MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE 3 LVAS IMPLANT KIT; VENTRICULAR (ASSIST) BYPASS

Model Number 106524US

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

Patient Problems Stroke/CVA (1770); Paralysis (1997); Ulcer (2274); Fungal Infection (2419); Ischemia Stroke (4418); Embolism/Embolus (4438); Gastrointestinal Hemorrhage (4476)

Event Date 04/29/2021

Event Type  Injury  

Event Description

It was reported that on (b)(6) 2021 the patient developed neurological dysfunction.The patient had a stroke from an embolism in the right hemisphere diagnosed via computed tomography (ct) and the left side of their body was paralyzed.

Manufacturer Narrative

No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed. .

Manufacturer Narrative

Manufacturer's investigation conclusion: a direct relationship between the device and the report of stroke and gi bleeding could not be determined.The patient remains ongoing on vad support and no further related issues have been reported.The relevant sections of the device history records were reviewed and showed no deviations from manufacturing or quality assurance specifications.The heartmate 3 instructions for use (japan) lists bleeding, stroke, and neurologic dysfunction as adverse events that may be associated with the use of heartmate 3 left ventricular assist system.The patient care and management section provides information regarding anticoagulation, including the recommended inr values.No further information was provided.The manufacturer is closing the file on this event.

Event Description

On (b)(6) 2021, the patient suffered major bleeding in their lower gastrointestinal (gi) tract.They were given 4-8 units of red cell concentrate, as well as warlfarin and asprin.

Event Description

It was reported that the patient had a fungal infection on (b)(6) 2021.Drug therapy was the only treatment for the infection.The cause of infection was depending on the patient's condition.The patient experienced massive bleeding in their lower gastrointestinal tract on (b)(6) 2021.The patient's blood was transfused between 4-8 units of packed red blood cells.There was treatment with drugs.Anticoagulant treatment at the time of the event was warfarin and aspirin.The patient's international normalized ratio was 2.4, activated partial thromboplastin time was 42 seconds, and platelet count was 333,000 / l.The cause of bleeding was due to the complexity of the medical management.On (b)(6) 2021 the patient experienced massive bleeding in their thoracic cavity.The patient's blood was transfused between 4-8 units of packed red blood cells.There was no drug treatment performed.There was no anticoagulant treatment at the time of the event.The patient's international normalized ratio was 2.0, activated partial thromboplastin time was 40 seconds, and platelet count was 279,000 / l.The cause of bleeding was due to the complexity of the medical management.On (b)(6) 2021 the patient experienced massive bleeding in their lower gastrointestinal tract.The patient's blood was transfused between 8-16 units of packed red blood cells.There was no drug treatment performed.There was no anticoagulant treatment at the time of the event.The patient's international normalized ratio was 1.7, activated partial thromboplastin time was 39 seconds, and platelet count was 214,000 / l.The cause of bleeding was due to the complexity of the medical management.It was later found that it was due to a rectal ulcer.On (b)(6) 2021 the patient experienced massive bleeding in their lower gastrointestinal tract.The patient's blood was transfused between 8-16 units of packed red blood cells.There was no drug treatment performed.There was no anticoagulant treatment at the time of the event.The patient's international normalized ratio was 1.4, activated partial thromboplastin time was 35 seconds, and platelet count was 126,000 / l.The cause of bleeding was due to the complexity of the medical management and a rectal ulcer.On (b)(6) 2021 the patient experienced massive bleeding in their lower gastrointestinal tract.The patient's blood was transfused between 8-16 units of packed red blood cells.There was no drug treatment performed.Anticoagulant treatment at the time of the event was warfarin and aspirin.The patient's international normalized ratio was 1.8, activated partial thromboplastin time was 45 seconds, and platelet count was 102,000 / l.The cause of bleeding was due to the complexity of the medical management and rectal ulcer.

Manufacturer Narrative

This event was originally reported under mfr# 2916596-2022-01919 as part of a historical jmacs patient registry review in japan through mcs abbott japan affiliate.On 26sep2022 the review of files of this event type was completed.No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is completed.

Manufacturer Narrative

Manufacturer's investigation conclusion: the heartmate 3 instructions for use (japan) lists bleeding, stroke, infection, sepsis, and neurologic dysfunction as adverse events that may be associated with the use of heartmate 3 left ventricular assist system.Section 6 ¿patient care and management" provides information regarding anticoagulation, including the recommended inr values.Additionally, section 6 lists infection as a potential late postimplant complication that may be associated with the use of heartmate 3 lvas.This section includes information for caring for the driveline exit site as well as information regarding how to prevent and control infection.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: HEARTMATE 3 LVAS IMPLANT KIT
• 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: lindsey sallese ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528207
• MDR Report Key: 14397455
• MDR Text Key: 291632579
• Report Number: 2916596-2022-10888
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024013297
• UDI-Public: 00813024013297
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P160054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 03/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/10/2023
• Device Model Number: 106524US
• Device Catalogue Number: 106524US
• Device Lot Number: 7471119
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/29/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/03/2020
• 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; Other
• Patient Age: 49 YR
• Patient Sex: Male
• Patient Weight: 69 KG