MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE II LVAS IMPLANT KIT (WITH SEALED GRAFTS); VENTRICULAR (ASSIST) BYPASS

Model Number 106015

Device Problems Mechanical Problem (1384); Pumping Stopped (1503); Infusion or Flow Problem (2964); Material Twisted/Bent (2981)

Patient Problems Dyspnea (1816); Dizziness (2194)

Event Date 02/04/2024

Event Type  Injury  

Event Description

It was reported that the patient had exertional dizziness/dyspnea starting on (b)(6) 2024 and presented on (b)(6) 2024 with low flow alarms with new orthopnea.Lactate dehydrogenase (ldh) was 271 and international normalised ratio (inr) was 2.6 and had been therapeutic.The system controller history showed a couple of pulsatility index (pi) events with lower than normal flow (3s) in the evening on (b)(6) 2024; the flow was consistently mid 2's on (b)(6) 2024.Log files were submitted for review with a concern about decreased flow through the pump.The log file appeared to show a downward trend in the recorded estimated flow and pi values from around (b)(6) 2024; it was noted that the trend did not appear to be equipment related but could have been of clinical significance.There were four low flow alarm events recorded on (b)(6) 2024 which were associated with recorded estimated flow values less than 2.5lpm.Overnight on (b)(6) 2024, the patient had an unexplained pump stop while on the power module.A computed topography (ct) was completed and showed an obstruction of flow through the outflow graft.The patient was taken to the operating room on (b)(6) 2024 for outflow graft revision.The bend relief was cut open revealing a twist section of the outflow graft.Bio-debris was removed.The outflow graft was clamped, cut, untwisted, and sewn back together.No product was replaced or removed.Flows were restored to 5.3 lpm.It was theorized that the twist was present at time of implant.The outflow graft revision resolved the event, and the patient was in recovery and discharge.Log files were submitted for review.The log files captured 7 pump stops and 22 low speed advisories on (b)(6) 2024, (b)(6) 2024, and (b)(6) 2024.These events did not appear to be associated with the manual pump stop that was done on (b)(6) 2024 at 10:41 am or the outflow graft obstruction.The patient did not experience any symptoms during the pump stops and the cause was a suspected short to shield.The patient was placed on an ungrounded cable/batteries only.

Manufacturer Narrative

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

• Brand Name: HEARTMATE II LVAS IMPLANT KIT (WITH SEALED GRAFTS)
• 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: lindsey sallese ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528207
• MDR Report Key: 18753184
• MDR Text Key: 335932867
• Report Number: 2916596-2024-00867
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P060040
• 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
• Report Date: 02/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 106015
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/06/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 51 YR
• Patient Sex: Male
• Patient Weight: 61 KG