MAUDE Adverse Event Report: KANEKA CORP. LIPOSORBER LA-15 SYSTEM; LDL APHERESIS SYSTEM

Model Number LA-15

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Arrhythmia (1721); Torsades-de-Pointes (2107); Heart Failure (2206)

Event Date 03/04/2015

Event Type  Injury  

Event Description

The case is (b)(6) male pt on maintenance hemodialysis.The ldl-apheresis therapy with the liposorber la-15 system (ldl-a) was commenced for the treatment of his arterio sclerosis obliterans (aso) on an outpatient basis on (b)(6) 2015.The pt was treated by ldl-a for the third time on (b)(6) 2015, and the treatment finished without problem and he went home.The next day, he developed arrhythmia with torsades de pointes, and admitted to the icu diagnosed with worsening of heart failure.Cpk elevation was observed from 105 iu / l (measurement date unk) to 1449 iu / l.Although acute myocardial infarction was suspected, no significant coronary stenosis was found by coronary angiography.Then, he felt at ease and was discharged from the hosp (date unk).

Manufacturer Narrative

The next (4th) ldl-a was conducted on (b)(6) (15 days after the reported event).On the same day, he underwent hemodialysis after the ldl-a.Immediately after the hemodialysis was over, cyanosis on peripheral limbs, and the lips were developed and then the symptoms were subsided.Blood pressure was stable during the ldl-a, and also in the hemodialysis.Since then, ldl-a therapy was suspended, and only hemodialysis has been continued without problem, as of (b)(6).Probable cause of event: about 400ml blood circulation volume may be increased by the blood and plasma return at the end of the ldl-a procedure, anda possibility that the increase in heart load led to development of arrhythmia and worsening of heart failure transiently can not be denied.The other possible cause may be the side effects of concomitant medications; although all drugs could not be confirmed, one of the possibilities of such side effects is that of nafamostat mesylate used as an anticoagulant only during ldl-a.Our comment: all four times ldl-a treatments had been completed without any abnormalities, and the event occurred the next day of the 3rd ldl-a.Since the pt had medical histories of arrythmia, heart failure and cardiovascular disease, we believe that the ldl-a procedure is not relevant to the event, but it's contribution to the event could not totally be denied.

• Brand Name: LIPOSORBER LA-15 SYSTEM
• Type of Device: LDL APHERESIS SYSTEM
• Manufacturer (Section D): KANEKA CORP.; osaka ; JA
• Manufacturer (Section G): KANEKA CORP
• Manufacturer Contact: masaharu inoue ; 546 fifth ave; 21st fl; new york, NY 10036 ; 8005263522
• MDR Report Key: 4749841
• MDR Text Key: 5821185
• Report Number: 9614654-2015-00007
• Device Sequence Number: 1
• Product Code: MMY
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P910018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/28/2015

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
• Device Model Number: LA-15
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/06/2015
• Initial Date FDA Received: 04/28/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: TUBING SYSTEM FOR PLASMAPGERESIS NK-M3R,; (NIKKISO CO., LTD.); APHERESIS MACHINE KANEKA MA-03 (NIKKISO CO., LTD.); PLASMA SEPARATOR,; SULFLUX FP-08 (AHAHI-KASEI MEDICAL CO., LTD.),
• Patient Outcome(s): Life Threatening
• Patient Age: 83 YR
• Patient Weight: 45