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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: QXMEDICAL, LLC Q50 PLUS STENT GRAFT BALLOON CATHETER

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QXMEDICAL, LLC Q50 PLUS STENT GRAFT BALLOON CATHETER Back to Search Results
Model Number 65P
Device Problem Leak/Splash (1354)
Patient Problems Death (1802); Hemorrhage/Bleeding (1888); Rupture (2208)
Event Date 07/28/2017
Event Type  Death  
Manufacturer Narrative

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. ".

 
Event Description

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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Brand NameQ50 PLUS STENT GRAFT BALLOON CATHETER
Type of DeviceBALLOON CATHETER
Manufacturer (Section D)
QXMEDICAL, LLC
2820 patton road
roseville MN 55113
Manufacturer Contact
fernando dicaprio
2820 patton rd
roseville, MN 55113
6518422053
MDR Report Key6791670
MDR Text Key82602519
Report Number3009766315-2017-00002
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
PMA/PMN NumberK120381
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type DISTRIBUTOR
Type of Report Initial
Report Date 07/28/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/14/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator
Device EXPIRATION Date03/18/2019
Device MODEL Number65P
Device Catalogue NumberQ50
Device LOT NumberS17B002
Was Device Available For Evaluation? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received07/28/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/18/2017
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient TREATMENT DATA
Date Received: 08/14/2017 Patient Sequence Number: 1
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