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

Model Number 106015

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

Patient Problems Pleural Effusion (2010); Tachycardia (2095); Heart Failure/Congestive Heart Failure (4446); Aortic Valve Insufficiency/ Regurgitation (4450)

Event Date 06/08/2016

Event Type  Injury  

Manufacturer Narrative

Specific patient information and device serial number are documented as unknown.Device was implanted at time of event.Author information: masaru hatano, et al.Journal of cardiology 80 (2022) 110¿115.Department of cardiovascular medicine, the university of tokyo hospital, tokyo, japan, department of advanced medical center for heart failure, the university of tokyo hospital, tokyo, japan, department of computational diagnostic radiology and preventive medicine, the university of tokyo, tokyo, japan, department of therapeutic strategy for heart failure, the university of tokyo, tokyo, japan, department of cardiac surgery, the university of tokyo hospital, tokyo, japan.No further information was provided.A supplemental report will be submitted once the manufacturer's investigation is complete.

Event Description

The event date is unknown and has been entered as the date the article was reviewed.It was reported through the case study "late-onset right ventricular failure after continuous-flow left ventricular assist device implantation: case presentation and review of the literature" that heartmate ii may be associated with arrhythmia, right heart failure, aortic insufficiency, and multisystem organ failure.This case study involved a patient that experienced frequent ventricular tachycardia (vt) 20 months after receiving a heartmate ii implant.The patient's arrhythmia was suppressed with by taking sotalol and bepridil daily.The patient was later hospitalized after 24 months of left ventricular assist device (lvad) support due to right heart failure (rhf).A chest radiography showed a large right pleural effusion and moderate aortic insufficiency that was not observed pre-implant.A right heart catheterization (rhc) was performed that revealed right arterial and right ventricular pressures were equal, which indicated severe rhf.Milrinone and tolvaptan were administered, sotalol was discontinued and carvedilol administration was reduced.A subsequent rhc revealed an improvement in the patient's rhf, and a subsequent chest radiography showed no pleural effusion.An aortic valve patch closure and a transcatheter aortic valve replacement (tvr) were performed.Although inotropes could not be discontinued following the operation, the patient was able to undergo a heart transplant after 30 months of lvad support.

Manufacturer Narrative

The patient's arrhythmia was first reported under mfr #: 2916596-2017-01633.Manufacturer's investigation conclusion: a direct correlation between the heartmate ii left ventricular assist system (lvas) and the reported adverse events could not be determined through this evaluation.The patient remained ongoing on heartmate ii lvas, serial number (b)(6), until they underwent a routine heart transplant on (b)(6) 2017.The relevant sections of the device history records for (b)(6) were reviewed and showed no deviations from manufacturing or quality assurance specifications.The pump shipped on (b)(6) 2014.The heartmate ii lvas instructions for use (ifu) (rev.B) and the heartmate ii lvas patient handbook (rev.D) are currently available.Section 1 of the ifu, ¿introduction¿, lists right heart failure and cardiac arrhythmia as adverse events that may be associated with the use of the heartmate 3 left ventricular assist system.This document states that moderate to severe aortic insufficiency must be corrected at the time of device implant.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: bob fryc ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528204
• MDR Report Key: 14939240
• MDR Text Key: 295398273
• Report Number: 2916596-2022-11848
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024011224
• UDI-Public: 813024011224
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P060040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Literature
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 09/21/2022

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?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/30/2016
• Device Model Number: 106015
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/15/2022
• Initial Date FDA Received: 07/06/2022
• Supplement Dates Manufacturer Received: 09/20/2022
• Supplement Dates FDA Received: 09/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2014
• 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): Required Intervention; Life Threatening; Hospitalization
• Patient Age: 32 YR
• Patient Sex: Male
• Patient Weight: 40 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian