MAUDE Adverse Event Report: ENDOLOGIX AFX; BIFURCATED STENT GRAFT

Model Number	BA28-80/I16-40
Medical Device Problem Codes	Leak/Splash (1354); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	10/12/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The lot history records related to the subject device referenced in this complaint record were reviewed for potential contributing factors for the failure mode(s) described in this event.A review of the device quality records showed that the device(s) demonstrated compliance to established procedures and specifications at the time of manufacture.
Event or Problem Description
The patient was initially implanted with a afx bifurcated stent graft, an infrarenal extension, and suprarenal stent graft to treat an abdominal aortic aneurysm.Approximately two (2) years post initial implant, an indeterminate endoleak was reported.No further information is available.As of the date of this report, there have been no additional patient sequelae reported.
Event or Problem Description
Additional information received confirming that the patient has not been scheduled for re-intervention; the physician continues to monitor the patient.
Additional Manufacturer Narrative
At the completion of the clinical evaluation and based on the information received, there was unsubstantial evidence to support the reported event of indeterminate endoleak.Procedure-related harms include a type ii endoleak after the initial implant.Event-relatedness and the final patient status could not be confirmed.The manufacturing lot review confirmed all devices met specifications prior to release.These types of events will be monitored and trended as part of the quality system.Correction: device code - remove 1354.Result code - remove 3233.Conclusion code - remove 11.

• Brand Name: AFX
• Common Device Name: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 8057750
• Report Number: 2031527-2018-00855
• Device Sequence Number: 13866419
• Product Code: MIH
• UDI-Device Identifier: 00818009010025
• UDI-Public: (01)00818009010025(17)190120
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/12/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/20/2019
• Device Model Number: BA28-80/I16-40
• Device Catalogue Number: BA28-80/I16-40
• Device Lot Number: 1285656018
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/12/2018
• Supplement Date Received by Manufacturer: 10/12/2018
• Initial Report FDA Received Date: 11/09/2018
• Supplement Report FDA Received Date: 03/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: INFRARENAL -1252187010; SUPRARENAL - LOT #1464243024
• Outcome Attributed to Adverse Event: Other
• Patient Age: 89 YR