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Catalog Number NCEUP37520X
Device Problem Detachment of Device or Device Component (2907)
Patient Problems Death (1802); Ischemia (1942); Thrombus (2101); Device Embedded In Tissue or Plaque (3165); Multiple Organ Failure (3261)
Event Date 12/12/2019
Event Type  Death  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event Description
During a procedure an attempt was made to use one nc euphora rx ptca balloon catheter to treat a lesion in the ostium of the lm/lad/cx arteries.The device was inspected with no issues noted.The device did pass through a previously deployed stent.Resistance was not encountered and excessive force was not used.It was reported that a detachment of the entire balloon from the shaft occurred.This was realised when the device was removed from the patient.An attempt was made to recover the detached balloon but was unsuccessful.48 hours post procedure the patient died.
Manufacturer Narrative
Image analysis review: very complex pci, with a critical left main lesion that involve proximal lcx and proximal lad.The lesion was treated with two stent technique, t-stenting and protrusion (tap).This technique intentionally leaves some struts 1-2 stent¿s crowns within the lumen of the main branch (e.G.Lm), which is then crushed with the stent place at the main branch (lm).That increases the chance of leaving malapposed struts and irregular stent segments within the lumen of the lm.Likely the nc euphora detachment occurred due to getting stuck with some stent¿s section/segment in this complex technique.There are at least two sections where the balloon could be trapped, at the overlapping section of the lad and at the tap section of the bifurcation (latter most likely).If information is provided in the future, a supplemental report will be issued.
Manufacturer Narrative
Additional information: the nc euphora was not fully inflated.It was reported that the case was fairly straight forward.No issues or resistance were noted when removing both kissing balloons.It was reported that the detached balloon was not fully deflated.If information is provided in the future, a supplemental report will be issued.
Manufacturer Narrative
Additional information: the nc euphora was being used to post dilate a stent in prox lad/ lm.Negative prep was performed.The balloon remained in the left main and an attempt was made to capture the balloon with a goose neck.Other stents were used to crush the detached components in the left main.This took around 5 hours.2 markerbands were visualised remaining in the patient.The marker bands remained with the balloon in the left main.The shaft detached just before the proximal radiopaque and the proximal edge of the balloon.The other part of the shaft was out of the patient.The patient became unstable at the end of the procedure.The cause of death was due to multi-organ failure, mainly severe acute kidney injury.The physician assessed that there was no direct relation between the event and the patient death, however assessed that there was an indirect association between events.It was the final kissing balloon technique after successful left main/left anterior descending/left circumflex double stenting according to the t-and-protrusion (tap) technique.This adverse event led to the significant prolongation of the procedure, about 2 hours more, attempting to retrieve the lost part of the catheter by snaring or trapping with another balloon.There was hemodynamic instability with low systemic arterial blood pressure necessitating inotropic agents.The procedure was 1:1 intra-aortic balloon pump-assisted.No more advanced circulatory supports were available.Orotracheal intubation and mechanical ventilation were needed.Indeed, the balloon was significantly reducing blood flow and initial signs of thrombosis, despite dual antiplatelet therapy and optimal periprocedural anticoagulation (act >250 seconds), were observed.During one of the last attempts of retrieval, the guidewire in the distal segment of the diagonal caused a perforation that required the exclusion of the branch by stent graft.The complication caused by the detached balloon was finally fixed by new double stenting according to the culotte technique and high-pressure double kissing balloon, followed by high-pressure proximal optimization technique in the left main coronary artery.Despite the patients was discharged from the cath lab with good final blood pressure and no pericardial tamponade or hemodynamic influenced of the pericardial effusion was observed by echocardiography, there was a progressive decline in the renal function and metabolic parameters.Intra-aortic balloon pump position was placed correctly at repeat controls.For these reasons it is believed there is a clear relationship between the adverse event with the device and the outcome.The procedure was uncomplicated before the complication occurred.The postdilation at 12 atm according to kissing balloon, causing the balloon detachment, was the final step of the intervention.A non-medtronic 7 fr xb 4.0 guide catheter with side holes was used at the moment of the balloon detachment.If information is provided in the future, a supplemental report will be issued.
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Brand Name
Type of Device
Manufacturer (Section D)
av. paseo del cucapah #10510
tijuana,bc 22570
MX  22570
Manufacturer (Section G)
av. paseo del cucapah #10510
tijuana,bc 22570
MX   22570
Manufacturer Contact
toni o'doherty
parkmore business park west
MDR Report Key9563433
MDR Text Key174091847
Report Number9612164-2020-00143
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Physician
Type of Report Initial,Followup,Followup,Followup
Report Date 04/07/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/08/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date01/09/2021
Device Catalogue NumberNCEUP37520X
Device Lot Number216906770
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/07/2020
Date Device Manufactured01/10/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Death; Required Intervention;
Patient Age87 YR