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 Codes	Aspiration/Inhalation (1725); Death (1802); No Consequences Or Impact To Patient (2199)
Date of Event	05/20/2019
Type of Reportable Event	Death
Additional Manufacturer Narrative
Film evaluation summary: the reported endoleak seen during implant was confirmed; however, the exact cause and type could not be determined from the films provided.Pre-implant ct¿s confirmed a severely angulated proximal neck (off-label) that ranged in diameter from 20 ¿ 26mm.It is likely that the highly angulated proximal neck was a major contributor to the endoleak which appeared most likely to have been a type i endoleak.It is also possible that oversizing of the 28mm catalog bifurcate into the 20mm neck, which also contained thrombus, may have led to the potential for stent graft infolding and a poor proximal seal.The reported type ii endoleak seen at the conclusion of the procedure was likely anatomy related.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 in a patient for the endovascular treatment of an abdominal aortic aneurysm of unknown size.The patient had a 75 degree angled aortic neck.It was reported that during the index procedure the final angiogram showed a type ia endoleak where the stent graft did not oppose the angled portion of the neck.It was noted that below the angulation there was neck and the aneurysm sac did not show any contrast.The physician placed 6 endoanchors and as the endoleak was now minimal the procedure was completed.The physician noted that the endoleak was potentially a type ii endoleak at this point.As per the physician, the cause of the event anatomy related due to the angulated neck.No additional clinical sequelae were reported and the patient is fine.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported the patient had suffered a stroke prior to the index procedure and a few days post the procedure the patient aspirated and expired.
Additional Manufacturer Narrative
Additional information received; the patient was discharged to rehab post op.It was reported the patient aspirated, causing hypoxia and death.The physician stated the death was due to aspiration not related to the procedure 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: 8686225
• Report Number: 9612164-2019-02275
• Device Sequence Number: 3030311
• Product Code: OTD
• UDI-Device Identifier: 00763000006617
• UDI-Public: 00763000006617
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 08/20/2019

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/12/2020
• Device Model Number: SA-85
• Device Catalogue Number: SA-85
• Device Lot Number: 0009492492
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2019
• Initial Date Received by Manufacturer: 05/20/2019
• Supplement Date Received by Manufacturer: 06/20/2019; 07/24/2019
• Initial Report FDA Received Date: 06/11/2019
• Supplement Report FDA Received Date: 07/17/2019; 08/20/2019
• 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: Death; Required Intervention
• Patient Age: 82 YR