FDA Adverse Event Injury Summary report: N

GORE® EXCLUDER® AAA ENDOPROSTHESIS

MDR report key: 4462062 · Received January 29, 2015

Report

Report Number
3007284313-2015-00008
Event Type
Injury
Date Received
January 29, 2015
Date of Event
December 31, 2014
Report Date
December 31, 2014
Manufacturer
W.L. GORE & ASSOCIATES
Product Code
MIH
PMA / PMN Number
P020004
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
UK
Reporter Occupation
HEALTH PROFESSIONAL

Narratives

Description of Event or Problem · 1

ON (B)(6) 2014, THE PATIENT WAS IMPLANTED WITH A GORE® EXCLUDER® AAA ENDOPROSTHESIS FEATURING C3® DELIVERY SYSTEM TO TREAT AN AORTIC ABDOMINAL ANEURYSM. FOLLOWING THE PRESENTATION OF A SMALL BLUSH AT THE LOCATION OF THE PLC271400 IMPLANT, THE CONTRALATERAL LEG WAS RE-BALLOONED. AFTER ANOTHER ANGIOGRAM, THE BLUSHING HAD SLIGHTLY INCREASED, SUGGESTING A TYPE 1B ENDOLEAK. A RE-INTERVENTION WAS SCHEDULED THE NEXT DAY BASED ON A FOLLOW-UP SCAN. HOWEVER, ROUGHLY AFTER AN HOUR IN RECOVERY, THE PATIENT EXPERIENCED A RAPID LOSS OF BLOOD PRESSURE, REQUIRING IMMEDIATE STABILISATION. ACCORDING TO THE PHYSICIAN, THE RE-INTERVENTION APPEARED TO HAVE BEEN NECESSARY DUE TO CIRCUMFERENTIAL CALCIFICATION WHICH HAD RUPTURED THE LEFT COMMON ILIAC VESSEL DURING BALLOONING AFTER THE FINAL RUN. IT IS UNKNOWN WHETHER THE VESSEL WAS RUPTURED DURING THE INITIAL SMALL BLUSH. THE CONTRALATERAL LEG WAS RELINED WITH TWO PXC 141400 DEVICES EXTENDING INTO THE LEFT EXTERNAL ILIAC. HENCE, THE LEFT HYPOGASTRIC ARTERY WAS INTENTIONALLY STENTED AND EMBOLIZED. THERE WAS NO EVIDENCE OF BLUSHING AFTER THE FINAL ANGIOGRAM.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
67467 GORE® EXCLUDER® AAA ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES 12977042

Patients

Seq Age Sex Outcome Treatment
1 74 YR Hospitalization| L| R