MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE VIABAHN ENDOPROSTHESIS; STENT, SUPERFICIAL FEMORAL ARTERY

Device Problems Obstruction of Flow (2423); Migration (4003)

Patient Problems Fever (1858); Unspecified Infection (1930); Sepsis (2067)

Event Date 01/13/2020

Event Type  Injury  

Manufacturer Narrative

Product surveillance coordinator emailed author request if requested information can be provided.Author emailed back that no further information with be disclosed with gore.Based on the received feedback the case/complaint will be closed with the information published in the article.The event date field will be completed with the date when the article was accepted, (b)(6) 2020, as no event date was provided within the articles itself.The case number will be used as patient identifier in the patient information section.Patient weight and d.O.B.Was not provided in the article.The case report #2 which was reported in the article will be also submitted to the fda with the gore reference number (b)(4).¿infected extrahepatic splanchnic venous stent(-grafts): clinical presentation, imaging, and treatment in three patients¿, published by lucien widmer et al with the journal of vascular interventional radiology (2020; 31:754¿758).

Event Description

Within the abstract ¿infected extrahepatic splanchnic venous stent(-grafts): clinical presentation, imaging, and treatment in three patients¿, published by lucien widmer et al with the journal of vascular interventional radiology (2020; 31:754¿758) the case reports indicates the following: a (b)(6) year-old male patient was referred to the hospital for interventional treatment of prehepatic portal hypertension.At the age of 2 years, he had exhibited variceal bleeding.Therefore, a 5-mm-diameter polytetrafluoroethylene mesocaval shunt was created.Thirteen years later, magnetic resonance (mr) imaging was performed because of recurrent portal variceal bleeding.Percutaneous transluminal angioplasty (pta) with placement of two 8-mm-diameter, 50-mm-long gore® viabahn® endoprostheses was performed.Three months later, the patient was readmitted for episodes of fever of unknown origin.An ultrasound examination showed thrombotic occlusion of the shunt.Transjugular recanalization with local thrombolysis, pta, and placement of 2 additional gore® viabahn® endoprostheses was performed.Completion venography revealed recurrent thrombosis of the shunt.Recurrence of fever was noted a few hours after this procedure.Fluorine-18 (18f) fludeoxyglucose (fdg) positron emission tomography (pet)/computed tomography (ct) demonstrated shunt occlusion with contiguous fat stranding and an area of high activity with a maximal standardized uptake value (suvmax) of 4.8 at the shunt level, indicating stent-graft infection.Gastric and oesophageal varices and progression of splenomegaly were noted, supporting portal hypertension.Therefore, a surgical distal splenorenal shunt was created.A second laparotomy was performed 3 months later because of recurrent septic episodes with eikenella corrodens and lactobacillus species in blood cultures despite ongoing antibiotic treatment.At the surgical exploration, the removed mesocaval shunt was shown to have eroded the duodenum.Bacterial analysis of the resected shunt showed a colonization by s.Epidermidis, lactobacillus species, and enterococcus faecalis.Antimicrobial therapy was discontinued 4 weeks after shunt removal.At 1.5 years after this operation, the patient was doing well and the splenorenal shunt was patent.

• Brand Name: GORE VIABAHN ENDOPROSTHESIS
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• Manufacturer (Section G): MEDICAL ECHO RIDGE B/P; 3250 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: barbara ulrich ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 10453382
• MDR Text Key: 204369889
• Report Number: 2017233-2020-01170
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: P040037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/26/2020

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/14/2020
• Initial Date FDA Received: 08/26/2020
• 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): Hospitalization; Required Intervention
• Patient Age: 16 YR