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

Model Number 106524INT

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

Patient Problems Wound Dehiscence (1154); Bacterial Infection (1735); Ischemia (1942); Thromboembolism (2654)

Event Date 06/13/2022

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that on (b)(6) 2022 the patient had critical left inferior limb ischemia with left foot gangrene that was an ongoing chronic issue and was treated with surgical intervention.On (b)(6) 2022, the patient experienced sternal wound dehiscence with the need for negative pressure wound therapy.

Manufacturer Narrative

Manufacturer's investigation conclusion: a direct correlation between heartmate 3 left ventricular assist system, serial number (b)(6) and the reported events cannot be conclusively determined through this evaluation.The patient remains ongoing on the heartmate (hm) 3 left ventricular assist system (lvas), serial number (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 heartmate 3 lvas instructions for use (ifu) and the heartmate 3 patient handbook are currently available.Section 1 of the ifu, ¿introduction¿, lists wound dehiscence, arterial non-central nervous system (cns) thromboembolism, and infection as adverse events that may be associated with the use of the heartmate 3 left ventricular assist system.Section 6, ¿patient care and management¿, also lists thromboembolism as a potential late postimplant complication.Additionally, section 6, under ¿anticoagulation¿, provides the recommended anticoagulation regimen, including international normalized ratio (inr) range, as well as suggested anticoagulation modifications.Section 6 of the ifu, ¿patient care and management¿, also lists infection as a potential late postimplant complication.Furthermore, several sections of the hm3 ifu and patient handbook provide care instructions regarding how to prevent infection as well as suggested responses in the event of infection.No further information was provided.The manufacturer is closing the file on this event.

Event Description

The limb ischemia was diagnosed by computed tomography (ct) scan, and the event was resolved with leg amputation.The patient had diabetes and obesity that pre-disposed them to poor wound healing.Only clinical and visual evaluation of the sternal wound was performed.The wound was biopsied and a bacterial infection was confirmed that could be a contributing factor to dehiscence together with pre-existing obesity and diabetes.

• 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: 14957109
• MDR Text Key: 295495852
• Report Number: 2916596-2022-12162
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P160054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/12/2023
• Device Model Number: 106524INT
• Device Lot Number: 8185471
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/19/2021
• 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; Disability
• Patient Age: 54 YR
• Patient Sex: Female
• Patient Weight: 70 KG