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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ENDOLOGIX INC. AFX2; BIFURCATED STENT GRAFT
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ENDOLOGIX INC. AFX2; BIFURCATED STENT GRAFT Back to Search Results
Model Number BEA28-70/I20-30
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes Death (1802); Heart Failure (2206)
Date of Event 12/12/2017
Type of Reportable Event Death
Additional Manufacturer Narrative
The devices involved in the event will not be returned for evaluation, they remain implanted in the patient.If additional information pertinent to the incident is obtained, a follow-up report will be submitted.
 
Event or Problem Description
It was reported that during the initial implant of an afx2 device on (b)(6) 2017 the patient expired.The implant of the afx2 device was successful and no issues were reported.After the placement of the device, the patient went into cardiac arrest, after 15 minutes of cpr, the physician was unable to return the patient's heart rate.Patient died on the operating table.
 
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Brand Name
AFX2
Common Device Name
BIFURCATED STENT GRAFT
Manufacturer (Section D)
ENDOLOGIX INC.
2 musick
irvine CA 92618
MDR Report Key7168375
Report Number2031527-2018-00014
Device Sequence Number11196691
Product Code MIH
UDI-Device Identifier00818009014566
UDI-Public(01)00818009014566(17)181016
Combination Product (Y/N)N
Initial Reporter StateFL
Initial Reporter CountryUS
PMA/510(K) Number
P040002
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 12/12/2017
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 Physician
Device Expiration Date10/16/2018
Device Model NumberBEA28-70/I20-30
Device Lot Number1750038-012
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 12/12/2017
Initial Report FDA Received Date01/05/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Death;
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