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

Model Number LA-15

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Apheresis (1719); Edema (1820); Low Blood Pressure/ Hypotension (1914)

Event Date 03/23/2018

Event Type  Injury  

Manufacturer Narrative

The manufacturer has received in total 3 incident reports from the same hospital; the reported events have occurred during treatment of pregnant women with pre-eclampsia.Patient are treated in an investigator initiated clinical trial.Medical device liposorber la-15 was used outside the intended purpose (removing of lipoprotein such as vldl, ldl and lp(a) from patients with dyslipidemia) for treatment of pre-eclampsia patients under an iit study carried out by the physician of the center.Treatment protocol and all set-up details like use of sodium citrate anticoagulation were not in context with instruction for use.Liposorber la-15 is intended for use with heparin anticoagulation since date for regional citrate anticoagulation (rca) are not available yet.Citrate delivery could not be controlled by the used apheresis equipment ma-03.Even company experience from pre-eclampsia studies from the past (raapid i, raapid ii) using of liposorber devices (liposorber la-15, liposorber d) were not considered, as kaneka was not informed about planned / ongoing iit study and wasn't involved in the design, review, and approval of this approach.The attending physician commented that the relationship between the ldl-apheresis and the reported event is "possibly related".Since we could not completely decline the relevance between the ldl-apheresis and the incident, we decided to make a mdr as a case caused sae.We believe this incident is attributable not to defect or malfunction of the devices but the treatment conditions out of ifu and the indication which is not approved.

Event Description

Patient pregnant, pre-eclampsia.2nd apheresis treatment (liposorber la-15), vital parameter @ start of apheresis: bp 135/87; hr 76.Event occurred at 2nd treatment session (liposorber la-15 apheresis treatment), after 1 hour treatment: blood pressure drops to bp 109/70, hr 94 / angioedema (lips).Previous (1st) liposorber la-15 apheresis treatment without notifiable side effects.Patient outcome: recovered after few minutes (of medical intervention and premature apheresis treatment termination).Blood pressure 160/98, heart rate 58.Afterwards moved to plasma-exchange (2 treatment procedures in total).Delivered with caesarean section.Remedial action taken by the healthcare facility relevant to the care of the patient: volume substitution by infusion of 1000 ml ringer lactate + antihistaminic drug + dexamethasone + premature termination of the apheresis treatment at 670 ml processed plasma volume.Initial e-mail of the attending physician (received 2018-07-12): "we are performing a study with ldl apheresis for severe preeclampsia.We have included 4 women.In 3 of them we had relatively severe reactions with severe hypotension and also quinque edema of lips, which we believe were mediated by bradikinin and started soon after starting apheresis and required termination of the procedure and switch to plasma exchange.The procedure was started slowly, with gradually increasing plasma flow.All women were taking only methyldopa or even nothing.The circuits were primed with bicarbonate." technical information: treatment goal: processing of 2 plasma volume blood flow: 50 ml/min @ start; 80 ml @ 15 min; 100 ml @ 45 min plasma flow: 10% of blood flow (5 ml/min); 15% of blood flow (12 ml/min); 20% of blood flow (20 ml/min).Citrate: flow: 120 ml/min.Calcium infusion: 1 m cacl2: 4 ml/ h.

• 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 city, osaka
• Manufacturer Contact: yoshiyuki kitamura ; 2-3-18,nakanoshima, kita-ku; osaka city, osaka 530-8-288 ; JA 530-8288
• MDR Report Key: 7763258
• MDR Text Key: 116528145
• Report Number: 3002808904-2018-00013
• Device Sequence Number: 1
• Product Code: MMY
• UDI-Device Identifier: 14993478010110
• UDI-Public: 14993478010110
• Combination Product (y/n): N
• Reporter Country Code: SI
• PMA/PMN Number: P910018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,s
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/11/2018

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
• Device Catalogue Number: N/A
• Device Lot Number: LAP1416
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/11/2018
• Initial Date FDA Received: 08/08/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2016
• 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