MAUDE MDR 4749841

MDR report key
4749841
Report number
9614654-2015-00007
Event key
0
Event type
3
Date of event
2015-03-04
Date received
2015-04-28
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
1
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
MASAHARU INOUE
Address
546 FIFTH AVE 21ST FL NEW YORK NY 10036 US
Phone
800-800-8005
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1LIPOSORBER LA-15 SYSTEMLDL APHERESIS SYSTEMKANEKA CORP.MMYLA-15UNKR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12015-04-2801. L

Event Narratives#

D

Patient 1

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).

N

Patient 1

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.