MAUDE Adverse Event Report: THORATEC CORPORATION PRESS FIT ASSY, APICAL CUFF, HMIII; VENTRICULAR (ASSISST) BYPASS

Model Number	10001258
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	12/04/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No further information was provided.A supplemental report will be submitted when the manufacturer's investigation is completed.
Event or Problem Description
It was reported that after implant the patient had bleeding below the mini apical cuff that required the placement of 2 umbilical tapes distal.Additional information was requested but not provided.
Additional Manufacturer Narrative
Device evaluation: a specific cause for the reported intraoperative bleeding below the mini apical cuff could not be determined through this evaluation.The heartmate 3 mini apical cuff kit ifu lists bleeding as an adverse event that may be associated with the use of the mini apical cuff kit.In addition, 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.The heartmate 3 mini apical cuff kit ifu (document 10006218, rev.E) lists bleeding as an adverse event that may be associated with the use of the mini apical cuff kit.The section titled ¿directions for use¿ explains how to secure the mini apical cuff to the left ventricle and cautions to ensure that apposition between the myocardial tissue and the cuff felt is continuous and sufficiently forceful to prevent bleeding.The ifu outlines how to check the hemostasis of the anastomosis of the mini apical cuff under the section titled ¿confirming hemostasis.This section cautions that it is important to check the hemostasis before installing the pump as it may be difficult to place additional sutures in the mini apical cuff once the pump is installed.The heartmate 3 lvas ifu (document 100169835, rev.A) lists bleeding as an adverse event that may be associated with the use of the heartmate 3 left ventricular assist system.Section 6 ¿patient care and management¿ (under "anticoagulation") outlines the recommended anticoagulation regimen for patients using the heartmate 3 lvas as well as the suggested anticoagulation modifications in the event there is a risk of bleeding.Section 6 also contains information on blood leak diagnosis.No further information was provided.The manufacturer is closing the file on the event.

• Brand Name: PRESS FIT ASSY, APICAL CUFF, HMIII
• Common Device Name: VENTRICULAR (ASSISST) BYPASS
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 95488
• MDR Report Key: 9519636
• Report Number: 2916596-2019-05842
• Device Sequence Number: 458933
• Product Code: DSQ
• UDI-Device Identifier: 00813024012825
• UDI-Public: 00813024012825
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/06/2020

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
• Operator of Device: Health Professional
• Device Model Number: 10001258
• Device Lot Number: 7161157
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/05/2019
• Supplement Date Received by Manufacturer: 03/27/2020
• Initial Report FDA Received Date: 12/26/2019
• Supplement Report FDA Received Date: 04/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention