MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM, EUROPE; LEFT VENTRICULAR ASSIST DEVICE

Catalog Number 106524INT

Device Problems Partial Blockage (1065); Kinked (1339)

Patient Problem Death (1802)

Event Date 04/17/2018

Event Type  Death  

Manufacturer Narrative

The patient¿s weight was not provided.Fda approval for heartmate 3 lvas was received on 23 august 2017.The gtin unique device identifier for the commercial heartmate3 lvas is (b)(4).Approximate age of device ¿ 9 months.The device was returned for investigation.The evaluation is not yet complete.No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is complete.

Event Description

The patient was implanted with a left ventricular assist device (lvad) on (b)(6) 2017.It was reported that the patient was admitted to the hospital on (b)(6) 2018 due to low flow alarms sounding from the system controller.Ct angiography revealed a kinked outflow graft after the bend relief.An outflow graft exchange was performed on (b)(6) 2018.Reportedly, the outflow graft exchange was a high risk operation.The patient subsequently expired on (b)(6) 2018 due to global heart failure.No additional information was provided.

Manufacturer Narrative

The report of a kinked outflow graft was confirmed via review of a submitted ct scan image while the report of low flow alarms was confirmed through the evaluation of the submitted log files and log files downloaded from the returned device; however, no device-related issues were discovered during the evaluation of heartmate 3 lvad.Review of the submitted controller event log file revealed continuous low flow hazard alarms throughout the entire log file.The submitted and downloaded lvad periodic log file data showed that the low flow events began as early as (b)(6) 2018.Despite the low flow condition, the pump was able to operate at the set speed without issue.The returned portion of the sealed outflow graft showed no evidence of distortion such as twisting or kinking.The lumen of the graft attachment and the outflow graft material revealed only traces of post-explant blood with no evidence of any adhered or developed depositions or thrombus formations.Visual examination of the remaining blood-contacting surfaces upon disassembly of the returned pump revealed a small amount of post-explant blood with no evidence of any adhered or developed depositions or thrombus formations.Review of the submitted ct scan image showed that the outflow graft was kinked in the area not covered by the bend relief.Upon evaluation of the returned device, it appeared that the center had removed the portion of the sealed outflow graft which contained the kink and anastomosed a new portion of graft material in its place.The kink in the outflow graft confirmed through the submitted ct image could have potentially contributed to the low flow events captured in the log file data.Visual inspection of the pump rotor and rotor well did not reveal any surface scratches or defects.The pump was cleaned, reassembled, and operated on a mock circulatory loop.The device functioned as intended and in accordance with manufacturing specifications.The heartmate 3 lvas instructions for use (ifu) contains information on preparing the sealed outflow graft and instructs the user to verify that the graft is not twisted or kinked by checking the position of the black line on the graft above and below the bend relief and ensuring that the line is straight.In addition, the ifu outlines all pump parameters, provides information regarding the assessment of pump flow, and outlines all system controller alarms and the appropriate actions associated with each alarm condition.A review of the device history records, including the sterilization and packaging documentation, found no deviations from manufacturing specifications.The manufacturer is closing the file on this event.

• Brand Name: HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM, EUROPE
• Type of Device: LEFT 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 ; 6101 stoneridge dr.; pleasanton, CA 94588 ; 7818528390
• MDR Report Key: 7498214
• MDR Text Key: 107715973
• Report Number: 2916596-2018-01698
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 06/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/31/2020
• Device Catalogue Number: 106524INT
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/31/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/24/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization; Required Intervention
• Patient Age: 63 YR