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Model Number 65P |
Device Problem
Leak/Splash (1354)
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Patient Problems
Death (1802); Hemorrhage/Bleeding (1888); Rupture (2208)
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Event Date 07/28/2017 |
Event Type
Death
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Manufacturer Narrative
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As outlined in the summary of incident," a qxmedical balloon was inflated with 30cc of saline" inside the stent (gore ® excluder® rlt351414) for the second inflation.
Per the compliance chart in the ifu, the 21mm diameter of the proximal neck was expanded close to 40mm.
Two balloons from different manufacturers were used to inflate the stent and it is unknown which caused the rupture.
It was also reported that "both balloons were extended outside of the 35 mm stent by approximately 5mm.
" the instructions for stent expansion in the ifu are as follows: "using fluoroscopic imaging, carefully advance the catheter to the desired location in the vasculature or stent graft using the markerbands (distal & proximal end of the balloon) for visual guidance.
When using the stent graft balloon catheter to expand a vascular prosthesis, use the radiopaque markers to ensure that the entire balloon is positioned within the prosthesis".
"open the stopcock and inflate the balloon at the target location.
Continuously monitor fluoroscope screen watching for stent movement.
Proper modeling should show very slight outward expansion of stent with balloon inflation.
Be careful not to over inflate - stop right after stent expansion is evident.
" the ifu contains warnings and precautions relating to over-inflation, rapid inflation, vessel rupture.
These include: "adhere to balloon inflation parameters outlined in the balloon compliance chart (table 1)".
"over-inflation may result in damage to vessel wall and/or vessel rupture, or damage to the stent graft".
"balloon us highly compliant.
Inflate slowly.
Do not overinflate balloon when modeling graft at all times during balloon inflation to detect any movement of the stent graft.
" "use special care in areas of diseased vessels to avoid rupture or vessel trauma".
"over inflation of the balloon can cause graft tears and/or vessel rupture.
" "over inflation of the balloon can cause graft tears and or vessel rupture.
Care should be taken when inflating the balloon in vessels, particularly when inflating in the distal-most area of the stent graft, or in calcified, stenotic, and/ or diseased vessels.
" "do not over-inflate balloon when modeling graft in vessels.
Operator should visualize the stent graft at all times during balloon inflation to detect any movement of the stent graft.
".
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Event Description
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On (b)(6) 2017, the patient underwent treatment of a symptomatic contained rupture using gore® excluder® aaa endoprostheses.
It was reported the patient presented with abdominal pain, but otherwise had a stable blood pressure and heart rate.
The patient was reported to have a reverse taper in the proximal neck with consecutive diameters of 27 mm, 31 mm, and 21 mm over a 3 cm segment.
It was also reported the patient's proximal neck measured greater than 90° in angulation.
On (b)(6) 2017, the patient underwent treatment of a symptomatic contained rupture using gore® excluder® aaa endoprostheses.
It was reported the patient presented with abdominal pain, but otherwise had a stable blood pressure and heart rate.
The patient was reported to have a reverse taper in the proximal neck with consecutive diameters of 27 mm, 31 mm, and 21 mm over a 3 cm segment.
It was also reported the patient's proximal neck measured greater than 90° in angulation.
It was reported that after a trunk-ipsilateral leg component (rlt351414/16422464) and contralateral leg component (pxc121000/16080303)were implanted and one post-implant dilation ballooning using a coda balloon was performed, intraoperative imaging identified a proximal type i endoleak.
It was reported the endoleak was caused by the reverse taper and highly angulated neck.
A second ballooning was reportedly performed using a qx medical balloon in the proximal neck to better seat the trunk.
It was reported the q50 balloon was inflated with 30 cc using a 35 cc syringe.
After the second ballooning, it was reportedly determined the patient's aorta had ruptured near the renal arteries.
It was reported it is unknown if the rupture occurred after the first ballooning with the coda balloon or the second ballooning with the q50 balloon.
It was further reported that both balloons were reportedly extended outside of the endograft approximately 5mm during ballooning of the proximal neck.
It was reported an aortic extender component (pla360400/16264591) was implanted in the proximal neck and successfully sealed the rupture.
However, it was reported the patient's condition did not improve or stabilize with the implant of the additional device, and the patient expired during the procedure.
The cause of death was reported to be the rupture during the procedure.
It is reportedly unknown if an autopsy was performed.
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Search Alerts/Recalls
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