MAUDE Adverse Event Report: ENDOLOGIX OVATION IX; ILIAC LIMB

Model Number	290-0077-35-01
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Leak/Splash (1354)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	07/17/2018
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 ovation ix.Approximately one month post index procedure a type ib endoleak was detected.On (b)(6) 2018, the physician elected coiled the internal iliac and extended into the external with an ovation limb to successfully resolve the endoleak.As of this report, no additional patient sequelae have been reported.
Additional Manufacturer Narrative
At the completion of the investigation, the reported type ib endoleak is confirmed.Device, user, procedure or anatomy relatedness of this complaint could not be determined.Procedure related harms for this complaint could not be determined.The final patient status was not reported.Devices remain implanted in the patient and were not returned, no evaluation completed.The review of manufacturing lot confirmed all devices met specifications prior to release.This complaint is not capa eligible at this time.These types of events will be monitored and trended as part of the quality system.
Additional Manufacturer Narrative
At the completion of the investigation, the reported type ib endoleak is confirmed.Device, user, procedure or anatomy relatedness of this complaint could not be determined.Procedure related harms for this complaint could not be determined.The final patient status was not reported.Devices remain implanted in the patient and were not returned, no evaluation completed.The review of manufacturing lot confirmed all devices met specifications prior to release.This complaint is not capa eligible at this time.These types of events will be monitored and trended as part of the quality system.

• Brand Name: OVATION IX
• Common Device Name: ILIAC LIMB
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 7793114
• Report Number: 3008011247-2018-00176
• Device Sequence Number: 1536193
• Product Code: MIH
• UDI-Device Identifier: M701TVIL1428160J1
• UDI-Public: +M701TVIL1428160J1/$$3200731FS07261713T
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P120006
• 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,Followup
• Report Date (Section B): 07/17/2018

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: 07/31/2020
• Device Model Number: 290-0077-35-01
• Device Catalogue Number: TV-IL1428160-J
• Device Lot Number: FS072617-13
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/17/2018
• Supplement Date Received by Manufacturer: 09/12/2018
• Initial Report FDA Received Date: 08/17/2018
• Supplement Report FDA Received Date: 11/09/2018
• 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: OVATION LIMB-LOT: FS050117-47; OVATION MAIN BODY-LOT: FS030118-40; OVATION LIMB-LOT: FS050117-47; OVATION MAIN BODY-LOT: FS030118-40
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 86 YR