MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE II LVAS IMPLANT KIT (WITH SEALED GRAFTS); VENTRICULAR (ASSISST) BYPASS

Model Number 106015

Device Problems Mechanical Problem (1384); Decreased Pump Speed (1500); Pumping Stopped (1503); High Readings (2459); Communication or Transmission Problem (2896); Infusion or Flow Problem (2964)

Patient Problems Syncope (1610); Dizziness (2194); Presyncope (4410)

Event Date 10/26/2020

Event Type  Injury  

Manufacturer Narrative

Previous driveline damage reported in: mfr 2916596-2020-05479.No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.

Event Description

It was reported that the patient called the site around 0500 and reported a constant beeping from their controller due to "driveline fault alarms." the patient was admitted to the ed.The patient reported feeling dizzy and light-headed.It was reported that the driveline was patched with tape and bandages and was also kinked pretty harshly in several areas.Upon interrogation, flow and power spikes were noted in the double digits that started around the same time as the controller alarms.A log file review was performed which confirmed the reported of a driveline fault alarms as well as power and flow elevations in the morning.Images were taken of the driveline, the patient had a driveline repair on (b)(6) 2020.The cause of the elevated flow and powers was noted to be unknown and did not resolve.It was reported that the patient was placed on an ungrounded cable on (b)(6) 2020 as there was a pump off and low speed advisory alarm that caused concern for a short to shield.It was reported that the patient continued to have driveline faults post driveline repair which indicates that the damage is internal on the driveline.It was reported that the patient was switched to an ungrounded cable and discharged on (b)(6) 2020 with the ungrounded cable.The patient was noted to be stable.No further information was provided.

Manufacturer Narrative

Incidental findings: visual inspection of the driveline revealed a slit, as well as multiple tears, in the silastic sleeve underneath rescue tape repairs, approximately 0.25¿, 2.5¿, and in-between 11.5¿-15.0¿ from the metal connector.Manufacturer's investigation conclusion: pump stop, low speed, and driveline fault events were confirmed via the submitted log file data.The patient reported driveline fault alarms and was admitted to the emergency department.The patient was in stable condition upon arrival, but stated they¿ve been feeling more dizzy/lightheaded than normal.The patient¿s driveline was noted to have extensive rescue taping, as well as several areas of kinking.The patient underwent a system controller exchange on 26oct2020 and later incurred numerous low speed/pump stop events while supported with the power module.The alarms resolved upon connection to battery power.A distal end driveline repair was performed by an abbott technical services representative on 29oct2020.The approximately 18.0" segment of driveline replaced by technical services was returned for evaluation.Electrical continuity testing did not reveal any discontinuities or shorts.Visual inspection of the wires did not reveal any breaches or areas of concern.The driveline was submerged in a saline bath for hipot testing to check for current leakage through each wire's insulation.The test did not reveal any insulation breaches that would have contributed to an electrical short.The driveline was connected to and operated on a mock circulatory loop and the driveline fault alarm was not able to be reproduced.The relevant sections of the device history records were reviewed and showed no deviations from manufacturing or quality assurance specifications.The implant kit was shipped on 03oct2016.The heartmate ii left ventricular assist system instructions for use discusses damage due to wear and fatigue of the driveline and includes driveline care instructions.The heartmate ii left ventricular assist system patient handbook also contains information on caring for the driveline.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 (ASSISST) BYPASS
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• MDR Report Key: 10809342
• MDR Text Key: 215295289
• Report Number: 2916596-2020-05430
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024011224
• UDI-Public: 00813024011224
• Combination Product (y/n): N
• PMA/PMN Number: P060040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 04/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/30/2019
• Device Model Number: 106015
• Device Catalogue Number: 106015
• Device Lot Number: 5670205
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 61 YR
• Patient Weight: 76