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

Patient Problems Intracranial Hemorrhage (1891); Pleural Effusion (2010); Thrombosis/Thrombus (4440); Lactate Dehydrogenase Increased (4567)

Event Date 02/16/2022

Event Type  Death  

Manufacturer Narrative

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

Event Description

It was reported that the patient presented with elevated lactate dehydrogenase (ldh) levels.The patient developed an intracranial bleed in their right temporal lobe as a result of tissue plasminogen activator (tpa) therapy.The intracranial bleed advanced to show midline shift resulting in altered mental status and eventual deterioration in clinical condition.The patient received 2 units of platelets and all anticoagulants were held.No further options were available for treatment due to patient condition.A decision was made to place patient on comfort measures.The patient expired on (b)(6) 2022.The cause of death was documented as pump thrombosis.

Event Description

It was reported that the tissue plasminogen activator therapy was performed as the patient was deemed to be a high risk surgical candidate.There were no changes to patient condition or pump parameters noted that would have contributed to thrombus.The thrombus did not resolve prior to death.Computed tomography angiography of the chest showed evidence of outflow graft kinking.There was a small fluid residual fluid collection noted around the driveline measuring 3.3 by 1.6 centimeters(cm).There was also a small left lateral chest fluid collection noted measuring 5.0 by 2.0 cm.Small left pleural effusion was noted with mediastinal lymphadenopathy.There was mild mosaic attenuation throughout both lower lobes, nonspecific but likely representing pulmonary edema.Echocardiogram showed a moderately dilated left ventricle.The left ventricular function could not be measured.The right ventricle was not seen well and systolic function was moderately decreased.Diastolic function could not be assessed due to pump.The aortic valve remained closed throughout the cardiac cycle.Inflow and outflow cannulas were poorly visualized with peak inflow cannula velocity of 2 meters/second and peak outflow cannula velocity of 1.5 meters/second.The patient had elevated lactate dehydrogenase levels of 1482, plasma-free hemoglobin levels of 43.3 and bilirubin levels of 4.5.Bivalirudin was administered.

Manufacturer Narrative

Manufacturer's investigation conclusion: the report of suspected thrombus could not be confirmed as no images were submitted from the account and no product was returned for evaluation.Additionally, a direct correlation between heartmate (hm) ii left ventricular assist system (lvas), serial number vad-21078, and the reported events and patient outcome, as well as a direct correlation between the suspected thrombus and the reported events, could not be conclusively established through this evaluation.It was reported that hmii lvas, serial number (b)(6), was not explanted and would not be returned for evaluation.The hmii lvas instructions for use (ifu) lists potential adverse events including pump thrombosis, bleeding, hemolysis, and stroke, that may be associated with the use of the heartmate ii left ventricular assist system.The ifu also lists thromboembolism as a potential late postimplant complication.In addition, the ifu outlines indications of pump thrombosis as well as how to respond to such events.The ifu also provides information regarding the recommended anticoagulation therapy, including inr range, as well as suggested anticoagulation modifications.The relevant sections of the device history records for (b)(6) were reviewed and showed no deviations from manufacturing or quality assurance specifications.The implant kit was shipped on 16sep2019.The heartmate ii lvas ifu is currently available.Section 1, ¿introduction¿, lists potential adverse events including device thrombosis, bleeding, hemolysis, stroke, and death that may be associated with the use of the heartmate ii left ventricular assist system.Section 6 of the ifu, ¿patient care and management¿, also lists thromboembolism as a potential late postimplant complication.Section 1 and section 6 of the ifu outline indications of pump thrombosis and how to respond to such events.Section 6, under ¿anticoagulation¿, provides information regarding the recommended anticoagulation therapy and 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 (ASSISST) 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: 13795929
• MDR Text Key: 287333932
• Report Number: 2916596-2022-01199
• 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: 03/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/05/2021
• Device Model Number: 106015
• Device Catalogue Number: 106015
• Device Lot Number: 6081210
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/18/2019
• 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; Life Threatening
• Patient Age: 39 YR
• Patient Sex: Male
• Patient Weight: 164 KG