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

Model Number	TV-IL1410140-J
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Codes	Failure of Implant (1924); Ischemia (1942); Occlusion (1984); Pain (1994)
Date of Event	09/24/2020
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 (one (1) main body and two (2) limb extensions) to treat an abdominal aortic aneurysm (aaa).Approximately eleven (11) months post initial procedure the patient presented at the er with a sore leg, proximal limb occlusion was identified.Reportedly, the physician treated the patient with placement of bilateral balloon expandable stents successfully regaining flow.Patient tolerated procedure well and was released home one day post intervention.
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.There are no other equivalent adverse events/incidents for this lot number existing within the endologix complaint handling system.An evaluation of the device could not be completed.The device was not returned to endologix for evaluation because it remains in the patient.A clinical evaluation of the adverse event/incident was completed.An examination of medical records and/or medical imaging received by endologix shows an occlusion within device (limb), urgent presentation and secondary endovascular procedure events are confirmed.This is consistent with the reported adverse event/incident.Device, user, procedure or anatomy relatedness of this complaint could not be determined with the medical records available for review.Procedure related harms identified were left lower leg ischemia.During the investigation and with the information available, endologix found no evidence to suggest the device was used off-label.The final patient status was reported as being stable post the secondary 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.

• 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: 10702111
• Report Number: 3008011247-2020-00115
• Device Sequence Number: 3059284
• Product Code: MIH
• UDI-Device Identifier: M701TVIL1410140J1
• UDI-Public: +M701TVIL1410140J1/$$3220405FS04021917F
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/24/2020

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/05/2022
• Device Model Number: TV-IL1410140-J
• Device Catalogue Number: TV-IL1410140-J
• Device Lot Number: FS040219-17
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/24/2020
• Supplement Date Received by Manufacturer: 11/23/2020
• Initial Report FDA Received Date: 10/19/2020
• Supplement Report FDA Received Date: 12/09/2020
• 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 FS011819-33); OVATION IX MAIN BODY (LN FS072919-05); OVATION PRIME FILL POLYMER (LN FF072919-01)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR