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

Model Number 106524INT

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

Patient Problems Hemorrhage/Bleeding (1888); Cardiac Tamponade (2226)

Event Date 06/01/2020

Event Type  Injury  

Manufacturer Narrative

Manufacturer's investigation conclusion: no specific patient or device information can be provided.Device was implanted at the time of the event.The date of the event is approximate as the data was collected between nov2016 and jun2020.Author of the article was listed as: damman, k.Et al (2022).Netherlands heart journal.Https://doi.Org/10.1007/s12471-022-01671-1.A direct correlation between the heartmate 3 devices and the reported bleeding and cardiac tamponade could not be conclusively determined through this evaluation.No product was evaluated under this complaint.The heartmate 3 device serial numbers and other specific case/patient information is not available and was not requested.The heartmate 3 lvas instructions for use (ifu) (rev.G) is currently available.Pericardial fluid collection and bleeding are listed as adverse events that may be associated with the use of the heartmate 3 left ventricular assist system.Section 6, ¿patient care and management¿ also provides information regarding anticoagulation, including the recommended inr (international normalized ratio) values.No further information was provided.The manufacturer is closing the file on this event.

Event Description

It was reported through the research article ¿conservative initial postoperative anticoagulation strategy after heartmate 3 left ventricular assist device implantation" identifying that heartmate 3 (hm3) may be related to postoperative bleeding or tamponade that requires re-operation, and death.This study compared two methods of anticoagulant administration following device implant.The first method (¿old protocol¿) administered a full-dose low molecular-weight heparin (lmwh) within the first 48 hours post-implant and had an overlapping administration of vitamin k.The second method (¿new protocol¿) did not start anticoagulation therapy until approximately 48 hours post-implant; a low dose of vitamin k was administered and gradually increased in dosage until 7 days post-implant at the earliest.No lmwh was administered for the new protocol unless the patient¿s mobility was poor, in which case lmwh would be administered prophylactically.This was a retrospective study that evaluated 73 hm3 patients implanted between 01nov2016 and 01jun2020; 48 of these patients were given the old protocol, and 25 patients were given the new protocol.The study found similar international normalized ratio (inr) and lactate dehydrogenase (ldh) values between the two groups (p=0.5 and p=0.997, respectively); however, it was noted that the old protocol group had a higher tendency to overshoot the upper inr limit while the new protocol group had a gradual inr increase that became therapeutic around day 5 post-implant.Of the 48 old protocol patients, 16 of them had a total of 19 bleeding or tamponade events that required re-operation; only 1 patient of the 25 new protocol patients required re-operation from bleeding or tamponade (33% vs.4%, p=0.005).Perioperative transfusions were similar for both groups, but the need for additional transfusions in the first three weeks post-implant was only observed in the old protocol group with 2 patients requiring additional transfusions (p=0.0065).Post-implant mortality was similar; 3 patients from the old protocol group and 1 patient from the new protocol group expired.There was no noted difference in the mortality rate six months post-implant.Finally, the length for both the intensive care unit (icu) stays and overall hospital stays was significantly shorter for the new protocol group; the new protocol group had an average of 2 days in the icu and 21 days overall in the hospital, while the old protocol group had 5 days in the icu and 27 days overall in the hospital (p<0.001).Related death mfr #: 2916596-2022-10844.

• 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: bob fryc ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528204
• MDR Report Key: 14398085
• MDR Text Key: 291725799
• Report Number: 2916596-2022-10843
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024013297
• UDI-Public: 813024013297
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: P160054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/13/2022

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: Lay User/Patient
• Device Model Number: 106524INT
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/04/2022
• Initial Date FDA Received: 05/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Hospitalization; Required Intervention; Life Threatening