MAUDE Adverse Event Report: ENDOLOGIX SANTA ROSA OVATION IX; MAIN BODY

Model Number	TV-AB3480-J
Medical Device Problem Codes	Use of Device Problem (1670); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/20/2021
Type of Reportable Event	Serious Injury
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 initially implanted with the ovation ix abdominal stent graft system to treat an abdominal aortic aneurysm (aaa).It was noted that the initial implant was outside the indications of use due to a large neck diameter and pre-existing thrombus.Approximately two (2) months post initial procedure, a type 1a endoeak as detected per ct (computed tomography) scan.The secondary procedure was done, coils were placed and the endoleak appeared to be resolved.This event was previously reported under (mdr # 2031527-2020-00188).Now approximately, one (1) year post-re-intervention, a follow-up ct (computed tomography) scan, another type 1a endoleak was identified.The patient is currently being monitored while an intervention is being discussed.
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 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 1a endoleak was conformed.This is consistent with the reported adverse event/incident.The most likely causation for this type 1a endoleak was due to the off label neck diameter of 30.3mm (diameter should be 16-30mm) as well as the thick calcifications and significant thrombus the final patient status was reported as being well.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.G1,2: contact office- name has been updated.G4 awareness date.H6 evaluation result codes; remove 3233.H6 evaluation conclusion codes; remove 11.
Event or Problem Description
The patient was initially implanted with the ovation ix abdominal stent graft system to treat an abdominal aortic aneurysm (aaa).It was noted that the initial implant was outside the indications of use due to a large neck diameter and pre-existing thrombus.Approximately two (2) months post initial procedure, a type 1a endoeak as detected per ct (computed tomography) scan.The secondary procedure was done, coils were placed and the endoleak appeared to be resolved.This event was previously reported under (mdr # 2031527-2020-00188).Now approximately, one (1) year post-re-intervention, a follow-up ct (computed tomography) scan, another type 1a endoleak was identified.The patient is currently being monitored while an intervention is being discussed.Correction and additional information: the patient was initially implanted with the ovation ix abdominal stent graft system to treat an abdominal aortic aneurysm (aaa).It was noted that the initial implant was outside the indications of use due to a large neck diameter and pre-existing thrombus.Approximately two (2) months post initial procedure, a type 1a endoeak as detected per ct (computed tomography) scan.The secondary procedure was completed with coils and bare metal palmaz (non-endologix device) stent were implanted and the endoleak appeared to be resolved.This event was previously reported under (mdr # 2031527-2020-00188).Now approximately, one (1) year post-re-intervention, a follow-up ct (computed tomography) scan, another type 1a endoleak was identified.The physician elected to coil and re-balloon the bare metal palmaz (non-endologix device) stent to resolve this new type 1a endoleak.The final patient status was reported as being well.

• Brand Name: OVATION IX
• Common Device Name: MAIN BODY
• Manufacturer (Section D): ENDOLOGIX SANTA ROSA; 3910 brickway blvd; santa rosa CA 95403
• MDR Report Key: 11728638
• Report Number: 3008011247-2021-00035
• Device Sequence Number: 16898749
• Product Code: MIH
• UDI-Device Identifier: M701TVAB3480J1
• UDI-Public: +M701TVAB3480J1/$$3210419FS022118498
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: P120006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/06/2021

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: 04/19/2021
• Device Model Number: TV-AB3480-J
• Device Catalogue Number: TV-AB3480-J
• Device Lot Number: FS022118-49
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/06/2021
• Supplement Date Received by Manufacturer: 05/14/2021
• Initial Report FDA Received Date: 04/26/2021
• Supplement Report FDA Received Date: 06/07/2021
• 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 ILIAC LIMB FS030518-37; OVATION IX ILIAC LIMB FS112917-16; OVATION PRIME FILL POLYMER FF021618-01
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 83 YR