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

Model Number TV-AB2380-N

Device Problem Malposition of Device (2616)

Patient Problem Obstruction/Occlusion (2422)

Event Date 03/25/2024

Event Type  Death  

Manufacturer Narrative

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

Event Description

The patient was being treated for an abdominal aortic aneurysm (aaa) on (b)(6) 2024 with the implant of an alto abdominal stent graft system.The device was brought up the left side to land on the right renal.The aortic neck was 10mm but angulated.The device ended up being straighter in the aorta than anticipated.So, when landing off the middle of the right it could be seen that the left side of the device was going to be a little bit low.The physician was advised to try to push the device up a little bit, but this was unsuccessful.So, with the markers in the middle of the right renal the alto main body was deployed, and the fill polymer was connected.Gate cannulation was performed using the crossover lumen.The entire procedure was unremarkable.The final angiogram showed a type ia endoleak.Ballooning was performed with a coda balloon; however, it was unsuccessful.The facility had run out of palmaz stents, and since the patient was symptomatic, the physician elected to deploy a medtronic (non-endologix) endurant cuff and laser fenestrate into the superior mesenteric artery (sma) and both renals.The physician was able to stent all three of the vessels successfully in preparation for the laser fenestration and the cuff was deployed without instance.While trying to laser fenestrate the sma, the steerable catheter got caught on the end of the cuff and prolapsed it into the proximal cuff, unsealing the cuff from the alto main body.The physician went ahead and laser fenestrated the right renal just to get some blood flow back into it, and then elected to do a deep branching procedure on the sma and right renal, sacrificing the left renal.Due to the complications the procedure was prolonged.The final patient status has not yet been 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.Endologix could not perform an evaluation of the device as the device remains implanted in the patient.A clinical evaluation of the adverse event/incident was completed.An examination of medical records and/or medical imaging received by endologix shows the alto malposition of the device and type ia endoleak complaints are confirmed.The left renal artery occlusion complaint is confirmed.This is consistent with the reported adverse event/incident.Device, user, procedure or anatomy relatedness of this complaint could not be determined.The procedure related harms are surgical conversion, prolonged procedure, acute kidney injury, respiratory complications, and death.The complaint is likely procedure related.It was reported that the alto graft did not conform to the neck as expected due to the angulation, creating a large type ia endoleak.It is unclear how much the angulation contributed to the reported event.It was reported that there was inability to pass the steerable catheter through the angulation and create fenestrations.The catheter wire got caught on the end of the cuff and distal seal was lost.This required surgical conversion for a right iliac to superior mesenteric artery and right renal artery bypass.The left renal artery was sacrificed.It was reported there was a malignant neoplasm (liver) with mediastinal adenopathy on the discharge summary.It is unclear if this in any way contributed to the cascade of clinical events following the endovascular repair.The final patient status was reported as deceased on postoperative day thirteen.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: b2: outcomes attributed to ae - updated.G3: awareness date ¿ updated.H6: investigation finding codes - remove code 3233.H6: investigation conclusion codes - remove code 11.

• Brand Name: ALTO
• Type of Device: MAIN BODY
• Manufacturer (Section D): ENDOLOGIX SANTA ROSA; 3910 brickway blvd; santa rosa CA 95403
• Manufacturer (Section G): ENDOLOGIX SANTA ROSA; 3910 brickway blvd; ,; santa rosa CA 95403
• Manufacturer Contact: gary kirchgater ; 3910 brickway blvd; ,; santa rosa, CA 95403 ; 8009832284
• MDR Report Key: 19168551
• MDR Text Key: 340899530
• Report Number: 3008011247-2024-00040
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00850007370886
• UDI-Public: (01)00850007370886(17)270104(10)FS010224-04
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P120006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 03/25/2024

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 Model Number: TV-AB2380-N
• Device Lot Number: FS010224-04
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/25/2024
• Initial Date FDA Received: 04/23/2024
• Supplement Dates Manufacturer Received: 05/20/2024
• Supplement Dates FDA Received: 05/23/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/03/2024
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: OVATION IX ILIAC LIMB (LN FS091423-01); OVATION IX ILIAC LIMB (LN FS092023-26); OVATION PRIME FILL POLYMER (LN FF083123-01)
• Patient Outcome(s): Required Intervention; Death
• Patient Age: 73 YR
• Patient Sex: Female