MAUDE Adverse Event Report: ENDOLOGIX AFX2; AFX2 BIFURCATED STENT GRAFT

Model Number	BEA28-120/I16-40
Medical Device Problem Codes	Collapse (1099); Use of Device Problem (1670); Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Codes	Failure of Implant (1924); Stenosis (2263)
Date of Event	01/13/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The devices involved in this event have not been returned for evaluation.If additional information is obtained at a later time that is pertinent to this event, a follow-up report will then be submitted.Device iteration is afx2.Device return status unknown.
Event or Problem Description
The patient was initially treated for an abdominal aortic aneurysm (aaa) with the afx2 abdominal aortic aneurysm stent.Approximately one (1) month post initial procedure, the patient presented at routine follow-up with a type ib endoleak as detected by ct (computed tomography) scan.The physician elected to treat the patient by implanting a covered (non-endologix) stent a few days later; this procedure is off-label due to use of afx2 with a noncompatible, non-endologix stent.A leak still appeared from the proximal neck (identified as a type ia endoleak) so the physician treated with several coils inside the aneurysm and at the level of the neck.The endoleak appeared resolved.Reference related mfr.Report # 2031527-2020-00072 for this previous event.Another month later, the patient presented with a collapsed proximal portion of the bifurcated device with a partial occlusion of the aorta.The physician elected to treat the patient by converting to open surgical repair on (b)(6) 2020.The patient was reportedly in stable condition.As of date, there have been no additional patient sequelae reported.
Additional Manufacturer Narrative
The manufacturing lot review confirmed all devices met specifications prior to release.The devices were not returned as they remain implanted, and therefore no sample evaluation was completed.A clinical assessment was completed based on the received medical records.The reported partial aortic occlusion due to severe buckling of the bifurcated stent graft is confirmed.The reported surgical conversion is unconfirmed due to a lack of relevant medical records or imaging.This event is most likely user-related due to the concomitant product use of a left renal (non-endologix) stent at 1-month post initial implant (off-label use due to incompatibility with afx) with coiling in the bifurcated device and right iliac artery stent.The procedure-related harms for this event could not be determined with medical records/ images.The final patient status post surgical conversion was reported to be in stable condition.Additional clarification per clinical evaluation, confirming that the reported buckling throughout graft with partial aortic occlusion were diagnosed per received/reviewed ct (computed tomography) scan from (b)(6) 2020 (date of event).No additional investigation of this reported event is planned; however, if additional information pertinent to the incident is obtained, a follow-up report will be submitted.Endologix will continue to monitor this complaint and similar complaints in the event further investigation is needed.Device iteration is afx2.H6 device code; remove 1099.H6 result code; remove 3233.H6 conclusion code; remove 11 and 24 h3 other text : explanted device not available for return.

• Brand Name: AFX2
• Common Device Name: AFX2 BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 9783120
• Report Number: 2031527-2020-00073
• Device Sequence Number: 2511990
• Product Code: MIH
• UDI-Device Identifier: 00818009014443
• UDI-Public: (01)00818009014443(17)200626
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/04/2020

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: Health Professional
• Device Expiration Date: 06/26/2020
• Device Model Number: BEA28-120/I16-40
• Device Lot Number: 2265482-002
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/04/2020
• Supplement Date Received by Manufacturer: 05/04/2020
• Initial Report FDA Received Date: 03/03/2020
• Supplement Report FDA Received Date: 08/12/2020
• 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: NON-ENDOLOGIX COVERED STENT; NON-ENDOLOGIX COVERED STENT
• Outcome Attributed to Adverse Event: Required Intervention