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

Model Number	TV-AB2980-J
Medical Device Problem Codes	Complete Blockage (1094); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Failure of Implant (1924); Occlusion (1984)
Date of Event	10/15/2020
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 an afx bifurcated stent graft and a suprarenal stent graft extension to treat an abdominal aortic aneurysm (aaa).Approximately 5.5 years post initial procedure, the device has completely broken apart (stent fracture with device separation) and sac growth of 10cm was identified.The physician completed a successful re-intervention and re-lined the existing grafts with the ovation ix abdominal stent graft system (off-label).This event is captured under (mdr #: 2031527-2019-00472).Now, approximately one (1) year post reintervention during routine follow up the patient presents with possible 1a endoleak and occluded right common iliac limb possibly due to outflow.The patient was report as doing well.
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.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 occlusion of the right common iliac artery and type 1a endoleak event/incidents were not able to be confirmed.This is not consistent with the reported adverse event/incident.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 was reported as doing well following an additional endovascular procedure.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: adverse event\product problem; b5: describe event or problem ; g4: awareness date ; h6: result code: remove code 3233; h6: conclusion code: remove code 11.
Event or Problem Description
The patient was initially implanted with an afx bifurcated stent graft and a suprarenal stent graft extension to treat an abdominal aortic aneurysm (aaa).Approximately 5.5 years post initial procedure, the device has completely broken apart (stent fracture with device separation) and sac growth of 10cm was identified.The physician completed a successful re-intervention and re-lined the existing grafts with the ovation ix abdominal stent graft system (off-label).This event is captured under (mdr #: 2031527-2019-00472).Now, approximately one (1) year post reintervention during routine follow up the patient presents with possible 1a endoleak and occluded right common iliac limb possibly due to outflow.The patient was report as doing well.Additional information: an intervention was completed.The physician performed an endarterectomy and implanted three (3) ovation iliac stent grafts to resolve the reported event.The patient was report as doing good.

• 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: 10830341
• Report Number: 3008011247-2020-00126
• Device Sequence Number: 3525291
• Product Code: MIH
• UDI-Device Identifier: M701TVAB2980J1
• UDI-Public: +M701TVAB2980J1/$$3220827FS08261906L
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: P120006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/15/2020

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: 08/27/2022
• Device Model Number: TV-AB2980-J
• Device Catalogue Number: TV-AB2980-J
• Device Lot Number: FS082619-06
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/15/2020
• Supplement Date Received by Manufacturer: 01/06/2021
• Initial Report FDA Received Date: 11/12/2020
• Supplement Report FDA Received Date: 01/11/2021
• 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: AFX BIFURCATED STENT GRAFT - 1101031-015; AFX SUPRARENAL AORTIC EXTENSION - 1056076-017; OVATION IX ILIAC LIMB - FS121418-26; OVATION IX ILIAC LIMB - FS100418-41; OVATION IX ILIAC LIMB - FS110117-35; OVATION IX ILIAC LIMB - FS120518-49; OVATION PRIME FILL POLYMER - FF082719-01; AFX BIFURCATED STENT GRAFT - 1101031-015; AFX SUPRARENAL AORTIC EXTENSION - 1056076-017; OVATION IX ILIAC LIMB - FS121418-26; OVATION IX ILIAC LIMB - FS100418-41; OVATION IX ILIAC LIMB - FS110117-35; OVATION IX ILIAC LIMB - FS120518-49; OVATION PRIME FILL POLYMER - FF082719-01
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 67 YR