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

Model Number	TV-AB2680-J
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Patient-Device Incompatibility (2682); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Aneurysm (1708); Failure of Implant (1924)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The devices involved in this event will not be returned for evaluation and remain implanted in the patient.If additional information is obtained at a later time that is pertinent to this event, a follow-up report will then be submitted.Devices remains implanted in patient.
Event or Problem Description
The patient was initially treated for an abdominal aortic aneurysm (aaa) with the afx2 abdominal aortic aneurysm stent and a palmaz (non-endologix) stent; this constitutes an off-label initial case due to use with an adjunctive device.Approximately one (1) month post initial procedure, the patient presented with a type iiia endoleak.The physician elected to treat the patient by implanting an ovation ix main body and iliac limb on (b)(6) 2019; this is also an off-label procedure due to use of afx with ovation ix devices.This acute event was previously reported per mfr.Report # 2031527-2019-00266.In addition and during the re-intervention procedure in (b)(6) of 2019, the patient experienced hypotension and anaphylaxis post polymer fill of the ovation ix main body.The patient was successfully treated for the anaphylactic reaction per device ifu, after which the patient stabilized.The re-intervention was reported to have taken approximately eight (8) hours to complete, which is considered a prolonged procedure.This intraoperative event was previously reported per mfr.Report # 3008011247-2019-00094.Another five (5) months post re-intervention (sometime in (b)(6) 2019), the patient presented with a type i (a or b) endoleak at routine follow-up and the aneurysm measured at 10.5cm (aaa sac growth).The physician will continue to monitor the patient but a re-intervention is not scheduled at this time.As of date, there have been no additional patient sequelae reported.
Event or Problem Description
The patient was initially treated for an abdominal aortic aneurysm (aaa) with the afx2 abdominal aortic aneurysm stent and a palmaz (non-endologix) stent; this constitutes an off-label initial case due to use with an adjunctive device.Approximately one (1) month post initial procedure, the patient presented with a type iiia endoleak.The physician elected to treat the patient by implanting an ovation ix main body and iliac limb on (b)(6) 2019; this is also an off-label procedure due to use of afx with ovation ix devices.This acute event was previously reported per mfr.Report # 2031527-2019-00266.In addition and during the re-intervention procedure in (b)(6) 2019, the patient experienced hypotension and anaphylaxis post polymer fill of the ovation ix main body.The patient was successfully treated for the anaphylactic reaction per device ifu, after which the patient stabilized.The re-intervention was reported to have taken approximately eight (8) hours to complete, which is considered a prolonged procedure.This intraoperative event was previously reported per mfr.Report # 3008011247-2019-00094.Another five (5) months post re-intervention (sometime in (b)(6) 2019), the patient presented with a type i (a or b) endoleak at routine follow-up and the aneurysm measured at 10.5cm (aaa sac growth).The physician will continue to monitor the patient but a re-intervention is not scheduled at this time.As of date, there have been no additional patient sequelae reported.Additional information: clinical assessment shows the type ia endoleak event is confirmed.
Additional Manufacturer Narrative
The manufacturing lot evaluation confirmed all devices met specifications prior to release.The device was not returned as the device remains implanted therefore no evaluation was completed.The type ia endoleak and sac growth event is confirmed.The persistent type ia endoleak was likely related to the off label nature of the neck, length was 10mm (should be greater than or equal to 15mm), as well as the infrarenal neck angle was 74° (should be less than or equal to 60 degrees).The event is most likely user related.Concomitant use of products outside the ifu is off label.Revision of a previously placed graft is a cautionary product use condition.Procedure related harms for this event could not be determined.The final patient status was not reported.No additional investigation of this reported event is planned however if additional information pertinent to the incident is obtained, a follow-up report will be submitted.Endologix will continue to monitor this complaint and similar complaints in the event further investigation is needed.Corrections: b5: describe event or problem h6: device code: remove code3190 h6: method code: remove code 4114 h6: result code: remove code 3233 h6: conclusion code: remove code 11.

• 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: 9599107
• Report Number: 3008011247-2020-00007
• Device Sequence Number: 3604378
• Product Code: MIH
• UDI-Device Identifier: M701TVAB2680J1
• UDI-Public: +M701TVAB2680J1/$$3220403FS032819335
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/17/2019

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: 04/03/2022
• Device Model Number: TV-AB2680-J
• Device Catalogue Number: TV-AB2680-J
• Device Lot Number: FS032819-33
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/17/2019
• Supplement Date Received by Manufacturer: 12/17/2019
• Initial Report FDA Received Date: 01/16/2020
• Supplement Report FDA Received Date: 08/12/2020
• 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: AFX INFRARENAL AORTIC EXTENSION 1710335-002; AFX INFRARENAL AORTIC EXTENSION 1739571-004; AFX VELA INFRARENAL 1955852-001; AFX VELA SUPRARENAL 2168711-002; AFX2 BIFURCATED STENT 2047479-003; OVATION IX ILIAC LIMB FS012919-08; OVATION IX ILIAC LIMB FS112118-53; PALMAZ (NON-ENDOLOGIX) STENT
• Outcome Attributed to Adverse Event: Other
• Patient Age: 84 YR