MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM, JP; VENTRICULAR (ASSIST) BYPASS

Model Number 104911JPN

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

Patient Problems Hemorrhage/Bleeding (1888); Heart Failure/Congestive Heart Failure (4446); Peripheral Edema (4578)

Event Date 10/01/2021

Event Type  Injury  

Event Description

It was reported that on (b)(6) 2021, the patient developed major bleeding in the respiratory organs.The patient received a blood transfusion.The patient was on warfarin at the time of the event.The cause of the bleeding was indicated to be complexities of medical management.The patient also developed right heart failure with peripheral edema.

Manufacturer Narrative

No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is completed.Reporter email: (b)(6).

Manufacturer Narrative

Manufacturer's investigation conclusion: a direct correlation between heartmate ii lvas, serial number: (b)(6), and the reported bleeding and right heart failure with peripheral edema could not be conclusively determined through this evaluation.Multiple attempts were made to obtain additional information from the customer regarding the event; however, the hospital would not communicate any additional information.The patient remains ongoing on the heartmate (hm) ii left ventricular assist system (lvas), (b)(6).No product is available for investigation.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 29jan2017.The heartmate ii left ventricular assist system (lvas) instructions for use (ifu) and the heartmate ii lvas patient handbook is currently available.Section 1 entitled ¿introduction¿ lists bleeding and right heart failure as adverse events that may be associated with the use of the heartmate ii left ventricular assist system.Section 6 entitled ¿patient care and management¿ provides information regarding the recommended anticoagulation therapy and international normalized ratio (inr) range, as well as the suggested anticoagulation modifications in the event there is a risk of bleeding.This section also suggests increasing antiplatelet medications and decreasing heparin/warfarin to decrease the risk of bleeding.Section 6, under "right heart failure", discusses the potential development of right heart failure during use of the heartmate ii lvas and outlines the associated treatment options.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM, JP
• 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: 15094501
• MDR Text Key: 296494126
• Report Number: 2916596-2022-12171
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P060040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/08/2022

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 Expiration Date: 12/31/2019
• Device Model Number: 104911JPN
• Device Lot Number: 5832301
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/05/2022
• Initial Date FDA Received: 07/25/2022
• Supplement Dates Manufacturer Received: 09/07/2022
• Supplement Dates FDA Received: 09/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/27/2017
• 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
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Weight: 45 KG