MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE II LVAS IMPLANT KIT (WITH SEALED GRAFTS); VENTRICULAR (ASSIST) DEVICE

Model Number 104911

Device Problems Mechanical Problem (1384); Detachment of Device or Device Component (2907); Infusion or Flow Problem (2964); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abdominal Pain (1685); Cardiac Arrest (1762); Hematoma (1884); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Thrombosis/Thrombus (4440)

Event Date 10/01/2023

Event Type  Death  

Event Description

It was reported that the patient was admitted for right upper quadrant abdominal pain and infectious symptoms.A computed tomography (ct) scan showed a new hematoma from the driveline up to the pump and circumferential thrombus or fibrin sheath within the outflow cannula.The ct results showed that there was a small amount of fluid in the anterior mediastinum, surrounding the outflow cannula.The fluid was relatively hyperattenuating and was likely hematoma contiguous with the abdominal hematoma.A developing phlegmon was not excluded in the appropriate clinical setting.This finding was similar when compared to the same day ct examination of the abdomen, but new when compared to the ct pulmonary angiogram from (b)(6) 2023.There was an unremarkable appearance of the inflow cannula.Additionally, there was cardiomegaly, with asymmetric enlargement of the left ventricular chamber.There was also thinning of the left ventricular myocardium and findings were suggestive of dilated cardiomyopathy.There were trace layering bilateral pleural effusions and atelectatic foci in the bilateral lower lobes.The patient denied any trauma to the abdomen or driveline.When they got up to use the bathroom, they immediately had low flow alarms, internal bleeding, and cardiac arrest, and subsequently passed away.It was noted that the patient passed away due to internal bleeding.It was suspected that the bend relief had become disconnected from the outflow graft causing erosion of the graft.It was uncertain if an autopsy will be performed.

Manufacturer Narrative

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

Manufacturer Narrative

Manufacturer's investigation conclusion: the report that the sealed outflow graft bend relief was separated from the outflow graft hardware was confirmed through the evaluation of the submitted images; however, the reported outflow graft thrombosis could not be confirmed.A specific cause for the reported infectious symptoms could not be determined.Additionally, a direct correlation between heartmate (hm) ii left ventricular assist system (lvas), serial number (b)(6), and the patient's outcome could not be conclusively determined through this evaluation.The submitted images showed the outflow graft bend relief hardware separated from the graft hardware.In one image, the bend relief appeared to be off-center from the graft, resulting in a slight kink at the proximal end of the graft; however, the condition of the outflow graft beneath the bend relief could not be determined.Hmii lvas, serial number (b)(6), was not explanted for evaluation.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 ii lvas instructions for use (ifu), rev.C and the heartmate ii patient handbook, rev.C are currently available.Section 1 of the ifu, ¿introduction¿, lists potential adverse events, including bleeding, device thrombosis, infection (local, driveline, and pump pocket), and death as potential adverse events that may be associated with the use of the heartmate ii left ventricular assist system.This section also addresses pump parameters.Section 1 and section 6 of the ifu, ¿patient care and management¿, outline indications of pump thrombosis and how to respond to such events.Additionally, section 6, under ¿anticoagulation¿, provides information regarding the recommended anticoagulation therapy and inr range, as well as suggested anticoagulation modifications.Section 6 of the ifu, also lists infection as a potential late postimplant complication.Section 4 of the ifu also describes situations which may result in a low flow hazard alarm, including changes in patient condition.Per design of the system, once each monitoring cycle, the calculated average flow value is compared to the limit (2.5 lpm).If the calculated value is less than the expected value, a low flow hazard is posted to the log file.A ten second delay is imposed between the detection of a low flow hazard alarm condition and the activation of the associated audio and visual indicators on the controller.Section 15.5 of the ifu, "preparing a sealed outflow graft", provides information regarding how to prepare the sealed outflow graft for implant.Section 16.7 of the ifu, "de-airing the lvad" explains how to install the bend relief over the graft during implant and instructs: "slide the bend relief over the metal fitting toward the locking screw ring until it snaps into place.Visually inspect the bend relief to assure it is fully connected and seated to the sealed outflow graft.This is confirmed by the inability of the bend relief to slide back toward the anastomosis." section 16.8 of the ifu, "securing the pump and connections" states that once the flow through the blood pump is satisfactory, assure that all sealed inflow and sealed outflow connections are dry and secure.The hmii ifu cautions that care should be taken to ensure the sealed outflow graft bend relief remains connected during sternal closure.It also outlines the proper methods to install and suture the sealed outflow bend relief collar.An insert was included in the older version of the instructions for use to incorporate the enhanced attachment instructions provided in the medical device correction notification.This document cautions that care should be taken to ensure the sealed outflow graft bend relief remains connected during sternal closure.In addition, the sobr collar addendum was included in the older version of the ifu, which outlines the proper methods to install and suture the sealed outflow bend relief collar.The information is now incorporated in the current versions of the instructions for use.Section 7 of the ifu, ¿alarms and troubleshooting¿, and section 5 of the patient handbook, ¿alarms and troubleshooting¿, describe alarm conditions, as well as the appropriate actions associated with each condition.The patient handbook also contains a section on handling emergencies.Furthermore, several sections of the 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.

• Brand Name: HEARTMATE II LVAS IMPLANT KIT (WITH SEALED GRAFTS)
• Type of Device: VENTRICULAR (ASSIST) DEVICE
• 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: 18013952
• MDR Text Key: 326638422
• Report Number: 2916596-2023-07362
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024011170
• UDI-Public: 00813024011170
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P060040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 01/31/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/31/2014
• Device Model Number: 104911
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/30/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/12/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: FA-Q217-MCS-2
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 36 YR
• Patient Sex: Male
• Patient Weight: 81 KG