MAUDE Adverse Event Report: ENDOLOGIX SANTA ROSA ALTO; MAIN BODY

Model Number TV-AB2980-N

Device Problems Material Invagination (1336); Lack of Effect (4065)

Event Date 05/18/2023

Event Type  Injury  

Manufacturer Narrative

The devices involved in this event will not be returned for evaluation and remain implanted in the patient.Patient medical records and imaging studies will be requested for further evaluation by a clinical specialist.If additional information pertinent to the incident is obtained, a follow-up report will be submitted.H3 other text : devices remain implanted.

Event Description

The patient was initially treated for an abdominal aortic aneurysm (aaa) with implant of the alto abdominal aortic aneurysm stent system.At the conclusion of the initial implant procedure, a small type ia endoleak was observed.The patient will continue to be monitored to discern if the endoleak self-resolves at 30-day follow-up.

Event Description

The patient was initially treated for an abdominal aortic aneurysm (aaa) with implant of the alto abdominal aortic aneurysm stent system.At the conclusion of the initial implant procedure, a small type ia endoleak was observed.The patient will continue to be monitored to discern if the endoleak self-resolves at 30-day follow-up.Additional information: it was reported that the type ia endoleak was found resolved per aortogram at two (2) months post initial implant procedure.No additional intervention was required.Aneurysm sac regression was also evident.In addition, clinical assessment identified that infolding of the primary sealing rings was also present at time of event.

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 the reported alto, type ia endoleak (resolved) is confirmed.This is consistent with the reported adverse event/incident.The clinical evaluation also shows reasonable evidence to suggest an additional endovascular procedure (diagnostic angiogram) and infolding (of the primary sealing rings) occurred that were not included in the event as reported.These findings were discovered during an examination of the three diagnostic angiogram videos and ct (computed tomography) scan dated (b)(6) 2023, respectively.The most likely causation for the reported event is anatomy-related due to the thrombus in the proximal neck, which was taken into account in using the 29mm main body; this cautionary product use condition likely contributed to the infolding.In addition, the infolding of the primary sealing rings likely caused the type ia endoleak.The procedure-related harms identified were a non-endologix device failure (palmaz deployed in distal right common iliac artery).The final patient status was reported as discharged home in stable condition.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.Corrections: b5 describe event or problem g3 awareness date h6 medical device problem codes; remove 4065 h6 investigation finding codes; remove 3233 h6 investigation conclusion codes; remove 11.

• Brand Name: ALTO
• Type of Device: MAIN BODY
• Manufacturer (Section D): ENDOLOGIX SANTA ROSA; 3910 brickway blvd; santa rosa CA 95403
• Manufacturer (Section G): ENDOLOGIX SANTA ROSA; 3910 brickway blvd; ,; santa rosa CA 95403
• Manufacturer Contact: gary kirchgater ; 3910 brickway blvd; ,; santa rosa, CA 95403 ; 8009832284
• MDR Report Key: 17125732
• MDR Text Key: 317177561
• Report Number: 3008011247-2023-00077
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00850007370909
• UDI-Public: (01)00850007370909(17)260208(10)FS020623-30
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P120006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 05/18/2023

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
• Device Operator: Health Professional
• Device Model Number: TV-AB2980-N
• Device Catalogue Number: TV-AB2980-N
• Device Lot Number: FS020623-30
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/18/2023
• Initial Date FDA Received: 06/14/2023
• Supplement Dates Manufacturer Received: 06/29/2023
• Supplement Dates FDA Received: 08/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/06/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: OVATION IX ILIAC LIMB, LN FS011623-35; OVATION IX ILIAC LIMB, LN FS072122-53; OVATION IX ILIAC LIMB, LN FS102422-17; OVATION PRIME FILL POLYMER, LN FF020921-01
• Patient Outcome(s): Other
• Patient Age: 78 YR
• Patient Sex: Male