MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES GORE VIABAHN® ENDOPROSTHESIS; STENT, SUPERFICIAL FEMORAL ARTERY

Catalog Number PAC081002

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Pneumonia (2011); Respiratory Distress (2045); Septic Shock (2068); Paraplegia (2448)

Event Date 12/06/2011

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: pxt311413/8829797, pxc181200/9500022, pxc201400/7799837, pxt231216/9472086, pac061002/9047052, pac061002/9047047, pac061002/9018650, pac071002/8896681, pac071002/8896667, pac081002/9146751, pac081002/9146745, pac081002/9179022, (b)(4).A review of the manufacturing records for the device verified that the lot met all pre-release specifications.The device remained implanted; consequently, a direct product analysis was not possible.

Event Description

On (b)(6) 2011, a patient underwent endovascular treatment for a thoracoabdominal aneurysm measuring 54.5mm in diameter and was implanted with goreexcluderaaa endoprostheses in zone 4 of the distal descending thoracic aorta.Nine gore viabahnendoprosthesis with heparin bioactive surface were also implanted ending up in the renal arteries, celiac trunk and superior mesenteric artery.The technique used for this patient was a "tandem-of-the-shelf" technique.The procedure performed was not exactly the same but it was similar.An excluder bifurcated device was placed on the thoracic aorta of the patient and through the contralateral limb the viabahn devices were advanced to the left renal artery, celiac trunk and superior mesenteric artery.Through the long limb of the excluder, a viabahn was inserted for the right renal artery and a excluder extension for the abdominal aorta.Inside of this excluder extension, another excluder bifurcated was inserted, with the long limb finishing at left common iliac artery and the contralateral limb was placed at the right common iliac artery in the distal third.Almost all the extension of the thoracoabdominal aorta was covered including the exclusion of the distal thoracic arteries, all lumbar arteries and the inferior mesenteric artery.The patient tolerated the procedure, however, it was reported that the same day the patient experienced paraplegy and developed pneumonia.The patient expired on (b)(6) 2011.The cause of death was septic shock due to pneumonia.The patient woke up from anesthesia the first day after the surgery and had abdominal distention with respiratory distress, and needed to be re-intubated.He developed pneumonia and septic shock and died 6 days from the procedure date.

Manufacturer Narrative

The gore® viabahn® endoprostheses used in this procedure did not have the heparin bioactive surface as stated in the initial medwatch.

• Brand Name: GORE VIABAHN® ENDOPROSTHESIS
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• Manufacturer (Section G): MEDICAL ECHO RIDGE B/P; 3250 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: sandra whicker ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 5727891
• MDR Text Key: 47496684
• Report Number: 2017233-2016-00583
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: P040037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: study
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2014
• Device Catalogue Number: PAC081002
• Device Lot Number: 9179024
• 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: 05/19/2011
• 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): Disability
• Patient Age: 67 YR
• Patient Weight: 82