ENDURANT ABDOMINAL STENT GRAFT SYSTEM

Report

Report Number: 2953200-2011-00448
Event Type: Injury
Date Received: February 18, 2011
Date of Event: January 20, 2011
Report Date: January 20, 2011
Manufacturer: MEDTRONIC CARDIOVASCULAR GALWAY
Product Code: MIH
PMA / PMN Number: P100021
Removal / Correction Number: NA
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: KS, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

(B)(4): EVAL, RESULTS: (STENT GRAFT MISPLACEMENT, OCCLUSION, PERFORATION). (INADVERTENTLY COVERING THE HYPOGASTRIC ARTERY AND AGGRESSIVE BALLOONING). EVAL, CONCLUSION: (INADVERTENTLY COVERING THE HYPOGASTRIC ARTERY AND AGGRESSIVE BALLOONING).

Description of Event or Problem · 1

AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF A 5.2 CM ABDOMINAL AORTIC ANEURYSM. VESSEL MORPHOLOGY WAS REPORTED AS THE AORTIC NECK WAS 2 CM LONG AND MEASURED 24 MM IN DIAMETER BELOW THE RENAL ARTERIES, THEN IT WENT TO 26 AND 28 MM JUST ABOVE THE ANEURYSM. THE ILIAC VESSELS MEASURED 9 MM IN DIAMETER BILATERALLY. THERE WAS NO TORTUOSITY OR CALCIFICATION NOTED. IT WAS REPORTED THAT BOTH HYPOGASTRIC ARTERIES WERE INADVERTENTLY COVERED WITH THE STENT GRAFTS. THE PHYSICIAN RE-WIRED ONE OF THE HYPOGASTRIC ARTERIES AND IMPLANTED A STENT. DURING THE BALLOONING, WHICH WAS TOO AGGRESSIVE AND THE ILIAC ARTERY AT THE ILIAC BIFURCATION WAS PERFORATED BY AN OTHER MANUFACTURER'S BALLOON. THE PHYSICIAN EXTENDED WITH A 16 X 10 ENDURANT ILIAC LIMB, COVERING THE RUPTURED VESSEL. THE PT LOST ABOUT A UNIT OF BLOOD. AT THE END OF THE CASE THERE WAS NO ENDOLEAK AND THE ILIAC WAS PATENT. NO CLINICAL SEQUELAE WERE REPORTED AND THE PT IS FINE. (REF MFR# 2953200-2011-00447).

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ENDURANT ABDOMINAL STENT GRAFT SYSTEM		MIH	MEDTRONIC CARDIOVASCULAR GALWAY	NA	V00563077

Patients

Seq	Age	Sex	Outcome	Treatment
1	71 YR		Required Intervention