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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ENDOLOGIX INC. AFX; BIFURCATED STENT GRAFT
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ENDOLOGIX INC. AFX; BIFURCATED STENT GRAFT Back to Search Results
Model Number BA28-80/I16-40
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code No Information (3190)
Date of Event 10/18/2017
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
The devices involved in this event will not be returned for evaluation and remain implanted in the patient.If additional information is obtained at a later time that is pertinent to this event, a follow-up report will then be submitted.
 
Event or Problem Description
The patient was implanted with an afx bifurcated stent graft, vela infrarenal, and two (2) limb stent grafts on (b)(6) 2016.A secondary procedure was performed for this patient on (b)(6) 2017 for an unknown reason and the physician implanted an afx2 bifurcated stent graft and new vela infrarenal.
 
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Brand Name
AFX
Common Device Name
BIFURCATED STENT GRAFT
Manufacturer (Section D)
ENDOLOGIX INC.
2 musick
irvine CA 92618
MDR Report Key7445070
Report Number2031527-2018-00195
Device Sequence Number13862321
Product Code MIH
UDI-Device Identifier00818009010025
UDI-Public(01)00818009010025(17)180212
Combination Product (Y/N)N
Initial Reporter CountryFR
PMA/510(K) Number
P040002
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2016
Reporter Type Manufacturer
Report Source company representative,other
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 04/19/2018
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 Date02/12/2018
Device Model NumberBA28-80/I16-40
Device Lot Number1251787-010
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 10/18/2017
Initial Report FDA Received Date04/19/2018
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 Required Intervention;
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