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

Catalog Number RLT261212

Device Problems Material Separation (1562); Sticking (1597)

Patient Problem Calcium Deposits/Calcification (1758)

Event Date 05/27/2015

Event Type  Injury  

Event Description

On (b)(6) 2015, the patient was implanted with gore® excluder® aaa endoprostheses to treat an abdominal aortic aneurysm.The patient had reported severe calcification within the aneurysm sac as well as along the abdominal aorta.It was reported that the physician initiated deployment of the trunk-ipsilateral leg component at the intended position.The physician attempted to canulate the contralateral gate, however, the gate was pinched and could not be cannulated.The physician utilized the constraining mechanism of the c3 handle and attempted to rotate the gate to a different position.This was attempted at eight different times, the device would not rotate due to the extreme calcification.The physician noticed the delivery mechanism appeared to look like a ¿corkscrew¿ and felt it was better to convert the patient to an aui.Due to the excessive torquing of the delivery catheter the deployment line was not able to be utilized from the c3 handle.The physician utilized the backup deployment mechanism and the device was deployed.Upon retrieving the delivery catheter, the physician noticed the proximal olive of the device had become separated from the device.The physician used a snare to retrieve the olive.The olive was removed from the patient, and the procedure concluded with no further issue.After the device was deployed the physician implanted a gore® excluder® trunk-ipsilateral leg component device within the already implanted trunk-ipsilateral leg component to create an aorta uni iliac.The physician then performed a femoral-femoral bypass.The patient tolerated the procedure.

Manufacturer Narrative

The review of the manufacturing paperwork verified that this lot met all pre-release specifications.

• 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: rachael chascsa ; 1500 n. 4th street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 4859752
• MDR Text Key: 15912451
• Report Number: 3007284313-2015-00064
• 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: 05/27/2015

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: 01/28/2018
• Device Catalogue Number: RLT261212
• Device Lot Number: 13494678
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/22/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/23/2015
• 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; Required Intervention
• Patient Age: 82 YR
• Patient Weight: 50