MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES GORE® EXCLUDER® AAA ENDOPROSTHESIS; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Catalog Number RLT261412

Device Problems Leak/Splash (1354); Material Rupture (1546); Improper or Incorrect Procedure or Method (2017)

Patient Problems Death (1802); Hemorrhage/Bleeding (1888); Renal Failure (2041)

Event Date 02/24/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Results: the review of the manufacturing records verified that this lot met all pre-release specifications.Results: a review of the images is currently in progress.Results: an explant analysis is currently in progress.

Event Description

On (b)(6) 2016 a patient underwent treatment of an abdominal aortic aneurysm with gore® excluder® aaa endoprostheses.The patient's aortic neck angle was reported to be 90 degrees.Following deployment of three gore® excluder® aaa endoprostheses, an angiographic run showed the presence of a type i or ii endoleak.The type could not be ascertained due to limited space between the endoprosthesis and the renal arteries.A 26mm x 40mm sinus xl stent was deployed to provide additional radial force.The sinus stent was ballooned with a coda balloon.An angiographic run following the ballooning of the sinus stent showed a possible rupture just distal to the left renal artery.A gore® excluder® aaa aortic extender component was deployed to address the possible rupture.A final angiographic run showed significant improvement.The patient was asymptomatic during this time with no hemodynamic changes.Later that night, the patient was taken back to surgery due to bleeding.All components were explanted and the patient underwent open surgical repair.The patient received 6 units of blood in addition to cell saver (heamcel) of autologous blood.The physician stated he felt the cause of the rupture was over inflation of the balloon.On (b)(6) 2016, the patient¿s condition was reportedly critical due to renal complications during the open repair.On an unknown date after (b)(6) 2016 and prior to (b)(6) 2016 the patient expired due to renal failure.

Manufacturer Narrative

The date of death timeframe was corrected in the description, originally reported to have occurred after (b)(6) 2016 and prior to (b)(6) 2016.A review of the manufacturing records for the device verified the lot met all pre-release specifications.This should not have been on the previous report sent on (b)(6) 2016 as the device history review was completed on march 21, 2016.

Event Description

On (b)(6) 2016 a patient underwent treatment of an abdominal aortic aneurysm with gore® excluder® aaa endoprostheses.The patient's aortic neck angle was reported to be 90 degrees.Following deployment of three gore® excluder® aaa endoprostheses, an angiographic run showed the presence of a type i or ii endoleak.The type could not be ascertained due to limited space between the endoprosthesis and the renal arteries.A 26mm x 40mm sinus xl stent was deployed to provide additional radial force.The sinus stent was ballooned with a coda balloon.An angiographic run following the ballooning of the sinus stent showed a possible rupture just distal to the left renal artery.A gore® excluder® aaa aortic extender component was deployed to address the possible rupture.A final angiographic run showed significant improvement.The patient was asymptomatic during this time with no hemodynamic changes.Later that night, the patient was taken back to surgery due to bleeding.All components were explanted and the patient underwent open surgical repair.The patient received 6 units of blood in addition to cell saver (heamcel) of autologous blood.The physician stated he felt the cause of the rupture was over inflation of the balloon.On (b)(6) 2016, the patient's condition was reportedly critical due to renal complications during the open repair.On an unknown date after (b)(6) 2016 and prior to (b)(6) 2016 the patient expired due to renal failure.

Manufacturer Narrative

The imaging evaluation stated the angiographic images illustrate what appears to be a 75 degree angled proximal neck.There is contrast pooling outside of the device contrast is pooling outside the device at the level of the renal arteries.The final angiographic run illustrates the endoleak appears to be resolved.The explant analysis stated the following were returned for analysis: four gore® excluder® aaa endoprosthesis; one trunk ¿ ipsilateral leg endoprosthesis (trunk), two contralateral leg endoprosthesis (cl-1 and cl-2), and one aortic extender endoprosthesis (ae).Also submitted was one non-gore sinus xl stent (ng).All devices were generally devoid of tissue except for scattered plaques of friable red brown tissue on abluminal surface.The lumina of all devices were widely patent and generally devoid of tissue except for scattered plaques of friable red brown tissue.The friable red brown plaques of tissue were consistent with dried blood.The proximal portion of cl-2 is contained within the distal portion of the ipsilateral limb of the trunk component.The constraint sleeve associated with cl-1 was not returned the devices were not properly stored in a fixative solution for proper preservation of the tissue on and within the devices.Therefore, a histopathological examination of the tissue could not be performed due to the lack of proper fixation prior to arrival at w.L.Gore & associates.The devices were subjected to an enzymatic digestion process to remove biologic debris.Following digestion all devices were examined for material disruptions with the aid of a stereomicroscope.Indications for use of this product states: ¿proximal aortic neck angulation = 60°¿.No wear related disruptions were identified.According to the gore® excluder® aaa endoprosthesis instructions for use (ifu), adverse events that may occur and/or require intervention include, but are not limited to: endoleak, vascular trauma, bleeding and surgical conversion.

• Brand Name: GORE® EXCLUDER® AAA ENDOPROSTHESIS
• Type of Device: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• Manufacturer (Section G): MEDICAL PHOENIX 2 B/P; 32470 n. north valley parkway; phoenix AZ 85085
• Manufacturer Contact: heidi inskeep ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 5492791
• MDR Text Key: 40121606
• Report Number: 3007284313-2016-00026
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P020004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/02/2018
• Device Catalogue Number: RLT261412
• Device Lot Number: 14440748
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2016
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/03/2015
• 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
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 83 YR
• Patient Weight: 75