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It was reported in a literature article that an aortic neck rupture occurred in a patient during an endovascular abdominal aortic aneurysm repair after using a coda balloon catheter.The aortic neck rupture was able to be resolved within the same procedure using a modified banding technique.An (b)(6)-year-old male patient underwent an aneurysm repair for an infrarenal abdominal aortic (conical) aneurysm just below the lowest right renal artery using a zenith endograft.A coda 32mm balloon catheter was used concomitantly in the most proximal covered stent, in the overlap zones between the main body, and the iliac limbs for low pressure ballooning.The final angiography showed extravasation around the right infrarenal neck of the aorta along with a type 1a endoleak (reported under patient identifier (b)(6)) which persisted despite attempting to re-balloon proximally in the neck.Re-ballooning with gradual slow inflation was performed a third time, which resulted in "a sudden abrupt increase in the diameter of the endograft during balloon inflation".The balloon was immediately advanced and inflated above the renal arteries, resulting in hemodynamic stability.The balloon was not inflated above 25 cc at any time.The extravasation was attributed to a "sudden and significant decrease in arterial pressure".Additionally, during the surgery, "a longitudinal aortic tear of 0.8 cm was found below the right renal artery" which was repaired with a 10-mm polyester dacron limb.This is when a conversion to open repair was completed.The longitudinal aortic neck rupture was attributed to repeated attempts at ballooning."effective external banding of the infrarenal neck with 2 polyester limbs tied in the same fashion, close to one another, and parallel just below the renal arteries" was performed to treat the aortic neck rupture with "excellent" results.The patient was discharged six days after the procedure "in good general condition" and was reported to be "in excellent condition" three months following the procedure.Imaging has been requested but is unavailable at this time.Moulakakis, k.G., kakisis, j.D., & geroulakos, g.(2019).Aortic banding to treat simultaneously a type ia endoleak and aortic neck rupture during endovascular abdominal aortic aneurysm repair.Annals of vascular surgery, 61, 455¿458.Doi: 10.1016/j.Avsg.2019.04.025.
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H6 ¿ additional method code: (4114) device not returned.Investigation / evaluation: during review of a journal article from attikon university general hospital, cook became aware of an incident involving a coda balloon catheter (unknown rpn).An 84-year-old man with a history of chronic pulmonary obstructive disease and arterial hypertension presented with an 5.8 cm infrarenal abdominal aortic aneurysm (aaa) and underwent an endovascular aneurysm repair (evar) procedure.A zenith endograft was used and low pressure ballooning was performed with a coda 32mm balloon catheter in the most proximal covered stent and in the overlap zones between the main body and the iliac limbs (page 1, column 1).The final angiography showed a type ia endoleak, and low-pressure reballooning was performed proximally in the neck (page 1, column 1).However, the endoleak persisted, and low-pressure reballooning was performed again.In the final angiography, extravasation around the right part of the infrarenal neck of the aorta was observed (page 1, column 1) the balloon was immediately advanced and inflated above the renal arteries, and the patient became hemodynamically stable.(page 1, column 2).During the surgery, a longitudinal aortic tear of 0.8 cm was found below the right renal artery.(page 1, column 2).It was repaired with a 10-mm polyester dacron limb, and the patient was discharged on the sixth postoperative day in good general condition (page 1, column 2 and page 2, column 1).Three months post-surgery, the patient was in excellent condition (page 2, column 1).The authors attributed the longitudinal aortic tear (also referred to as an aortic neck rupture) to repeated attempts at ballooning (page 2, column 1).Furthermore, the authors acknowledge that the endoleak may have been avoided if a larger diameter endograft had been used (page 2, column 1)."effective external banding of the infrarenal neck with 2 polyester limbs tied in the same fashion, close to one another, and parallel just below the renal arteries" was performed to treat the type 1a endoleak and aortic rupture with excellent results."the neck aneurysm was conical with a diameter of 22 mm just below the lowest right renal artery and 25 mm 1 cm distally.Low-pressure ballooning was performed with a coda 32-mm balloon catheter in the area of the most proximal covered stent and after complete deflation in the distal fixation sites, as well as in the overlap zones between the main body and the iliac limbs.The final angiography revealed a type 1a endoleak that was attributed to the conical shape and slight angulation of the infrarenal neck, leading to imperfect apposition of the endograft.Low-pressure reballooning was performed proximally in the neck, but the angiography showed the persistency of the type 1a endoleak.Reballooning with gradual slow inflation was performed for the third time, and we observed a sudden abrupt increase in the diameter of the endograft during balloon inflation.Less than 25 cc volume was inflated at all ballooning times.In the subsequent final angiography, extravasation around the right part of the infrarenal neck of the aorta was observed to be associated with a sudden and significant decrease in arterial pressure.The balloon was immediately advanced and inflated above the renal arteries, the arterial pressure was increased, and the patient became hemodynamically stable.A conversion to open repair was performed." "to avoid the endograft explantation, control the bleeding, and seal the type 1a endoleak, we decided to perform banding around the neck with a 10-mm polyester dacron limb." "the initial approach to the treatment of the type 1a endoleak is balloon dilation to push the device against the vessel wall.We used a coda 32-mm balloon catheter." suspected endoleak cause: "the cause of the proximal endoleak in our case was the conical shape and the slight angulation of the infrarenal neck, leading to imperfect apposition of the endograft.Probably, a larger diameter endograft could have led to avoidance of this complication." suspected aortic neck rupture cause: "because we did not over-dilate the balloon catheter, we believe that repeated attempts at ballooning (even with less inflation volume than indicated in the user manual) led to aortic neck rupture." a review of documentation including the complaint history, drawing, instructions for use (ifu) and quality control of the device, as well as a visual inspection of imaging was conducted during the investigation.Ct and angiogram imaging dated 27feb2020 was returned for expert image review.Aortic neck rupture was confirmed, as a rupture was noted between the right renal artery and the sealing stent.Per the expert image reviewer, the rupture was caused by the sealing stent and/or aorta overexpansion.Additionally, a document-based investigation evaluation was performed.A review of the device master record (dmr) found that sufficient inspection activities are in place to identify this failure mode prior to distribution.A review of the design history file (dhf) found that the affected product is safe and effective for its intended use.A review of the device history record (dhr) for could not be completed, as lot information was not provided.Although a lot number was not provided, based on review of both quality control and manufacturing instruction documentation in previous investigations on coda prefix devices, it has been determined that adequate inspection activities have been established to conclude that there is no evidence that nonconforming product exists in house or in the field.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: "balloon preparation note: balloon and balloon lumen of the coda and the coda lp balloon catheters contain air.The air must be removed from balloon and balloon catheter prior to insertion using standard technique.1.Remove protective balloon sleeve.2.Prepare balloon lumen with standard 3:1 saline and contrast mixture as follows: a.Attach syringe, with appropriate amount of 3:1 saline and contrast mixture, to stopcock on balloon lumen b.Purge all air from balloon in standard fashion.C.Completely deflate balloon and close stopcock.3.To increase ease of insertion, balloon may be lubricated with a thin layer of sterile, biocompatible lubricant.Balloon introduction and inflation 1.Flush the distal lumen using heparinized saline solution.2.Advance the balloon catheter over a pre-positioned.035 inch wire guide, utilizing a minimum 14.0 french introducer sheath for the 10.0 french coda balloon catheter or a minimum 12.0 french introducer sheath of the 9.0 french coda lp balloon catheter.Note: if resistance is met while advancing the wire guide or balloon catheter, determine the cause and proceed with caution.Caution: prior to introduction, determine the amount of standard 3:1 saline and contrast mixture needed to inflate the balloon to the desired inflation diameter.Refer to the balloon inflation parameters chart in fig.1.Over-inflation of the balloon may result in damage to vessel wall and/or vessel rupture.3.Under fluoroscopy, advance the balloon to the desired position using radiopaque markers.Caution: if the coda or coda lp balloon catheter is being utilized to expand a vascular prosthesis, use the radiopaque markers to ensure that the entire balloon is positioned within the prosthesis.4.Inflate balloon with standard 3:1 saline and contrast mixture using a 20 cc or larger syringe.Adhere to recommended balloon inflation volumes.5.If balloon pressure is lost and/or balloon rupture occurs, deflate the balloon and remove balloon and sheath as a unit.Note: care should be taken to monitor balloon manipulations an inflation using fluoroscopy at all times.¿ based on the information provided, examination of the imaging and the results of our investigation, a definitive conclusion has been determined to be due to the patient condition (i.E.Chronic pulmonary obstructive disease and arterial hypertension) and the medical procedure itself (i.E.The sealing stent and/or perirenal aorta overexpansion occurred as a result of repeated ballooning attempts during the procedure).Per cook¿s ifu, it states the appropriate balloon inflation parameters for proper saline and contrast mixture and inflation volume capacities.The authors stated regarding the suspected aortic neck rupture cause: "because we did not over-dilate the balloon catheter, we believe that repeated attempts at ballooning (even with less inflation volume than indicated in the user manual) led to aortic neck rupture." the author also indicates that the incorrect size graft may have been used.It is likely that improper sizing and patient anatomy played as a contributing factor to the reported aortic neck rupture.However, due to the quality of the imaging provided, these factors could not be pinpointed or ruled out as potential cause.The appropriate personnel have been notified.Per the quality engineering risk assessment no further action is required.We will continue to monitor for similar complaints.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
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