MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES BIFURCATED GORE-TEX® STRETCH VASCULAR GRAFT; PROSTHESIS, VASCULAR GRAFT

Catalog Number SBT1601

Device Problem Insufficient Information (3190)

Patient Problems Abdominal Pain (1685); Nausea (1970); Seroma (2069); Dizziness (2194)

Event Date 04/08/2014

Event Type  Injury  

Manufacturer Narrative

Lot: 06472718 (b)(4) 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.

Event Description

On (b)(6) 2009, the patient underwent abdominal aortic replacement procedure using a bifurcated gore-tex stretch vascular graft to treat a juxta-renal abdominal aortic aneurysm.The patient tolerated the procedure.On (b)(6) 2014, the patient was admitted to another hospital and it was revealed that a seroma was formed around the previously implanted graft.The seroma was monitored.On (b)(6) 2014, the patient was emergently admitted to the hospital due to severe upper abdominal pain.A computed tomography (ct) revealed that the seroma had enlarged to 164mm in diameter.The physician diagnosed the patient with intra-seroma bleeding and stopped giving anti-coagulant drugs to the patient.On (b)(6) 2014, the upper abdominal pain resolved, and the patient was discharged from the hospital.On (b)(6) 2015, the patient visited a general physician due to symptoms of abdominal pain, nausea and dizziness.A ct revealed that the seroma had further enlarged to 173mm in diameter, oppressing the abdominal wall.On (b)(6) 2015, a ct angiography revealed the rupture of the enlarged seroma.The seroma had shrunk in diameter due to the rupture, but the patient was willing to receive treatment.On (b)(6) 2015, the patient was implanted with two gore excluder aaa endoprostheses aortic extender components and two contralateral leg components as a part of the reintervention to treat the seroma.Additionally, the seroma was removed by open abdominal surgery.On (b)(6) 2015, the patient was discharged from the hospital.

• Brand Name: BIFURCATED GORE-TEX® STRETCH 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 ; 9285263030
• MDR Report Key: 5389450
• MDR Text Key: 36885443
• Report Number: 2017233-2016-00078
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K904282
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 01/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/15/2013
• Device Catalogue Number: SBT1601
• Device Lot Number: 06472718
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/17/2008
• 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: 86 YR