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

Model Number	HA-18-114
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/19/2018
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
A valiant stent graft system was implanted in a patient for the endovascular treatment of a 56mm diameter thoracic aortic aneurysm.It was planned that heli-fx endoanchors would also be used prophylactically in the procedure due to concern over a short distal landing zone.It was reported that during the index procedure the first valiant stent graft was placed in a straight segment of the thoracic aorta and deployed without issue.A second valiant stent graft was then deployed proximal to the celiac trunk without issue.A reliant balloon was used to seal the proximal, overlap and distal seal zones.Then a total of 8 endoanchors were placed in the distal seal zone and an angiogram was preformed that showed a type ib endoleak.The physician re-ballooned the distal seal more aggressively and this showed the type ib endoleak was greatly reduced.The physician decided to end the procedure.As per the physician, the cause of the event was anatomy related due to the short distal seal zone.No additional clinical sequelae were reported and the patient will be monitored.
Additional Manufacturer Narrative
Films review summary: the exact cause of the reported distal type i endoleak observed during implant could not be determined from the limited films provided.A returned pre-implant 3d-ct film report revealed that the patient had a 56mm max diameter taa located in the distal portion of the descending thoracic.The distal seal landing zone was short and tapered, ranging from 39 ¿ 43 ¿ 45mm along a 10mm length.Several returned still ct angiograms during implant revealed that 2 valiant stent grafts had been implanted into the descending thoracic.After ballooning was performed, multiple endoanchors (~n=6) were seen having been implanted around the right & left side of the distal stent ring and penetrating into the thoracic aorta.Angio injection showed contrast primarily near the distal overlapping junctional area along the left side of the distal device.After additional ballooning was performed on the distal od near the endoanchors, final angiogram showed a noticeable reduction of the previously seen endoleak.The exact type and cause of the endoleak occurring during implant could not be determined from the limited still films provided.Lack of returned cine angiograms during angio injection did not allow for a thorough assessment of the endoleak.While this appeared most likely to have been a distal type i due implanting within a short distal seal length, an acute type iv blush endoleak also cannot be ruled out.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ENDO ANCHOR SYSTEM - HELI-FX TAA
• Common Device Name: ENDOVASCULAR SUTURING SYSTEM
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 7514282
• Report Number: 2953200-2018-00706
• Device Sequence Number: 19213405
• Product Code: OTD
• UDI-Device Identifier: 00763000006648
• UDI-Public: 00763000006648
• 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): 06/13/2018

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: 06/26/2019
• Device Model Number: HA-18-114
• Device Catalogue Number: HA-18-114
• Device Lot Number: 0008687963
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2018
• Initial Date Received by Manufacturer: 04/19/2018
• Supplement Date Received by Manufacturer: 05/24/2018
• Initial Report FDA Received Date: 05/15/2018
• Supplement Report FDA Received Date: 06/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 59 YR