 12/16/2020
• Device Model Number: SA-85
• Device Catalogue Number: SA-85
• Device Lot Number: 0009497576
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2019
• Initial Date Received by Manufacturer: 05/15/2019
• Supplement Date Received by Manufacturer: 05/29/2019; 08/15/2019
• Initial Report FDA Received Date: 05/28/2019
• Supplement Report FDA Received Date: 06/25/2019; 09/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR