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

Model Number	TV-AB3480-N
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Myocardial Infarction (1969)
Date of Event	08/23/2021
Type of Reportable Event	Death
Additional Manufacturer Narrative
The device involved in this event will not be returned for evaluation as it remains implanted in the patient.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 or Problem Description
The patient was implanted with the alto stent graft system to treat a pre-operatively ruptured abdominal aortic aneurysm (aaa).It was reported that the case was done emergently to treat the ruptured aaa; however, the patient expired one day after the procedure due to a myocardial infarction (mi).
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.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 reported aortic rupture (prior to the evar procedure), and patient death are confirmed.The reported myocardial infarction is not confirmed.This is moderately consistent with the reported adverse event/incident.The most likely causation for the reported event is anatomy-related due to the pre-existing rupture (cautionary product use condition) and the subsequent hypovolemic shock, which appears to be cause of death; the patient death was determined to be unrelated to the device, procedure or use environment.In addition, the patient's hemoglobin level was noted at 6.9, indicating massive blood loss.No procedure-related harms were identified.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: h6 device codes (as evaluated); remove 3190, h6 evaluation result codes; remove 3233, h6 evaluation conclusion codes; remove 11.

• Brand Name: ALTO
• Common Device Name: MAIN BODY
• Manufacturer (Section D): ENDOLOGIX SANTA ROSA; 3910 brickway blvd; santa rosa CA 95403
• MDR Report Key: 12436472
• Report Number: 3008011247-2021-00107
• Device Sequence Number: 4082452
• Product Code: MIH
• UDI-Device Identifier: M701TVAB3480N1
• UDI-Public: +M701TVAB3480N1/$$3240311FS030921093
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P120006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/23/2021

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: 03/11/2024
• Device Model Number: TV-AB3480-N
• Device Catalogue Number: TV-AB3480-N
• Device Lot Number: FS030921-09
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/23/2021
• Supplement Date Received by Manufacturer: 09/20/2021
• Initial Report FDA Received Date: 09/07/2021
• Supplement Report FDA Received Date: 09/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: OVATION IX EXTENDER, LOT # FS011421-12; OVATION IX ILIAC LIMB, LOT # FS011221-43; OVATION IX ILIAC LIMB, LOT # FS011620-20; OVATION IX ILIAC LIMB, LOT # FS021220-19; OVATION PRIME FILL POLYMER, LOT # FF031221-01; OVATION IX EXTENDER, LOT # FS011421-12; OVATION IX ILIAC LIMB, LOT # FS011221-43; OVATION IX ILIAC LIMB, LOT # FS011620-20; OVATION IX ILIAC LIMB, LOT # FS021220-19; OVATION PRIME FILL POLYMER, LOT # FF031221-01
• Outcome Attributed to Adverse Event: Death
• Patient Age: 80 YR