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

Model Number 106524

Device Problems Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)

Patient Problem Unspecified Infection (1930)

Event Date 05/01/2021

Event Type  Injury  

Event Description

The date of the event is approximate as the data was collected between (b)(6) 2018 and (b)(6) 2021.It was reported through the research article ¿novel plug device for heartmate 3 explantation: first multicenter experience¿ that heartmate 3 (hm3) may be associated with infection and suction events.This retrospective study followed patients who had their hm3 explanted between (b)(6) 2018 and (b)(6) 2021.Several patients had complications while on left ventricular assist device (lvad) support prior to their explant.One of these patients was a 73-year-old man that had a previous lvad-related infection.After 22 months of hm3 support, the patient experienced suction events.A right heart catheterization (rhc) and echocardiography were performed.The patient underwent a device explant and was implanted with a novel apical ring plug for myocardial recovery.

Manufacturer Narrative

Specific patient information and device serial number are documented as unknown.Device was implanted at time of event.Author information: mariani, silvia from the department of cardiothoracic, transplantation and vascular surgery, hannover medical school, hannover, germany., department of cardio-thoracic surgery, heart and vascular centre, maastricht university medical centre (mumc+), maastricht, netherlands.No further information was provided.A supplemental report will be submitted once the manufacturer's investigation is complete.

Manufacturer Narrative

Section a: hospital privacy policy prohibited the identification of the patient.Section b3: event date was estimated.Manufacturer's investigation conclusion: a direct correlation between the heartmate 3 lvas and the reported infection and suction events could not be determined through this evaluation.The heartmate 3 lvas instructions for use (ifu) (rev.G) and the heartmate 3 lvas patient handbook (rev.G) are currently available.Section 1 of the ifu, ¿introduction¿, lists infection, as an adverse event that may be associated with the use of the heartmate 3 left ventricular assist system.Care instructions in reference to preventing infection are provided throughout this ifu, including sections titled "caring for the driveline exit site" and "controlling infection." section 4 explains that pi events are assumed by the system during cases when there are sudden and substantial changes in the pulsatility index.These events are also referred to as pi events and may be initiated for reasons other than true pi events.Some reasons include sudden changes in a patient¿s volume status, arrhythmias, sudden changes in power, and sudden changes in pump speed.There are no audible alarms with a pi event.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM
• 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: 15075415
• MDR Text Key: 296312246
• Report Number: 2916596-2022-12334
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024013297
• UDI-Public: 813024013297
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P160054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 10/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 106524
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/25/2022
• 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): Life Threatening; Required Intervention
• Patient Age: 73 YR
• Patient Sex: Male