MAUDE Adverse Event Report: ENDOLOGIX AFX2; BIFURCATED STENT GRAFT

Model Number	BEA22-70/I16-30
Medical Device Problem Codes	Complete Blockage (1094); Fracture (1260); Improper or Incorrect Procedure or Method (2017); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Unspecified Infection (1930); Occlusion (1984); Thrombus (2101)
Date of Event	09/25/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device involved has not been returned.Patient medical records and imaging studies will be requested for further evaluation by the clinical specialist.If additional information pertinent to the incident is obtained, a follow-up report will be submitted.Device iteration is afx2.
Event or Problem Description
The patient was implanted with a afx2 bifurcated stent graft.The pre-case plan was reviewed indicating several area's of anatomy outside the indications for use.The final angiogram showed there was thrombus present (location of the thrombus was not reported).Later the same day, the device was explanted due to an occlusion (location of the occlusion was not reported) and a surgical graft (non- endologix) was implanted.It was also reported at a later date that the surgical graft might be infected.The patient is currently doing better 2 weeks post explant.
Additional Manufacturer Narrative
The manufacturing lot review confirmed all devices met specifications prior to release.A clinical evaluation of the reported event could not be completed due to a lack of receipt of relevant medical records and/or imaging; several requests were made and a denied response was received.As such, the event determination, off-label conditions, related patient harms, and patient disposition could not be assessed with medical records/ images.However, the reported event was most likely due to the patient's off-label anatomy, as indicated per the pre-case sizing report.Additionally, endologix received one bifurcated device (bea22-70/i16-30) for evaluation, packaged in a biohazard bag with blood and tissue residue present.The graft material of the main body and the bifurcation are free of damage or defect.The stent cage shows evidence of strut fracture and deformity at the proximal end, and the flow lumen is clear.It is noted that the discovered fracture is consistent with damage caused during an explant procedure; however due to the lack of medical records/images, the causation of the strut fracture/deformity is indeterminate.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.Corrections: all fields have been filled in and updated to the correct information due to the incorrect / mix up in the maunfaturer reporting #.
Event or Problem Description
The patient was implanted with a afx2 bifurcated stent graft.The pre-case plan was reviewed indicating several area's of anatomy outside the indications for use.The final angiogram showed there was thrombus present (location of the thrombus was not reported).Later the same day, the device was explanted due to an occlusion (location of the occlusion was not reported) and a surgical graft (non-endologix) was implanted.It was also reported at a later date that the surgical graft might be infected.The patient is currently doing better 2 weeks post explant.Additional information received per product evaluation confirming that the stent cage of the bifurcated stent graft showed evidence of a strut fracture at the proximal portion of the device.Note: the initial report to patient identifier (b)(6) was inadvertently never submitted under the assigned mfr.Report # 2031527-2019-00471; rather, the initial report per mfr.Report # 2031527-2019-00466 (intended for patient identifier (b)(6) ) was submitted in its place on 23 october 2019 for a separate event/patient.Due to the confusion, a duplicate initial report for patient identifier (b)(6) was also submitted under mfr.Report # 2031527-2019-09999 on 25 october 2019.Therefore, the initial report for patient identifier (b)(6) was never received by the fda.To resolve any further confusion, a final and all-encompassing report will be submitted for patient identifier (b)(6) under mfr.Report # 2031527-2019-00466.Also, a final report will be submitted for patient identifier (b)(6) under mfr.Report # 2031527-2019-09999.

• Brand Name: AFX2
• Common Device Name: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine, ca CA 92618
• MDR Report Key: 9241336
• Report Number: 2031527-2019-09999
• Device Sequence Number: 18870820
• Product Code: MIH
• UDI-Device Identifier: 00818009015143
• UDI-Public: (01)00818009015143(17)200506
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2019

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: 05/06/2020
• Device Model Number: BEA22-70/I16-30
• Device Lot Number: 2246105-008
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 09/25/2019
• Supplement Date Received by Manufacturer: 03/03/2020
• Initial Report FDA Received Date: 10/25/2019
• Supplement Report FDA Received Date: 08/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 79 YR