MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES GORE® HYBRID VASCULAR GRAFT; PROSTHESIS, VASCULAR GRAFT

Catalog Number 0650HYB0705B

Device Problem Extrusion (2934)

Patient Problems Abscess (1690); Unspecified Infection (1930)

Event Date 08/26/2014

Event Type  Injury  

Event Description

On (b)(6) 2014, a patient was implanted with a gore® hybrid vascular graft from the brachial artery to axilliary vein.It was reported to gore that on (b)(6) 2014, the patient presented with an infection in the axilla region in the postoperative period which required surgical drainage of the abscess and a penrose drain.Antibiotic therapy treatment and daily surveillance was also performed.One and half months following implant the patient presented with a small graft exposure.A reintervention was performed to dissect the graft and close the exposed graft.

Manufacturer Narrative

A review of the manufacturing records for the device verified that the lot met all pre-release specifications.The device was not returned; consequently, a direct product analysis was not possible.Without additional information it is impossible to further investigate this event.

• Brand Name: GORE® HYBRID VASCULAR GRAFT
• Type of Device: PROSTHESIS, VASCULAR GRAFT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• Manufacturer (Section G): MEDICAL WEST B/P; 1505 n. fourth street; flagstaff AZ 86004
• Manufacturer Contact: sandra whicker ; 1500 n. 4th street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 4785129
• MDR Text Key: 5883162
• Report Number: 2017233-2015-00304
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K093934
• 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: 05/05/2015

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
• Device Expiration Date: 03/12/2016
• Device Catalogue Number: 0650HYB0705B
• Device Lot Number: 12415927A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/20/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/30/2014
• 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: 27 YR
• Patient Weight: 70