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

Model Number	TV-AB2080-N
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	05/05/2022
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
The patient was being treated for an abdominal aortic aneurysm (aaa) with the alto stent graft system (one (1) alto main body and three (3) ovation ix iliac limbs).Post-deployment, while attempting to advance the q50 merit medical balloon to mold the rings, the nose cone of the balloon became caught on the distal suprarenal portion of the alto main body, pushing the alto main body proximally about 1cm and partially covering left renal.Arm access was obtained, and the left renal was successfully stented.There seemed to be seal in the neck at the second ring; however, the final angio showed a possible type ia endoleak or type ii endoleak.The patient left the operating room and was being monitored.
Additional 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 dislodged aortic body with reported partial covering of the left renal artery by the first polymer sealing ring which required an additional endovascular procedure (left renal artery stent placement), was confirmed.This is consistent with the reported adverse event/incident.The clinical evaluation also shows reasonable evidence to suggest a type ii endoleak (non ¿ device related failure) of the lumbar artery also occurred.The most likely causation for this issue would be user related due to malposition of the device during the initial implant procedure.Procedure-related harms of this complaint could not be determined with the medical records available for review.The final patient status was reported as being monitored.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 ¿ updated.G3: awareness date ¿ updated.H6: investigation finding codes - remove code 3233.H6: investigation conclusion codes - remove code 11.
Event or Problem Description
The patient was being treated for an abdominal aortic aneurysm (aaa) with the alto stent graft system (one (1) alto main body and three (3) ovation ix iliac limbs).Post-deployment, while attempting to advance the q50 merit medical balloon to mold the rings, the nose cone of the balloon became caught on the distal suprarenal portion of the alto main body, pushing the alto main body proximally about 1cm and partially covering left renal.Arm access was obtained, and the left renal was successfully stented.There seemed to be seal in the neck at the second ring; however, the final angio showed a possible type ia endoleak or type ii endoleak.The patient left the operating room and was being monitored.Additional information: during the clinical assessment it was identified that there was a type 2 (non ¿ device related failure), not a type 1a endoleak.The clinical assessment also identified an iliac occlusion that occurred (8) eight days after the initial procedure and there was also a suspected abdominal abscess or infection.These additional events that were identified will be handled under a new complaint file.

• Brand Name: ALTO
• Common Device Name: 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: 14454507
• Report Number: 3008011247-2022-00047
• Device Sequence Number: 14530599
• Product Code: MIH
• UDI-Device Identifier: 00850007370381
• UDI-Public: (01)00850007370381(17)250215(10)FS021222-11
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P120006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/05/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/15/2025
• Device Model Number: TV-AB2080-N
• Device Lot Number: FS021222-11
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/05/2022
• Supplement Date Received by Manufacturer: 07/13/2022
• Initial Report FDA Received Date: 05/20/2022
• Supplement Report FDA Received Date: 07/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/07/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: OVATION IX ILIAC LIMB (LN FS021122-01); OVATION IX ILIAC LIMB (LN FS021922-11); OVATION IX ILIAC LIMB (LN FS030922-43); OVATION PRIME FILL POLYMER (LN FF070121-03); Q50 (MERIT MEDICAL) BALLOON CATHETER (LN S21K01)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR
• Patient Sex: Male