MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE 3 LEFT VENTRICULAR ASSIST DEVICE; VENTRICULAR (ASSIST) BYPASS

Model Number 106524US

Device Problems Infusion or Flow Problem (2964); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hemorrhage/Bleeding (1888); Pleural Effusion (2010); Cardiac Tamponade (2226); Thrombosis/Thrombus (4440)

Event Date 05/13/2022

Event Type  Injury  

Event Description

It was reported that after implant the patient had mediastinal bleeding, diffuse bleeding from all dissected raw surface and apical pump area, diffuse coagulopathy, and tamponade physiology with low flows.All cannulation and anastomotic sites were intact with no active surgical bleed.There were multiple clots in the mediastinum over the outflow graft and apical pump area, as well as pleural effusion in the right atrial gutter.The patient was given blood products.The bleeding resolved on (b)(6) 2022.

Manufacturer Narrative

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

Event Description

Additional information: it was reported that surgery was performed.

Manufacturer Narrative

Manufacturer's investigation conclusion: a direct correlation between heartmate 3 left ventricular assist system (lvas), serial number (b)(6), and the reported events could not be conclusively established through this evaluation.Additionally, the reported low flow alarms could not be confirmed through this evaluation as no log files were submitted for review.A specific cause for the alarms could not be conclusively determined through this evaluation.Multiple attempts were made to obtain additional information from the customer regarding the event; however, no additional information was provided.The patient remains ongoing on heartmate 3 lvas, serial number (b)(6).No product is available for investigation.The relevant sections of the device history records for (b)(6) were reviewed and showed no deviations from manufacturing or quality assurance specification.The heartmate 3 left ventricular assist system (lvas) instructions for use (ifu), rev.C, and the heartmate 3 lvas patient handbook, rev.D, are currently available.Section 1 of the ifu, ¿introduction¿, lists bleeding and pericardial fluid collection as adverse events that may be associated with the use of the heartmate 3 lvas.This section also addresses all pump parameters, including pump flow.Section 4, ¿system monitor¿, describes the pump flow display and the hazard alarms.The ifu states that per design, when the estimated flow value is calculated at less than 2.5 lpm, a low flow status is posted to the log file.If the flow remains below 2.5 lpm for 10 seconds, a low flow hazard alarm is triggered.This section also explains that changes in patient condition can result in low flow.Section 6 of the ifu, ¿patient care and management¿, provides information regarding the recommended anticoagulation regimen and international normalized ratio (inr) values as well as suggested anticoagulation modifications in the event that there is a risk of bleeding.Section 7 of the ifu, "alarms and troubleshooting", and section 5 of the patient handbook, "alarms and troubleshooting", address all system alarm conditions as well as the appropriate actions associated with each condition.Furthermore, section 8 of the patient handbook, ¿handling emergencies¿, also provides examples of emergencies and the proper actions to take in the event an emergency occurs.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: HEARTMATE 3 LEFT VENTRICULAR ASSIST DEVICE
• 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: 14565551
• MDR Text Key: 293083977
• Report Number: 2916596-2022-11371
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024013297
• UDI-Public: 813024013297
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P160054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/15/2024
• Device Model Number: 106524US
• Device Lot Number: 8430321
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/14/2022
• 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): Other; Required Intervention
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Weight: 95 KG