MAUDE Adverse Event Report: ENDOLOGIX OVATION IX; MAIN BODY

Model Number TV-AB2680-J

Device Problems Failure To Adhere Or Bond (1031); Bent (1059); Leak/Splash (1354); Retraction Problem (1536); Failure to Advance (2524); Patient-Device Incompatibility (2682)

Patient Problems Death (1802); Low Blood Pressure/ Hypotension (1914); Failure of Implant (1924)

Event Date 05/15/2018

Event Type  Injury  

Manufacturer Narrative

The devices involved in the event will not be returned for evaluation, they remain implanted in the patient.If additional information pertinent to the incident is obtained, a follow-up report will be submitted.

Event Description

An ovation ix abdominal stent graft system was implanted to treat an abdominal aortic aneurysm.The patient presented with an infrarenal aneurysm with a 42 degree juxtarenal angle and heavily calcified vessels.After the deployment of the stent grafts, it was noted that the pigtail became "stuck" or "caught" on something below the aortic body graft legs and could not be advanced or retracted.The radiopaque markers on the pigtail seemed to "accordion" on each other.Finally pig was removed with a little force.The contra and ipsi iliac limbs were deployed without incident.Upon demate of the aortic body from the stent graft, there was difficulties retracting the nosecone.The final angiogram showed the presence on a type ia endoleak.Ballooning was used to try to seal the leak but it was unsuccessful.A palmaz stent was then prepped and loaded onto the coda balloon, advanced and precisely positioned and deployed via a sheath at the level of the sealing rings and sealing collar, the balloon burst upon palmaz deployment, and at that time the patient's blood pressure dropped.An angled image showed a tear in aorta just proximal to highest renal artery.The patient was transferred to or and converted to open surgical repair where the patient coded two times and expired.

Manufacturer Narrative

At the conclusion of the investigation the type ia endoleak intra-operative, balloon rupture, aortic rupture, surgical conversion, death complaint are confirmed.The complaint is most likely procedure related.The procedure related harms identified were cardiac arrest and death.The patient expired in the operating room during the open repair procedure.The review of manufacturing lot confirmed all devices met specifications prior to release.Devices remain implanted in the patient and were not returned, no evaluation completed.The review of manufacturing lot confirmed all devices met specifications prior to release.This complaint is not capa eligible at this time.These types of events will be monitored and trended as part of the quality system.

• Brand Name: OVATION IX
• Type of Device: MAIN BODY
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 7598580
• MDR Text Key: 110971067
• Report Number: 3008011247-2018-00130
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: M701TVAB2680J1
• UDI-Public: +M701TVAB2680J1/$$3201006FS092117251
• Combination Product (y/n): N
• PMA/PMN Number: P120006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 05/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 10/06/2020
• Device Model Number: TV-AB2680-J
• Device Catalogue Number: TV-AB2680-J
• Device Lot Number: FS092117-25
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/07/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: OVATION IX ILIAC LIMB-LOT: FS021418-82; OVATION IX ILIAC LIMB-LOT: FS031418-07; OVATION IX ILIAC LIMB-LOT: FS110617-22; OVATION IX ILIAC LIMB-LOT: FS021418-82; OVATION IX ILIAC LIMB-LOT: FS031418-07; OVATION IX ILIAC LIMB-LOT: FS110617-22
• Patient Outcome(s): Death
• Patient Age: 68 YR