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); Pumping Stopped (1503); Low Readings (2460)

Patient Problems Arrhythmia (1721); Bacterial Infection (1735); Death (1802); Purulent Discharge (1812); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); No Consequences Or Impact To Patient (2199); Heart Failure (2206); Blood Loss (2597); Heart Failure/Congestive Heart Failure (4446)

Event Date 10/07/2020

Event Type  Death  

Manufacturer Narrative

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 had low speed advisories as well as pump off alarms while connected to the mpu.No alarms noted on batteries.Concern for short to shield.X-rays were provided which were unremarkable.A driveline repair was performed on (b)(6) 2020.The driveline was sent in for analysis which found no issues with the driveline.A log file review sent in on 12oct2020 found low speed operations and pump stops while connected to the power module.It appeared that the driveline repair performed did not remove the section that was causing issues.This indicates that the section of the driveline is internal.The patient was still on the grounded cable, still hospitalized.Plan of care was to determine pump decommission vs.Pump exchange.It was reported that the patient had left ventricle recovery so discussions on vad decommission were being made.The plan of care was to continue to follow the patient.

Event Description

It was reported that the patient had a confirmed mssa (methicillin-susceptible staphylococcus aureus) bacteremia.The patient had a cta (computed tomography angiography) concerning for fluid collection surrounding the pump.On (b)(6) 2020 the patient's tee (transesophageal echocardiogram) with mobile echo density attached to lvad cannula, no echo densities were associated with the icd (internal cardiac defibrillator) leads.Although there was no definite vegetation on the icd, it was felt that there was a secondary infection of the icd.It was noted that the driveline exit site remained clean / dry.The patient had their pump explanted due to left ventricular recovery, the suspected short to shield, and the infection.Due to fevers and elevated wbc (white blood cell count), infectious workup began and found fluid collection surrounding vad (ventricular assist device).It was then determined that due to infection of lvad hardware, that patient would need to undergo explant of all implanted hardware.This was a high risk procedure but the only possible chance for infectious recovery.Her vad and icd were removed on (b)(6) 2020.The operating room course was complicated by significant bleeding, multiple episodes of vf (ventricular failure) and biventricular failure requiring central va ecmo (veno-arterial extracorporeal membrane oxygenation) with lv (left ventricle) venting and open chest.Echo continued to demonstrate biventricular failure and she had minimal pulsatility.On (b)(6) 2020, she developed dysrhythmias and had further loss of pulsatility, and had bedside washout of chest.The patient was transitioned to comfort care on (b)(6) 2020 where the patient passed away on that day.It was noted that the patient had an infection of their lvad hardware which ultimately lead to their death.It was also noted that the device did not operated as expected as the patient had pump stops due to a suspected internal driveline fracture which caused phase to phase shorts.No additional 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

It was reported that the patient had their pump explanted on (b)(6) 2020.The patient had a history of left ventricle recovery and a suspected internal dl fracture.The patient was placed on ecmo (extracorporeal membrane oxygenation) and reported to not be doing great, it was noted that the patient had a very difficult surgery.It was noted that the patient had puss all around their pump and outflow graft.No further information was provided.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported pump stop and low speed events were confirmed via the submitted log file data.A direct correlation between (b)(6) and the reported events (infection, bleeding, cardiac arrhythmia, right heart failure, patient condition, and patient expiration) cannot be conclusively determined.The account communicated that the patient incurred low speed and pump stop events while they were supported with the mobile power unit.The patient was sent for x-ray imaging of their driveline, and a distal end driveline repair was performed by an abbott technical services representative on 09oct2020.The approximately 18.75" 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 submitted log files contained overlapping data spanning from (b)(6) 2020 at 18:06:19 to (b)(6) 2020 at 09:33:20, per the timestamps.A pump stop event was captured on (b)(6) 2020, beginning at 04:44:11, while the system was supported with the mobile power unit.Low speed events were also captured on (b)(6) 2020 from 04:44:29 to 04:44:40, as well as 08oct2020 from 00:13:06 to 02:46:29, while the system was supported with the mobile power unit.Following the distal end driveline repair on (b)(6) 2020, an additional pump stop event was captured on (b)(6) 2020, beginning at 07:05:36, while the system was supported with the power module.Based on our complaint history and similarly reported events, the data captured in the log file is consistent with potential wire compromise within the patient¿s driveline; however, a specific cause for the pump stop and low speed events cannot be conclusively determined through the evaluation of the returned portion of driveline.Following the external driveline repair, the center began discussions regarding ventricular assist device (vad) decommissioning as the patient¿s left ventricle showed signs of recovery.During the decommissioning discussions, the patient was noted to have fevers and an elevated white blood cell count.An infectious diseases workup was conducted and revealed methicillin-sensitive staphylococcus aureus (mssa) bacteremia.A computed tomography angiography (cta) scan was performed and was concerning for fluid collection around the vad.A transesophageal echocardiogram (tee) was performed on (b)(6) 2020 and revealed a mobile echodensity attached to the vad cannula.There were no echodensities associated with the patient¿s implantable cardioverter defibrillator (icd) leads.Although there was no definite vegetation on icd, the infectious diseases department felt that there was a secondary infection of icd.The driveline exit site was noted to be clean/dry.Due these findings, the center determined that all of the implanted hardware would need to be explanted.It was a high-risk procedure, but the only possible chance for infectious recovery, per the account.(b)(6) and the patient¿s icd were removed on (b)(6) 2020.The operating room course was complicated by significant bleeding, multiple episodes of ventricular fibrillation, and biventricular failure requiring central venoarterial extracorporeal membrane oxygenation (va ecmo) with left ventricular venting and an open chest.Echocardiograms continued to demonstrate biventricular failure and the patient had minimal pulsatility.On (b)(6) 2020, the patient developed dysrhythmias, had further loss of pulsatility, and had a bedside washout of their chest.The patient transitioned to comfort care on (b)(6) 2020, where they ultimately expired.The account communicated that (b)(6) would not be returned for evaluation.Incidental findings: visual inspection of the driveline in its returned state revealed rescue taping in-between approximately 4.75-5.5¿ from the controller connector.The rescue taping was removed and revealed a tear in the silastic sleeve approximately 5.125¿ from the controller connector.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 10nov2016.The heartmate ii left ventricular assist system instructions for use lists bleeding, infection, cardiac arrhythmia, right heart failure, and death as adverse events that may be associated with the use of the heartmate ii left ventricular assist system.The instructions for use cautions: ¿right heart failure can occur following implantation of the pump.Right ventricular dysfunction, especially when combined with elevated pulmonary vascular resistance, may limit the effectiveness of the left ventricular assist system due to reduced filling of the pump.¿ information regarding how to prevent infection is also provided in the instructions for use.This document 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.The heartmate ii left ventricular assist system patient handbook contains information on caring for the driveline and provides information regarding how to prevent infection.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: 10726949
• MDR Text Key: 212757329
• Report Number: 2916596-2020-05120
• 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,Followup
• Report Date: 08/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2019
• Device Model Number: 106015
• Device Catalogue Number: 106015
• Device Lot Number: 5726610
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/08/2020
• Initial Date FDA Received: 10/23/2020
• Supplement Dates Manufacturer Received: 11/06/2020; 11/24/2020; 08/11/2021
• Supplement Dates FDA Received: 11/18/2020; 12/03/2020; 08/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization; Required Intervention
• Patient Age: 58 YR
• Patient Weight: 54