MAUDE Adverse Event Report: ENDOLOGIX AFX2; BIFURCATED STENT GRAFT

Model Number BEA28-100/I20-40

Device Problems Collapse (1099); Device-Device Incompatibility (2919); Insufficient Information (3190)

Patient Problems Bacterial Infection (1735); Failure of Implant (1924); Ischemia (1942); Pain (1994); Rupture (2208)

Event Date 10/15/2021

Event Type  Death  

Manufacturer Narrative

The devices involved in this event will not be returned for evaluation and remain implanted in the patient.Patient medical records and imaging studies will be requested for further evaluation by a clinical specialist.If additional information pertinent to the incident is obtained, a follow-up report will be submitted.Device iteration is afx2.

Event Description

The patient was initially treated for an abdominal aortic aneurysm (aaa) with an afx2 bifurcated stent graft and two (2) afx vela suprarenals.Approximately four (4) years later, the patient presented for a follow up where a computed tomography (ct) scan identified a potential 1b endoleak.The physician completed a re-intervention and treated the patient with an ovation ix limb stent graft extension on the left limb, and a right coil embolization and afx limb stent graft placement.The endoleak was resolved.(reported under mfr # 2031527-2020-00250).Approximately one (1) year post-reintervention the patient presented emergently with abdominal pain, a rupture and indeterminate endoleak.Further review of the computerized tomography found that the sac looked inflammatory and there was an unusual bulge by the bifurcation.Reintervention was performed with implant of an afx2 bifurcated stent graft and an additional ovation ix extender.Reportedly, while testing to be sure the device was not behind a stent strut, a 12x4 balloon (non-endologix) became stuck inside the initially implanted afx limb stent graft on the right and dislodged from the afx2 body/limb.The limb became deformed and was extended, bridging the gap between the 2 ovation ix extenders on the right.It was then determined that it was a type iiia endoleak which was resolved along with the unusual bulge by the bifurcation.Additionally, an icast (non-endologix) stent was implanted on the right to extend further into external and repair deformed afx limb stent graft.Due to the inflamed appearance of the aneurysm sac, the patient may have also had an infection.Patient was stable post reintervention.One (1) month post reintervention the patient expired due to unknown causes.

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.An evaluation of the device could not be completed.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 the reported infection is unconfirmed.The reported endoleak (at indeterminate origin), buckling (of the right iliac extension graft), secondary endovascular procedure, rupture and death are confirmed.This is moderately consistent with the reported adverse event/incident.The clinical evaluation also shows reasonable evidence to suggest right limb ischemia (resolved with a non-endologix stent) occurred that was not included in the event as reported.This finding was discovered during an examination of the operative note dated (b)(6) 2021.The procedure-related harm identified was hemodynamic instability.Device, user, procedure, or anatomy relatedness of this event could not be determined with the medical records available for review.However, the following contributing factors were identified: patient was admitted on (b)(6) 2021 with covid-19 pneumonia, which complicated the intervention for the ruptured aaa; respiratory failure on (b)(6) 2021 was attributed to covid-19, and the hypotension appeared related to the ruptured aaa; concomitant product use of the afx2 system with an ovation ix extender and a non-endologix stent in the right common iliac artery.The patient death was found to be related to respiratory insufficiency from covid-19 pneumonia.Patient passed away on (b)(6) 2021 at 04:20.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: b2 date of death.B5 describe event or problem.G4 awareness date.H6 device codes (as evaluated); remove 3190.H6 evaluation result codes; remove 3233.H6 evaluation conclusion codes; remove 11.

Event Description

The patient was initially treated for an abdominal aortic aneurysm (aaa) with an afx2 bifurcated stent graft and two (2) afx vela suprarenals.Approximately four (4) years later, the patient presented for a follow up where a computed tomography (ct) scan identified a potential 1b endoleak.The physician completed a re-intervention and treated the patient with an ovation ix limb stent graft extension on the left limb, and a right coil embolization and afx limb stent graft placement.The endoleak was resolved.(reported under mfr# 2031527-2020-00250).Approximately one (1) year post-reintervention the patient presented emergently with abdominal pain, a rupture and indeterminate endoleak.Further review of the computerized tomography found that the sac looked inflammatory and there was an unusual bulge by the bifurcation.Reintervention was performed with implant of an afx2 bifurcated stent graft and an additional ovation ix extender.Reportedly, while testing to be sure the device was not behind a stent strut, a 12x4 balloon (non-endologix) became stuck inside the initially implanted afx limb stent graft on the right and dislodged from the afx2 body/limb.The limb became deformed and was extended, bridging the gap between the 2 ovation ix extenders on the right.It was then determined that it was a type iiia endoleak which was resolved along with the unusual bulge by the bifurcation.Additionally, an icast (non-endologix) stent was implanted on the right to extend further into external and repair deformed afx limb stent graft.Due to the inflamed appearance of the aneurysm sac, the patient may have also had an infection.Patient was stable post reintervention.One (1) month post reintervention the patient expired due to unknown causes.Additional information received per clinical assessment indicating right limb ischemia also occurred at the time of the reported event.

• Brand Name: AFX2
• Type of Device: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• Manufacturer (Section G): ENDOLOGIX; 2 musick; ,; irvine CA 92618
• Manufacturer Contact: gary kirchgater ; 2 musick; ,; irvine, CA 92618 ; 8009832284
• MDR Report Key: 12682442
• MDR Text Key: 277921119
• Report Number: 2031527-2021-00450
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00818009014405
• UDI-Public: (01)00818009014405(17)170916
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 10/15/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 09/16/2017
• Device Model Number: BEA28-100/I20-40
• Device Lot Number: 1591299-012
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/15/2021
• Initial Date FDA Received: 10/22/2021
• Supplement Dates Manufacturer Received: 11/03/2021
• Supplement Dates FDA Received: 11/09/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/07/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: AFX LIMB STENT GRAFT (LN 2249167-004); AFX VELA SUPRARENAL (LN 1252473-017); AFX VELA SUPRARENAL (LN 1593641-001); OVATION IX EXTENDER (LN FS071320-31); AFX LIMB STENT GRAFT (LN 2249167-004); AFX VELA SUPRARENAL (LN 1252473-017); AFX VELA SUPRARENAL (LN 1593641-001); OVATION IX EXTENDER (LN FS071320-31)
• Patient Outcome(s): Death
• Patient Age: 65 YR
• Patient Sex: Male