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

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Abdominal Pain (1685); Vomiting (2144)

Event Date 09/05/2019

Event Type  Injury  

Manufacturer Narrative

Age at the time of event/date of birth: as the mean age of the pgh subgroup was 68.2 years old, the patient age has been estimated as (b)(6) years.Patient weight: unavailable.Date of event: as the date of event is unavailable, the date of event has been estimated as the article presentation date: (b)(6) 2019.Other relevant history, including preexisting medical conditions: pre-existing conditions of the pgh subgroup.Device information: the device lot/serial number is unavailable.Therefore device information remains unknown.If implanted, give date: the date of device implant remains unknown.Concomitant medical products and therapy dates: unavailable device manufacture date: as the device lot/serial number is unavailable, the device manufacture date is unknown.Attempts were made to obtain the device lot/serial number, and the lot/serial number remains unavailable.No device history record review was able to be completed.

Event Description

The following literature article was reviewed: frequency of perigraft hygroma after open aortic reconstruction.Background: perigraft hygroma (pgh) is a persistent collection of sterile fluid around a prosthetic vascular graft.The incidence of pgh development after aortic reconstruction remains poorly defined and its clinical relevance is questionable.Most pghs are asymptomatic and do not require surgical intervention.However, with expansion these fluid collections can present symptoms of abdominal pain, vomiting, and, in worst cases, graft compression with thrombosis or rupture of the pgh sac.This study was designed to establish the incidence of and determine the risk factors associated with pgh formation and its outcomes.Patients and methods: patients who underwent open aortic reconstruction for either aneurysmal or occlusive disease with an expanded polytetrafluoroethylene (eptfe) or polyester graft from 2004 to 2018 were retrospectively reviewed (n=262).Only those who had follow-up imaging 3 or more months after repair were included.Patients with mixed graft types were excluded.Pgh was defined as a perigraft fluid collection of 30 mm or greater in diameter with a radiodensity of 30 or fewer hounsfield units on computed tomography at a minimum of 3 postoperative months.Analysis was conducted between patients with and without pgh.Results: one hundred forty patients met the inclusion criteria: 88 were treated with eptfe (all manufactured by w.L.Gore & associates) and 52 with polyester grafts.Twenty-three patients (16.4%) were found to have radiologic evidence of pgh.Pgh developed more frequently in patients with eptfe (21/88 [23.9%]) compared with those with polyester grafts (2/52 [3.8%]) (p=.002).One patient presented with an expanding 11.2-cm symptomatic pgh with severe umbilical/abdominal pain and vomiting.He was admitted to hospital in preparation for surgical conversion.The physician planned to resect the graft and replace it with a dacron graft.However, on admission day 3 the patient suffered a fatal hemorrhagic stroke before the pgh could be resected.

Manufacturer Narrative

After additional review of the literature it was determined that this case is non-reportable as the perigraft hygroma was left untreated and no reintervention was performed, this report will be retracted.This report will be retracted.G1 - reporting contact first name updated to (b)(6).G1 - reporting contact last name updated to (b)(6).G1 - manufacturing site name and address (enter complete address for esubmission), updated.G4 - pma/510(k)number, updated to k904282.D1/d2 - brand name, updated to gore-tex® stretch vascular graft.D1/d2 - product code, updated to dsy.D1/d2 - common device name, updated to prosthesis, vascular graft.

• Brand Name: GORE-TEX® STRETCH VASCULAR GRAFT
• Type of Device: PROSTHESIS, VASCULAR GRAFT
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• Manufacturer (Section G): MEDICAL WEST B/P; 1505 n. fourth street; flagstaff AZ 86004
• Manufacturer Contact: nick lafave ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 12226076
• MDR Text Key: 263491441
• Report Number: 3007284313-2021-01515
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K904282
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2021
• 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
• Date Manufacturer Received: 06/03/2022
• 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; Other
• Patient Age: 68 YR
• Patient Sex: Male