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

Device Problem Insufficient Information (3190)

Patient Problems Cardiac Arrest (1762); Hemorrhage/Bleeding (1888); Laceration(s) (1946)

Event Date 04/28/2015

Event Type  Injury  

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.

Manufacturer Narrative

This initial procedure involved two gore viabahn® endoprosthesis.Device #1 manf.Report #2017233-2015-00319.Device #2 manf.Report #2017233-2015-00320.

• 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: 4799902
• MDR Text Key: 15129486
• Report Number: 2017233-2015-00319
• 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: 05/27/2015
• 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): Required Intervention
• Patient Age: 66 YR