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

Device Problem Insufficient Information (3190)

Patient Problems Abnormal Blood Gases (1034); Cardiac Arrest (1762); Death (1802); Hemorrhage/Bleeding (1888); Laceration(s) (1946)

Event Date 04/28/2015

Event Type  Death  

Event Description

The patient presented with a thoracic aortic aneurysm.During the procedure, a solo path sheath was used to successfully implant a conformable gore® tag® thoracic endoprosthesis.When removing the solo path sheath, the left external iliac artery was torn.An occlusion balloon was used to stop the bleeding and two gore® viabahn® endoprosthesis were implanted to treat the external iliac artery tear.Final angio confirmed the vessel tear was sealed and good flow was present through the two gore® viabahn® endoprosthesis.After the initial procedure was completed, the patient started to move around and "coded." an angio revealed a new vessel tear 2cm distal to the previously placed gore® viabahn® endoprosthesis.Two additional gore® viabahn® endoprosthesis were placed to treat the new vessel tear; however, the patient expired during the second procedure to seal the new vessel tear and stabilize the patient.The reported cause of death was reportedly related to an increase in co2 levels related to the resuscitation.

Manufacturer Narrative

This event involved two gore viabahn® endoprosthesis.Device #1 manf.Report #2017233-2015-00317, device #2 manf.Report #2017233-2015-00316.

• 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 86001
• Manufacturer Contact: roger smith ; 1500 n. 4th street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 4796556
• MDR Text Key: 18892374
• Report Number: 2017233-2015-00316
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040037
• 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: 04/28/2015

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/26/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Death
• Patient Age: 66 YR