MAUDE Adverse Event Report: ENDOLOGIX SANTA ROSA OVATION IX; ILIAC LIMB

Model Number	TV-IL1428160-J
Medical Device Problem Codes	Use of Device Problem (1670); Migration (4003)
Health Effect - Clinical Code	Pain (1994)
Date of Event	02/18/2020
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.
Event or Problem Description
The patient was initially treated for a ruptured abdominal aortic aneurysm (aaa) with the ovation ix abdominal aortic aneurysm stent; this initial procedure is off-label due to emergent use of an ovation device.Approximately ten (10) days post initial implant procedure, the patient presented emergently with abdominal pain.The ct (computed tomography) scan detected a type ia and ib endoleaks with migration (unknown distance) of the left limb.The physician elected to treat the patient by implanting an additional ovation ix iliac limb device and a palmaz stent on (b)(6) 2020.The type ib and ia endoleaks were confirmed resolved.The patient was extubated and transferred to the icu (intensive care unit), and is reportedly in stable condition.As of date, there have been no additional patient sequelae reported.
Additional Manufacturer Narrative
The manufacturing lot evaluation confirmed all devices met specifications prior to release.The device was not returned therefore no evaluation was completed.At the completion of the clinical assessment, the urgent presentation with ruptured aaa at the initial procedure and recurrent rupture 10 days post the initial procedure event was confirmed.Type 1a and left 1b endoleak with migration left limb events were unconfirmed due to a lack of the relevant medical information.The event is most likely user related due to the urgent nature of placing an ovation implants in a ruptured aaa (cautionary product use condition) and unable to perform the procedure planning before the implants could most likely contribute to the recurrent rupture and reported type 1a and type1b endoleak in 10 days post the initial implant (off-label -outside the treatment range).The procedure related harms identified were acute blood loss, sepsis (positive urine culture), reoccurred rupture in 10 days, additional endovascular procedure.The final patient status was reported stable post the secondary endovascular procedure.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: h6: result code: remove code 3233.H6: conclusion code: remove code 11.

• Brand Name: OVATION IX
• Common Device Name: ILIAC LIMB
• Manufacturer (Section D): ENDOLOGIX SANTA ROSA; 3910 brickway blvd; santa rosa CA 95403
• MDR Report Key: 9845124
• Report Number: 3008011247-2020-00042
• Device Sequence Number: 19014311
• Product Code: MIH
• UDI-Device Identifier: M701TVIL1428160J1
• UDI-Public: +M701TVIL1428160J1/$$3221107FS11041925P
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P120006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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): 02/18/2020

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/07/2022
• Device Model Number: TV-IL1428160-J
• Device Catalogue Number: TV-IL1428160-J
• Device Lot Number: FS110419-25
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/18/2020
• Supplement Date Received by Manufacturer: 02/18/2020
• Initial Report FDA Received Date: 03/17/2020
• Supplement Report FDA Received Date: 08/14/2020
• 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 EXTENDER FS030817-22; OVATION IX EXTENDER FS121318-41; OVATION IX ILIAC LIMB FS021319-10; OVATION IX ILIAC LIMB FS120319-43; OVATION IX MAIN BODY FS111619-07
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 77 YR