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

Model Number 106524US

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

Patient Problems Hemolysis (1886); Presyncope (4410); Thrombosis/Thrombus (4440); Lactate Dehydrogenase Increased (4567)

Event Date 06/20/2022

Event Type  Injury  

Event Description

It was reported that one week out from the initial pump implant on (b)(6) 2022, the patient experienced low flow alarms and there was a suspected clot.The patient's urine was dark and there was an increase in lactate dehydrogenase (ldh).A computed tomography (ct) scan was negative for outflow graft kink or twist.There was a pump exchange on (b)(6) 2022.

Manufacturer Narrative

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

Event Description

It was reported that one week out from the initial pump implant on (b)(6) 2022, the patient experienced low flow alarms and there was a suspected clot.The patient's urine was dark and there was an increase in lactate dehydrogenase (ldh).A computed tomography (ct) scan was negative for outflow graft kink or twist.There was a pump exchange on (b)(6) 2022.The patient had episodes of dizziness and lightheadedness when standing.A 3d ct scan of the heart revealed a large thrombus centered in the left coronary sinus.There was a small kink noted on the outflow cannula.There was no significant finding to suggest etiology of the low flows.An echocardiographic (echo) ramp study and the left ventricle decompressed per doctor.There was a pump exchange on (b)(6) 2022 due to the small kink found in the outflow graft.The patient was discharged from the hospital on (b)(6) 2022.

Manufacturer Narrative

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

Manufacturer Narrative

Manufacturer's investigation conclusion: the evaluation of heartmate (hm) 3 left ventricular assist system (lvas), serial number (b)(6), confirmed a kink in the sealed outflow graft; however, a specific cause for the observed outflow graft distortion could not be conclusively determined.The report of low flow alarms could not be confirmed as no log files were provided by the account for review; however, low flow values were observed in the retrieved lvad log files from the returned device.A direct correlation between the outflow graft distortion and the report of low flow alarms could not be conclusively established through this evaluation.Furthermore, the report of a suspected clot could not be confirmed.A direct correlation between (b)(6) and the reported hemolysis as well as a direct correlation between the suspected clot and the reported hemolysis could not be conclusively determined through this evaluation.(b)(6) was returned assembled with the pump cable severed approximately 6¿ from the pump header.The distal portion of the pump cable and the modular cable were not returned.Approximately 6¿ of the sealed outflow graft was returned detached from the pump cover outlet port.The sealed outflow graft bend relief was not returned.The cuff lock had been disengaged prior to the pump¿s return for evaluation and the apical cuff was not returned.Visual inspection of the sealed outflow graft revealed a kink in the graft material approximately 3¿ from the graft hardware.Although no tissue growth was observed in this location, the distortion appeared to be consistent with kink identified in the account¿s submitted images during the explant surgery, indicating that the distortion was present while the pump was supporting the patient.The lumen of the outflow graft revealed no evidence of developed or adhered depositions or thrombus formations.A specific cause for the observed outflow graft distortion and a duration of time for which it was present could not be conclusively determined through this evaluation.Furthermore, the kink did not appear extensive enough to establish a direct correlation between the outflow graft distortion and the reported low flow alarms.Upon disassembly of the returned pump, visual examination of the pump¿s blood-contacting surfaces revealed no evidence of any developed or adhered depositions or thrombus formations within the device that would have contributed to a flow or functional issue.Visual inspection of the pump rotor and rotor well did not reveal any surface scratches or defects.The lvad event and periodic log files retrieved from the returned device captured intermittent low flow values.Despite the decreases in pump flow, the files captured 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.The relevant sections of the device history records for (b)(6) were reviewed and showed no deviations from manufacturing or quality assurance specifications.The heartmate 3 lvas instructions for use (ifu) and the heartmate 3 patient handbook are currently available.Section 1 of the ifu, ¿introduction¿, lists venous thromboembolism, hemolysis, and pump thrombosis, as adverse events that may be associated with the use of the heartmate 3 left ventricular assist system.Section 1 of the ifu also addresses all pump parameters, including pump flow.Section 4, ¿system monitor¿, describes the pump flow display and the hazard alarms.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.Section 4 also explains that changes in patient condition can result in low flow.Section 5 of the ifu, ¿surgical procedures¿, outlines considerations for pump placement and provides instructions regarding the preparation, installation, and orientation of the sealed outflow graft.Section 5, under "attaching the sealed outflow graft to the pump," 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.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." section 6, ¿patient care and management¿, lists thromboembolism as a potential late postimplant complication.Additionally, this section, under ¿anticoagulation¿, provides the recommended anticoagulation regimen, including inr values, as well as suggested anticoagulation modifications.Furthermore, 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.

• Brand Name: HEARTMATE 3 LVAS IMPLANT KIT
• 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: 15059246
• MDR Text Key: 296208742
• Report Number: 2916596-2022-12306
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/31/2022

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: Lay User/Patient
• Device Expiration Date: 03/05/2024
• Device Model Number: 106524US
• Device Catalogue Number: 106524US
• Device Lot Number: 8458962
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/11/2022
• Initial Date FDA Received: 07/19/2022
• Supplement Dates Manufacturer Received: 07/28/2022; 10/28/2022
• Supplement Dates FDA Received: 08/08/2022; 10/31/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/04/2022
• 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): Required Intervention; Hospitalization
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 75 KG