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 Post Operative Wound Infection (2446); Skin Infection (4544)

Event Date 04/21/2022

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 the patient was admitted on (b)(6) 2022 for a xiphoid infection, the driveline exit site was not effected.The patient was treated with antibiotics and a positron emission tomography (pet) computed tomography (ct) scan on (b)(6) 2022.The ct scan showed an infection of the system and a part of the inner driveline.The exit site and about 10 cm upwards were blande in the ct scan.On 29apr2022 vacuum assisted driveline dressing was started and on 06may2022 the heartmate 3 (hm3) was exchanged.

Manufacturer Narrative

Manufacturer's investigation conclusion: no device-related issues were identified during evaluation of heartmate 3 left ventricular assist system (lvas), (b)(6).A specific cause for the patient¿s reported infection could not be conclusively determined through this evaluation.(b)(6) was returned assembled with the pump cable severed approximately 9 inches from the pump header.The remaining portion of the pump cable and the modular cable were not returned.The sealed outflow graft attachment was returned attached to the pump cover outlet port and secured with an outflow graft collar.The apical cuff was not returned.Upon disassembly of the returned pump, examination of the blood-contacting surfaces revealed no adhered depositions or thrombus formations that would have contributed to a flow or functional issue.Visual inspection of the pump rotor and rotor well did not reveal any obvious surface scratches or defects.The lvad event and periodic log files retrieved from the returned device appeared to capture the device functioning as intended.(b)(6) was cleaned, rebuilt, and functionally tested on a mock circulatory loop.The device operated as intended and in accordance with manufacturing specifications.Review of the device history records showed no deviations from manufacturing or quality assurance specifications.The heartmate 3 lvas instructions for use (ifu) is currently available.The ifu lists infection (driveline, localized, and pump pocket or pseudo pocket) and death as adverse events that may be associated with the use of the heartmate 3 left ventricular assist system.Care instructions in regard to preventing infection are included in several sections of the ifu, including in section 6 "patient care and management" (under "caution!", "caring for the driveline exit site", and "controlling infection").Section 6 also provides suggested responses in the event of infection.The heartmate 3 lvas patient handbook provides care instructions in regard to preventing infection in several sections, including section 4 ¿living with the heartmate 3¿ (under ¿caring for the driveline exit site¿).The patient handbook instructs the patient to call their hospital contact immediately if any signs of infection are noticed.No further information 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: 14461861
• MDR Text Key: 292368900
• Report Number: 2916596-2022-10934
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P160054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/16/2022
• Device Model Number: 106524INT
• Device Lot Number: 7628796
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/31/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/18/2020
• 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): Hospitalization; Required Intervention
• Patient Age: 54 YR
• Patient Sex: Male
• Patient Weight: 96 KG