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

Model Number	TV-IL1418140-J
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	08/25/2021
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 implanted with the alto stent graft system and (2) two ovation ix iliac limbs to treat an abdominal aortic aneurysm (aaa).Approximately (4) four months post initial procedure, a right common iliac occlusion that caused the graft to shut down on the right was identified during a routine follow-up.A re-intervention was performed, the physician elected to balloon the bilateral limbs at the divider to extended both limbs proximally to the rings.The physician also implanted (2) two ovation ix iliac limbs.The final patient status was reported as being good.(reported under mfr # 3008011247-2021-00071).Approximately two (2) months post reintervention, it was identified at routine follow-up that the right common iliac had become occluded once more.The physician elected to aspirate using a penumbra lightning 12 (non-endologix).Additionally, two (2) atrium (non-endologix) balloon expandable ptfe covered stents were placed to the ring and a extending the limb.The results were good and the patient was reported to be 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 imaging received by endologix shows the re-occlusion at the right limb stent is confirmed.This is 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 being stable.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: 12469125
• Report Number: 3008011247-2021-00109
• Device Sequence Number: 4892534
• Product Code: MIH
• UDI-Device Identifier: M701TVIL1418140J1
• UDI-Public: +M701TVIL1418140J1/$$3230917FS09152027Y
• 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: 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): 08/25/2021

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: 09/17/2023
• Device Model Number: TV-IL1418140-J
• Device Catalogue Number: TV-IL1418140-J
• Device Lot Number: FS091520-27
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/25/2021
• Supplement Date Received by Manufacturer: 10/18/2021
• Initial Report FDA Received Date: 09/14/2021
• Supplement Report FDA Received Date: 10/25/2021
• 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: ALTO MAIN BODY (LN FS102720-31); OVATION IX EXTENDER (LN FS033120-29); OVATION IX ILIAC LIMB (LN FS071720-11); OVATION IX ILIAC LIMB (LN FS090920-09); OVATION IX ILIAC LIMB (LN FS091520-05); OVATION PRIME FILL POLYMER (LN FF091120-01); ALTO MAIN BODY (LN FS102720-31); OVATION IX EXTENDER (LN FS033120-29); OVATION IX ILIAC LIMB (LN FS071720-11); OVATION IX ILIAC LIMB (LN FS090920-09); OVATION IX ILIAC LIMB (LN FS091520-05); OVATION PRIME FILL POLYMER (LN FF091120-01)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 54 YR