MAUDE Adverse Event Report: HEARTWARE, INC. HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP; VENTRICULAR (ASSISST) BYPASS

Model Number 1103

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

Patient Problems Anemia (1706); Hemorrhage/Bleeding (1888); Melena (4480)

Event Date 12/30/2018

Event Type  Injury  

Event Description

It was reported that post implant the patient had a suspected gastrointestinal (gi) bleed, with a drop in hemoglobin/hematocrit from 8.5/24.9 to 6.9/20.7.The patient also had melena and anemia.Gastroenterology was consulted and upper gi endoscopy was performed which showed no evidence of bleeding.The patient was transfused one unit of packed red blood cells (prbcs) after values for hemoglobin and hematocrit were 7.1/21.5 and the day after 7.8/23.Treatment consisted of stents, oral anticoagulants, and ferrous gluconate to address the anemia.The ventricular assist device (vad) remains in use.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

This regulatory report is being submitted as part of a retrospective review and remediation per d00700870.This information was received from the mechanical circulatory support product surveillance registry study.Product event summary: hw40121 was not returned for evaluation.This complaint is associated with a clinical adverse event.Information received from the site indicated that the patient had a suspected gastrointestinal (gi) bleed, melena, and anemia; however, an upper gi endoscopy showed no evidence of bleeding.The patient received a blood transfusion and was treated with stents, oral anticoagulants, and ferrous gluconate to address the anemia.Based on the available information, including the occurrence of the event within 30 days of implant, the device may have caused or contributed to the reported event.Per the instructions for use, gi bleeding is a known potential complication associated with the implantation of a vad.There was no evidence that the patient had a history of prior bleed events.Possible clinical factors that may have contributed to this event include the patient¿s pre-existing history and related comorbidities, the progression of their underlying disease, issues related to the therapeutic use of anticoagulant and antiplatelet medications and the patient's complex post-operative course.There are possible patient, pharmacological and procedural factors that may have contributed to this event.Investigation of this event is completed and the file will be closed.If new information is received, the file will be re-opened and a supplemental will be submitted.If information is provided in the future, a supplemental report will be issued.

• Brand Name: HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP
• Type of Device: VENTRICULAR (ASSISST) BYPASS
• Manufacturer (Section D): HEARTWARE, INC.; 14400 nw 60th ave; miami lakes FL 33014
• Manufacturer (Section G): HEARTWARE, INC.; 14400 nw 60th ave; miami lakes FL 33014
• Manufacturer Contact: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 15052938
• MDR Text Key: 296145411
• Report Number: 3007042319-2022-06637
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00888707003261
• UDI-Public: 00888707003261
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/31/2020
• Device Model Number: 1103
• Device Catalogue Number: 1103
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/31/2018
• Date Device Manufactured: 08/31/2018
• 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): Life Threatening; Required Intervention
• Patient Age: 70 YR
• Patient Sex: Female