MAUDE Adverse Event Report: ENDOLOGIX SANTA ROSA OVATION IX; AORTIC MAIN BODY

Model Number	TV-AB3480-J
Medical Device Problem Codes	Use of Device Problem (1670); Device-Device Incompatibility (2919); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Death (1802); Low Blood Pressure/ Hypotension (1914)
Date of Event	04/16/2020
Type of Reportable Event	Death
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
During the initial implantation of the ovation ix abdominal stent graft system to treat an abdominal aortic aneurysm (aaa), the nose cone of the ovation ix abdominal stent graft delivery system became detached and was left inside the patient.It was reported that the nose cone become trapped behind the palmaz (non - endolgoix) bare metal stent.Retrieval was attempted and during that maneuver the nose cone became detached.The patients access sites were closed after the final angiograms showed no leaks.The patient was removed from the exam table after anesthesia extubated and was in transport to the icu when the transport team returned.The patient was placed back on the exam table and access was re-obtained.An angiogram revealed no extravasation and a computed tomography (ct) scan revealed a small tear in the aorta.The patient was slightly hypotensive, but was responding to treatment.The endologix representative was informed by the physician that the patient expired post op day two (2).The physician stated that the patient's blood pressure became unstable and the patient fibrillated but the exact cause of death was not 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 detachment of the nosecone behind the palmaz stent, hypotension, and death events were confirmed.Additional a pararenal rupture had occurred.Procedure-related harms include abnormal bleeding, hypotension, respiratory failure, additional endovascular procedure (angiogram), and cpr.These events are most likely user related due to the perirenal pre implant was challenging and off label (angulation 61 degrees should be less than or equal to 60 as well as the diameter of 28.3-34.1mm should be 16-30mm).It is difficult to determine the exact landing zone the physician planned on due to the challenging anatomy.There was also off label placement of a right renal stent, coil in the internal mesenteric artery and 2 palmaz stents during the index procedure (concomitant product use conditions).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: b5: describe event or problem, h6: device code: remove code 3190, h6: result code: remove code 3233, h6: conclusion code: remove code 11.
Event or Problem Description
During the initial implantation of the ovation ix abdominal stent graft system to treat an abdominal aortic aneurysm (aaa), the nose cone of the ovation ix abdominal stent graft delivery system became detached and was left inside the patient.It was reported that the nose cone become trapped behind the palmaz (non - endolgoix) bare metal stent.Retrieval was attempted and during that maneuver the nose cone became detached.The patients access sites were closed after the final angiograms showed no leaks.The patient was removed from the exam table after anesthesia extubated and was in transport to the icu when the transport team returned.The patient was placed back on the exam table and access was re-obtained.An angiogram revealed no extravasation and a computed tomography (ct) scan revealed a small tear in the aorta.The patient was slightly hypotensive, but was responding to treatment.The endologix representative was informed by the physician that the patient expired post op day two (2).The physician stated that the patient's blood pressure became unstable and the patient fibrillated but the exact cause of death was not reported.Updated information: the clinical assessment determined a pararenal rupture occurred.The rupture was discovered during review of the immediate post-operative ct (computed tomography) scan.

• Brand Name: OVATION IX
• Common Device Name: AORTIC MAIN BODY
• Manufacturer (Section D): ENDOLOGIX SANTA ROSA; 3910 brickway blvd; santa rosa CA 95403
• MDR Report Key: 10048066
• Report Number: 3008011247-2020-00064
• Device Sequence Number: 766155
• Product Code: MIH
• UDI-Device Identifier: M701TVAB3480J1
• UDI-Public: +M701TVAB3480J1/$$3210914FS09071808E
• Combination Product (Y/N): N
• Initial Reporter State: NM
• 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): 04/17/2020

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: 09/14/2021
• Device Model Number: TV-AB3480-J
• Device Catalogue Number: TV-AB3480-J
• Device Lot Number: FS090718-08
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/17/2020
• Supplement Date Received by Manufacturer: 04/17/2020
• Initial Report FDA Received Date: 05/12/2020
• Supplement Report FDA Received Date: 08/18/2020
• 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: ILIAC LIMB, LOT FS090618-31; ILIAC LIMB, LOT FS092618-39; POLYMER, LOT, FF072919-01; ILIAC LIMB, LOT FS090618-31; ILIAC LIMB, LOT FS092618-39; POLYMER, LOT, FF072919-01
• Outcome Attributed to Adverse Event: Death
• Patient Age: 83 YR