MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,l report with the FDA on 2019-05-07 for LIPOSORBER LA-15 SYSTEM manufactured by Kaneka Corporation.
[144396996]
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.
Patient Sequence No: 1, Text Type: N, H10
[144396997]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002808904-2019-00009 |
| MDR Report Key | 8589384 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,L |
| Date Received | 2019-05-07 |
| Date of Report | 2019-04-16 |
| Date Mfgr Received | 2019-04-16 |
| Date Added to Maude | 2019-05-07 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. YOSHIYUKI KITAMURA |
| Manufacturer Street | 2-3-18 NAKANOSHIMA, KITA-KU |
| Manufacturer City | OSAKA, OSAKA 530-8288 |
| Manufacturer Country | JA |
| Manufacturer Postal | 530-8288 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LIPOSORBER LA-15 SYSTEM |
| Generic Name | LIPOPROTEIN, LOW DENSITY, REMOVAL |
| Product Code | MMY |
| Date Received | 2019-05-07 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KANEKA CORPORATION |
| Manufacturer Address | 2-3-18, NAKANOSHIMA, KITA-KU, OSAKA, 530-8288 JA 530-8288 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-05-07 |