MAUDE Adverse Event Report: ENDOLOGIX AFX2; AFX2 BIFRUCATED STENT GRAFT

Model Number	BEA22-70/I16-30
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Death (1802); Failure of Implant (1924); Rupture (2208)
Date of Event	01/14/2020
Type of Reportable Event	Death
Additional Manufacturer Narrative
The device involved in the event has not been returned for evaluation.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."device iteration is afx2".
Event or Problem Description
The patient was initially implanted with an afx2 bifurcated stent graft and a vela suprarenal to treat an abdominal aortic aneurysm (aaa).Approximately, 5 months post initial procedure the patient presented with a aneurysm rupture and duodenum damage.The physician performed an emergency endovascular aneurysm repair and elected to place an excluder cuff (non-endologix).The excluder cuff was successfully implanted, but the patient passed away from excessive bleeding.Duodenum damage was caused by the impact and pressure from aneurysm rupture and not due to device contact.
Event or Problem Description
The patient was initially implanted with an afx2 bifurcated stent graft and a vela suprarenal to treat an abdominal aortic aneurysm (aaa).Approximately, 5 months post initial procedure the patient presented with a aneurysm rupture and duodenum damage.The physician performed an emergency endovascular aneurysm repair and elected to place an excluder cuff (non-endologix).The excluder cuff was successfully implanted, but the patient passed away from excessive bleeding.Duodenum damage was caused by the impact and pressure from aneurysm rupture and not due to device contact.Correction: the patient was initially implanted with an afx2 bifurcated stent graft and a vela suprarenal to treat an abdominal aortic aneurysm (aaa).It was noted that the vessel condition was not good at initial implant with thrombi in the proximal landing zone.Post computerized tomography showed that the aneurysm size had decreased.Patient status was good.Approximately, 5 months post initial procedure the patient presented with stomach pain and thrombi was identified outside of the graft.The physician performed an emergency endovascular aneurysm repair due to aneurysm rupture and duodenum damage.An excluder cuff (non-endologix) was successfully implanted; however, the patient passed away from excessive bleeding.The doctor stated that the duodenum damage was caused by the impact and pressure from aneurysm rupture and not due to device contact.
Additional Manufacturer Narrative
Clinical assessment was completed based on the received medical records.The reported type iiia endoleak of the aortic components with complete component separation and rupture was confirmed.The report of the additional endovascular procedure (placement of a non endologix proximal extension) was confirmed.The report of the patient death was unconfirmed due to a lack of relevant medical records.The pre-planning image provided showed proximal thrombus and calcifications (cautionary product use condition).Device, user or anatomy relatedness of this event could not be determined.Procedure related harms for this event include abnormal bleeding and the reported mesenteric ischemia.The manufacturing lot evaluation confirmed all devices met specifications prior to release.The device was not returned as the device remains implanted; therefore, no evaluation was completed.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.Device iteration is afx2 corrections: b1: adverse event/product problem - updated b5: describe event or problem ¿ updated h6: device code ¿ remove 3190 h6: result code ¿ remove 3233 h6: conclusion code ¿ remove 11.

• Brand Name: AFX2
• Common Device Name: AFX2 BIFRUCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 9759423
• Report Number: 2031527-2020-00065
• Device Sequence Number: 714075
• Product Code: MIH
• UDI-Device Identifier: 00818009015143
• UDI-Public: (01)00818009015143(17)200323
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Remedial Action: Other,Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 01/27/2020

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/23/2020
• Device Model Number: BEA22-70/I16-30
• Device Lot Number: 2231742-006
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/27/2020
• Supplement Date Received by Manufacturer: 01/27/2020
• Initial Report FDA Received Date: 02/26/2020
• Supplement Report FDA Received Date: 05/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0007-2019
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: VELA SUPRARENAL, LOT # 2088142-001; VELA SUPRARENAL, LOT # 2088142-001
• Outcome Attributed to Adverse Event: Death
• Patient Age: 70 YR