MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE 3 LVAS IMPLANT KIT; VENTRICULAR (ASSIST) BYPASS

Model Number 106524

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

Patient Problems Anemia (1706); Hemorrhage/Bleeding (1888); Obstruction/Occlusion (2422); Thromboembolism (2654); Heart Failure/Congestive Heart Failure (4446); Swelling/ Edema (4577)

Event Date 06/09/2022

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 had an auxiliary balloon pump placed on (b)(6) 2022 pre left ventricular assist device (lvad) implant on (b)(6) 2022.The patient's hemoglobin reportedly dropped and they were given 1 unit of packed red blood cells (pcrbs).On (b)(6) 2022 it was reported that the patient had venous thromboembolism revealed by ultrasound.The patient had a swollen right arm and the picc was discontinued on the right side and was moved to the left.Heparin and coumadin doses were increased.It was reported on (b)(6) 2022 that the patient was pre-op for acute blood loss anemia as well as venous thromboembolism.It was also reported that the patient continued to be supported on inotropes mere than 7 days post-op.The plan was to start slowly weaning the patient off.

Event Description

The patient was treated with dobutamine and inhaled nitric oxide.The right heart failure resolved without sequalae on (b)(6) 2022.

Manufacturer Narrative

Manufacturer's investigation conclusion: a direct correlation between heartmate (hm) 3 left ventricular assist system (lvas) and the report of deep vein thrombosis (dvt)/ pericatheter thrombus could not be conclusively determined through this evaluation.The patient remains ongoing on hm3 lvas.No further related events have been reported at this time.The relevant sections of the device history records were reviewed and showed no deviations from manufacturing or quality assurance specifications.The implant kit was shipped on 24may2022 the heartmate 3 lvas ifu is currently available.Section 1 of the ifu, ¿introduction¿, lists peripheral thromboembolic event as a potential adverse event that may be associated with the use of the heartmate 3 left ventricular assist system.Section 6 of the ifu, ¿patient care and management¿, lists thromboembolism as a potential late postimplant complication.Section 6 of the ifu, under ¿anticoagulation¿, provides information regarding the recommended anticoagulation regimen, including inr values, as well as suggested anticoagulation modifications.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: HEARTMATE 3 LVAS IMPLANT KIT
• 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: 14882302
• MDR Text Key: 295112289
• Report Number: 2916596-2022-11849
• 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: Study,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/24/2024
• Device Model Number: 106524
• Device Lot Number: 8465251
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/30/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/10/2022
• 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; Hospitalization; Life Threatening
• Patient Age: 38 YR
• Patient Sex: Female
• Patient Weight: 91 KG