MAUDE Adverse Event Report: ENDOLOGIX SANTA ROSA OVATION ALTO; AORTIC BODY

Model Number TV-AB3480-N

Device Problems Improper or Incorrect Procedure or Method (2017); Unintended Movement (3026)

Patient Problems Failure of Implant (1924); Ischemia (1942)

Event Date 11/11/2020

Event Type  Injury  

Manufacturer Narrative

The device remains implanted in the patient; therefore, it will not be returned for evaluation.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 being implanted with an ovation alto stent graft system to treat an abdominal aortic aneurysm (aaa).Reportedly, the patient had pre-existing bad renal function, the iliacs were extremely tortuous and the aortic neck was moderately angled.After pre-closing the iliac, the ovation alto was inserted in the right side for usual deployment.The physician (reportedly, controlling x-ray machine and positioning) performed several angios to agree upon correct landing spot.The physician then attempted to adjust the shutter collimation to reduce exposure.In hindsight, the physician may have inadvertently adjusted the x-ray magnification.Before the second nested knob was released, the imaging went live and it was noticed that the markers were lower than a moment before, the physician proceeded to reposition the marks upward to compensate for the droppage.Additional angio was not taken and deployment continued as normal; however, there was difficulty cannulating the contra-lateral gate, integrated ballooning was done at 14 minutes on the proximal rings.The up and over wire lumen was then used to get contra-lateral gate access, and the procedure continued as per usual.After the limbs were in place, additional angio identified the rings were at least a centimeter higher than target and positioned directly over the renals.Attempts were made with an aortic occlusion balloon to pull the rings down a few millimeters, which was partially successful.Attempts made to cannulate the renals from the groin were unsuccessful.During cut down from the left arm to attempt renal cannulation from above, additional angio noted that while the renals were covered, there was flow.It was also noted that the pulling on the rings with the occlusion balloon had resulted in a downward shift that resulted in a small type 1a endoleak.Due to the patients age and pre-existing kidney function issues the physician decided to abandon efforts to cannulate the renals, stating there was some flow to the renals and even though the stent ring was deployed right at the ostium of the renals at the end of the procedure there was better renal flow.The patient will continue to be monitored.

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 type ia endoleak is unconfirmed.The malposition of the aortic body and the acute kidney injury with renal ischemia events are confirmed.This is moderately consistent with the reported adverse event/incident.The most likely causation for the type ia endoleak, malposition of the aortic body, and the acute kidney injury with renal ischemia was user and procedure related due to the graft landing proximal to the intended location and the maneuvering during the procedure to pull the graft down.The procedure related harm identified was acute renal injury with pre-existing kidney disease.The final patient status was reported as being discharged home four (4) days post operative.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.Corrections: a3: patient gender has been updated.G4: date of received by manufacturer has been updated.H3: device evaluated by manufacturer has been updated.H6: result code: remove code 3233.H6: conclusion code: remove code 11.

• Brand Name: OVATION ALTO
• Type of Device: AORTIC BODY
• Manufacturer (Section D): ENDOLOGIX SANTA ROSA; 3910 brickway blvd; santa rosa CA 95403
• MDR Report Key: 10959684
• MDR Text Key: 219927658
• Report Number: 3008011247-2020-00140
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: M701TVAB3480N1
• UDI-Public: +M701TVAB3480N1/$$3230723FS072120153
• 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: 11/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/23/2023
• Device Model Number: TV-AB3480-N
• Device Catalogue Number: TV-AB3480-N
• Device Lot Number: FS072120-15
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: OVATION IX EXTENDER (LN FS081720-03).; OVATION IX EXTENDER (LN FS121219-39).; OVATION IX ILIAC LIMB (LN FS080420-25).; OVATION IX ILIAC LIMB (LN FS082620-15).; OVATION PRIME FILL POLYMER (FF091420-01).; OVATION IX EXTENDER (LN FS081720-03); OVATION IX EXTENDER (LN FS121219-39); OVATION IX ILIAC LIMB (LN FS080420-25); OVATION IX ILIAC LIMB (LN FS082620-15); OVATION PRIME FILL POLYMER (FF091420-01)
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR