MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE II LVAS IMPLANT KIT (WITH SEALED GRAFTS); VENTRICULAR (ASSISST) BYPASS

Model Number 106015

Device Problem Obstruction of Flow (2423)

Patient Problems Anemia (1706); Hemolysis (1886); Thrombosis (2100); Obstruction/Occlusion (2422)

Event Date 11/09/2020

Event Type  Injury  

Manufacturer Narrative

The patient remains ongoing with the lvad device.No further information was provided.A supplemental report will be submitted when the manufacturer's investigation is completed.

Event Description

It was reported that the patient presented with an increase in lactate dehydrogenase (ldh) to greater than 850 u/l over two days.The patient was a recent hip fracture and plavix was stopped due to anemia.The patient was inpatient as of (b)(6) 2020, and was completing a course of intravenous (iv) anticoagulation.Changes to pump parameters included power increased to 7, but trended down to mid 5 (patient¿s baseline).An echocardiogram (echo) ramp study, trending ldh, and ct (computed tomography) chest were all completed while inpatient.The patient was asymptomatic and on bivalrudin infusion but was discontinued from drip to trend stable ldh.It was noted that the patient did not need a new back up battery.It is unclear why the patient's ldh was elevated however cessation of plavix may have contributed.Inr (international normalized ratio) goal had been 2.5-3 prior to admission.The patient was to be monitored and remain inpatient.No additional information was provided.

Manufacturer Narrative

Section d4 and h4: additional information manufactures investigation conclusion: analysis of the submitted log file appeared to show the pump operating as intended.A direct correlation between the reported anemia, elevated ldh (lactate dehydrogenase), and heartmate ii left ventricular assist system (hmii lvas), serial number (b)(6) could not be conclusively established through this evaluation.The submitted log file contains data from (b)(6) 2020 at 06:13:50 through (b)(6) 2020 at 12:30:37.Overall, power ranged from 4.7-7.0 w, estimated flow ranged from 3.2-7.3 lpm, and average pulsatility index (pi) was between 1.5-5.7.No abnormal trends in pump parameters were observed.A backup battery fault alarm was captured on (b)(6) 2020 at 12:29:56 (investigated under pi-2020-0214191-02, for system controller serial number (b)(6)).No additional atypical alarms were captured.The pump speed remained above the low speed limit for the duration of the file.On (b)(6) 2020 the center reported that the patient had an increase in lactate dehydrogenase (ldh) to greater than 850 u/l over the last 2 days.The patient had a recent hip fracture (fx) and plavix was stopped due to (d/t) anemia.The patient was currently inpatient and completing a course of intravenous (iv) anticoagulation.Although the center initially asked abbott technical services to advise for possible pump thrombosis, it should be noted that the center later reported that the patient was asymptomatic.The patient being off plavix may have contributed to the elevated ldh.The inr (international normalized ratio) goal had been 2.5-3 prior to admission.It should be noted that the center reported ventricular tachycardia on (b)(6) 2020 and submitted additional log files for review, which showed elevations in power and estimated flow that the center attributed to elevated ldh (investigated under cs-144717, per-0216531).The patient remains ongoing on hmii lvas, serial number (b)(6).The relevant sections of the device history records for (b)(6) were reviewed and showed no deviations from manufacturing or quality assurance specifications.The implant kit was shipped on (b)(6)2014.The hmii lvas instructions for use (ifu) outlines the recommended anticoagulation therapy and international normalized ratio (inr) range.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: HEARTMATE II LVAS IMPLANT KIT (WITH SEALED GRAFTS)
• Type of Device: VENTRICULAR (ASSISST) BYPASS
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• MDR Report Key: 10981153
• MDR Text Key: 220649342
• Report Number: 2916596-2020-05784
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024011224
• UDI-Public: 00813024011224
• Combination Product (y/n): N
• PMA/PMN Number: P060040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 12/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2020
• Device Model Number: 106015
• Device Catalogue Number: 106015
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 77 YR
• Patient Weight: 86