MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM, NA; VENTRICULAR (ASSISST) BYPASS

Model Number 106015

Device Problem Malposition of Device (2616)

Patient Problems Dyspnea (1816); Hemolysis (1886); Dizziness (2194); Palpitations (2467)

Event Date 08/17/2018

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

The site reported the heartmate ii inflow cannula was not positioned well.The patient experienced hemolysis symptoms.The patient received a device explant on (b)(6) 2018.The patient was implanted with a hvad on (b)(6) 2018.No further information was reported.

Manufacturer Narrative

Section b2, d4, h4: correction.Manufacturer's investigation conclusion: a direct correlation between the reported events (inflow cannula alignment issue, hemolysis, decreased flow, patient condition) and heartmate ii lvas, serial number (b)(6) could not be conclusively established through this evaluation.Although a specific cause for the reported events could not be determined, the center reported that the cause of the hemolysis was related to the patient¿s pump migrating with their weight gain, causing the inflow to push towards the septum causing decreased flows due to the obstruction of the inflow.The hmii lvas ifu provides an image of the proper hmii implantation configuration and discusses implanting and orienting the sealed inflow conduit.This ifu also lists hemolysis as an adverse event that may be associated with the use of the heartmate ii left ventricular assist system; however, it should be noted that the center reported that the hemolysis was related to the patient¿s pump migrating.No further information was provided.The manufacturer is closing the file on this event.

Event Description

The cause of hemolysis was identified to be cause by the patient's pump migration due to weight gain.The inflow cannula was pushed towards the septum.The decrease in flow was due to the obstruction of the inflow.During the flow, the patient experienced dizziness, shortness of breath and palpitations.The patient heartmate ii was exchanged to a heartmate hvad.No further information was reported.

Manufacturer Narrative

Sections b5 and h6: additional information.

• Brand Name: HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM, NA
• Type of Device: VENTRICULAR (ASSISST) BYPASS
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 95488
• MDR Report Key: 9419083
• MDR Text Key: 169521913
• Report Number: 2916596-2019-05699
• 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: 02/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2020
• Device Model Number: 106015
• Device Catalogue Number: 106015
• Device Lot Number: 6011643
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 61 YR
• Patient Weight: 123