MAUDE Adverse Event Report: ENDOLOGIX OVATION IX; EXTENDER

Model Number	TV-EX222245-J
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/24/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The devices involved in the event will not be returned for evaluation, they remain implanted in the patient.If additional information pertinent to the incident is obtained, a follow-up report will be submitted.
Event or Problem Description
The patient was initially treated with afx2 for aorto-iliac occlusive disease (aiod) which is currently outside the indications for use.The afx 2 bifurcated was placed without issue.The physician proceeded to place an ovation ix extender as a infrarenal cuff, upon removal of the ovation delivery system it was noted that the extension was dislodged and covering the left renal.The physician attempted to pull down the extension with both a reliant and powerflex balloon, but it was unsuccessful.Another unsuccessful attempt was performed with a destino tunnel.The physician elected to convert to open repair and perform a left external iliac bypass with a non endologix stent, and another two (2) non endologix stent was placed in the proximal common iliac down to the hypogastric.A final angio was completed showing all vessel patent.A left renal bypass was completed to restore the renal flows.Patient was reported to tolerate the procedure well.No additional patient sequalae has been reported.

• Brand Name: OVATION IX
• Common Device Name: EXTENDER
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 7801085
• Report Number: 3008011247-2018-00182
• Device Sequence Number: 1052793
• Product Code: MIH
• UDI-Device Identifier: M701TVEX222245J1
• UDI-Public: +M701TVEX222245J1/$$3210517FS05031821S
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: P12006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/17/2021
• Device Model Number: TV-EX222245-J
• Device Catalogue Number: TV-EX222245-J
• Device Lot Number: FS050318-21
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/24/2018
• Initial Report FDA Received Date: 08/21/2018
• 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: AFX2 BIFURCATED-LOT: 1930470010
• Outcome Attributed to Adverse Event: Other
• Patient Age: 50 YR