ENDURANT STENT GRAFT SYSTEM

Report

Report Number: 2953200-2012-02200
Event Type: Injury
Date Received: November 15, 2012
Date of Event: December 6, 2010
Report Date: November 19, 2012
Manufacturer: MEDTRONIC CARDIOVASCULAR SANTA ROSA
Product Code: MIH
PMA / PMN Number: P100021
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: IL, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

(B)(4): EVALUATION, RESULTS: INHERENT RISK OF PROCEDURE (OCCLUSION, ENDOLEAK). PATIENT'S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (SEVERE TORTUOSITY IN THE VESSELS). CONCLUSION: DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION (SEVERE TORTUOSITY IN THE VESSELS).

Additional Manufacturer Narrative · 1

EVALUATION METHOD: (FILM).

Description of Event or Problem · 1

FILMS 2-MONTHS POST-IMPLANT SHOW THE IPSILATERAL LIMB AND 24MM EXTENSION WERE IMPLANTED INTO THE RIGHT ILIAC, AND THE CONTRALATERAL AND 28MM EXTENSION WERE IMPLANTED INTO THE LEFT ILIAC; THE LIMBS WERE CROSSED. THERE WAS APPROXIMATELY 2 -2.5 CM OF DEVICE OVERLAP (2 TO 3 STENT RINGS) ON THE CONTRALATERAL (LEFT) LIMBS, AND 3CM (3 STENT RINGS) ON THE IPSILATERAL (RIGHT) LIMBS. NO SIGNIFICANT STENT GRAFT KINKING WAS SEEN. THE AAA WAS 8.3 X 7.9CM. FILMS FROM 14 MONTHS POST IMPLANT SHOW THAT THE CONTRALATERAL STENT GRAFT OVERLAP HAS DECREASED TO LESS THAN 1CM; THERE IS LITTLE CHANGE IN OVERLAP ON THE RIGHT SIDE. FILMS FROM 2 YEARS POST IMPLANT SHOW THAT THE LEFT LIMBS HAVE SEPARATED; THE CONTRALATERAL LIMBS ARE OCCLUDED BEGINNING AT THE FLOW DIVIDER. ON THE IPSILATERAL SIDE; THE IPSILATERAL EXTENSION OVERLAP IS APPROXIMATELY 1CM. THE AAA IS 8.5 X 7.9CM. FILMS AT 3 YEARS POST IMPLANT SHOW FURTHER SEPARATION OF THE CONTRA LIMBS. THE IPSILATERAL EXTENSION HAS ALSO DETACHED FROM THE IPSILATERAL LIMB, AND THERE IS A TYPE III JUNCTIONAL ENDOLEAK. THE AAA IS 8.8 X 7.9CM. FILMS AT 4 YEARS POST IMPLANT SHOW THAT THE RIGHT AND LEFT LIMBS HAVE FURTHER SEPARATED. THE AAA IS 8.9X7.8CM. THE STENT GRAFTS ARE COMPLETELY OCCLUDED; FLOW TO BOTH LEGS APPEAR TO BE PERFUSED BY COLLATERAL'S. THE CAUSE OF THE BILATERAL STENT GRAFT SEPARATION COULD NOT BE DETERMINED. ALTHOUGH THERE WAS APPROXIMATELY 3 STENT RING OVERLAP; THERE WAS LIKELY INSUFFICIENT EXTENSION OVERLAP AT IMPLANT.

Description of Event or Problem · 1

AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN 8.3 CM IN DIAMETER FUSIFORM ABDOMINAL AORTIC ANEURYSM. THE AORTIC NECK HAS AN INFRARENAL ANGLE OF 25 DEGREES. AORTIC NECK WAS 26 MM IN DIAMETER AND 23 MM LONG. DISTAL AORTA WAS 65 MM IN DIAMETER. ILIAC ARTERIES WERE MODERATELY TO SEVERELY TORTUOUS WITH 20% STENOSIS ON THE RIGHT SIDE AND 28% STENOSIS ON THE LEFT. RIGHT HAD A 25 MM DIAMETER X 18 MM LONG ANEURYSM. INDEX PROCEDURE WAS PERFORMED WITHOUT ISSUES. TWO YEAR FOLLOW UP X-RAY AND CT FOLLOW-UP DEMONSTRATED THAT THE PATIENT WAS ASYMPTOMATIC, BUT THERE WERE ENDOLEAKS, GRAFT OCCLUSION, AND GRAFT THROMBOSIS WERE NOTED. A JUNCTIONAL TYPE III ENDOLEAK WAS NOTED ON THE LEFT SIDE; THERE WAS NO EXTRAVASATION OF DYE BUT A DISCONNECTION THAT RESULTED IN LIMB THROMBOSIS. A TYPE II ENDOLEAK FROM MULTIPLE PATENT COLLATERAL VESSELS WAS ALSO NOTED. AT THE THREE YEAR FOLLOW UP THE ULTRASOUND REVEALED THAT THE AAA WAS F, 8 CM IN DIAMETER, WITH GRAFT OCCLUSION AND THROMBOSIS EVIDENT DUE TO THE SEPARATED LIMB. NO INTERVENTION WAS REPORTED. FOUR YEAR FOLLOW UP CT SCAN SHOWED THROMBOSIS OF THE BIFURCATED STENT GRAFT, AS WELL AS A OCCLUSION AND KINK IN THE RIGHT LIMB. ADDITIONALLY THE PATIENT HAS RIGHT LEG PAIN, RESULTING IN A NEW CLINICAL EVENT HOWEVER THE INVESTIGATOR ASSESSED THIS TO BE NON DEVICE/NON PROCEDURE RELATED. THE THROMBOSIS, OCCLUSION AND KINK ARE TECHNICAL OBSERVATIONS. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ENDURANT STENT GRAFT SYSTEM	SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT	MIH	MEDTRONIC CARDIOVASCULAR SANTA ROSA		V00142741

Patients

Seq	Age	Sex	Outcome	Treatment
1	00077 YR