MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE 3 LVAS IMPLANT KIT; VENTRICULAR (ASSIST) BYPASS

Model Number 106524US

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

Patient Problems Abdominal Pain (1685); Hemorrhage/Bleeding (1888); Seroma (2069); Hematuria (2558)

Event Date 07/07/2022

Event Type  Injury  

Event Description

It was reported that the patient had hematuria and seroma near the surgical site and the received 2 units of packed red blood cells (prbcs) two days after radical prostatectomy.On (b)(6) 2022, additional information was received that the patient developed post operative abdominal pain with seroma and may need drain for the seroma.Nasogastric (ng) tube was to be used to suction for nausea, vomiting, and likely ileus.

Manufacturer Narrative

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

Manufacturer Narrative

Manufacturer's investigation conclusion: a direct relationship between the device and the reported bleeding could not be conclusively determined through this evaluation.The patient remains ongoing on ventricular assist device (vad) support with no further issues reported at this time.Review of the available device history records showed no deviations from manufacturing and qa (quality assurance) specifications.The heartmate 3 lvas instructions for use (ifu) is currently available.Bleeding is listed in the heartmate 3 lvas ifu as an adverse event that may be associated with the use of heartmate 3 left ventricular assist system.The ifu also provides information regarding anticoagulation, including the recommended international normalized ratio (inr) values.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: HEARTMATE 3 LVAS IMPLANT KIT
• Type of Device: VENTRICULAR (ASSIST) 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: 15067829
• MDR Text Key: 296256317
• Report Number: 2916596-2022-12395
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024013297
• UDI-Public: 00813024013297
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P160054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/15/2022
• Device Model Number: 106524US
• Device Catalogue Number: 106524US
• Device Lot Number: 7670613
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/23/2020
• 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): Required Intervention; Hospitalization
• Patient Age: 58 YR
• Patient Sex: Male
• Patient Weight: 118 KG