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

Catalog Number RLT311413

Device Problems Material Rupture (1546); Fitting Problem (2183); Difficult to Advance (2920)

Patient Problems Hematoma (1884); Hemorrhage/Bleeding (1888)

Event Date 08/19/2014

Event Type  Injury  

Event Description

On (b)(6) 2014, the patient underwent treatment of an abdominal aortic aneurysm with gore® excluder® aaa endoprostheses.The patient¿s right external iliac artery (reia) was reported to be calcified and outside of ifu for an 18 fr sheath in some areas (measurements unknown).It was reported that during the procedure, there was some difficulty advancing and withdrawing a gore® dryseal sheath in the reia.However, three gore® excluder® aaa endoprostheses were reportedly implanted with no issue, and final angiography showed exclusion of the aneurysm with no damage to the reia.It was reported that while the patient was in recovery the same day, a large hematoma on the right side was identified.The patient was brought back to the operating room, where it was reportedly determined the reia had ruptured during removal of the sheath.It was reported a small tear occurred during the procedure, but when the patient went to recovery, she was jostled which reportedly caused the tear in the reia to enlarge.A gore® viabahn® endoprosthesis was implanted in the reia to cover the tear.Angiography also reportedly showed bleeding near the ipsilateral limb of the rmt in the distal right common iliac artery (rcia).It was reported the rcia measured 8-10 mm, and the device was oversized for the rcia.There was also some reported difficulty advancing the sheath through the rcia in addition to the reia.It was reported it was unknown if there was an endoleak or if the rcia also ruptured, so the physician elected to extend the ipsilateral limb of the rmt distally with an iliac extender component to the origin of the right hypogastric artery.Final angiography showed exclusion of the aneurysm and rupture, and the patient tolerated the procedure.

Manufacturer Narrative

Patient medications include spiriva, aspirin, citalopram, furosemide, lisinopril, metoprolol, nitroglycerin, omeprazole, oxycodone, rosuvastatin, sevelamer carbonate, tizanidine, and trazodone.The review of the manufacturing paperwork verified that this lot met all pre-release specifications.The cause of the bleeding near the ipsilateral limb could not be determined with the provided information.

• 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: claire west ; 1500 n. 4th street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 4064432
• MDR Text Key: 4814967
• Report Number: 3007284313-2014-00077
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: US
• 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
• Report Date: 08/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2017
• Device Catalogue Number: RLT311413
• Device Lot Number: 12703996
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/23/2014
• 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; Required Intervention
• Patient Age: 64 YR
• Patient Weight: 50