MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE 3 LVAS IMPLANT KIT; VENTRICULAR (ASSISST) BYPASS

Model Number 106524INT

Device Problems Infusion or Flow Problem (2964); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Right Ventricular Dysfunction (2054); Low Cardiac Output (2501)

Event Date 03/29/2020

Event Type  Injury  

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 called a vad-coordinator on (b)(6) 2020 due to intermittent but regular low flow alarms since (b)(6) 2020.The patient also reported worsening from a general condition.The patient was readmitted on (b)(6) 2020 and an echo showed a small diameter of the left ventricle but a bad right ventricle function.Log files were downloaded and followed in a presumption of an obstruction somewhere in the inflow or outflow cannula.A ct angiography scan was scheduled for the next day.The scan showed a big obstruction/compression of the outflow graft beneath and directly in front of the outflow graft bend relief.A twist was not suspected at this time from the clinic.A re-exploration was completed on (b)(6) 2020.The surgeon prepared the old outflow graft over the entire length and during the preparation they noticed a hardened adhesion of very fatty tissue knots directly in front of the bend relief.The surgeon then opened the outflow graft bend relief with a pair of scissors.Beneath the bend relief was a small amount of jelly tissue was found but it did not explain the drop in flop.A twist was also excluded.The surgeon decided to change the whole outflow graft and installed an outflow graft clip.They checked the old graft for thrombus formation inside, but was also excluded.Flow began to increase to normal values.Hemodynamic was still restricted because of the bad right ventricle function.Cannulas were switched to an extracorporeal membrane oxygenation (ecmo) circulation device to relieve the right ventricle from higher volume load.Medical treatment via catecholamine therapy, volume therapy, volume substitution and transfer to the icu.An issue with the old outflow graft was excluded and the old one was disposed of.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported outflow graft obstruction could not be conclusively determined through the evaluation of the images provided by the account and the outflow graft was not available for investigation as it was disposed of.The controller event log file contained data spanning from 29mar2020 at 23:48:38 to 30mar2020 at 09:34:00, per the timestamp.Numerous low flow events were captured throughout the log file, beginning on (b)(6) 2020 at 23:48:38, due to the estimated flow being calculated below the threshold of 2.5lpm.A total of 17 low flow events persisted for 10 seconds or more, activating low flow alarms.No other notable alarms were recorded and the system appeared to have been operating as intended.The patient reported experiencing intermittent but regular low flow alarms since (b)(6)2020, as well as a worsening general condition.The patient was admitted on (b)(6) 2020 and an echocardiogram performed revealed a small left ventricle diameter and poor right ventricle function.A ct angiogram was performed on (b)(6) 2020 and revealed a big obstruction/compression of the outflow graft directly in front of the outflow graft bend relief.A re-exploration of the outflow graft was performed on (b)(6) 2020.The surgeon prepared the outflow graft over its entire length.During the preparation, the physicians noticed a hardened adhesion and many fatty tissue knots directly in front of the outflow graft bend relief, as seen in the ct scan, which could have contributed to the flow issue.The surgeon opened the outflow graft bend relief with a scissor, which revealed a small amount of "jelly" tissue.The observed tissue, however, did not explain the drop in the flow and an outflow graft twist was also excluded from causes of the decreased flow state.The surgeon ultimately decided to change the entire outflow graft and installed an outflow graft clip.The exchanged outflow graft was inspected for thrombus formations, but none were identified.Following the outflow graft exchange, flow was increased up to normal values.Hemodynamics were still restricted because of bad right ventricle function.Hlm cannulas were switched to an ecmo circulation device to relieve the right ventricle from higher volume load.Medical treatment included catecholamine therapy, volume substitution, and transfer to the icu.An issue with the exchanged outflow graft was excluded.The exchanged outflow graft was disposed.The patient remains ongoing on heartmate 3 lvas and no further events have been reported at this time.The heartmate 3 lvas ifu contains information regarding the preparation and attachment of the sealed outflow graft.This document instructs the user to verify that the graft is not twisted or kinked by checking the position of the black line on the graft above and below the bend relief and ensuring that the line is straight.Failure to connect the bend relief so that it is fully and evenly connected can allow kinking and abrasion of the graft, which may to serious adverse events such as low left ventricular assist device flow and/or bleeding.The relevant sections of the device history records were reviewed and showed no deviation from manufacturing or quality assurance specifications.The implant kit shipped on (b)(6) 2017.No further information was provided.The manufacturer is closing the file on this event.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported outflow graft obstruction could not be conclusively determined through the evaluation of the images provided by the account and the outflow graft was not available for investigation as it was disposed of.The controller event log file contained data spanning from 29mar2020 at 23:48:38 to 30mar2020 at 09:34:00, per the timestamp.Numerous low flow events were captured throughout the log file, beginning on 29mar2020 at 23:48:38, due to the estimated flow being calculated below the threshold of 2.5lpm.A total of 17 low flow events persisted for 10 seconds or more, activating low flow alarms.No other notable alarms were recorded and the system appeared to have been operating as intended.The heartmate 3 lvas ifu contains information regarding the preparation and attachment of the sealed outflow graft.This document instructs the user to verify that the graft is not twisted or kinked by checking the position of the black line on the graft above and below the bend relief and ensuring that the line is straight.Failure to connect the bend relief so that it is fully and evenly connected can allow kinking and abrasion of the graft, which may to serious adverse events such as low left ventricular assist device flow and/or bleeding.The relevant sections of the device history records were reviewed and showed no deviation from manufacturing or quality assurance specifications.The implant kit shipped on 30jun2017.The heartmate 3 lvas ifu, rev.G, section 5 entitled ¿surgical procedures¿ contains information regarding the preparation and attachment of the sealed outflow graft.This section instructs the user to verify that the graft is not twisted or kinked by checking the position of the black line on the graft above and below the bend relief and ensuring that the line is straight.This section warns that failure to connect the bend relief so that it is fully and evenly connected can allow kinking and abrasion of the graft, which may to serious adverse events such as low left ventricular assist device flow and/or bleeding.Section 6 warns about static electricity and explains that strong static discharges should be avoided.Section 7 explains all system alarms and the recommended actions associated with them.In addition, the safety testing and classification tables in this document include electrostatic discharge.Heartmate 3 lvas patient handbook, rev.G, is currently available.Section 1 warns not to touch the television or computer screen, and not to vacuum or engage in activities that create static electricity.This section also explains that a strong electric shock can damage electrical parts of the system and cause the pump to stop.Section 5 explains all system alarms and the recommended actions associated with them.Additionally, the safety testing and classification tables in this document include electrostatic discharge.No further information was provided.The manufacturer is closing the file on this event.

Manufacturer Narrative

No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: HEARTMATE 3 LVAS IMPLANT KIT
• Type of Device: VENTRICULAR (ASSISST) 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: 9947673
• MDR Text Key: 187304450
• Report Number: 2916596-2020-01874
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024011712
• UDI-Public: (01)00813024011712(10)6046643(17)200331
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P160054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Notification
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/31/2020
• Device Model Number: 106524INT
• Device Catalogue Number: 106524INT
• Device Lot Number: 6046643
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/09/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/02/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: FA-Q124-HF-1
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention