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); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Gastrointestinal Hemorrhage (4476)

Event Date 03/04/2024

Event Type  Injury  

Event Description

It was reported that the patient was admitted for a gastrointestinal (gi) bleed confirmed by lab testing.The patient had a history of coagulopathy and had a stent in the outflow graft last year (cs-193357).The patient had 199 driveline fault alarms.The event log files captured multiple driveline fault alarms.It was noted that the year on the system controller was wrong.A system controller exchange was performed.The new system controller was tested with 25 intentional power cable disconnects and no driveline fault alarms occurred over the span of the event log files.The patient had 28 driveline faults overnight on the new system controller.A driveline x-ray was scheduled.It was recommended to keep the patient on batteries or an unshielded patient cable in case there was possible conductor or wire damage in the driveline.

Manufacturer Narrative

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

Event Description

It was additionally reported that additional event log files captured more driveline fault alarms.The phase a issue persisted.Due to the patient's medical history, it was determined that they were not a pump exchange candidate.The driveline was not fixed or spliced.The plan of care was to check the driveline issues monthly.Related mfr #: (b)(4).Captures stent in the outflow graft.

Manufacturer Narrative

Manufacturer's investigation conclusion: a direct correlation between heartmate ii left ventricular assist system (lvas), serial number (b)(6) and the reported event of gastrointestinal bleeding could not be conclusively established through this evaluation.Review of the submitted log files confirmed silenced driveline fault alarms.Based on previous experienced with the heartmate ii lvas and similar reported events, these events could be indicative of an issue with the driveline.The submitted log files collectively contained events from 27feb2024 through 14mar2024.Several silenced driveline fault alarms were captured.No other notable alarms or events were captured.The pump appeared to function as intended at the fixed speed.The patient remains ongoing on heartmate ii lvas, serial number (b)(6) with no further complaints reported at this time.The relevant sections of the device history records for (b)(6) and the driveline, serial number (b)(6) were reviewed and showed no deviations from manufacturing or quality assurance specifications.The heartmate ii left ventricular assist system (lvas) instructions for use (ifu) rev.C, and the heartmate ii lvas patient handbook rev.C are currently available.Section 1 of the ifu, ¿introduction¿, lists potential adverse events that may be associated with the use of the heartmate ii lvas, including bleeding.Section 6 of the ifu, ¿patient care and management¿ provides information regarding anticoagulation, including the recommended inr (international normalized ratio) values.This section also discusses damage due to wear and fatigue of the driveline.This section also contains information on ¿caring for the driveline¿ (under ¿ongoing system assessment and care¿) and provides possible indications of driveline damage as well as how to respond to such events.This section also instructs to check the driveline daily for signs of damage, such as cuts, holes, or tears.Section 8 ¿equipment storage and care¿ also contains information on ¿care of the driveline,¿ and provides possible indications of driveline damage.Section 7 of the ifu, "alarms and troubleshooting" outlines system controller alarms as well as how to respond to each alarm condition.The patient handbook contains a section on ¿caring for the driveline¿; however, all heartmate ii lvad drivelines have the potential for wire/shield breakdown to occur dependent upon length of use and patient handling.Section 4 of the handbook, ¿living with the heartmate ii¿ contains information on caring for the driveline.Section 5 of the handbook, "alarms and troubleshooting" outlines system controller alarms as well as how to respond to each alarm condition.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: 18861610
• MDR Text Key: 337161919
• Report Number: 2916596-2024-01466
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/31/2016
• 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: 04/23/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2013
• 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): Hospitalization; Required Intervention; Life Threatening
• Patient Age: 54 YR
• Patient Sex: Male
• Patient Weight: 145 KG