MAUDE Adverse Event Report: ENDOLOGIX AFX; VELA SUPRARENAL

Model Number	A34-34/C100-O20 V
Medical Device Problem Codes	Material Puncture/Hole (1504); Deformation Due to Compressive Stress (2889); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Aneurysm (1708); Failure of Implant (1924)
Date of Event	06/30/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was initially implanted with a bifurcated stent graft and a suprarenal stent graft extension to treat an abdominal aortic aneurysm (aaa).Approximately 6 years post initial procedure aneurysm enlargement was identified during a routine follow up.Reportedly, the patient is stable and is pending a re-intervention.
Additional Manufacturer Narrative
The device remains implanted in the patient; therefore, it will not be returned for evaluation.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 afx with duraply.
Additional Manufacturer Narrative
The reported adverse event/incident was investigated in alignment with endologix operating procedures and work instructions.Where possible, it is endologix practice to make at least three good faith efforts to retrieve a reported adverse event/incident related device as well as medical records and medical imaging.An evaluation of the manufacturing record was completed.A review of the part number/lot number combination needed for device identification shows the device to have been properly manufactured and released in accordance with the device master record.An evaluation of the device could not be completed.The device was not returned to endologix for evaluation because it remains implanted.A clinical evaluation of the adverse event/incident could not be completed.No medical records nor medical imaging relevant to the reported adverse event/incident was received by endologix.The user facility was unable to provide this information.Due to the absence of medical records and medical imaging device, use, procedure, and/or anatomy relatedness to this adverse event/incident could not be evaluated.The final patent status was reported to be stable.No additional investigation of this reported adverse event/incident is planned.However, should additional information relevant to the investigation outcome become available, a follow-up report will be submitted.Endologix will continue to monitor this and similar adverse events/incidents.B2: outcomes attributed to ae - updated b5: describe event or problem - updated d10: therapy dates and concomitant products - updated g3: awareness date - updated h6: health effect - impact code - removed 4614 h6: investigation finding codes - remove code 3233 h6: investigation conclusion codes - remove code 11.
Event or Problem Description
The patient was initially implanted with a bifurcated stent graft and a suprarenal stent graft extension to treat an abdominal aortic aneurysm (aaa).Approximately 6 years post initial procedure aneurysm enlargement was identified during a routine follow up.Reportedly, the patient is stable and is pending a re-intervention.After the initial report, it was determined that the patient the patient had previously undergone intervention (reported under mfr# 2031527-2018-00965).An afx bifurcated and suprarenal were initially implanted.The two (2) year follow-up showed evidence of decreased graft overlap and an unknown aneurysm sac enlargement with a possible type 3b endoleak.The physician elected to treat the patient by relining with the implant of an afx2 bifurcated stent graft, an afx infrarenal, and an afx suprarenal on (b)(6) 2018.The patient was reportedly in stable condition.Now, on (b)(6) 2022, reintervention was completed with the implant of two (2) afx vela infrarenal stents.The final patent status was reported to be stable.
Event or Problem Description
The patient was initially implanted with a bifurcated stent graft and a suprarenal stent graft extension to treat an abdominal aortic aneurysm (aaa).Approximately 6 years post initial procedure aneurysm enlargement was identified during a routine follow up.Reportedly, the patient is stable and is pending a re-intervention.After the initial report, it was determined that the patient had previously undergone intervention (reported under mfr#: 2031527-2018-00965).An afx bifurcated and suprarenal were initially implanted.The two (2) year follow-up showed evidence of decreased graft overlap and an unknown aneurysm sac enlargement with a possible type 3b endoleak.The physician elected to treat the patient by relining with the implant of an afx2 bifurcated stent graft, an afx infrarenal, and an afx suprarenal on (b)(6) 2018.The patient was reportedly in stable condition.Now, on (b)(6) 2022, re-intervention was completed with the implant of two (2) afx vela infrarenal stents.The final patent status was reported to be stable.Additional information per clinical assessment: a type 3b endoleak of the vela suprarenal implanted in 2016, and stent buckling of the vela suprarenal implanted in 2018 were confirmed per 2022 event.In addition, the reported aneurysm enlargement was confirmed as insignificant in growth (less than 5mm).This mfr.Report#: 2031527-2022-00190 (patient id: (b)(6) addresses the event of insignificant (2mm) aneurysm enlargement, type 3b endoleak and stet buckling with tertiary intervention in 2022.
Additional Manufacturer Narrative
The reported adverse event/incident was investigated in alignment with endologix operating procedures and work instructions.Where possible, it is endologix practice to make at least three good faith efforts to retrieve a reported adverse event/incident related device as well as medical records and medical imaging.An evaluation of the manufacturing record was completed.A review of the part number/lot number combination needed for device identification shows the device to have been properly manufactured and released in accordance with the device master record.The review confirms there were no manufacturing or processing non-conformities identified that would contribute to the reported adverse event/incident.An evaluation of the device could not be completed.The device was not returned to endologix for evaluation because it remains implanted.A clinical evaluation of the adverse event/incident was completed.An examination of medical records and/or medical imaging received by endologix shows that the aneurysm enlargement of 2mm and the additional endovascular procedure are confirmed.This is consistent with the reported adverse event/incident.The clinical evaluation also shows reasonable evidence to suggest a type 3b endoleak of the original suprarenal proximal extension placed in 2016, and stent buckling of the suprarenal proximal extension placed in 2018.These findings were discovered during an examination of the ct (computed tomography) scan dated on (b)(6) 2022.Procedure related harms, device, user, procedure or anatomy relatedness of the overall event could not be determined with the medical records available for review.However, the type 3b endoleak was most likely due to the buckling, and the buckling was most likely related to the increase in the infrarenal angulation from 41 to 62 degrees (aortic remodeling).In addition, there were two revisions of a previously placed graft in 2018 and 2022 (cautionary product use).The final patient status was reported to be stable.No additional investigation of this reported adverse event/incident is planned.However, should additional information relevant to the investigation outcome become available, a follow-up report will be submitted.Endologix will continue to monitor this and similar adverse events/incidents.Device iteration is afx with duraply.Corrections: b5: describe event or problem section d suspect medical device.G3: awareness date.H4: release date (primary).H6: health effect - clinical code; remove 1708.H6: medical device problem codes; remove 3190.

• Brand Name: AFX
• Common Device Name: VELA SUPRARENAL
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• Manufacturer (Section G): ENDOLOGIX; 2 musick; ,; irvine CA 92618
• Manufacturer Contact: gary kirchgater ; 2 musick; ,; irvine, CA 92618 ; 8009832284
• MDR Report Key: 15067335
• Report Number: 2031527-2022-00190
• Device Sequence Number: 14883751
• Product Code: MIH
• UDI-Device Identifier: 00818009013651
• UDI-Public: (01)00818009013651(17)190331
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/30/2022

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: 03/31/2019
• Device Model Number: A34-34/C100-O20 V
• Device Lot Number: 1472863-001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/30/2022
• Supplement Date Received by Manufacturer: 07/26/2022; 11/06/2022
• Initial Report FDA Received Date: 07/20/2022
• Supplement Report FDA Received Date: 09/07/2022; 12/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/18/2016
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0008-2019
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AFX BIFURCATED STENT GRAFT, SN: (B)(6).; AFX VELA INFRARENAL LOT 1738155008.; AFX VELA INFRARENAL, SN: (B)(6).; AFX VELA SUPRARENAL LOT 1472863001.; AFX VELA SUPRARENAL LOT 1472863001.; AFX VELA SUPRARENAL LOT 1732115005.; AFX VELA SUPRARENAL, SN: (B)(6).; AFX2 BIFURCATED STENT GRAFT LOT 1809852004.; AFX2 BIFURCATED STENT GRAFT, SN: (B)(6).
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 80 YR
• Patient Sex: Male