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 Thrombosis/Thrombus (4440); Aortic Valve Insufficiency/ Regurgitation (4450); Mitral Valve Insufficiency/ Regurgitation (4451); Lactate Dehydrogenase Increased (4567)

Event Date 07/06/2022

Event Type  Injury  

Manufacturer Narrative

No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is complete.

Event Description

It was reported that the patient was admitted for suspicion of pump thrombosis.The patient had elevated lactate dehydrogenase (ldh), peaking at 1899.Urine was reportedly tea colored and power was in the 8's.The patient was put on heparin and integrilin.Noncontrast computerized tomography (ct) was performed, but unable to assess due to not using contrast.The team was unable to perform ct with contrast due to creatinine levels.Ramp echo was performed on (b)(6) 2022 and it was found that at 9800 rpm the mitral valve leaflets fail to coapt and septum bowed slightly to the right with intermittent aortic valve opening with left ventricular end-diastolic diameter (lvedd) of 9.3 cm, as well as severe mitral regurgitation (mr) and mild aortic regurgitation (ar).At 11000 rpm the septum appears more midline and lvidd measures 9 cm with slightly reduced mitral regurgitation (better leaflet coaptation) but slightly worse ar (moderate).The log file review found low supply voltage values when connected to the power module.A patient cable replacement was recommended.It was reported on (b)(6) 2022 that the patient was taken to the operating room for a heartmate ii to heartmate 3 exchange due to the suspected thrombus and elevated ldh.

Manufacturer Narrative

Manufacturer's investigation conclusion: thrombus was confirmed through the evaluation of heartmate ii left ventricular assist system (lvas).The submitted log file contains data captured from (b)(6) 2022 through (b)(6) 2022 and recorded several intermittent elevations in pump power and corresponding estimated flow; however, the pump appeared to have operated as intended at or above the set speed throughout the file.The device was returned assembled with the driveline (dl) severed approximately 2" from the pump housing.A distal portion of the dl was returned with the silicone jacket removed, measuring approximately 9".The remainder of the dl including the controller connector was not returned.The sealed inflow cannula (inlet extension, flex section, inlet elbow) was returned assembled and detached from the pump inlet port.The apical sewing ring was not returned with the device.The sealed outflow graft was returned attached to the outlet elbow, which was attached to the pump¿s outlet port.The sealed outflow graft bend relief was returned separately and severed near the hardware into two portions with the bend relief collar detached.Visual inspection of the rotor revealed a ring-like formation around its bearing ball which appeared to have extended to one side of the inlet stator's bearing cup.This deposition was adhered, hard, laminated, and appeared to be a mix of denatured blood and tissue, suggesting that it had developed in this location during support.Upon disassembly, a part of the formation appeared to have separated and remained on one side of the inlet stator's bearing cup.The outlet stator also revealed a tissue-like deposition between the bearing ball and one of the stator blades.This deposition appeared denatured, grainy, slightly adhered, and appeared to have favored one side of the outlet stator.Although the deposition did not appear to have initially formed in the outlet stator, the origin could not be determined.Furthermore, a duration of time for which the depositions were present in the device could not be determined through this evaluation.A specific cause for the presence of the observed depositions on the rotor and in the outlet stator could not be conclusively determined; however, they would have contributed to the reported increase in ldh, as well as the increase in pump power that was confirmed through the evaluation of the submitted log file.Upon removal of the depositions, the device was cleaned.The bearings, rotor and blood contacting surfaces were then examined under a microscope; no anomalies related to wear or damage were observed.Electrical continuity testing of the returned portions of the dl did not reveal any discontinuities or shorts.The pump was reassembled and functionally tested under normal operating conditions using a mock circulatory loop.The data retrieved from that testing revealed normal pump power consumption and pressure values that met manufacturing specification; the device functioned as intended.The relevant sections of the device history records were reviewed and showed no deviations from manufacturing or quality assurance specifications.The hmii left ventricular assist system (lvas) instructions for use (ifu), document section 1 of this ifu lists hemolysis and device thrombosis as adverse events that may be associated with the use of the hmii lvas.Section 5 of the ifu, ¿surgical procedures¿, warns that moderate to severe aortic insufficiency must be corrected at the time of device implant.Section 6, ¿patient care and management¿ (under ¿anticoagulation¿), provides the recommended anticoagulation regimen, including international normalized ratio (inr) range, as well as suggested anticoagulation modifications.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: 15107785
• MDR Text Key: 296654971
• Report Number: 2916596-2022-12158
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024011224
• UDI-Public: 00813024011224
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P060040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/31/2020
• Device Model Number: 106015
• Device Catalogue Number: 106015
• Device Lot Number: 6109652
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/15/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/15/2017
• 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: 55 YR
• Patient Sex: Male
• Patient Weight: 124 KG