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	11/08/2019
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 ii stent graft system was implanted in a patient for the endovascular treatment of a 54 mm diameter abdominal aortic aneurysm.The proximal neck length was 10 mm, and the neck diameter ranged from 23-25 mm.Mild proximal neck calcification and thrombus was present.It was reported that during the index procedure, a type ia endoleak was observed on the completion angiogram.The physician carried out another proximal balloon inflation, however the type ia endoleak persisted.The physician was satisfied with the proximal position of the stent graft, and so they elected to implant heli-fx endoanchors in the proximal neck to treat the endoleak.6 endoanchors were implanted, however the type ia endoleak was observed again on another angiogram.The physician then elected to complete the procedure and follow up on a later date.As per the physician, the cause of the event could not be determined.No additional clinical sequelae were reported and the patient is fine.
Additional Manufacturer Narrative
Film evaluation summary the cause of the proximal type ia endoleak reported at implant could not be determined from the film report provided.Images during implant were not provided and the reported event could not be assessed.In addition, post-implant ct¿s are currently not available for evaluation of the stent graft in-vivo configuration.Pre-implant ct¿s revealed that the patient had a short (10mm length) and calcified proximal neck which also contained irregular thrombus.Therefore, it is possible that the type ia endoleak was anatomy related due to implanting into a challenging neck.This short and calcified neck may have also contributed to the same endoleak seen after implanting the six (6) endoanchors.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: 9402834
• Report Number: 9612164-2019-04997
• Device Sequence Number: 2167487
• 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
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2019

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: 05/02/2021
• Device Model Number: SA-85
• Device Catalogue Number: SA-85
• Device Lot Number: 0009724799
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2019
• Initial Date Received by Manufacturer: 11/08/2019
• Supplement Date Received by Manufacturer: 12/04/2019
• Initial Report FDA Received Date: 12/03/2019
• Supplement Report FDA Received Date: 12/11/2019
• 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: 82 YR