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

Model Number 106015

Device Problems Failure to Align (2522); Malposition of Device (2616)

Patient Problems Dyspnea (1816); High Pulmonary Arterial Wedge Pressure (2480); Cough (4457)

Event Date 09/08/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that the patient had their pump exchanged on (b)(6) 2020 due to inflow cannula malposition with pulmonary artery diastolic (pad) pressure persistently greater than 20mmhg from cardiomems.The patient was reportedly recovering.Additional information received on 11sep2020 reported that leading up to the pump exchange the patient presented to the clinic with worsening shortness of breath (sob), orthopnea, and cough.A computed tomography (ct) scan had been taken and noted the inflow cannula malposition, which prompted for admission and pump exchange.

Manufacturer Narrative

Manufacturer's investigation conclusion: the report of inflow cannula malposition could not be confirmed through this evaluation; no device-related issues were identified through the evaluation of heartmate ii left ventricular assist system (lvas), serial number (b)(6).Additionally, a direct correlation between the pump and the reported elevated pulmonary artery diastolic pressure could not conclusively be established through this evaluation.(b)(6) was returned assembled with the driveline (dl) cut approximately 1.5¿ from the pump housing.A middle segment was returned measuring approximately 12¿ and the distal portion of the dl was not returned.The sealed inflow conduit (inlet tube, flex section, and inlet elbow) was returned attached to the pump¿s inlet port.The sealed outflow conduit (outflow elbow, outflow graft, and outflow graft bend relief) was returned attached to the pump¿s outlet port.The bend relief collar was sutured in place around the outflow graft nut.Examination of the pump's blood-contacting surfaces revealed no adhered depositions or thrombus formations that would have contributed to a functional or flow issue.The device was cleaned.The pump's bearings, rotor, and blood-contacting surfaces were then examined under a microscope and no anomalies were observed.The pump was reassembled and functionally tested under normal operating conditions using a mock circulatory loop.The data retrieved from that testing revealed normal pump power consumption and pressure values that met manufacturing specification and the device functioned as intended.The heartmate ii left ventricular assist system (lvas) instructions for use (ifu) is currently available.Section 1 of this ifu lists the adverse events that may be associated with the use of the heartmate ii left ventricular assist system.Section 5, ¿surgical procedures¿ outlines considerations for pump placement and orientation and also provides instructions regarding the preparation, installation, and orientation of the sealed inflow conduit.Section 5 (under ¿inserting the sealed inflow conduit¿) states to ¿select the optimal sealed inflow conduit orientation at the ventricular apex.The following is critical in determining orientation: the opening of the sealed inflow conduit should be directed toward the mitral valve and away from the intraventricular septum.Care must be taken to avoid excessive angulation of the sealed inflow conduit once the left ventricular assist device is in-situ.The ideal orientation will anticipate that the dilated lv may shrink in size as its workload is assumed by the pump.¿ 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 shipped on 21dec2016.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 (ASSISST) BYPASS
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• MDR Report Key: 10581294
• MDR Text Key: 208370863
• Report Number: 2916596-2020-04515
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024011224
• UDI-Public: 00813024011224
• Combination Product (y/n): N
• PMA/PMN Number: P060040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 03/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/31/2019
• Device Model Number: 106015
• Device Catalogue Number: 106015
• Device Lot Number: 5784197
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 48 YR
• Patient Weight: 133