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); Naturally Worn (2988)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/01/2022

Event Type  malfunction  

Event Description

It was reported that the patient had low speed advisories and pump off alarms on interrogation from (b)(6) 2022.The log files confirmed the pump stop on (b)(6) 2022 at 22:21.This event occurred while on the mobile power unit and there was an elevation in power noted in the log files.The patient presented to the emergency department for nausea/vomitting and was found asymptomatic to the pump stop.The cause of the pump stop/ elevated power was thought to be due to short to shield as the patient's lactate dehydrogenase was normal and the elevated power resolved when the patient was transitioned to an ungrounded cable.

Manufacturer Narrative

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

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported pump-stop events can be confirmed based on the evaluation of the submitted log files.Based on complaint history and similarly reported events, the data captured in the log file is potentially consistent with a damaged wire in the patient¿s driveline, however, a specific cause for the low speed, low flow, and pump stop events cannot be conclusively determined.The submitted log captured a pump-stop event on (b)(6) 2022 at 22:21:31 while the patient was supported by the power module.The log file captured 2 low speed advisories and a power elevation of 9.2 watts during the pump-stop event.The pump speed dropped to as low as 0 rpms.No other atypical events were captured.Multiple attempts were made to obtain additional information from the customer regarding the event; however, no additional information was provided.The patient remains ongoing on heartmate ii (hmii) left ventricular assist system (lvas), serial number (b)(6).No product is available for investigation.The relevant sections of the device history records for (b)(6) was reviewed and showed no deviations from manufacturing or quality assurance specifications.The heartmate ii lvas patient handbook, rev.C, is currently available.Section 4 of this handbook contains information on ¿caring for the driveline.¿ however, all hmii lvad drivelines have the potential for wire/shield breakdown to occur depending upon the length of use and movement/flexing over time.No further information was provided.The manufacturer is closing the file on this event.

• 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: bob fryc ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528204
• MDR Report Key: 15506628
• MDR Text Key: 306267753
• Report Number: 2916596-2022-13596
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024011224
• UDI-Public: 00813024011224
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 10/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/31/2017
• Device Model Number: 106015
• Device Catalogue 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: 10/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/23/2014
• 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 Age: 56 YR
• Patient Sex: Male
• Patient Weight: 82 KG