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

Model Number TV-AB3480-N

Device Problem Lack of Effect (4065)

Patient Problem Ruptured Aneurysm (4436)

Event Date 03/19/2024

Event Type  Injury  

Manufacturer Narrative

The device involved in this event will not be returned for evaluation as it remains at the hospital.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.H3 other text : hospital wanted to keep the device.

Event Description

The patient was treated for an abdominal aortic aneurysm (aaa) on (b)(6) 2024, with the implantation of an alto abdominal aortic graft system.Following the deployment of the alto abdominal aortic graft system, a final angiography revealed the presence of a type 1a endoleak.Despite attempts to address this with a compliant balloon, the leak persisted.A (non-endologix) 22x40mm atlas balloon was employed.During the inflation of the non-compliant balloon, a rupture occurred.As a result of the rupture, the patient's blood pressure dropped, necessitating the placement of an occlusion balloon while initiating chest compressions.The physician made the decision to explant the alto graft and limbs and opted to proceed with an axillary-femoral bypass.It was reported that the patient's condition was stable following the procedure.

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.The review confirms there were no manufacturing or processing non-conformities identified that would contribute to the reported adverse event/incident.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 intraoperative, type ia endoleak complaint is confirmed.The device, user, procedure, or anatomy-relatedness of this complaint is undetermined.The ruptured aorta, explant, and death complaints are also confirmed.This is consistent with the reported adverse event/incident.The clinical evaluation shows that during an attempt to resolve the type ia endoleak, using intraoperative ballooning of the neck, an aortic rupture occurred.The intraoperative aortic rupture led to surgical conversion, massive internal bleeding, cardiac arrest, and deterioration of the patient's condition which ultimately led to patient death on postoperative day one.The complaint is most likely procedure-related.Procedure-related harms are surgical conversion, abnormal blood loss, cardiac arrest, hemodynamic instability, prolonged procedure, and death.The final patient status was reported as deceased on postoperative day one.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 adverse events has been updated; b5: describe event or problem ¿ updated; g3: awareness date ¿ updated; h1: type of reportable event ¿ updated; h6: investigation finding codes - remove code 3233; h6: investigation conclusion codes - remove code 11.

Event Description

The patient was treated for an abdominal aortic aneurysm (aaa) on (b)(6) 2024, with the implantation of an alto abdominal aortic graft system.Following the deployment of the alto abdominal aortic graft system, a final angiography revealed the presence of a type 1a endoleak.Despite attempts to address this with a compliant balloon, the leak persisted.A (non-endologix) 22x40mm atlas balloon was employed.During the inflation of the non-compliant balloon, a rupture occurred.As a result of the rupture, the patient's blood pressure dropped, necessitating the placement of an occlusion balloon while initiating chest compressions.The physician made the decision to explant the alto graft and limbs and opted to proceed with an axillary-femoral bypass.It was reported that the patient's condition was stable following the procedure.Additional information: the clinical evaluation reveals that during an attempt to resolve the type ia endoleak using intraoperative ballooning of the neck, an aortic rupture occurred.This intraoperative aortic rupture resulted in surgical conversion, massive internal bleeding, cardiac arrest, and deterioration of the patient's condition, ultimately leading to the patient's death on postoperative day one (1).

• 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: 19068307
• MDR Text Key: 339679192
• Report Number: 3008011247-2024-00037
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00850007370916
• UDI-Public: (01)00850007370916(17)261214(10)FS120723-43
• 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
• Report Date: 03/19/2024

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-AB3480-N
• Device Lot Number: FS120723-43
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/08/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/12/2024
• 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 FS060823-38.; OVATION IX ILIAC LIMB FS070723-52.; OVATION PRIME FILL POLYMER FF100223-01.
• Patient Outcome(s): Death; Required Intervention
• Patient Age: 81 YR
• Patient Sex: Female