MAUDE Adverse Event Report: MEDTRONIC MEXICO NC EUPHORA RX; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

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.

• Brand Name: NC EUPHORA RX
• Type of Device: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer (Section G): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 9563433
• MDR Text Key: 174091847
• Report Number: 9612164-2020-00143
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K141090
• Number of Events Reported: 1
• 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 Received: 01/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/09/2021
• Device Catalogue Number: NCEUP37520X
• Device Lot Number: 216906770
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/07/2020
• Date Device Manufactured: 01/10/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Required Intervention
• Patient Age: 87 YR