MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM; VENTRICULAR (ASSIST) BYPASS

Model Number 106524

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

Patient Problems Respiratory Failure (2484); Heart Failure/Congestive Heart Failure (4446); Tricuspid Valve Insufficiency/ Regurgitation (4453); Renal Impairment (4499)

Event Date 07/31/2020

Event Type  Death  

Event Description

It was reported through the research article "preimplant hyponatremia does not predict adverse outcomes in patient with left ventricular assist devices." they performed a retrospective study of adult patients who underwent lvad (exclusively heartmate 3 abbott, usa) implantation from august 2015 to july 2020.They obtained the following postoperative outcomes hemodialysis, reintubation, days on mechanical ventilation, intensive care unit (icu) length of stay (los) and hospital los.Long term outcomes collected included heart failure (hf) admission (defined as any hospital admission with hf symptoms/signs requiring intravenous diuretics), mortality, and heart transplantation.From a total of 202 heartmate 3 lvads being followed, they excluded 7 patients; three were implanted at an outside facility and four had lvad exchanges.Postoperatively, patients with preimplant hyponatremia had a prolonged hospital los with 46.4 (+31.6) days vs.36.8 (+21.5) days in the group with normal sodium.We found no significant differences in need for hemodialysis, mechanical ventilation days or icu los.Our study showed similar findings.The 78 (40%) patients with hyponatremia prior to lvad implantation had higher blood urea nitrogen (bun), chromium (cr), and total bilirubin, more patients were intermacs 1 and 2, and used higher doses of loop diuretics.In addition, they had evidence of a larger right ventricle, significant degrees of tricuspid regurgitation (tr) and higher pulmonary artery systolic pressure (pasp) and central venous pressure (cvp), suggesting right ventricular (rv) dysfunction which could lead to hyponatremia by increased vascular renal congestion and subsequent activation of the renin¿angiotensin system (raas).Lastly, the hyponatremic group required more mechanical circulatory support (mcs) and inotropes.

Manufacturer Narrative

Specific patient information and device serial number are documented as unknown.Device was implanted at time of event.Date of event and date of death is approximate as the data were collected between august 2015 and (b)(6) 2020.Antonio duran1,4,* (b)(6)@ochsner.Org, austin tutor2, farnoosh shariati2, amber sleem2, james wever-pinzon1,3, sapna desai1,3, clement eiswirth1,3, hector o.Ventura1,3,4, selim r.Krim1,3,4,1.Division of cardiology, (b)(6) heart and vascular institute, (b)(6) medical center, (b)(6).No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is completed.

Event Description

Related manufacturer report number: 2916596-2022-11498.

Manufacturer Narrative

Manufacturer's investigation conclusion: a direct correlation between the heartmate 3 left ventricular assist systems (lvas) and the reported event could not conclusively be established through this evaluation.The research abstract titled ¿preimplant hyponatremia does not predict adverse outcomes in patient with left ventricular assist devices¿ identified the postoperative and long-term outcomes in patients with low and normal blood levels of sodium prior to the left ventricular assist device (lvad) implantation.Hyponatremia if <135 milliequivalents per liter (meq/l) and normal sodium if 135 - 145 meq/l.A retrospective review included 195 patients in a single center from august 2015 through july 2020.Preimplant hyponatremia was present in 78 (40%) patients vs 117 (60%) patients had normal sodium prior to implant.Patient¿s interagency registry for mechanical circulatory support (intermacs) profile was different within the study population with a higher proportion of patients with intermacs profiles 1 and 2 in those with hyponatremia and intermacs profiles 3 and 4 in those with normal sodium.The study focused on postoperative outcomes related to hemodialysis, reintubation, days on mechanical ventilation, percutaneous endoscopic gastrotomy (peg) tube, tracheostomy, intensive care unit (icu) length of stay (los) and hospital los.In addition, the study also focused on long term outcomes related to heart failure (hf) admission (defined as any hospital admission with hf symptoms/signs requiring intravenous diuretics), mortality, and heart transplantation.Postoperatively, patients with preimplant hyponatremia had a prolonged hospital los with 46.4 (+/- 31.6) days vs.36.8 (+/- 21.5) days in the group with normal sodium.There were no significant differences in need for hemodialysis, mechanical ventilation days or icu los.The long-term outcome at one year showed no significant differences were observed in any of the other outcomes.The study showed that 78 (40%) patients with hyponatremia prior to lvad implantation had higher blood urea nitrogen (bun), chromium (cr), and total bilirubin, more patients were intermacs 1 and 2, and used higher doses of loop diuretics.In addition, they had evidence of a larger right ventricle, significant degrees of tricuspid regurgitation (tr) and higher pulmonary artery systolic pressure (pasp) and central venous pressure (cvp), suggesting right ventricular (rv) dysfunction which could lead to hyponatremia by increased vascular renal congestion and subsequent activation of the renin¿angiotensin system (raas).Lastly, the hyponatremic group required more mechanical circulatory support (mcs) and inotropes.No differences were observed in the postoperative or long-term outcomes.It was concluded that preimplant hyponatremia was not associated with mortality or heart failure (hf) admissions, likely due to adequate left ventricular unloading and resolution of the mechanisms that lead to hyponatremia.These results suggest that optimization of mild hyponatremia may not be critical and should not delay lvad placement.Manufacturer report number 2916596-2022-11498 addresses the reported serious injuries within the study.The specific information regarding the expired patients, as well as heartmate 3 device serial numbers were not available.The device history records could not be reviewed as the heartmate 3 device serial numbers, as well as other specific case information, are not available.The heartmate 3 lvas instructions for use (ifu), rev.C.Is currently available.Section 1 of this document lists adverse events that may be associated with the use of the heartmate 3 lvas, including death.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM
• 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: 14776243
• MDR Text Key: 294516305
• Report Number: 2916596-2022-11886
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024013297
• UDI-Public: 813024013297
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P160054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 07/27/2022

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 Model Number: 106524
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/31/2022
• Initial Date FDA Received: 06/22/2022
• Supplement Dates Manufacturer Received: 07/26/2022
• Supplement Dates FDA Received: 07/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Death