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

Model Number 106015

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Infarction, Cerebral (1771); Death (1802); Hematoma (1884); Hemorrhage/Bleeding (1888); Hemorrhage, Cerebral (1889)

Event Date 11/03/2020

Event Type  Death  

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 the patient passed away due to "head bleed".The patient was seen in clinic on (b)(6) 2020 with an inr (international normalized ratio) of 3.6 and warfarin dose was adjusted.The patient's inr was rechecked on (b)(6) 2020 and was 2.8.The goal inr was between 2 and 3.Upon arrival to the emergency department, the patient's inr was 3.4.This was reversed with vitamin k and pcc (prothrombin complex concentrate).The patient has a history transient ischemic attack (tias).A head computed tomography (ct) was done and it showed a large acute chronic left parietal subdural hematoma with the descending transtentorial herniation with the medial left temporal lobe.The patient was taken to the operating room for a left side craniotomy for the subdural hematoma.On arrival to the intensive care unit, the patient was obtunded with fixed and dilatated pupils.A head ct after surgery showed an enlarging mixed attenuation left hemispheric extra-axial hemorrhage contributing to worsening midline shift.There was a left uncal herniation with distortion of the left midbrain.It was noted that the device operated as expected and would not be returned for evaluation.

Manufacturer Narrative

Manufacturer¿s investigation conclusion: the pump remains in use supporting the patient.A correlation between the device and the report of stroke could not be conclusively determined.Stroke is listed in the instructions for use as a potential adverse event that may be associated with the use of heartmate ii left ventricular assist system.Stroke has been previously investigated and will continue to be monitored through quality data reviews, which are conducted on production and post product signals to evaluate if products are conforming to product requirements.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: 10939501
• MDR Text Key: 219297691
• Report Number: 2916596-2020-05723
• 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: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2017
• Device Model Number: 106015
• Device Catalogue Number: 106015
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization
• Patient Age: 75 YR
• Patient Weight: 113