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

Catalog Number JHJR050502J

Device Problem Complete Blockage (1094)

Patient Problems Occlusion (1984); No Information (3190)

Event Date 05/08/2017

Event Type  Injury  

Manufacturer Narrative

A review of the manufacturing records for the device verified the lot met all pre-release specifications.Jhjr050502j/14857814 udi# (b)(4).

Event Description

On (b)(6) , 2017, this patient underwent endovascular repair of iatrogenic arterial perforation and pseudoaneurysm of the hepatic artery using a gore® viabahn® endoprosthesis with heparin bioactive surface (5mm x 5cm).Follow-up examination (on (b)(6) , 2017) reportedly confirmed an occlusion of the endoprosthesis.Reintervention was not performed.No further information is available.

• 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: nataliya baramzina ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 7035839
• MDR Text Key: 92157252
• Report Number: 2017233-2017-00601
• Device Sequence Number: 1
• Product Code: PFV
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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
• Report Date: 10/27/2017

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: 11/16/2018
• Device Catalogue Number: JHJR050502J
• Device Lot Number: 14857814
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/15/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/17/2015
• 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): Other
• Patient Age: 63 YR
• Patient Weight: 51