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

Model Number TV-AB2980-N

Device Problems Filling Problem (1233); Short Fill (1575)

Event Date 05/30/2023

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).During this initial procedure there was partial/very slow polymer fill and only two rings of ipsilateral limb filled.The primary and secondary rings filled very late and possibly not fully.The contralateral limb did not fill at all and could not be visualized.During the 14 minute cure time a 0.014 inch and 0.018 inch wire were attempted to be inserted up and over to see if that would help fill but it did not.The lunderquist was pulled back and the alto balloon was inflated to see if that would help open and fill line but was not successful.At 14 minutes a 0.018 inch wire was inserted and snared into what was thought to be the contralateral limb but it was not possible to visualize the contralateral limb.Contrast injection and balloon were checked to see the wire was in the contralateral limb and it appeared it was.The balloon was disconnected and then the sealing ring was ballooned for one minute.Removed alto ab device.The procedure was completed and the aneurysm appeared to be sealed; however, there may be a small type 1a endoleak and late blush.The physician opted to follow the patient at 30 days with computed tomography angiogram (cta) to determine if anything further needs to be done.

Event Description

The patient was implanted with the alto stent graft system to treat an abdominal aortic aneurysm (aaa).During this initial procedure there was partial/very slow polymer fill and only two rings of ipsilateral limb filled.The primary and secondary rings filled very late and possibly not fully.The contralateral limb did not fill at all and could not be visualized.During the 14 minute cure time a 0.014 inch and 0.018 inch wire were attempted to be inserted up and over to see if that would help fill but it did not.The lunderquist was pulled back and the alto balloon was inflated to see if that would help open and fill line but was not successful.At 14 minutes a 0.018 inch wire was inserted and snared into what was thought to be the contralateral limb but it was not possible to visualize the contralateral limb.Contrast injection and balloon were checked to see the wire was in the contralateral limb and it appeared it was.The balloon was disconnected and then the sealing ring was ballooned for one minute.Removed alto ab device.The procedure was completed and the aneurysm appeared to be sealed; however, there may be a small type 1a endoleak and late blush.The physician opted to follow the patient at 30 days with computed tomography angiogram (cta) to determine if anything further needs to be done.Additional information: the physician elected to perform a secondary procedure on (b)(6) 2023 to address type 1a endoleak where a coda (non-endologix) balloon was utilized to place a p4010 palmaz (non-endologix) stent which was centered in the proximal partially filled sealing ring and secondary ring.Angiogram was taken and showed there was still a small type 1a endoleak.A maxi ld 20 mm diameter x 40 mm (non-endologix) non-compliant balloon was inflated in the palmaz stent and rings.Another angiogram was taken and showed there was still a small type 1a endoleak.A maxi ld 22 mm diameter x 40 mm (non-endologix) non-compliant balloon was utilized to repeat process.Another angiogram was taken and showed there was still a small type 1a endoleak.It was noted that the iliac limbs were twisted and being pulled away from vessel wall; therefore, two (2) icast 10x38 (non-endologix) covered "kissing" stents were placed just under the secondary ring and extending into each limb and ballooned with two (2) 12x20 (non-endologix) balloons.The icast stents were flared out to 50% proximally.A final angiogram showed the endoleak was resolved and the patient was reported as doing well the next day.

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, additional endovascular procedure, no polymer fill of the proximal two rings of the ipsilateral limb and the entire contralateral limb, and slow fill of the proximal sealing rings of the aortic body are confirmed.This is consistent with the reported adverse event/incident.The type 1a endoleak is most likely anatomy related.The type 1a endoleak was seen at an area of thickened calcifications in the aortic neck - cautionary product use condition, anatomy related.It is unclear if the thickened calcifications contributed to the polymer fill issues.Device, user, procedure or anatomy relatedness of the polymer fill issues could not be determined.No procedure related harms were identified.The final patient status was discharged on the first post operative day.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: b2: outcomes attributed to adverse events has been updated.B5: describe event or problem has been updated.G3: awareness date has been updated.H6: health effect - impact code: remove code 4614.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: 17174904
• MDR Text Key: 317630613
• Report Number: 3008011247-2023-00082
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00850007370909
• UDI-Public: (01)00850007370909(17)260206(10)FS020123-26
• 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: 05/30/2023

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: FS020123-26
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/30/2023
• Initial Date FDA Received: 06/21/2023
• Supplement Dates Manufacturer Received: 07/12/2023
• Supplement Dates FDA Received: 09/01/2023
• 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, LOT # FS020123-31; OVATION IX ILIAC LIMB, LOT # FS101921-27; OVATION IX ILIAC LIMB, LOT # FS101922-57; OVATION PRIME FILL POLYMER, LOT # FF012423-01
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 91 YR
• Patient Sex: Male