FDA Adverse Event Malfunction Summary report: N

ANEURX

MDR report key: 1221623 · Received October 31, 2008

Report

Report Number
1221623
Event Type
Malfunction
Date Received
October 31, 2008
Date of Event
September 12, 2008
Report Date
October 31, 2008
Manufacturer
MEDTRONIC, INC.
Product Code
MIH
Product Problem
Yes
Report Source
User Facility report
Reporter Location
FL, US
Reporter Occupation
NURSE

Narratives

Description of Event or Problem · 1

THIS PATIENT HAD A MEDTRONIC 26MM X 15 MM MODULAR GRAFT (ANEUREX) PLACED. THE PATIENT PRESENTED TO THE ER 5 YRS LATER WITH AN ENDOLEAK WITH RUPTURED AAA, AND WAS TAKEN TO THE OR FOR EMERGENCY SURGERY. NOTES FROM THE OPERATIVE NOTE: "DISSECTION WAS CARRIED DOWN USING ELECTROCAUTERY. THE ABDOMEN WAS ENTERED. THERE WERE EXTENSIVE ADHESIONS AND THEY WERE LYSED. THE SMALL BOWEL WAS THEN RETRACTED TO THE RIGHT. THERE WAS A LARGE HEMATOMA IN THE RETROPERITONEUM. THIS HAD ESSENTIALLY DISSECTED OUT THE AORTA FOR US. WE THEN TURNED OUR ATTENTION TO THE SUPRACELIAC AORTA. THIS WAS MOBILIZED WITH FINGER DISSECTION AND A CLAMP WAS THEN PLACED. WE THEN TURNED OUR ATTENTION TO THE INFRARENAL AORTA AND DISSECTED OUT THE INFRARENAL ASPECTS OF THE ABDOMINAL AORTA AND PLACED A CLAMP JUST BELOW THE RENAL ARTERIES. WE THEN EXPOSED THE COMMON ILIAC ARTERIES, AND WE NOTED A PAUCITY OF ATHEROSCLEROTIC ARTERIAL DISEASE IN THE COMMON ILIAC ARTERIES. WE COULD VISUALIZE THE STENT GRAFTS WITHIN THE COMMON ILIAC ARTERY. WE CLAMPED THE COMMON ILIAC ARTERIES BILATERALLY, BELOW THE STENT GRAFTS. WE THEN OPENED THE ANEURYSMAL CAVITY AND REMOVED THE STENT GRAFT WITH GREAT DIFFICULTY. WE LEFT 2 ILIAC LIMBS IN PLACE. WE THEN SEWED THE PROXIMAL ANASTOMOSIS USING 3-0 ON A SH NEEDLE IN THE CIRCUMFERENTIAL FASHION. ONE POSTERIOR REPAIR STITCH WAS NEEDED TO CONTROL BLEEDING WITH THE PLEDGET. WE THEN ANASTOMOSED BOTH LIMBS OF THE ENDOGRAFT TO OUR 16 X 8 BIFURCATED DEVICE." THE PATIENT'S CONDITION CONTINUED TO DETERIORATE AND THE PATIENT LATER EXPIRED.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 ANEURX STENT, VASCULAR MIH MEDTRONIC, INC. * *

Patients

Seq Age Sex Outcome Treatment
1 81 YR