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

Model Number 106524INT

Device Problems Fluid/Blood Leak (1250); Malposition of Device (2616); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 11/17/2021

Event Type  Injury  

Event Description

It was reported that during left ventricular assist system (lvas) implant, the surgeon noted bleeding from the posterior part of the heart.After "re-connecting" the pump to the apical cuff the bleeding stopped.During implant the slide lock mechanism was well adapted, which was confirmed visually and by the standard "click-sound" by the field clinical specialist and proctor.The surgeon mentioned that the pump was rotated so that the outflow graft was standing more on top of the heart.No lvas alarms occurred during the event.

Manufacturer Narrative

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

Event Description

It was reported that during left ventricular assist system (lvas) implant, the surgeon noted bleeding from the posterior part of the heart.After "re-connecting" the pump to the apical cuff the bleeding stopped.During implant the slide lock mechanism was well adapted, which was confirmed visually and by the standard "click-sound" by the field clinical specialist and proctor.The surgeon mentioned that the pump was rotated so that the outflow graft was standing more on top of the heart.No lvas alarms occurred during the event.

Manufacturer Narrative

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

Event Description

It was reported that the pump did not rotate more easily than expected and that the rest of the implant procedure was uneventful.

Manufacturer Narrative

Manufacturer's investigation conclusion: a specific cause for the reported apical cuff blood leak could not conclusively be determined through this evaluation; however, the account indicated that pump malposition was related to the surgeon¿s actions.It was reported that the surgeon noted bleeding from the posterior part of the heart.After "re-adapting" the pump to the apical cuff, bleeding stopped but the surgeon mentioned a rotation of the pump.During implant, the slide lock mechanism was well adapted confirmed visually and by standard "click-sound" by fcs and proctor.The pump did not rotate easier than expected, and the case was uneventful with no adverse events.There were no alarms, just bleeding behind the heart.The patient remains ongoing on heartmate 3 left ventricular assist system (lvas), serial number: (b)(6).No product is available for investigation.The relevant sections of the device history records for (b)(6) was reviewed and showed no deviations from manufacturing or quality assurance specifications.The lvas kit shipped on 10sep2021.The heartmate 3 lvas instructions for use (ifu) is currently available.Section 1 ¿introduction¿ of this document lists bleeding as an adverse event that may be associated with the use of the heartmate 3 lvas.This document also provides information regarding anticoagulation, including recommended inr values, and the suggested anticoagulation modifications in the event that there is a risk of bleeding.Section 5 ¿surgical procedures¿ (under ¿preparing the ventricular apex site¿) contains information regarding the preparation of the ventricular apex site, including how to affix the apical cuff to the left ventricle.This section cautions that after the apical cuff has been sewn to the heart, the metal ring on the apical cuff should extend above the felt surface to allow proper engagement and locking with the slide lock of the heartmate 3 lvad.Ensure that apposition between the myocardial tissue and the cuff felt is continuous and sufficiently forceful to prevent bleeding.No further information was provided.The manufacturer is closing the file on this event.

Manufacturer Narrative

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 (ASSISST) 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: 12971076
• MDR Text Key: 285537743
• Report Number: 2916596-2021-07055
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: P160054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Notification
• Type of Report: Initial,Followup,Followup
• Report Date: 04/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/13/2023
• Device Model Number: 106524INT
• Device Lot Number: 8094121
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/19/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/13/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: FA-Q124-HF-2
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 53 YR
• Patient Sex: Male
• Patient Weight: 98 KG