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	01/17/2018
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 iis stent graft system was implanted in a patient for the endovascular treatment of an 7.2cm abdominal aortic aneurysm with approx 5mm of proximal neck length.It was reported that after implantation of the endurant bifurcate and the placement of 6 helifx endoanchors, both in good proximal position, a completion angiogram showed a type ia endoleak.As per the physician the cause of the event is anatomy related and was due to the short, conical proximal neck.It was reported that intervention was performed, diagnostic angiogram demonstrated approximately 1mm of proximal neck could be achieved by placing an aortic cuff.The physician made the decision to balloon the proximal stent graft several times, with the addition of 8 endoanchors implanted at the proximal end of the stent graft.A follow up angiogram showed a significant reduction of the endoleak after the intervention.Additional information received reported that during a follow up ct, no endoleak was observed.No clinical sequelae were reported.
Additional Manufacturer Narrative
Additional information received reported that during a follow up ct, no endoleak was observed.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: 7285184
• Report Number: 2953200-2018-00263
• Device Sequence Number: 11261037
• Product Code: OTD
• UDI-Device Identifier: 00643169647695
• UDI-Public: 00643169647695
• 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: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2018

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: 07/31/2018
• Device Model Number: SA-85
• Device Catalogue Number: SA-85
• Device Lot Number: 50007084
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/25/2018
• Supplement Date Received by Manufacturer: 02/16/2018
• Initial Report FDA Received Date: 02/21/2018
• Supplement Report FDA Received Date: 03/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 75 YR