MAUDE Adverse Event Report: ENDOLOGIX AFX; VELA SUPRARENAL

Model Number	A34-34/C80-O20 V
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Failure of Implant (1924); Rupture (2208)
Date of Event	11/09/2020
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.Device iteration is afx2.
Event or Problem Description
The patient was initially implanted with an afx2 bifurcated stent graft, two (2) vela (afx) suprarenal aortic extensions, a vela (afx) infrarenal aortic extension and two (2) ovation ix iliac limb extender stent grafts 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 afx2 system per the ifu.Approximately two (2) years post initial procedure, the patient presented in the emergency room with a ruptured abdominal aortic aneurysm.An intervention was performed.The physician implanted two (2) vela (afx) suprarenal stent grafts and performed ballooning.This did not resolve the rupture therefore the physician elected to convert to an open repair to resolve this event.The patient was reported as stable post intervention.
Additional Manufacturer Narrative
The reported adverse event/incident was investigated in alignment with endologix operating procedures and work instructions.Where possible, it is endologix practice to make at least three good faith efforts to retrieve a reported adverse event/incident related device as well as medical records and medical imaging.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.The device was not returned to endologix for evaluation because it remains implanted.A clinical evaluation of the adverse event/incident was completed.An examination of medical records and/or medical imaging received by endologix shows that the rupture and additional endovascular procedure with surgical conversion were confirmed.This is consistent with the reported adverse events/incidents.The clinical evaluation also shows reasonable evidence to suggest a type 1a endoleak with the migration of the suprarenal proximal extension of 29.2mm, also occurred.The most likely causation for type 1a endoleak with the migration was due to the off label nature of the neck anatomy (distal diameter 34.6mm should be 18-32mm as well as neck length of 7mm should be > or = to 15mm).The rupture and additional endovascular procedure with surgical conversion were related to the type 1a endoleak.The procedure-related harms identified were abnormal blood loss, hypotension, and hemodynamic instability.The final patient status was reported as being transferred back to acute rehabilitation stable.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.Device iteration is afx2.Corrections: b5: describe event or problem.D1: brand name has been updated.D2: product description has been updated.D4: model number has been updated.D11: concomitant medical products and therapy dates.G4: date of received by manufacturer.H4: device manufacture date has been updated.H6: device code: remove code 3190.H6: result code: remove code 3233.H6: conclusion code: remove code 11.
Event or Problem Description
The patient was initially implanted with an afx2 bifurcated stent graft, two (2) vela (afx) suprarenal aortic extensions, a vela (afx) infrarenal aortic extension and two (2) ovation ix iliac limb extender stent grafts 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 afx2 system per the ifu.Approximately two (2) years post initial procedure, the patient presented in the emergency room with a ruptured abdominal aortic aneurysm.An intervention was performed.The physician implanted two (2) vela (afx) suprarenal stent grafts and performed ballooning.This did not resolve the rupture therefore the physician elected to convert to an open repair to resolve this event.The patient was reported as stable post intervention.Additional information: the clinical assessment determined that there was evidence to reasonably suggest a type 1a endoleak with migration occurred.The type 1a endoleak with migration was discovered during review of the twenty-three (23) month post implant (computed tomography) ct scan.

• Brand Name: AFX
• Common Device Name: VELA SUPRARENAL
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 10962754
• Report Number: 2031527-2020-00363
• Device Sequence Number: 2419188
• Product Code: MIH
• UDI-Device Identifier: 00818009014450
• UDI-Public: (01)00818009014450(17)19103
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/09/2020

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: 03/16/2020
• Device Model Number: A34-34/C80-O20 V
• Device Lot Number: 1667656004
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/09/2020
• Supplement Date Received by Manufacturer: 01/22/2021
• Initial Report FDA Received Date: 12/07/2020
• Supplement Report FDA Received Date: 02/02/2021
• 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: AFX BIFURCATED STENT GRAFT - 2006716004.; AFX VELA INFRARENAL - 1591903003.; AFX VELA SUPRARENAL - 1667656004.; AFX VELA SUPRARENAL - 1951858001.; OVATION IX EXTENDER - FS061418-32.; OVATION IX EXTENDER - FS061918-52.; AFX VELA INFRARENAL - 1591903003; AFX VELA SUPRARENAL - 1667656004; AFX VELA SUPRARENAL - 1951858001; OVATION IX EXTENDER - FS061418-32; OVATION IX EXTENDER - FS061918-52
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR