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

Model Number 106524

Device Problems Obstruction of Flow (2423); Material Twisted/Bent (2981)

Patient Problems Dyspnea (1816); Obstruction/Occlusion (2422)

Event Date 10/12/2021

Event Type  Injury  

Manufacturer Narrative

Patient weight was requested but not provided.No further information was provided.A supplemental report will be submitted once the manufacturer's investigation is complete.

Event Description

It was reported that the patient was seen in clinic and found to have increased shortness of breath.The patient underwent a right heart catheterization which showed normal right sided filling pressures with an elevated pulmonary wedge pressure (pwp).The speed was increased but was but was not able to capture the aortic valve.A computed tomography (ct) scan was ordered and the patient was found to have an outflow graft twist/obstruction at the base.On (b)(6) 2021 the patient was taken to operating room (or) and the outflow graft was found to be twisted 180 degrees.It was untwisted and a heartmate 3 clip was placed.

Manufacturer Narrative

Manufacturer's investigation conclusion: the report of an outflow graft twist could not be confirmed as no images were provided by the account and the device remains in use.A specific cause for the outflow graft distortion could not be conclusively determined through this evaluation.The patient remains ongoing on heartmate (hm) 3 left ventricular assist system (lvas), serial number (b)(6), and no further events have been reported at this time.The relevant sections of the device history records for (b)(6) were reviewed and showed no deviations from manufacturing or quality assurance specifications.The implant kit was shipped on 25oct2017.The heartmate 3 lvas instructions for use (ifu), rev.C and the heartmate 3 patient handbook, rev.C are currently available.Section 5 of the ifu, "surgical procedures", contains information on "preparing the sealed outflow graft" and explains that prior to implantation, the bend relief should be disengaged from the graft for the de-airing procedure.Section 5 also contains a sub-section on "attaching the sealed outflow graft to the aorta", which instructs the user to stretch the graft completely and then measure and cut the sealed outflow graft to the appropriate length.Section 5, under "attaching the sealed outflow graft to the pump", instructs the user to verify that the outflow 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.Section 5, under "de-airing the pump", cautions the user: "do not rotate/twist the sealed graft.Check the alignment of the black line on the graft to verify that the sealed graft is not twisted or kinked." this section also explains how to attach the bend relief once the vent needle has been removed from the sealed outflow graft and leaks have been ruled out.Section 5, under "preimplant procedures" and "implant procedures" cautions the user: "the sealed outflow graft must not be kinked or positioned where it could abrade against a pump component or body structure" and "stretch the sealed outflow graft completely prior to measuring and cutting the graft to the appropriate length." additionally, section 5 includes instructions for installing the outflow graft clip, and states to attach the outflow graft clip to prevent post-operative outflow graft twisting.This section further warns that failure to install the outflow graft clip so that it is flush with the bend relief can allow graft twisting or abrasion which may lead to serious adverse events such as bleeding, graft occlusion, thrombosis, and/or death.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.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.

Event Description

It was reported that the outflow graft revision was successful.

• Brand Name: HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM
• 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: 12790795
• MDR Text Key: 280690142
• Report Number: 2916596-2021-06068
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024013297
• UDI-Public: 00813024013297
• 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: Health Professional,Company Representative
• Reporter Occupation: Nurse
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 02/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/31/2020
• Device Model Number: 106524
• Device Catalogue Number: 106524US
• Device Lot Number: 6112854
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/08/2017
• 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-Q118-MCS-1
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 79 YR
• Patient Sex: Male
• Patient Weight: 118 KG