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

Model Number	TV-IL1422120-J
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Not Applicable (3189)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the clinical assessment for this event, the most likely cause of the reported malposition of the right iliac limb could not be determined due to a lack of relevant medical imaging surrounding the event.However, at the index procedure, a longer right iliac limb length, placed distally at the right internal iliac, likely contributed to the unintentional covering of the right internal iliac artery.There were no off-label product use conditions determined (ide study patient).Unable to determined cautionary product use conditions due to a lack of relevant medical records/imaging.There was no additional patient sequelae reported for this patient.A review of the device quality records shows that the device demonstrated compliance to established procedures and specifications at the time of manufacture.
Event or Problem Description
Upon the clinical assessment of this event, it was discovered that the right ovation limb was the potential cause for the right hypogastric occlusion.

• Brand Name: OVATION ALTO
• Common Device Name: ILIAC LIMB
• Manufacturer (Section D): ENDOLOGIX (TRIVASCULAR INC.); 3910 brickway blvd.; santa rosa CA 95403
• MDR Report Key: 7134128
• Report Number: 3008011247-2017-00122
• Device Sequence Number: 16466251
• Product Code: MIH
• UDI-Device Identifier: M701TVIL1422120J1
• UDI-Public: +M701TVIL1422120J1/$$3200412FS03211739E
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/11/2017

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: 04/30/2020
• Device Model Number: TV-IL1422120-J
• Device Catalogue Number: TV-IL1422120-J
• Device Lot Number: FS032117-39
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/11/2017
• Initial Report FDA Received Date: 12/20/2017
• 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 ALTO MAIN BODY: TV-AB2380-K; OVATION IX ILIAC LIMB: TV-IL1422100-J
• Outcome Attributed to Adverse Event: Other
• Patient Age: 72 YR
• Patient Weight: 106