MAUDE Adverse Event Report: KANEKA CORPORATION LIPOSORBER LA-15 SYSTEM; LIPOPROTEIN, LOW DENSITY, REMOVAL

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Apheresis (1719); Low Blood Pressure/ Hypotension (1914); Malaise (2359); Sweating (2444)

Event Type  Injury  

Manufacturer Narrative

One month after the onset of takotsubo cardiomyopathy la-15 treatment was resumed.It is considered that the improvement of left ventricular outflow area disorder and overcontraction of the myocardium might have not been sufficient enough.Even when the blood circulation volume in the body started to reduce during the treatment, it is plausible that the pumping motion of his heart would not compensate the decrease in blood pressure and the hypovolaemia lead to low blood pressure and presyncope.

Event Description

Based on a case report on liposorber la-15 from italy: beatrice dal pino et.Al, "recent takotsubo syndrome and lipoprotein apheresis: an alert for a safe procedure." european journal of preventive cardiology 0 (00) 1-3, 2019.A patient with hyper-lp(a) and polygenic hypercholesterolaemia treated by liposorber la-15 system every other week for 5 months without problem.The patient experienced a takotsubo syndrome triggered by sexual act, with mid-to-apical hypokinesia in the anterior septum and anterior wall.Therapy with bisoprolol 1.25 mg once a day was started.Ne month after the takotsubo episode, the patient presented systemic malaise characterized by sweating and presyncope.The episode occurred after half an hour, at 600 ml plasma volume treated, and resolved with fluid administration and an intravenous bolus of 500mg methylprednisolone.His blood pressure, which was normal before the start of lipoprotein apheresis, was low and poorly responsive to administration of fluids; his symptoms, however, were so severe as to require the discontinuation of lipoprotein apheresis procedures.Two months after the episode an echocardiography showed the resolution of hypercontractility and of the left ventricular outflow tract obstruction.Therefore, lipoprotein apheresis was started again without problems but with the precaution of limiting the blood flow to 65 ml/min and administering a bolus of physiological solution (150-200 ml) at the beginning of treatment to reduce the risk of hypovolaemia.

• Brand Name: LIPOSORBER LA-15 SYSTEM
• Type of Device: LIPOPROTEIN, LOW DENSITY, REMOVAL
• Manufacturer (Section D): KANEKA CORPORATION; 2-3-18, nakanoshima, kita-ku,; osaka, 530-8 288; JA 530-8288
• Manufacturer Contact: yoshiyuki kitamura ; 2-3-18 nakanoshima, kita-ku; osaka, osaka 530-8-288 ; JA 530-8288
• MDR Report Key: 8589384
• MDR Text Key: 144396996
• Report Number: 3002808904-2019-00009
• Device Sequence Number: 1
• Product Code: MMY
• UDI-Device Identifier: 14993478010110
• UDI-Public: 14993478010110
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: H120005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/16/2019
• Initial Date FDA Received: 05/07/2019
• Was Device Evaluated by Manufacturer?: No
• 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): Other
• Patient Age: 62 YR