MAUDE Adverse Event Report: ENDOLOGIX SANTA ROSA OVATION IX; MAIN BODY

Model Number TV-AB2680-I

Device Problems Material Invagination (1336); Improper or Incorrect Procedure or Method (2017)

Patient Problem Failure of Implant (1924)

Event Date 11/07/2017

Event Type  Injury  

Manufacturer Narrative

The reported adverse event/incident was investigated in alignment with endologix operating procedures and work instructions.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 a type ia endoleak with possible invagination.This is consistent with the reported adverse event/incident.The clinical evaluation also shows reasonable evidence to suggest incorrect sizing of the ab (main body) stent with protruding calcifications at the aortic neck, which are the most likely causation for the reported type ia endoleak.These findings were discovered during an examination of the ct (computed tomography) scan from 31 august 2017.Procedure-related harms of this event could not be determined with the medical records available for review.The final patient status was reported under surveillance.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.Devices remain implanted.

Event Description

The patient was initially treated for an abdominal aortic aneurysm (aaa) with the ovation ix abdominal aortic aneurysm stent.At the conclusion of the initial procedure, a type ia endoleak was detected and noted to possibly be caused by infolding of the polymer rings.The physician elected to monitor the patient and see if the endoleak spontaneously resolves.Additional information received per clinical assessment confirming that the main body was oversized at initial implant (cautionary product use).

• Brand Name: OVATION IX
• 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: emile pinsonneault ; 3910 brickway blvd; ,; santa rosa, CA 95403 ; 8009832284
• MDR Report Key: 10591451
• MDR Text Key: 208720063
• Report Number: 3008011247-2020-00108
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: M701TVAB2680I1
• UDI-Public: +M701TVAB2680I1/$$3200807FS070617103
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P120006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 11/07/2017

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 Expiration Date: 08/31/2020
• Device Model Number: TV-AB2680-I
• Device Lot Number: FS070617-10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/02/2018
• Initial Date FDA Received: 09/28/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/07/2017
• 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: FILL POLYMER, SERIAL # (B)(4); OVATION IX ILIAC LIMB, SERIAL # (B)(4); OVATION IX ILIAC LIMB, SERIAL # (B)(4)
• Patient Outcome(s): Other
• Patient Age: 85 YR