MAUDE Adverse Event Report: ENDOLOGIX SANTA ROSA ALTO; MAIN BODY

Model Number TV-AB2980-N

Device Problems Improper or Incorrect Procedure or Method (2017); Insufficient Information (3190)

Patient Problems Death (1802); Rupture (2208)

Event Date 01/22/2021

Event Type  Death  

Manufacturer Narrative

The device involved in this event will not be returned for evaluation as it remains implanted in the patient.Patient medical records and imaging studies will be requested for further evaluation by the clinical specialist.If additional information pertinent to the incident is obtained, a follow-up report will be submitted.

Event Description

The patient was initially implanted with an ovation alto stent graft system to treat an abdominal aortic aneurysm (aaa).An intraoperative type 1a endoleak was observed.The physician attempted ballooning and implanted a non-endologix (palmaz) bare metal stent.The non-endologix (palmaz) bare metal stent was mounted on a tyshak (non - endologix) balloon.The balloon was overinflated and dissected the aorta above the renal arteries.The intraoperative type 1a endoleak was resolved.Two (2) non-endologix (cook) endografts were implanted to correct the dissection of the aorta and a rupture the rupture appeared to be contained and the patient¿s access sites were closed.The procedure has concluded however, it was later reported that the patient expired later that day.The exact cause of death was not provided.

Manufacturer Narrative

The reported adverse event/incident was investigated in alignment with endologix operating procedures and work instructions.Where possible, it is endologix practice to make at least three good faith efforts to retrieve a reported adverse event/incident related device as well as medical records and medical imaging.An evaluation of the manufacturing record was completed.A review of the part number/lot number combination needed for device identification shows the device to have been properly manufactured and released in accordance with the device master record.An evaluation of the device could not be completed.The device was not returned to endologix for evaluation because it remains implanted.A clinical evaluation of the adverse event/incident was completed.An examination of medical records and/or medical imaging received by endologix shows the intraoperative type ia endoleak, (resolved with a bare metal stent and ballooning), and dissection below right renal artery, (resolved by implanting two additional non-endologix stents) were confirmed.This is consistent with the reported adverse event/incident.The most likely causation for the intra-operative aorta dissection was due to over ballooning (user related) after the implant of non-endologix bare metal stent (to resolve the type ia endoleak).As the type ia endoleak was resolved intraoperatively, it is not a patient clinical harm.Procedure related harms, device, user, procedure, or anatomy relatedness of this complaint could not be determined for the death with the medical records available for review.The final patient status was reported as expired on (b)(6) 2021.No additional investigation of this reported adverse event/incident is planned.However, should additional information relevant to the investigation outcome become available, a follow-up report will be submitted.Endologix will continue to monitor this and similar adverse events/incidents.

• Brand Name: ALTO
• Type of Device: MAIN BODY
• Manufacturer (Section D): ENDOLOGIX SANTA ROSA; 3910 brickway blvd; santa rosa CA 95403
• MDR Report Key: 11340864
• MDR Text Key: 232318326
• Report Number: 3008011247-2021-00013
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: M701TVAB2980N1
• UDI-Public: +M701TVAB2980N1/$$3231028FS102420030
• Combination Product (y/n): N
• PMA/PMN Number: P120006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 01/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/28/2023
• Device Model Number: TV-AB2980-N
• Device Catalogue Number: TV-AB2980-N
• Device Lot Number: FS102420-03
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/22/2021
• Initial Date FDA Received: 02/17/2021
• Supplement Dates Manufacturer Received: 03/15/2021
• Supplement Dates FDA Received: 04/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: OVATION IX ILIAC LIMB FS112320-22; OVATION IX ILIAC LIMB FS120420-15; OVATION PRIME FILL POLYMER FF090920-01
• Patient Outcome(s): Death
• Patient Age: 85 YR