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

Model Number 106524

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

Patient Problems Right Ventricular Failure (2055); Heart Failure/Congestive Heart Failure (4446)

Event Date 01/01/2014

Event Type  Injury  

Manufacturer Narrative

Specific patient information and device serial number are documented as unknown.Date of event is approximate as the data were collected between 2014 and 2019.D marshall, et al.Journal of heart and lung transplantation, volume: 39, issue: 4, pages: s408.Doi: 10.1016/j.Healun.2020.01.165 medicine, columbia university, new york, ny.No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.

Event Description

It was reported through the research abstract ¿pulmonary artery pulsatility index (papi) is a predictor of right ventricular assist device (rvad) use following heartmate 3 left ventricular assist device implantation¿ identifying that papi is an independent predictor of right ventricular failure in heartmate 3 patients.This retrospective study evaluated 175 patients implanted with heartmate 3 at a single academic center between 2014 and 2019.The primary outcome was right ventricular assist device (rvad) use following heartmate 3 implant.A total of 55 patients (31.4%) required rvad following hm3 implantation including 19 percutaneous, 24 paracorporeal, and 2 durable rvads.Age, gender, and implant strategy were comparable between right ventricular assist device and no right ventricular assist device groups.Patients requiring right ventricular assist device were more likely to be intermacs class i or ii (78.2% vs.56.6%), have a higher white blood cell count (9.2±3.4 vs.8.1±2.8) and c-reactive protein (57.7±59.2 vs.38.4±34.7) prior to device implant (all p <0.05).Right ventricular assist device group had significantly lower papi (3.4±2.0 vs.6.0±6.8, p=0.001), higher central venous pressure/ pulmonary artery capillary wedge pressure ratio (cvp/pcwp ratio) (0.50±0.27 vs.0.42±0.25, p=0.036) and comparable right ventricular stroke work index (rvswi) (0.534±0.285 vs.0.572±0.240, p=0.368) before device implant.Roc curve analysis provided higher auc for papi compared to cvp/pcwp ratio or rvswi.After adjusting for age, etiology of hf, creatinine, bilirubin, white blood cell count, intermacs class, rvswi, and cvp/pcwp ratio, papi was the only significant predictor of rvad use in multivariable model (or 0.913 [95%ci: 0.835 - 0.999], p=0.049).Device was implanted at time of event.

Manufacturer Narrative

Manufacturer's investigation conclusion: a direct correlation between the reported right ventricular failure and heartmate 3 left ventricular assist systems (hm3 lvas) could not be conclusively established through this evaluation.All available information for conducting this investigation was provided from a literature review.Attempts for further information, including heartmate 3 device serial numbers, are unavailable.No product was evaluated under this complaint.The heartmate 3 left ventricular assist system (hm3 lvas) instructions for use (ifu), rev.C, is currently available.Section 1 of this ifu lists right heart failure as an adverse event that may be associated with the use of the hm3 lvas.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 (ASSISST) BYPASS
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• MDR Report Key: 11084459
• MDR Text Key: 225323147
• Report Number: 2916596-2020-06237
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024013297
• UDI-Public: 00813024013297
• Combination Product (y/n): N
• PMA/PMN Number: P160054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Type of Report: Initial,Followup
• Report Date: 04/26/2021

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?: No
• Device Operator: Lay User/Patient
• Device Model Number: 106524
• Device Catalogue Number: 106524US
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/08/2020
• Initial Date FDA Received: 12/28/2020
• Supplement Dates Manufacturer Received: 04/23/2021
• Supplement Dates FDA Received: 04/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening