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 12/20/2023

Event Type  Injury  

Manufacturer Narrative

The device involved in this event will not be returned for evaluation as it remains implanted in the patient.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.H3 other text : device remains implanted.

Event Description

The patient was implanted with the alto stent graft system to treat an abdominal aortic aneurysm (aaa).A type 1a endoleak was present at the end of this procedure.The physician ballooned initially at sixteen (16) minutes, and after the final run, ballooned and held for two (2) minutes.The type 1a endoleak improved, but there was still a little bit of filling.The physician's decision was to bring the patient back for a 30 day computed tomography angiogram (cta) before proceeding.At that point, if there is an endoleak, a palmaz (non-endologix) stent will be placed.No intervention was performed and the patient is being monitored.

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 type 1a endoleak is confirmed.This is consistent with the reported adverse event/incident.The clinical assessment also determined invagination of the first polymer ring occurred that was not in the event as reported.The invagination was discovered during a review of the ct scan dated 12/25/2023.It was reported that it was planned to land the fabric at the level of right renal artery due to conical neck.This may have contributed to a type 1a endoleak but could not conclusively be determined.The invagination of the first ring could have contributed to the reported event, however that could not be conclusively determined.The readmission on 12/25/2023 was related to exacerbation of a chronic medical conditions including congestive heart failure and chronic atrial fibrillation (non-device related).Device, user, procedure or anatomy relatedness of this complaint could not be determined.No procedure related harms for this complaint were identified.The final patient status was reported as discharged home on postoperative day one 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: g3: awareness date has been updated.H6: medical device problem codes: remove code 4065.H6: investigation finding codes: remove code 3233.H6: investigation conclusion codes: remove code 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: 18418849
• MDR Text Key: 331605009
• Report Number: 3008011247-2023-00215
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00850007370909
• UDI-Public: (01)00850007370909(17)250518(10)FS051622-63
• 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: 12/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2023
• 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 Lot Number: FS051622-63
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/21/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/12/2022
• 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, LOT # FS111622-22; OVATION IX ILIAC LIMB, LOT # FS112822-05; OVATION PRIME FILL POLYMER, LOT # FF100623-01
• Patient Outcome(s): Other
• Patient Age: 77 YR