MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM; VENTRICULAR (ASSISST) BYPASS

Model Number 106524

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

Patient Problems Hematoma (1884); Respiratory Distress (2045); Blood Loss (2597)

Event Date 10/07/2019

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 was admitted on (b)(6) 2019 for worsening gluteal pain limiting the patient's ability to stand or walk.A computed tomography (ct) scan revealed a stable left gluteal intramuscular hematoma extending inferiorly to the greater trochanter.The patient had decreased hemoglobin.The event resolved on (b)(6) 2019 without sequelae.The patient was hospitalized and received 2 united of packed red blood cells (prbc) and prothrombin complex concentrate.The patient was also treated with an ace bandage.The patient's admission course was complicated by volume overload with nocturnal hypoxia and possible rounded atelectasis on ct chest scan.The patient had a prolonged hospitalization.

Manufacturer Narrative

Sections d4, h4: additional information.Manufacturer's investigation conclusion: a specific cause for the reported event, as well as a direct correlation to heartmate 3 lvas, serial number (b)(6), could not be conclusively determined.The patient remains ongoing on heartmate 3 lvas, serial number (b)(6).No product is available for investigation.The heartmate 3 lvas ifu lists bleeding as an adverse event that may be associated with the use of the heartmate 3 left ventricular assist system and provides information regarding anticoagulation, including the recommended inr values.No further information was provided.The manufacturer is closing this event.

• Brand Name: HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM
• Type of Device: VENTRICULAR (ASSISST) BYPASS
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• MDR Report Key: 10502167
• MDR Text Key: 205965191
• Report Number: 2916596-2020-04281
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• PMA/PMN Number: P160054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,study
• Type of Report: Initial,Followup
• Report Date: 09/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2016
• Device Model Number: 106524
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 73 YR
• Patient Weight: 94