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

Model Number 106524INT

Device Problems Low Readings (2460); Infusion or Flow Problem (2964); Material Twisted/Bent (2981)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/20/2020

Event Type  Injury  

Manufacturer Narrative

(b)(6).No further information was provided.A supplemental report will be submitted when the manufacturer's investigation is completed.

Event Description

It was reported that the patient came to the hospital on (b)(6) 2020 for routine outpatient management.The ventricular assist device (vad) coordinator recognized a reduced flow.The patient's mean arterial pressure was elevated to a mean of 140 mmhg.A transthoracic echocardiogram (tte) was performed.Low flow alarms appeared when the patient was lying down.The tte showed no pulsatile flow in the outflow graft and a poor unloading of the left ventricle.A computed tomography angiography (cta) was performed which showed a twist in the outflow graft.The patient returned to the operating room on (b)(6) 2020.The graft was untwisted during the procedure and an outflow graft clip was implanted.Ct scans were provided for analysis.The patient's outflow graft (ofg) was exchanged and fixed with an ofg clip.The patient was stable and asymptomatic following this procedure.All of the patient's pump values were in a normal range.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported outflow graft twist could not be confirmed via the submitted photos.A specific cause could not conclusively be determined through this evaluation.The submitted photos show ct scan images of the outflow graft.The submitted ct images could not confirm the reported outflow graft twist.The patient remains ongoing on heartmate 3 lvas, serial number (b)(6).No product is available for investigation.The relevant sections of device history records for (b)(6) were reviewed and showed no deviations from manufacturing or quality assurance specifications.The pump was shipped on 09jun2017.The heartmate 3 lvas ifu contains information regarding the preparation of the sealed outflow graft.This document instructs the user to verify that the graft is not twisted or kinked by checking the position of the black line on the graft above and below the bend relief and ensuring that the line is straight.When de-airing is completed, slide the bend relief over the metal fitting of the sealed outflow graft toward the locking screw ring.Failure to connect the bend relief so that it is fully and evenly connected can allow kinking and abrasion of the graft, which may to serious adverse events.Additionally, the heartmate 3 left ventricular assist system (lvas) instructions for use (ifu) explains that the low flow hazard alarm will be triggered when pump flow is less than 2.5 liters per minute (lpm) and notes that changes in patient conditions can result in low flow.This ifu also describes all system alarms and the recommended actions associated with them.The heartmate 3 lvas ifu contains information on preparing the sealed outflow graft and cautions the user not to rotate/twist the graft.The ifu instructs the user to verify that the graft is not twisted or kinked by checking the position of the black line on the graft above and below the bend relief and ensuring that the line is straight.No further information was provided.The manufacturer is closing 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
• MDR Report Key: 10801976
• MDR Text Key: 215078068
• Report Number: 2916596-2020-05308
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• PMA/PMN Number: P160054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 06/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2020
• Device Model Number: 106524INT
• Device Lot Number: 6020000
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: FA-Q118-MCS-1
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention