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

Device Problems Deformation Due to Compressive Stress (2889); Patient Device Interaction Problem (4001)

Patient Problems Abdominal Pain (1685); Pain (1994); Rupture (2208)

Event Date 09/05/2019

Event Type  Injury  

Manufacturer Narrative

Additional devices included on this report are as follows: gore® excluder® aaa endoprosthesis contralateral leg component - catalog #unk/ serial #unk/ udi #unk which is captured in manufacturer report #3013164176-2021-01216.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.If explanted, give date: the date of device explant 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.

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 11.0cm sac with compression symptoms including moderate/severe left flank pain radiating to the groin.Percutaneous aspiration of periaortic fluid was performed at 33 months.The patient's pain symptoms were relieved by the aspiration.The pgh, however, recurred, measuring 14cm at 59 months accompanied by vague abdominal pain and distension.While the patient was awaiting open surgical revision, the pgh expanded rapidly to 18 cm and ruptured into the inferior vena cava.He underwent emergent partial explantation of the eptfe graft and replacement with a bifurcated polyester graft.Protein-rich coagulum was observed on the surface of the bifurcated device leading to hygroma formation and rupture site into the cava.The patient was allowed to recover and underwent relining of the distal remnants of the eptfe graft with a gore® excluder® aaa iliac extender component 6 weeks later.There was no hygroma recurrence after explant/replacement.

Manufacturer Narrative

Section h6 updated to reflect completion of investigation.The identity of the device was not provided; therefore, the device history record could not be examined to identify any potential root causes attributable to the manufacture of the device.The case description could not be confirmed, as no identity of the device was provided for evaluation and the image provided is not sufficient to confirm the case description.The evaluation found no anomalies attributable to the manufacture of the device.Further information regarding this event was requested by gore, but no further information has been reported, therefore this investigation is considered complete.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: 12226077
• MDR Text Key: 263481322
• Report Number: 3007284313-2021-01516
• 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
• Patient Age: 68 YR
• Patient Sex: Male