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

Model Number	TV-IL1414140-E
Medical Device Problem Codes	Device-Device Incompatibility (2919); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Failure of Implant (1924); Thrombus (2101)
Date of Event	06/05/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device involved in this event will not be returned for evaluation as it remains implanted in the patient.Patient medical records and imaging studies will be requested for further evaluation by the clinical specialist.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 ovation prime abdominal stent graft system (one (1) aorta main body, six (6) iliac limb stent grafts and one (1) extender limb stent graft) and a non- endologix (genesis) left renal stent to treat an abdominal aortic aneurysm (aaa).This initial procedure is outside the indications of use (off-label) due to the use of adjunctive devices not compatible with ovation system per the ifu.Approximately two (2) years post initial procedure, thrombus was present within the devices.The patient elected to defer intervention as the abdominal aortic aneurysm (aaa) sac was stable.The left limb had been occluded since 2017 (patient started having lle (lower limb extremity) claudication symptoms in 2016).An intervention was completed.The physician elect to stent the right external iliac artery with non - endologix stents and preform a fem-fem bypass with non ¿ endologixz stents.
Event or Problem Description
The patient was initially implanted with an ovation prime abdominal stent graft system, five (5) ovation prime iliac limbs, and one (1) ovation prime extender to treat an abdominal aortic aneurysm (aaa).Additionally, a genisis l (non-endologix) stent was implanted.Approximately two (2) years post initial implant, patient experienced left lower extremity claudication.Left limb occlusion was identified.Patient was treated with stenting of the right external iliac artery (type of stent not reported) and fem-fem bypass graft.The final patient status was not reported.
Additional Manufacturer Narrative
An evaluation of the manufacturing record was completed.A review of the part number / lot number combination needed for device identification shows the device to have been properly manufactured and released in accordance with the device master record.The review confirms there were no manufacturing or processing non-conformities identified that would contribute to the reported adverse event/incident.There are no other equivalent adverse events/incidents for this lot number existing within the endologix complaint handling system.An evaluation of the device could not be completed.The device was not returned to endologix for evaluation because it remains in the patient.A clinical evaluation of the adverse event / incident was completed.An examination of medical records and/or medical imaging received by endologix shows the occlusion, claudication and surgical procedure of fem- fem bypass events as unconfirmed.This is not consistent with the reported adverse event/incident.Procedure related harms, device, user, procedure or anatomy relatedness of this complaint could not be determined with the medical records available for review.During the investigation, endologix found reasonable evidence to suggest the device was used off-label.The initial procedure was off label due to concomitant use with products outside of the indications for use however endologix is unable to identify if this was a contributing factors due to a lack of the relevant medical information.The final patient status remains unknown.The final patient status was not made available to endologix.No additional investigation of this reported adverse event/incident is planned.However, should additional information relevant to the investigation outcome become available, a follow-up report will be submitted.Endologix will continue to monitor this and similar adverse events/incidents.Corrections: b5: describe event or problem - correction.D11: concomitant medical devices - updated.G4: awareness date - updated.H6: result code ¿ remove 3233.H6: conclusion code ¿ remove 11.

• Brand Name: OVATION PRIME
• Common Device Name: ILIAC LIMB
• Manufacturer (Section D): ENDOLOGIX SANTA ROSA; 3910 brickway blvd; santa rosa CA 95403
• MDR Report Key: 10596715
• Report Number: 3008011247-2020-00107
• Device Sequence Number: 13741061
• Product Code: MIH
• UDI-Device Identifier: M701TVIL1414140E1
• UDI-Public: +M701TVIL1414140E1/$$3171106FS09121433G
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P120006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/31/2020

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: 11/06/2017
• Device Model Number: TV-IL1414140-E
• Device Catalogue Number: TV-IL1414140-E
• Device Lot Number: FS091214-33
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/31/2020
• Supplement Date Received by Manufacturer: 11/10/2020
• Initial Report FDA Received Date: 09/28/2020
• Supplement Report FDA Received Date: 11/30/2020
• 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: GENESIS L (NON- ENDOLOGIX RENAL STENT).; NON- ENDOLOGIX (GENESIS) STENT.; OVATION PRIME FILL POLYMER FF100614-01.; OVATION PRIME EXTENDER (LN FS102113-28).; OVATION PRIME EXTENDER FS102113-28.; OVATION PRIME FILL POLYMER (LN FF100614-01).; OVATION PRIME ILIAC LIMB (LN FS052314-08).; OVATION PRIME ILIAC LIMB (LN FS091614-33).; OVATION PRIME ILIAC LIMB (LN FS101014-19).; OVATION PRIME ILIAC LIMB (LN FS102214-26).; OVATION PRIME ILIAC LIMB FS052314-08.; OVATION PRIME ILIAC LIMB FS101014-19.; OVATION PRIME ILIAC LIMB FS102214-26.; OVATION PRIME MAIN BODY (LN FS042814-29).; OVATION PRIME MAIN BODY FS042814-29.; NON- ENDOLOGIX (GENESIS) STENT; OVATION PRIME FILL POLYMER FF100614-01; OVATION PRIME EXTENDER FS102113-28; OVATION PRIME ILIAC LIMB FS052314-08; OVATION PRIME ILIAC LIMB FS101014-19; OVATION PRIME ILIAC LIMB FS102214-26; OVATION PRIME MAIN BODY FS042814-29
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR