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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ENDOLOGIX AFX; BIFURCATED STENT GRAFT

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ENDOLOGIX AFX; BIFURCATED STENT GRAFT Back to Search Results
Model Number BA25-100/I16-40
Device Problems Loss of or Failure to Bond (1068); Leak/Splash (1354); Stretched (1601)
Patient Problem Failure of Implant (1924)
Event Date 09/20/2018
Event Type  Injury  
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 Description
Patient was initially implanted with an afx bifurcated and vela suprarenal device in 2014.Recently, patient present with an endoleak type 1a.On (b)(6) 2018, the patient was relined with an ovation graft.The endoleak was successfully sealed and patient is in stable condition.
 
Manufacturer Narrative
At the completion of the clinical evaluation and based on the information received, there was substantial evidence to refute the reported event of type ia endoleak.The clinical assessment determined that there was evidence to reasonably suggest the following: a non-endologix stent was implanted at index into the right iliac artery (off-label), there was multiple type ii endoleaks, and presence of stent cage dilation of the main body stent (28%) that were not included in the event as reported.These events were discovered during review of the event imaging study, 49 months post implant.Relatedness and procedure harms could not be determined.The patient was reported to be in stable condition.The manufacturing lot review confirmed all devices met specifications prior to release.This complaint is not capa eligible at this time.These types of events will be monitored and trended as part of the quality system.(b)(4).
 
Event Description
Additional information received refuting the reported type ia endoleak and rather, confirming multiple type ii endoleaks with stent cage dilcation of the main body.
 
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Brand Name
AFX
Type of Device
BIFURCATED STENT GRAFT
Manufacturer (Section D)
ENDOLOGIX
2 musick
irvine CA 92618
MDR Report Key8002735
MDR Text Key124946477
Report Number2031527-2018-00791
Device Sequence Number1
Product Code MIH
UDI-Device Identifier00818009013637
UDI-Public(01)00818009013637(17)141212
Combination Product (y/n)N
PMA/PMN Number
P040002
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 09/20/2018
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? Yes
Device Operator Health Professional
Device Expiration Date03/31/2017
Device Model NumberBA25-100/I16-40
Device Lot Number1055792-004
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 09/20/2018
Initial Date FDA Received10/24/2018
Supplement Dates Manufacturer Received10/26/2018
Supplement Dates FDA Received12/14/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
AFX-BIFURCATED-LOT: 1055792-004; AFX-VELA SUPRARENAL:12016850-002
Patient Outcome(s) Required Intervention;
Patient Age68 YR
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