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

Model Number TV-AB2980-L

Device Problem Material Invagination (1336)

Patient Problem Failure of Implant (1924)

Event Date 11/15/2022

Event Type  Injury  

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, a follow-up report will be submitted.

Event Description

The patient was initially treated for an abdominal aortic aneurysm (aaa) with the implant of the alto abdominal aortic aneurysm stent system.During the initial implant procedure, a type 1a endoleak was identified.A few days after post initial procedure an angiogram showed the 1a endoleak was still visible with infolding of the sealing rings.The physician elected to treat the patient with coils and an implant of a (non-endologix) cp stent.The final patient status remains unknown.The final patient status was not made available to endologix.

Event Description

The patient was initially treated for an abdominal aortic aneurysm (aaa) with the implant of the alto abdominal aortic aneurysm stent system.During the initial implant procedure, a type 1a endoleak was identified.A few days after post initial procedure an angiogram showed the 1a endoleak was still visible.The physician elected to treat the patient with coils and an implant of a (non-endologix) cp stent.The final patient status remains unknown.The final patient status was not made available to endologix.Additional information: a clinical evaluation provided reasonable evidence to indicate that the polymer rings underwent enfoldment.

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.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 and additional endovascular procedures are confirmed.This is consistent with the reported adverse event/incident.The clinical evaluation also shows reasonable evidence to suggest.The enfolding of the polymer rings also occurred.No contributing factors were identified.Procedure-related harms, device, user, procedure, or anatomy-relatedness of this complaint could not be determined with the medical records available for review.The final patient status remains unknown.The final patient status was not made available to endologix.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: b5: describe event or problem g3 awareness date h6 health effect - clinical code; remove 1924 h6 investigation finding codes; remove 3233 h6 investigation conclusion codes; remove 11.

Event Description

The patient was initially treated for an abdominal aortic aneurysm (aaa) with the implant of the alto abdominal aortic aneurysm stent system.During the initial implant procedure, a type 1a endoleak was identified.A few days after post initial procedure an angiogram showed the 1a endoleak was still visible.A clinical evaluation provided reasonable evidence to indicate infolding of the polymer rings and twisting of the aortic body occurred which lead to the 1a endoleak.The physician elected to treat the patient with implant of a (non-endologix) cp stent.The final patient status remains unknown.The final patient status was not made available to endologix.Additional information: it was reported that the type 1a endoleak was resolved post re-intervention.

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.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 and additional endovascular procedures are confirmed.This is consistent with the reported adverse event/incident.A clinical evaluation provided reasonable evidence to show infolding of the polymer rings and twisting of the aortic body also occurred.The infolding of the polymer rings could have been due to the twisting of the aortic body but that could not be conclusively determined.The causation of the aortic body twisting could not be determined.The type ia endoleak was likely due to the infolding of the polymer rings.Procedure-related harms, device, user, procedure, or anatomy-relatedness of this complaint could not be determined with the medical records available for review.While the final patient status remains unknown, the type ia endoleak was reportedly resolved.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: b5: describe event or problem.

• 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: 15980379
• MDR Text Key: 305492168
• Report Number: 3008011247-2022-00154
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00850007370954
• UDI-Public: (01)00850007370954(17)250513(10)FS051122-56
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P120006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/20/2022

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-AB2980-L
• Device Lot Number: FS051122-56
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/20/2022
• Initial Date FDA Received: 12/14/2022
• Supplement Dates Manufacturer Received: 01/03/2023; 01/03/2023
• Supplement Dates FDA Received: 02/07/2023; 02/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/08/2022
• 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 FS070122-21; OVATION IX ILIAC LIMB FS070722-56; OVATION PRIME FILL POLYMER FF012522-01
• Patient Outcome(s): Required Intervention
• Patient Sex: Male