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

Model Number	SA-85
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Ischemia (1942); Occlusion (1984); Renal Failure (2041); Thrombus (2101)
Date of Event	06/06/2016
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
Heli-fx endoanchors and an endurant aortic cuff were implanted for the treatment of migration and a type ia endoleak in a talent stent graft system.The talent stent graft was originally implanted approximately 13 years previously.The current aaa diameter measured 42.8mm.The diameter at the proximal aortic neck measured 33.5mm-33.3mm with a 30 degree angulation.Moderate thrombus and localised calcification were observed at the seal zone.It was reported during the index procedure unintentional partial coverage of the right renal artery occurred.A non mdt renal stent was implanted and the event resolved.It was further reported approximately 2 weeks post the index procedure, right renal artery stent thrombosis occurred with a decrease in renal function.A ct confirmed lower pole ischemia/infarct of the right kidney.The event is currently unresolved with permanent adverse sequelae.Per the investigator the cause of the right renal stent thrombosis was related to the index procedure.The patient will continue to be monitored.
Additional Manufacturer Narrative
Additional information received; it was reported that 6 weeks post implant, the patient was diagnosed with acute kidney injury on ckd.The event was assessed by the investigator as not related to the devices or index procedure.The patient recovered without treatment.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
• MDR Report Key: 8314154
• Report Number: 2953200-2019-00199
• Device Sequence Number: 64545
• Product Code: OTD
• UDI-Device Identifier: 00643169647695
• UDI-Public: 00643169647695
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K140036
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: study,user facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/29/2019

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2017
• Device Model Number: SA-85
• Device Catalogue Number: SA-85
• Device Lot Number: 49491245
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/01/2019
• Supplement Date Received by Manufacturer: 08/07/2019
• Initial Report FDA Received Date: 02/07/2019
• Supplement Report FDA Received Date: 08/29/2019
• 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: Disability
• Patient Age: 80 YR
• Patient Weight: 77