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

Model Number 106015

Device Problems Mechanical Problem (1384); Infusion or Flow Problem (2964)

Patient Problems Hemolysis (1886); Thrombosis (2100); Thrombosis/Thrombus (4440); Gastrointestinal Hemorrhage (4476); Lactate Dehydrogenase Increased (4567)

Event Date 11/24/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that the patient's lactate dehydrogenase (ldh) levels were rising.At the end of (b)(6), their level was 281 units/liter (u/l).On approximately (b)(6) 2020, their level was above 900 u/l.On 2020, their level was 1338 u/l, and they were admitted to the hospital.On (b)(6) 2020, their level was 1559 u/l, and the level ultimately reached above 1600 u/l.The patient's device parameters were stable, with no rise in pump power.Hemolysis was not able to be confirmed as there were no indicators from analysis of the patient's urine, and their creatinine levels were stable.Upon admission to the hospital, the patient was started on heparin (delivered intravenously) and aggrastat.After the patient's platelet count dropped, they were switched to intravenous angiomax.Despite these medication changes, the patient's ldh levels did not respond.The patient underwent a pump exchange to a new heartmate ii device on (b)(6) 2020.The site reported that there was suspected pump thrombosis.

Manufacturer Narrative

Manufacturer's investigation conclusion: the evaluation of the heartmate ii left ventricular assist system, serial number (b)(6), confirmed pump thrombosis.Although a root cause for the development of this deposition could not conclusively be determined through this evaluation, it could have contributed to the reported increase in lactate dehydrogenase (ldh).The pump was returned assembled with the driveline (dl) cut approximately 2¿ from the pump housing; the distal end of the dl was also returned.The inflow conduit (inlet tube, flex section, and inlet elbow), outflow graft, and the outflow graft bend relief were not returned.The outflow elbow was returned attached to the pump¿s outlet port.Examination of the blood contacting surfaces of the pump upon disassembly revealed a tissue-like deposition surrounding the bearing ball within the proximal side of the outlet stator.This deposition lacked concentric layering but extended into the vanes of the outlet stator.Although the origin of this deposition could not be determined, its areas of denaturation and the contact marks observed at the distal end of the rotor suggest that it was present while (b)(6), was supporting the patient.The remaining blood-contacting surfaces revealed no evidence of depositions or thrombus formations.Electrical continuity testing of the returned portion of the driveline did not reveal any discontinuities or shorts.The pump underwent cleaning, reassembly, and functional testing under load conditions using a mock circulatory loop.The retrieved data revealed pump power consumption and pressure values that met manufacturing specification.The pump operated as intended.The relevant sections of the device history records were reviewed and showed no deviations from manufacturing or quality assurance specifications.The heartmate ii left ventricular assist system (lvas) instructions for use (ifu), rev.C, is currently available.Section 1 ¿introduction¿ of this document lists device thrombosis and hemolysis as adverse events that may be associated with the use of heartmate ii lvas.Additionally, section 6 ¿patient care and management¿ (under "pump performance monitoring") outlines indications of pump thrombosis as well as how to respond to such events.This section (under "anticoagulation") also contains information regarding the recommended anticoagulation therapy and inr range.No further information was provided.The manufacturer is closing the file on this event.

Event Description

It was reported that the patient was admitted for gastrointestinal bleeding on (b)(6) 2020.

Manufacturer Narrative

Updated manufacturer's investigation conclusion: the evaluation of heartmate ii left ventricular assist system (lvas), serial number (b)(6), confirmed pump thrombosis.Although a root cause for the development of this deposition could not conclusively be determined through this evaluation, it could have contributed to the reported increase in lactate dehydrogenase (ldh).A cause for the reported gastrointestinal bleeding, as well as a direct correlation to (b)(6), could not be conclusively determined through this evaluation.The pump was returned assembled with the driveline (dl) cut approximately 2¿ from the pump housing; the distal end of the dl was also returned.The inflow conduit (inlet tube, flex section, and inlet elbow), outflow graft, and the outflow graft bend relief were not returned.The outflow elbow was returned attached to the pump¿s outlet port.Examination of the blood contacting surfaces of the pump upon disassembly revealed a tissue-like deposition surrounding the bearing ball within the proximal side of the outlet stator.This deposition lacked concentric layering but extended into the vanes of the outlet stator.Although the origin of this deposition could not be determined, its areas of denaturation and the contact marks observed at the distal end of the rotor suggest that it was present while (b)(6) was supporting the patient.The remaining blood-contacting surfaces revealed no evidence of depositions or thrombus formations.Electrical continuity testing of the returned portion of the driveline did not reveal any discontinuities or shorts.The pump underwent cleaning, reassembly, and functional testing under load conditions using a mock circulatory loop.The retrieved data revealed pump power consumption and pressure values that met manufacturing specification.The pump operated as intended.The heartmate ii left ventricular assist system (lvas) instructions for use (ifu) is currently available.Section 1 ¿introduction¿ of this document lists bleeding, device thrombosis and hemolysis as adverse events that may be associated with the use of heartmate ii lvas.Additionally, section 6 ¿patient care and management¿ (under "pump performance monitoring") outlines indications of pump thrombosis as well as how to respond to such events.This section (under "anticoagulation") also contains information regarding the recommended anticoagulation therapy and inr range.The relevant sections of the device history records were reviewed and showed no deviations from manufacturing or quality assurance specifications.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 (ASSISST) BYPASS
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• MDR Report Key: 11059634
• MDR Text Key: 223722878
• Report Number: 2916596-2020-06003
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024011224
• UDI-Public: 00813024011224
• Combination Product (y/n): N
• PMA/PMN Number: P060040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/18/2021

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?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/31/2020
• Device Model Number: 106015
• Device Catalogue Number: 106015
• Device Lot Number: 6171031
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/28/2020
• Initial Date FDA Received: 12/22/2020
• Supplement Dates Manufacturer Received: 01/29/2021; 09/29/2021
• Supplement Dates FDA Received: 02/02/2021; 10/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 71 YR
• Patient Weight: 83