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	11/02/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information received reported that as per the physician, the cause of the type ia endoleak was thought to be the calcium in the proximal neck.Film evaluation summary: the cause of the inability to track the 32mm bifurcate to the target landing zone and the proximal type i endoleak occurring after implant of the 28mm bifurcate, could not be determined from the pre-implant films provided.Films during implant were not provided and the reported events could not be evaluated, and the post-implant ct¿s were not provided for assessment of the stent graft in-vivo configuration.It is most likely that these events were anatomy related.Implanting via the small caliber and calcified iliac arteries most likely contributed to the positioning difficulties of the 32mm (20fr) device, as downsizing to the 28mm bifurcate (18fr) did result in reaching the intended landing zone and successful deployment.The cause of the proximal type i endoleak, which was reported as greatly reduced after implanting the endoanchors, may have been related to implanting into the short, conical-shaped, and calcified neck.If information is provided in the future, a supplemental report will be issued.
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 unknown diameter abdominal aortic aneurysm.It was reported that during the index procedure, the access vessels were tight and calcified.The physician attempted to implant a esbf3214c103e bifurcate initially, however it could not be tracked to the target landing zone.The device was removed from the patient and replaced with a second bifurcate (esbf2814c103e), which was able to reach the intended landing zone and was successfully deployed.However, after deployment the final angiogram showed a type ia endoleak.The physician implanted 9 endoanchors in the proximal neck as treatment.As per the physician, the endoleak then had improved greatly.As per the physician, the cause of the event was anatomy related, due to the small calcified vessels and calcified reverse funnel neck.No additional clinical sequelae were reported and the patient is being monitored.

• 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: 9314446
• Report Number: 9612164-2019-04730
• Device Sequence Number: 10914331
• Product Code: OTD
• UDI-Device Identifier: 00763000006617
• UDI-Public: 00763000006617
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 12/09/2019

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: 03/11/2021
• Device Model Number: SA-85
• Device Catalogue Number: SA-85
• Device Lot Number: 0009638217
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2019
• Initial Date Received by Manufacturer: 11/02/2019
• Supplement Date Received by Manufacturer: 11/22/2019
• Initial Report FDA Received Date: 11/13/2019
• Supplement Report FDA Received Date: 12/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 73 YR