FDA Adverse Event Other Summary report: N

MEDTRONIC ANEURX BIFURCATED STENT GRAFT (FLEXIBLE)

MDR report key: 339706 · Received June 27, 2001

Report

Report Number
2953738-2001-00128
Event Type
Other
Date Received
June 27, 2001
Date of Event
May 29, 2001
Report Date
June 8, 2001
Manufacturer
MEDTRONIC AVE PERIPHERAL DIV
Product Code
MIH
Removal / Correction Number
UNK
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
MN, US
Reporter Occupation
PHYSICIAN

Narratives

Description of Event or Problem · 1

A 26MM DIAMETER X 15MM DIAMETER X 16.5 CM LENGTH ANEURX BIFURCATED STENT GRAFT AND ITS COMPONENTS WERE IMPLANTED FOR THE TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM IN 2001. IT IS REPORTED THAT THE DIAMETER OF THE PROXIMAL NON-ANEURYSMAL AORTIC NECK MEASURED 22-24MM AND THE LENGTH FROM THE PROXIMAL NON-ANEURYSMAL AORTIC NECK TO THE DISTAL NON-ANEURYSMAL ILIAC NECK WAS 19-20CM. THE PT HAD A HISTORY OF BLADDER CANCER. THE VESSEL MORPHOLOGY IS UNKNOWN. THE LEFT COMMON FEMORAL ARTERY WAS CANNULATED AND A WIRE WAS MANIPULATED THROUGH THE LEFT ILIAC ARTERY INTO THE AORTA. THIS WAS EXCHANGED FOR AN 8 FRENCH VASCULAR SHEATH THROUGH WHICH A DIRECTIONAL CATHETER AND WIRE WERE ADVANCED THROUGH THE AORTIC ANEURYSM INTO THE SUPRARENAL ABDOMINAL AORTA. AFTER A WIRE EXCHANGED, A 16 FRENCH VASCULAR SHEATH WAS PLACED. A STRAIGHT FLUSH CATHETER WAS PLACED OVER THIS WIRE AND THE WIRE WAS REMOVED. ATTENTION WAS DIRECTED TO THE RIGHT GROIN. A SKIN INCISION WAS MADE INFERIOR TO THE LEFT FEMORAL SITE. AFTER A SUBCUTANEOUS TUNNEL, THE LEFT FEMORAL ARTERY WAS CANNULATED USING A 19 GAUGE NEEDLE. THIS ACCESS WAS UTILIZED TO HAVE A MORE STRAIGHT DIRECTION OF THE VASCULAR SHEATH. THROUGH THE NEEDLE, A WIRE WAS ADVANCED CENTRALLY INTO THE AORTA. THE NEEDLE WAS EXCHANGED FOR AN 8 FRENCH VASCULAR SHEATH THROUGH WHICH A COBRA II CATHETER AND WIRE WERE EVENTUALLY MANIPULATED THROUGH THE ANEURYSM INTO THE SUPRARENAL AORTA. AFTER EXCHANGE OVER A LUNDERQUIST WIRE, A 22 FRENCH VASCULAR SHEATH WAS ADVANCED INTO THE AORTA. THROUGH THE SHEATH, A 26MM X 16MM DIAMETER X 16.5CM LENGTH MEDTRONIC AVE BIFURCATED STENT GRAFT WAS ADVANCED. THE PHYSICIAN STATED THAT AFTER SEVERAL AORTOGRAMS PERFORMED THROUGH THE STRAIGHT FLUSH CATHETER, THE PROXIMAL PORTION OF THE BIFURCATED STENT GRAFT WAS DEPLOYED, LEAVING THE DISTAL END SHEATHED IN ORDER TO GAIN STABILITY. ATTENTION WAS THEN DIRECTED AT CANNULATING THE LEFT LIMB OF THE GRAFT FROM A LEFT GROIN APPROACH. THE PHYSICIAN REPORTED THAT MULTITUDES OF WIRES AND CATHETERS WERE USED TO MANIPULATE THROUGH THE REGION BUT THIS WAS UNSUCCESSFUL. APPROACH WAS ABORTED AND IT WAS ELECTED TO ATTEMPT TO CANNULATE FROM A MORE SUPERIOR LOCATION. THE LEFT UPPER ARM WAS PREPPED AND THE LEFT BRACHIAL ARTERY WAS DIRECTLY CANNULATED. USING SELDINGER TECHNIQUE, A VASCULAR SHEATH WAS PLACED THROUGH WHICH A BERENSTEIN CATHETER AND WIRE WERE ADVANCED RETROGRADE IN THE BRACHIAL ARTERY AND MANIPULATED INTO THE DESCENDING AORTA. AFTER A WIRE EXCHANGE, A 6 FRENCH X 55 CM VASCULAR SHEATH WAS ADVANCED OVER THE REGION TO PROTECT THE AXILLARY AND SUCLAVIAN ARTERIES FROM WIRE INJURY. THE SHEATH TIP WAS PLACED INTO THE SUPRARENAL AORTA AND THROUGH THE SHEATH, A DIRECTIONAL CATHETER AND WIRE WERE ADVANCED INTO THE PARTIALLY DEPLOYED BIFURCATED STENT GRAFT AND INTO THE ANEURYSM. THIS WAS THE ADVANCED INTO THE TERMINAL AORTA. THEN, FROM THE LEFT GROIN APPROACH, A DIRECTIONAL CATHETER AND WIRE WERE ADVANCED INTO THE AORTA AND EXCHANGED FOR A SNARE. THE LEFT BRACHIAL WIRE WAS THEN SNARED AND BROUGHT THROUGH THE LEFT GROIN SHEATH. THEN, OVER THE WIRE, THE 16 FRENCH SHEATH COULD BE ADVANCED INTO THE BIFURCATED STENT GRAFT AND THIS WAS PARTIALLY DEPLOYED. AFTER PARTIAL DEPLOYMENT, THE RIGHT BIFURCATED GRAFT WAS COMPLETELY UNSHEATHED AND THE RUNNERS WERE ATTEMPTED TO BE PULLED BACK. THE PHYSICIAN STATED THAT DUE TO THE NARROW TERMINAL AORTA, THE BIFURCATED STENT GRAFT RETRACTED SOMEWHAT INTO THE DISTAL MOST AORTIC NECK INTO THE PROXIMAL AORTA NECESSITATING THE NEED TO PLACE A MORE PROXIMAL EXTENDER CUFF. A LEFT 15 X 11.5CM LENGTH EXTENDER LIMB STENT GRAFT WAS COMPLETELY DEPLOYED. THROUGH THE LEFT GROIN APPROACH, THE STRAIGHT FLUSH CATHETER WAS RE-ADVANCED. THROUGH THE RIGHT GROIN APPROACH, A 28 X 3.75CM LENGTH AORTIC EXTENSION CUFF WAS ADVANCED INTO THE PROXIMAL AORTA. THIS WAS DEPLOYED USING REPEATED ARTERIOGRAMS FOR EXACT POSITIONING. AFTER DEPLOYMENT, THE PROXIMAL AORTA WAS BALLOON DILATED WITH A 25MM ANGIOPLASTY BALLOON TO 2 ATMOSPHERES OF PRESSURE IN ORDER TO OBTAIN AN ADEQUATE SEAL PROXIMALLY. ATTENTION WAS THEN DIRECTED TO THE LEFT ILIAC SEGMENT, WHICH WAS NOT COMPLETELY IN THE LEFT COMMON ILIAC ARTERY. FOR STABILITY, THE PHYSICIAN USED AN ILIAC EXTENSION CUFF. THROUGH THE SHEATH, A 15MM X 5.5CM AORTIC EXTENSION CUFF WAS ADVANCED AND DEPLOYED INTO THE LEFT COMMON ILIAC ARTERY. A LEFT ILIAC ATERIOGRAM WAS PERFORMED THROUGH THE LEFT GROIN SHEATH, WHICH DEMONSTRATED EXCELLENT POSITIONING OF THAT CUFF. FINAL AORTOGRAM DEMONSTRATED NO PROXIMAL OR DISTAL (TYPE I) ENDOLEAK AND NO COLLATERAL (TYPE II) ENDOLEAK. THE PHYSICIAN STATED THE ENDOVASCULAR REPAIR WAS SUCCESSFUL WITH EXCLUSION OF THE ANEURYSM. THE PT IS REPORTEDLY DOING FINE, AND THERE WAS NO ADDITIONAL CLINICAL SEQUELAE REPORTED RELATIVE TO THE EVENT. THE DEVICE WAS DISCARDED AND NOT AVAILABLE FOR INVESTIGATION.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
29045 MEDTRONIC ANEURX BIFURCATED STENT GRAFT (FLEXIBLE) AAA STENT GRAFT MIH MEDTRONIC AVE PERIPHERAL DIV NA M01D750540

Patients

Seq Age Sex Outcome Treatment
1 72 YR Required Intervention