FDA Adverse Event Injury Summary report: N

GORE® EXCLUDER® AAA ENDOPROSTHESIS

MDR report key: 3811352 · Received May 15, 2014

Report

Report Number
2017233-2014-00247
Event Type
Injury
Date Received
May 15, 2014
Date of Event
May 30, 2013
Report Date
April 28, 2014
Manufacturer
W.L. GORE & ASSOCIATES
Product Code
MIH
PMA / PMN Number
P020004
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
IT
Reporter Occupation
PHYSICIAN

Narratives

Description of Event or Problem · 1

IN A REVIEW OF PUBLISHED LITERATURE, THESE FINDINGS WERE NOTED. ENRICO CIERI, MD, PHD, PAOLA DE RANGO, MD, PHD, GIACOMO ISERNIA, MD, GIOELE SIMONTE, MD, ANDREA CIUCCI, MD, GIANBATTISTA PARLANI, MD, FABIO VERZINI, MD, PHD, FEBVS AND PIERGIORGIO CAO, MD, FRCS, UNIT OF VASCULAR AND ENDOVASCULAR SURGERY, HOSPITAL S. MARIA DELLA MISERICORDIA, UNIVERSITY OF PERUGIA, PERUGIAA; AND THE UNIT OF VASCULAR AND ENDOVASCULAR SURGERY, DEPARTMENT OF CARDIOSCIENCES, HOSPITAL S. CAMILLO-FORLANINI, PERUGIA AND ROME, ITALY; TYPE II ENDOLEAK IS AN ENIGMATIC AND UNPREDICTABLE MARKER OF WORSE OUTCOME AFTER ENDOVASCULAR ANEURYSM REPAIR. COPYRIGHT 2014 BY THE SOCIETY FOR VASCULAR SURGERY. THE AVERAGE AGE OF THE PATIENTS WAS 73 YEARS, AND THE MAJORITY OF THE PATIENTS WERE MALE. IN 1997-2011, 1412 CONSECUTIVE PATIENTS (91.4% MALES; MEAN AGE, 72.9 YEARS) UNDERWENT ELECTIVE EVAR AND WERE SUBSEQUENTLY FOLLOWED UP FOR A MEDIAN OF 45 MONTHS. TYPE II ENDOLEAK DEVELOPED IN 218. AT 60 MONTHS AFTER EVAR, RATES OF ANEURYSM SAC GROWTH GREATER THAN 5 MM WERE HIGHER IN PATIENTS WITH TYPE II ENDOLEAK. THE PRESENCE OF TYPE II ENDOLEAK LED TO REINTERVENTIONS IN 40% OF PATIENTS AND CONVERSION TO OPEN SURGERY IN 8%. AS THE INFORMATION IN THIS ARTICLE WAS FIRST PRESENTED AS A RAPID SESSION ORAL PRESENTATION AT THE 2013 VASCULAR ANNUAL MEETING OF THE SOCIETY FOR VASCULAR SURGERY, MAY 30-JUNE 1, 2013, MAY 30, 2013 WILL BE USED AS THE DATE OF EVENT THROUGHOUT THIS FILE. THIS ARTICLE MENTIONS THAT 233 PATIENTS WERE IMPLANTED WITH GORE EXCLUDER AAA ENDOPROSTHESIS DURING THIS TIME PERIOD. 38 PATIENTS WHO RECEIVED A GORE DEVICE WERE IDENTIFIED WITH TYPE II ENDOLEAK, HOWEVER THE ARTICLE DOES NOT SPECIFICALLY MENTION IF THESE PATIENTS UNDERWENT REINTERVENTIONS, SURGICAL CONVERSIONS OR HAD ANEURYSM ENLARGEMENT OF GREATER THAN OR EQUAL TO 5MM. HOWEVER, BASED ON STATISTICAL PROBABILITY, AS MANY AS 18 PATIENTS IMPLANTED WITH GORE EXCLUDER AAA ENDOPROSTHESES MAY HAVE HAD AN INTERVENTION OR CONVERSION.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
291235 GORE® EXCLUDER® AAA ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES

Patients

Seq Age Sex Outcome Treatment
1 73 YR Hospitalization| O| R