MAUDE Adverse Event Report: ENDOLOGIX (TRIVASCULAR INC.) OVATION IX; ILIAC LIMB

Model Number	TV-IL1416140-J
Medical Device Problem Codes	Off-Label Use (1494); Improper or Incorrect Procedure or Method (2017); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	01/20/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device involved in the event will not be returned for evaluation as it remains 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 implanted with an afx2 bifurcated stent graft, a non- endologix (medtronic, thoracic cuff) proximal stent graft, an ovation ix extender and two (2) ovation iliac limbs to treat an abdominal aortic aneurysm (aaa).This initial procedure is outside the indications of use (off label).During the routine 1 month follow up visit ((b)(6) 2018), a type 3a endoleak between the afx2 bifurcated stent graft and the left ovation iliac limb (16x140) was identified and later confirm with an angiogram ((b)(6) 2018).A secondary procedure was completed.The physician elected to implant another ovation iliac limb to bridge the gap between the bifurcated stent graft and the left ovation iliac limb.A small leak was still present post- secondary procedure.Approximately 1 month later ((b)(6) 2018), another intervention was performed.The physician elected to implant a non- endologix (palmaz) stent.A small leak was still present post intervention but the physician decided to monitor the patient as there was no sac growth.The patient was reported as being as being stable post intervention.
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.At the completion of the clinical assessment, clinical was able to find substantial evidence to support the following events of a type 3a endoleak.This event is most likely user related due to the off- label concomitant use of afx/ ovation and medtronic (non- endologix) stents.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.

• Brand Name: OVATION IX
• Common Device Name: ILIAC LIMB
• Manufacturer (Section D): ENDOLOGIX (TRIVASCULAR INC.); 3910 brickway blvd.; santa rosa CA 95403
• MDR Report Key: 8492214
• Report Number: 3008011247-2019-00053
• Device Sequence Number: 16584759
• Product Code: MIH
• UDI-Device Identifier: M701TVIL1416140J1
• UDI-Public: +M701TVIL1416140J1/$$3201012FS09181705L
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P120006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/20/2018

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: 10/12/2020
• Device Model Number: TV-IL1416140-J
• Device Catalogue Number: TV-IL1416140-J
• Device Lot Number: FS091817-05
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/20/2018
• Supplement Date Received by Manufacturer: 02/20/2018
• Initial Report FDA Received Date: 04/08/2019
• Supplement Report FDA Received Date: 10/03/2019
• 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: BIFURCATED STENT GRAFT, LOT 1721822007; EXTENDER STENT GRAFT, LOT FS092517-02; ILIAC LIMB, LOT FS092815-55; ILIAC LIMB, LOT FS111617-24; NON- ENDOLOGIX (MEDTRONIC, THORACIC CUFF); NON- ENDOLOGIX (PALMAZ) STENT; BIFURCATED STENT GRAFT, LOT 1721822007; EXTENDER STENT GRAFT, LOT FS092517-02; ILIAC LIMB, LOT FS092815-55; ILIAC LIMB, LOT FS111617-24; NON- ENDOLOGIX (MEDTRONIC, THORACIC CUFF); NON- ENDOLOGIX (PALMAZ) STENT
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR