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

Model Number	TV-AB3480-J
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Material Deformation (2976); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	09/01/2020
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 ovation ix main body and two (2) iliac limb stent grafts to treat a pre-operatively contained ruptured abdominal aortic aneurysm (aaa).Approximately two (2) days post initial procedure there was a type ia endoleak the physician elected to place a palmaz stent and ballooned it.Approximately eleven (11) days post initial procedure a follow up computed tomography (ct) was done and the type ia endoleak was still present.The interventional radiologist put in coils and glue.It is unknown if the endoleak was resolved.The patient is stable.
Event or Problem Description
The patient was initially implanted with an ovation ix main body and two (2) iliac limb stent grafts to treat a pre-operatively contained ruptured abdominal aortic aneurysm (aaa).Approximately two (2) days post initial procedure there was a type ia endoleak the physician elected to place a palmaz stent and ballooned it.Approximately eleven (11) days post initial procedure a follow up computed tomography (ct) was done and the type ia endoleak was still present.The interventional radiologist put in coils and glue.It is unknown if the endoleak was resolved.The patient is stable.Note: the pre-existing ruptured aaa is cautionary product use.Additional information received per clinical assessment confirming that multiple type ii endoleaks (non-device-related failure) and invagination of the polymer ring were also present at the time of the reported event.
Additional Manufacturer Narrative
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 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 reported type ia endoleak and coiling procedure on (b)(6) 2020 are confirmed.This is consistent with the reported adverse event/incident.The clinical evaluation also shows reasonable evidence to suggest type ii endoleaks of the internal mesenteric and lumbar arteries (anatomy-related), and invagination of the second polymer ring occurred that were not included in the event as reported.These findings were discovered during an examination of the 1-day post ct scan and 1-month post angiogram.The most likely causation for the reported event is anatomy-related due to the neck calcifications, which likely contributed to the invagination then the type ia endoleak.The final patient status was reported to be 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: MAIN BODY
• Manufacturer (Section D): ENDOLOGIX SANTA ROSA; 3910 brickway blvd; santa rosa CA 95403
• MDR Report Key: 10646236
• Report Number: 3008011247-2020-00112
• Device Sequence Number: 2631424
• Product Code: MIH
• UDI-Device Identifier: M701TVAB3480J1
• UDI-Public: +M701TVAB3480J1/$$3230528FS05272029B
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 09/10/2020

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: 05/28/2023
• Device Model Number: TV-AB3480-J
• Device Catalogue Number: TV-AB3480-J
• Device Lot Number: FS052720-29
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/10/2020
• Supplement Date Received by Manufacturer: 11/17/2020
• Initial Report FDA Received Date: 10/07/2020
• Supplement Report FDA Received Date: 12/01/2020
• 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 - FS050820-41; OVATION IX ILIAC LIMB - FS101419-16; OVATION PRIME FILL POLYMER - FF041020-01
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 82 YR