MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM, JP; VENTRICULAR (ASSIST) BYPASS

Model Number 104911JPN

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

Patient Problems Anemia (1706); Hemorrhage/Bleeding (1888); Coma (2417); Loss of consciousness (2418); Hemorrhagic Stroke (4417)

Event Date 03/17/2021

Event Type  Injury  

Manufacturer Narrative

Manufacturer's investigation conclusion: the pump remains in use supporting the patient.A correlation between the device and the report of stroke could not be conclusively determined.Stroke is listed in the instructions for use as a potential adverse event that may be associated with the use of heartmate ii left ventricular assist system.Stroke has been previously investigated and will continue to be monitored through quality data reviews, which are conducted on production and post product signals to evaluate if products are conforming to product requirements.No further information was provided.The manufacturer is closing the file on this event.

Event Description

It was reported that the patient was readmitted for neurological dysfunction (b)(6) 2021 to (b)(6) 2021.Intracranial bleeding in right hemisphere was observed through computed tomography.The patient had brain stroke/coma.Warfarin and aspirin administered at time of event.Surgical removal of hematoma was performed.The causal relationship to the device was reportedly low but undeniable because it might be caused by external wounds.

Manufacturer Narrative

No further information was provided.The manufacturer is closing the file on this event.

Event Description

It was reported that the patient also developed major bleeding/anemia on (b)(6) 2021 during (b)(6) 2021 admission.The patient was transfused with less than 4 units of red blood cells.The patient was on heparin anticoagulation at time of event.The patient had an acute subdural hematoma that caused the bleeding to develop.

Manufacturer Narrative

Manufacturer's investigation conclusion: a specific cause for the reported events as well as a direct correlation to the heartmate ii lvas, serial number (b)(6), could not be conclusively established through this evaluation.The patient remained ongoing on the heartmate (hm) ii left ventricular assist system (lvas), (b)(6), until receiving a routine heart transplant on 17jan2022.The hmii lvas ifu lists bleeding, and stroke as adverse events that may be associated with the use of the heartmate ii left ventricular assist system.This document also provides information regarding the recommended anticoagulation therapy, including inr range, as well as suggested anticoagulation modifications.No further information was provided.The manufacturer is closing the file on this event.

Event Description

It was reported that the patient developed bleeding again on (b)(6) 2021 due to anemic tendency.Less than four units of red cell concentrate per 24 hours were transfused.The anticoagulant drug at the time of the event was warfarin and aspirin.

Manufacturer Narrative

This event was originally reported under mfr# 2916596-2022-02063 as part of a historical jmacs patient registry review in japan through mcs abbott japan affiliate.On (b)(6) 2022 the review of files of this event type was completed.No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.

Event Description

The patient fell and lost consciousness on (b)(6) 2021.The caregiver noticed and was transported from the management facility to the planting facility by a doctor helicopter.Head surgery was performed.

Manufacturer Narrative

Manufacturer's investigation conclusion: the relevant sections of the device history records for (b)(6) were reviewed and showed no deviations from manufacturing or quality assurance specifications.The heartmate ii lvas instructions for use (ifu) and the heartmate ii lvas patient handbook are currently available.Section 1 of the ifu, ¿introduction¿, listed bleeding, and stroke as adverse events that may be associated with the use of the heartmate ii left ventricular assist system.Section 6, ¿patient care and management¿ (under ¿anticoagulation¿), provides information regarding the recommended anticoagulation therapy, including inr values, as well as the suggested anticoagulation modifications.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM, JP
• Type of Device: VENTRICULAR (ASSIST) BYPASS
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• Manufacturer (Section G): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• Manufacturer Contact: bob fryc ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528204
• MDR Report Key: 13711028
• MDR Text Key: 286859307
• Report Number: 2916596-2022-01406
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P060040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 10/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/31/2019
• Device Model Number: 104911JPN
• Device Lot Number: 5854424
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/09/2017
• 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): Required Intervention; Hospitalization
• Patient Age: 61 YR
• Patient Sex: Male
• Patient Weight: 76 KG