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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ENDOLOGIX AFX2; BIFURCATED STENT GRAFT

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ENDOLOGIX AFX2; BIFURCATED STENT GRAFT Back to Search Results
Model Number BEA28-80/I20-40
Device Problem Difficult or Delayed Positioning (1157)
Patient Problem Ruptured Aneurysm (4436)
Event Date 01/28/2024
Event Type  Death  
Manufacturer Narrative
The devices involved in this event will not be returned for evaluation as they were explanted and not returned by the hospital.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.H3 other text: device discarded by the hospital.
 
Event Description
An emergency endovascular aneurysm repair (evar) was performed on (b)(6) 2024 for a rupture.Reportedly, the patient was very obese.The endologix representative was not present at the case; however, was called via facetime when the afx2 bifurcated stent graft (bsg) main body was in the aorta and snared with the afx2 bsg limbs appearing to be wrapped.The physician was attempting to orientate the afx2 bsg limbs to get them unwrapped.However, the afx2 bsg limbs could not be separated after approximately 30 minutes and the decision was made to abort and open.The staff was doing some compressions as the patient coded on the table a couple times.This made it more challenging to see what was happening on the screen.The patient was opened and the afx2 bsg was explanted.The physician continued to try and save the patient.The patient expired approximately five hours post-explant.The explanted devices were not returned by the hospital.
 
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.Endologix could not perform an evaluation of the device was explanted and discarded by the hospital.A clinical evaluation of the adverse event/incident was completed.An examination of medical records and/or medical imaging received by endologix shows the ruptured abdominal aortic aneurysm, intraoperative unable to deploy stent graft, surgical conversion with explant and death complaints are confirmed.This is consistent with the reported adverse event/incident.The patient death was determined to be anatomy related (aortic rupture pre procedure).There was cautionary usage as this was an emergent procedure due to the ruptured abdominal aortic aneurysm and hemodynamic instability (having received 8 units of blood preoperatively).Additionally, it was reported the patient was very obese.Cpr was done prior to the main body being placed.Procedure related harms were prolonged procedure and hemodynamic instability.The final patient status was reported as deceased.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: g3: awareness date ¿ updated.H1: type of reportable event - corrected.H6: investigation finding codes - remove code 3233.H6: investigation conclusion codes - remove code 11.
 
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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 Key18754462
MDR Text Key335933469
Report Number3011063223-2024-00020
Device Sequence Number1
Product Code MIH
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P040002
Number of Events Reported1
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 01/28/2024
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 Model NumberBEA28-80/I20-40
Device Lot Number2693065010
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/28/2024
Initial Date FDA Received02/21/2024
Supplement Dates Manufacturer Received03/12/2024
Supplement Dates FDA Received04/05/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/31/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
OVATION IX ILIAC LIMB (LN FS081023-58).
Patient Outcome(s) Death;
Patient Age68 YR
Patient SexMale
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