MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE; VENTRICULAR (ASSISST) BYPASS

Model Number 105306

Device Problems Circuit Failure (1089); Naturally Worn (2988)

Patient Problems Complaint, Ill-Defined (2331); No Known Impact Or Consequence To Patient (2692)

Event Date 07/09/2019

Event Type  Injury  

Manufacturer Narrative

Approximate age of device- 7 years, 4 months.No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.

Event Description

The patient was implanted with a left ventricular assist device (lvad) on (b)(6) 2012.It was reported that the patient experienced multiple driveline fault alarms.Upon analysis of the log the driveline fault alarm was believed to be true.Tech services requested x-rays of the percutaneous lead.The patient underwent a percutaneous lead repair.The morning after the percutaneous lead repair the patient still had ongoing driveline fault alarms but no other alarms.Log file analysis confirmed the intermittent driveline fault alarms.There were no other alarms noted post percutaneous lead repair.Driveline data showed that the percutaneous lead repair was not able to resolve the driveline fault issue.Log file analysis from (b)(6) 2019 showed no unusual events and the equipment was reportedly operating as intended.Technical services stated that a conductor is likely fractured and if the redundant conductor fractures the pump will stop and may not restart.Additional log files from (b)(6) 2019 to (b)(6) 2019 showed multiple alarms due to driveline faults.The wire being monitored appears to have degraded further as compared to the (b)(6) 2019 log file.No further information was provided.

Manufacturer Narrative

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

Event Description

Additional information: the patient underwent a pump exchange on (b)(6) 2019.The reason for the pump exchange was due to driveline fracture.

Event Description

Additional information: additional log files were sent for analysis on (b)(6) 2019 for the patient's ongoing driveline issue and it was reported that the patient was admitted for a medical issue at this time.Additional information was requested but was not provided.

Event Description

Additional information: manufacturer's technical service representative reviewed the log file and observed persisting driveline fault alarms.Phase c did not appear to have wire redundancy.

Manufacturer Narrative

Section b5: additional information.

Manufacturer Narrative

Manufacturer's investigation conclusion: although multiple yellow wrench advisories associated with driveline faults were confirmed via the submitted log file, the entire portion of the driveline was not returned and a specific cause for the driveline faults could not be confirmed.Additionally, evaluation of heartmate ii lvas, serial number (b)(6), confirmed driveline (dl) wire damage.(b)(6) was returned assembled with the dl cut approximately 12" from the pump housing and the distal portion of the dl was not returned.The inflow conduit (inlet tube, flex section, and inlet elbow), the outflow graft, and the outflow graft bend relief were not returned.The outflow elbow was returned connected to the pumps outlet port.Evaluation of the outflow elbow revealed no evidence of depositions or thrombus formations.Visual examination of the pump¿s blood-contacting surfaces upon disassembly of (b)(6) also revealed no evidence of developed depositions or developed thrombus formations.The disassembled pumps bearings, rotor, and blood-contacting surfaces were examined under a microscope and no anomalies were observed.Electrical continuity testing of the dl did not reveal any discontinuities or shorts.However, hipot and visual examination of the dl revealed a breach to the insulation of the brown wire located approximately 8.75¿ from the pump housing.The observed wire damage appeared to be the result of abrasion against the braided shield due to repetitive flexing.The breach in the brown wire is not consistent with the same phase causing the driveline fault alarms, therefore the observed damage is not related to the alarms.Analysis of the submitted log files also revealed multiple yellow wrench advisories associated with driveline faults which were silenced throughout the entirety of the log file.These driveline faults appeared to result from an issue with phase 3.The other phases did not appear to contribute to the fault.The pump remained above the low-speed limit and appeared to be functioning as intended.The heartmate ii lvas ifu and patient handbook outline indications of driveline wire damage as well as how to respond to such events.These documents also address how to care for the driveline; however, all heartmate ii lvad drivelines have the potential for wire/shield breakdown to occur dependent on duration of use and movement/flexing over time.Additionally, these documents outline all system controller alarms as well as the appropriate actions associated with them.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE
• Type of Device: VENTRICULAR (ASSISST) BYPASS
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 95488
• MDR Report Key: 8842729
• MDR Text Key: 152701328
• Report Number: 2916596-2019-03438
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 01/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2014
• Device Model Number: 105306
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 86 YR
• Patient Weight: 82