MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES GORE® VIABAHN® ENDOPROSTHESIS; NIP

Catalog Number PAH071002

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

Patient Problems Unspecified Infection (1930); Pain (1994); Perforation of Vessels (2135)

Event Date 11/01/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

In 2012 the patient was presented with an occlusion of the left superficial femoral artery which was successfully treated by implanting a gore® viabahn® endoprosthesis.It was reported to gore that in (b)(6) 2017, the patient was presented as an emergency case at the hospital complaining about the swollen and painful left leg.A computer tomography indicated that the patient¿s vessel showed a perforation at the distal end of the implanted gore® viabahn® endoprosthesis.Additionally, an infection of the gore® viabahn® endoprosthesis was diagnosed.Due to the results, the patient was converted to open surgery where the gore® viabahn® endoprosthesis was explanted and a bypass procedure was performed.The medical device history of the patient did not indicate any abnormalities, trauma etc.For the patient¿s left leg.

Manufacturer Narrative

Multiple attempts have been made from the gore associate to the complainant directly over an extended period of time in order to get additional information.No information related to this complaint has been or will be provided by the complainant.Therefore this event will be closed with the information received.

• Brand Name: GORE® VIABAHN® ENDOPROSTHESIS
• Type of Device: NIP
• 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: barbara ulrich ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 7132871
• MDR Text Key: 95321870
• Report Number: 2017233-2017-00666
• Device Sequence Number: 1
• Product Code: PFV
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P130006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: PAH071002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• 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: 72 YR