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); Decreased Pump Speed (1500); Pumping Stopped (1503)

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

Event Date 02/21/2024

Event Type  malfunction  

Manufacturer Narrative

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 had a suspected short to shield.The event log files captured 2 pump stops and 64 low speed advisory events.Speed drops were as low as 0 rotations per minute (rpm).These issues occurred while the patient was tethered to the mobile power unit (mpu).There was no visible damage to the external portion of the driveline.The patient had no recent weight loss or gain.The patient was asymptomatic at the time of the events.The patient also noted that they could not recall any specific movements that caused the alarms.X-rays were performed and were unremarkable.An external driveline revision was performed.No further alarms occurred.The system controller was exchanged due to the percutaneous lead changeover.Related manufacturer reference number: 2916596-2024-01259 (system controller pcx-19615).

Manufacturer Narrative

D9/h3 - a section of the percutaneous lead returned for evaluation.Incidental findings: visual inspection of the driveline in its returned state revealed a partial circumferential slit in the outer jacket approximately 0.25¿ from the controller connector.Manufacturer's investigation conclusion: the reported pump stop and low speed events while the patient was supported with the mobile power unit (mpu) were confirmed via the submitted system controller log files.A distal end driveline repair was performed by an abbott technical services representative on 22feb2024.The approximately 19" segment of driveline replaced by technical services was returned for evaluation, with the outer jacket, bionate, and metal-braided shielding removed approximately 14.5¿ from the controller connector.¿continuity testing was performed, and all the wires were found to be electrically intact.No shorts or discontinuities were found during electrical continuity testing.Upon disassembly, visual inspection of the underlying wires did not reveal any insulation breaches.The driveline was then submerged in a saline bath for high potential testing to check for current leakage through each wire's insulation, and a cut in the insulation of the yellow wire approximately 0.25¿ from the location where the outer jacket, bionate, and metal-braided shielding had been removed for the repair.The conductors of the yellow wire were exposed; however, they appeared clean and shiny.Additionally, no physical evidence of an electrical short was observed at the location of the breach.Due to the appearance and location of the observed cut, the yellow wire breach could not be conclusively correlated to the low speed/pump stop events recorded on the submitted log files.The patient remains ongoing on (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 heartmate ii left ventricular assist system instructions for use is currently available and discusses damage due to wear and fatigue of the driveline and includes driveline care instructions.All heartmate ii left ventricular assist device drivelines have the potential for wire/shield breakdown to occur depending upon the length of use and movement/flexing over time.Information that covers visual/audio alarms and what action(s) should be performed when they occur is also provided in this document.The heartmate ii left ventricular assist system patient handbook is currently available and contains information on caring for the driveline.Information that covers visual/audio alarms and what action(s) should be performed when they occur is also provided in this document.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: lindsey sallese ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528207
• MDR Report Key: 18791932
• MDR Text Key: 337442596
• Report Number: 2916596-2024-01230
• 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: 02/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/31/2019
• Device Model Number: 106015
• Device Lot Number: 5896361
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/21/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/07/2017
• 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
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Weight: 73 KG