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 Hemorrhage/Bleeding (1888); Confusion/ Disorientation (2553)

Event Date 12/21/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that the patient was admitted on (b)(6) 2021 for subdural hematoma confirmed by head cat scan.The cause of the head trauma was unknown.The patient had altered mental status.No alarms were associated with the event.The patient did not have any deficits due to the head trauma.The patient was discharged on (b)(6) 2021.

Manufacturer Narrative

Manufacturer's investigation conclusion: evaluation of the submitted computed tomography (ct) image confirmed the reported bleeding, however, a direct correlation between the device and the bleeding could not conclusively be determined through this evaluation.The patient remains ongoing on heartmate ii left ventricular assist system (lvas), serial number (b)(6).No product is available for investigation.The relevant sections of the device history records for (b)(6) was reviewed and showed no deviations from manufacturing or quality assurance specifications.The lvas kit shipped on 01aug2016.The heartmate ii lvas ifu lists bleeding as an adverse event that may be associated with the use of the heartmate ii left ventricular assist system.The patient care and management section provides information on anticoagulation, including recommended inr values.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
• 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: 13827516
• MDR Text Key: 287616534
• Report Number: 2916596-2022-01684
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024011224
• UDI-Public: 00813024011224
• 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
• Type of Report: Initial,Followup
• Report Date: 04/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/30/2019
• Device Model Number: 106015
• Device Catalogue Number: 106015
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/10/2022
• Initial Date FDA Received: 03/19/2022
• Supplement Dates Manufacturer Received: 04/15/2022
• Supplement Dates FDA Received: 04/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/19/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 84 KG