MAUDE Adverse Event Report: ENDOLOGIX SANTA ROSA OVATION IX; ILIAC LIMB

Model Number	TV-IL1418160-J
Medical Device Problem Codes	Insufficient Device Problem Information (3190); Migration (4003)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	10/16/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device remains implanted in the patient; therefore, it will not be returned for evaluation.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 and two (2) ovation ix iliac limbs to treat an abdominal aortic aneurysm (aaa).Approximately three (3) months post initial procedure a type 1b endoleak was identified during a scan.The patient was reported to be stable.Re-intervention was completed with implant of an additional ovation ix iliac limb.Reportedly the procedure went well.The final patient status was reported to be good.
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 1b endoleak of the right common iliac artery as being confirmed.This is consistent with the reported adverse event/incident.The clinical evaluation also shows reasonable evidence to suggest that a cranial migration of the right iliac stent occurred.The most likely causation for the cranial migration that resultant in a type 1b endoleak was calcification that was present in the right common iliac artery.Procedure-related harms, device, user, procedure, or anatomy relatedness of this complaint could not be determined with the medical records available for review.However calcifications were present in the right common iliac artery, this could have contributed to the cranial migration and resultant a type 1b endoleak.The final patient status was discharged on the first post-operative day home following a secondary endovascular procedure and was reported as being good, 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 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 and two (2) ovation ix iliac limbs to treat an abdominal aortic aneurysm (aaa).Approximately three (3) months post initial procedure a type 1b endoleak was identified during a scan.A re-intervention was completed with the implant of an additional ovation ix iliac limb.It was reported the procedure went well.The final patient status was reported to be good.Additional information: clinical assessment determined that there was evidence to reasonably suggest cranial migration of the right iliac stent had also occurred.The migration was discovered during a review of the four (4) month post implant angiogram.

• Brand Name: OVATION IX
• Common Device Name: ILIAC LIMB
• Manufacturer (Section D): ENDOLOGIX SANTA ROSA; 3910 brickway blvd; santa rosa CA 95403
• MDR Report Key: 10889927
• Report Number: 3008011247-2020-00127
• Device Sequence Number: 19532765
• Product Code: MIH
• UDI-Device Identifier: M701TVIL1418160J1
• UDI-Public: +M701TVIL1418160J1/$$3210713FS07111855U
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: P120006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/28/2020

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: 07/13/2021
• Device Model Number: TV-IL1418160-J
• Device Catalogue Number: TV-IL1418160-J
• Device Lot Number: FS071118-55
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/28/2020
• Supplement Date Received by Manufacturer: 01/11/2021
• Initial Report FDA Received Date: 11/24/2020
• Supplement Report FDA Received Date: 01/20/2021
• 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 (LN FS110719-31); OVATION IX MAIN BODY (LN FS020120-09); OVATION PRIME FILL POLYMER (LN FF040820-01); OVATION IX ILIAC LIMB (LN FS110719-31); OVATION IX MAIN BODY (LN FS020120-09); OVATION PRIME FILL POLYMER (LN FF040820-01)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR