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	05/23/2019
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 iis stent graft system was implanted in a patient for the endovascular treatment of a 46 mm diameter abdominal aortic aneurysm.The patient had a conical neck of length 40 mm and diameter 20-23 mm.Mild calcification and thrombus was present in the neck.The diameters of the left and right iliac arteries were 11-16 mm and 11-12 mm, respectively.Mild calcification was present.It was reported that during the index procedure, the evar was performed in typical fashion.Upon the completion angiogram, an endoleak was observed.After performing additional angiography, the physician felt that the leak was a type iii.The physician then successfully implanted an additional limb ((b)(4)) into the existing left limb ((b)(4)), however the endoleak was still present.The physician then implanted an additional limb ((b)(4)) within the existing right limb ((b)(4)), however the angiography showed that the endoleak persisted.The physician then successfully implanted 6 heli-fx endoanchors.Angiography then showed a reduced endoleak compared to the previous angiograms.The physician then decided to end the procedure.As per the physician, the cause of the event cannot be determined no additional clinical sequelae were reported and the patient is being monitored.
Additional Manufacturer Narrative
Film evaluation summary: the exact endoleak type and cause reported during implant could not be determined from the pre-implant films provided.Images during implant were not provided, and the reported endoleak could not be assessed.Return of angiograms (including endoleak interrogation) which could have allowed for a more comprehensive determination of the endoleak source/cause, and post-implant ct¿s, were also not provided.It was reported that the endoleak was reduced following implant of the 6 endoanchors; therefore, this may have been a proximal type i endoleak potentially due to the conical-shaped neck which ranged in diameter from 19.5 ¿ 24mm.While a type iii fabric endoleak cannot be ruled out, this may have also been an acute type iv blush endoleak caused by fabric porosity.Other factors such as heparin dose, outflow resistance, imaging quality, and volume of the aneurysm sac may have also contributed to this potential type iv endoleak.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: 8703044
• Report Number: 9612164-2019-02363
• Device Sequence Number: 1845000
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2019

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: 12/12/2020
• Device Model Number: SA-85
• Device Catalogue Number: SA-85
• Device Lot Number: 0009492487
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2019
• Initial Date Received by Manufacturer: 05/23/2019
• Supplement Date Received by Manufacturer: 08/30/2019
• Initial Report FDA Received Date: 06/17/2019
• Supplement Report FDA Received Date: 09/23/2019
• 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: 77 YR