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

Model Number 104911

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

Patient Problem Right Ventricular Dysfunction (2054)

Event Date 10/01/2019

Event Type  Injury  

Manufacturer Narrative

Event date estimated.No further information was provided.The manufacturer is closing the file on this event.

Event Description

Echo on (b)(6) 2019 showed right ventricular (rv) dysfunction.

Manufacturer Narrative

Section d4 and h4: additional information.Manufacturer's investigation conclusion: a direct correlation between heartmate ii lvas, serial number (b)(6), and the reported events could not be conclusively established through this evaluation.The patient remains ongoing on heartmate ii lvas, serial number (b)(6).Multiple attempts for additional information were sent to the customer and no further detail was provided.The relevant sections of the device history records for (b)(6) were reviewed and showed no deviations from manufacturing or quality assurance specifications.The implant kit shipped on (b)(6) 2011.The heartmate ii lvas ifu is currently available.Section 1 of this ifu lists right heart failure as an adverse event that may be associated with use of the heartmate ii left ventricular assist system.Section 6 ¿patient care and management¿ describes that right heart failure can occur post-implant and provides strategies for treating patients who experience right heart failure.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: 10391685
• MDR Text Key: 202410901
• Report Number: 2916596-2020-03956
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024011170
• UDI-Public: 00813024011170
• 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
• Report Date: 10/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/31/2013
• Device Model Number: 104911
• Device Catalogue Number: 104911
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 71 YR
• Patient Weight: 97