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

Model Number 106524INT

Device Problems Mechanical Problem (1384); Infusion or Flow Problem (2964)

Patient Problems Septic Shock (2068); Cardiogenic Shock (2262); Thrombosis/Thrombus (4440); Heart Failure/Congestive Heart Failure (4446)

Event Date 08/20/2021

Event Type  Injury  

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 patient had a computed tomography (ct) scan that revealed a thrombus on the outflow graft.On (b)(6) 2021 a surgical procedure to correct the thrombus was performed.The driveline was cut by accident during the surgery.The patient was stable during surgery so the surgical team decided to explant the pump and observe how the patient recovers.Following the driveline cut the patient started to have cardiogenic shock and right ventricular failure.The clinical team decided to implant a biventricular centrimag.

Event Description

The patient had been experiencing incessant low flow alarms prior to the ct scan that had revealed thrombus in the outflow graft.After the driveline had been cut during surgery, the patient was stable with an ejection fraction of 33%, premature ventricular contraction of 14.While waiting for a heart transplant, the patient was unable to recover and subsequently passed away.Related manufacturer's reference number: 3003306248-2021-05720.

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.Heartmate 3 left ventricle assist system (lvas) instructions for use (ifu) is currently available.Section 1, ¿introduction¿, lists device thrombosis as a potential adverse event that may be associated with the use of the heartmate 3 lvas.Section 4, ¿system monitor,¿ explains that the low flow hazard alarm occurs when pump flow is less than 2.5 liters per minute (lpm).A 10-second delay is imposed between the detection of the low flow status and the activation of the associated audio and visual indicators on the system controller.Changes in patient conditions can result in low flow.Section 6, ¿patient care and management,¿ outlines the suggested anticoagulation regimen and international normalized ratio (inr) range that should be maintained for patients using the heartmate 3 lvas as well as the suggested anticoagulation modifications.Section 7 entitled ¿alarms and troubleshooting¿ explains all system alarms and the recommended actions associated with them.Heartmate 3 lvas patient handbook section 5 entitled "alarms and troubleshooting" outlines all system controller alarms as well as how to respond to each alarm condition.The reported suspected thrombus in the outflow graft could not be confirmed through this evaluation.Additionally, review of the submitted log files confirmed low flow alarms; however, the cause of these low flow events could not be conclusively determined.(b)(6) was returned assembled with the pump cable severed approximately 2¿ from the pump housing.The distal portion and the modular cable were not returned.The sealed outflow graft was returned attached to the pump cover outlet port with the outflow graft bend relief secured to the outflow graft attachment.The distal end of the outflow graft was closed with sutures and sewn to the bend relief.The apical cuff was not returned.Examination of the interior of the outflow graft did not reveal any developed depositions or thrombus formations.Upon disassembly of the pump body, examination of the remaining blood-contacting surfaces revealed no depositions or thrombus formations.Visual inspection of the pump rotor and rotor well did not reveal any obvious surface scratches or defects.The submitted and retrieved log files captured low flow alarms starting on 18aug2021.No other atypical events were captured and the device functioning as intended.(b)(6) was cleaned, rebuilt, and functionally tested on a mock circulatory loop.The device operated as intended and in accordance with manufacturing specifications.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: bob fryc ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528204
• MDR Report Key: 12536717
• MDR Text Key: 273540999
• Report Number: 2916596-2021-05025
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/31/2022

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/14/2021
• Device Model Number: 106524INT
• Device Lot Number: 6661793
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/28/2021
• Initial Date FDA Received: 09/27/2021
• Supplement Dates Manufacturer Received: 01/17/2022
• Supplement Dates FDA Received: 02/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/25/2018
• 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): Life Threatening; Hospitalization; Required Intervention
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 95 KG