MAUDE Adverse Event Report: ENDOLOGIX OVATION IX; MAIN BODY

Model Number	TV-AB2680-J
Medical Device Problem Codes	Device-Device Incompatibility (2919); Separation Problem (4043)
Health Effect - Clinical Codes	Aneurysm (1708); Failure of Implant (1924); Thrombosis (2100); Rupture (2208); Blood Loss (2597)
Date of Event	07/14/2020
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.Device not returned after explant.
Event or Problem Description
The patient was initially implanted with the ovation ix abdominal stent graft system to treat an abdominal aortic aneurysm (aaa).There were an additional two gore (non-endologix) iliac limbs implanted (off label use of concomitant devices).Approximately 2 years post initial procedure the patient presented with a contained rupture.Additionally, there was a type 3a endoleak with separation between the ovation ix iliac limb and the gore (non-endologix) iliac limb.An attempt was made to reline the ovation ix with an endurant (non-endologix) stent graft; however, this was abandoned due to compression of the graft and coverage of both renals.Exploratory laparotomy was performed with removal of the endurant stent graft as well as the ovation ix with residual left iliac limb left in the left common iliac artery.Aortic thrombosis was also removed.Reportedly, only the gore (non-endologix) was left.Open repair of the ruptured aaa was completed with placement of a 22mm aortic tube graft.Patient is reported to have been discharged home on dialysis and 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.The review confirms there were no manufacturing or processing non-conformities identified that would contribute to the reported adverse event/incident.An evaluation of the device could not be completed.The device was not returned to endologix for evaluation because it was discarded at the user facility.A clinical evaluation of the adverse event/incident was completed.An examination of medical records and/or medical imaging received by endologix shows a type iiia endoleak of the ovation and non endologix stent in the contralateral limb, rupture, attempted but unsuccessful secondary endovascular repair and subsequent surgical conversion.This is consistent with the reported adverse event/incident.The most likely causation for the reported event is user related due to the concomitant product use of non-endologix devices (off label product use condition) likely.The procedure related harm identified for this event was abnormal blood loss.The final patient status was reported as being discharged home and well.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: d11: concomitant product (rfb).G4: awareness date.H6: patient code - removed 1708.H6: result code ¿ removed 3233.H6: conclusion code ¿ removed 11.

• Brand Name: OVATION IX
• Common Device Name: MAIN BODY
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 10394041
• Report Number: 3008011247-2020-00089
• Device Sequence Number: 3446627
• Product Code: MIH
• UDI-Device Identifier: M701TVAB2680J1
• UDI-Public: +M701TVAB2680J1/$$3210608FS060518079
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: P120006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted 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): 07/17/2020

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: 06/08/2021
• Device Model Number: TV-AB2680-J
• Device Catalogue Number: TV-AB2680-J
• Device Lot Number: FS060518-07
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/17/2020
• Supplement Date Received by Manufacturer: 10/01/2020
• Initial Report FDA Received Date: 08/11/2020
• Supplement Report FDA Received Date: 10/08/2020
• 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 FS071917-44).; OVATION IX ILIAC LIMB (LN ILIAC LIMB).; OVATION IX ILIAC LIMB (LN/SN FS052516-62 ).; OVATION IX ILIAC LIMB (LN/SN FS071917-44).; OVATION PRIME FILL POLYMER (FF040918-02).; OVATION PRIME FILL POLYMER (LN/SN FF040918-02).; X2 GORE ILIAC LIMB EXTENSION (NON-ENDOLOGIX).; X2 GORE ILIAC LIMB EXTENSION (NON-ENDOLOGIX).
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 64 YR