MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM; VENTRICULAR (ASSISST) BYPASS

Model Number 106524

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Bacterial Infection (1735); Septic Shock (2068); Skin Infection (4544); Insufficient Information (4580)

Event Date 03/02/2021

Event Type  Injury  

Event Description

It was reported the patient underwent a heartmate 3 to heartmate 3 pump exchange on (b)(6) 2021.

Manufacturer Narrative

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

Event Description

It was reported that the reason for pump exchange was an infection associated with driveline of the left ventricular assist device (lvad).

Manufacturer Narrative

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

Event Description

It was reported that the infection was device related and was diagnosed as staphylococcus aureus.The patient was admitted (b)(6) 2021 with concerns for sepsis/septic shock.Pump exchange was performed on (b)(6) 2021.The patient's driveline exit site drainage significantly improved.The plan of care was to continue on doxycycline 100 mg twice a day indefinitely.

Manufacturer Narrative

Manufacturer's investigation conclusion: a specific cause for the reported infection could not be conclusively determined through the evaluation of heartmate 3 left ventricular assist system (lvas), serial number (b)(6).(b)(6) was returned assembled with the pump cable was severed approximately 4.5¿ from the pump header.The remainder of the pump cable and the modular cable were also returned.A cut in the outer silicone jacket was noted 2.5 inches from the pump cable inline connector; however, the underlying armor layer appeared intact.Additionally, the pump cable inline connector bend relief showed gradient, dark red discoloration.The sealed outflow graft and the sealed outflow graft bend relief were returned attached to the device, and the outflow graft clip was not returned.The apical cuff was returned and disengaged from the cuff lock.Upon disassembly of the returned pump, examination of the blood-contacting surfaces revealed no developed 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.The heartmate 3 lvas ifu, is currently available.Section 1 ¿introduction¿ of this document lists infection and sepsis as adverse events that may be associated with the use of the heartmate 3 lvas.Care instructions in regard to preventing infection are provided in various sections of the ifu, including caring for the driveline exit site and controlling infection.Section 5 ¿surgical procedures¿ cautions the user that sharp bends, twists, or kinks in the driveline may make it more susceptible to wear and fatigue over time.Section 6 ¿patient care and management¿ cautions the user to avoid pulling on or moving the driveline.This section further cautions: "do not twist, kink, or sharply bend the driveline, system controller power cables, the power module patient cable, or the mobile power unit patient cable, which may cause damage to the wires inside, even if external damage is not visible.Damage to the driveline or cables could cause the left ventricular assist device to stop.If the driveline or cables become twisted, kinked, or bent, carefully unravel and straighten.¿ section 6 also instructs the user to check the driveline daily for signs of damage, such as cuts, holes, or tears and to counsel patients to inform their hospital contact immediately if they find signs of driveline damage.Section 7 ¿alarms and troubleshooting¿ provides additional instructions regarding driveline care in a sub-section entitled "what not to do: driveline and cables".Section 8 ¿equipment storage and care¿ states: "as needed, clean exterior surfaces of the driveline cables with a damp, lint-free cloth.If more aggressive cleaning is needed, use warm water and mild dish soap." the heartmate 3 lvas patient handbook, is also available at the time of implant.Several sections of this handbook provide care instructions in regards to preventing infection.Section 4 contains information on caring for the driveline and instructs the patient to keep the driveline clean.Wipe off any dirt or grime and if the driveline gets dirty, use a towel with mild dish soap and warm water to gently clean it.Never submerge the driveline or other system components in water or liquid.The relevant sections of the device history records for (b)(6) were reviewed and showed no deviations from manufacturing or quality assurance specifications.The relevant sections of the device history records for the percutaneous lead were also reviewed and showed no deviations from manufacturing or quality assurance specifications.The implant kit was shipped on 27jul2017.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM
• Type of Device: VENTRICULAR (ASSISST) BYPASS
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• MDR Report Key: 11697046
• MDR Text Key: 246468311
• Report Number: 2916596-2021-01974
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• PMA/PMN Number: P160054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2020
• Device Model Number: 106524
• Device Lot Number: 6078489
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 65 YR
• Patient Weight: 70