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

Model Number 1103

Device Problems Obstruction of Flow (2423); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Apnea (1720); Atrial Fibrillation (1729); Cardiomyopathy (1764); Coagulation Disorder (1779); Hemorrhage/Bleeding (1888); High Blood Pressure/ Hypertension (1908); Pocket Erosion (2013); Renal Failure (2041); Septic Shock (2068); Cardiogenic Shock (2262); Respiratory Failure (2484); Hypervolemia (2664); Thrombosis/Thrombus (4440); Heart Failure/Congestive Heart Failure (4446); Unspecified Heart Problem (4454); Swelling/ Edema (4577)

Event Date 05/19/2023

Event Type  Injury  

Manufacturer Narrative

Continuation of d10: 6996sq5 lead implanted (b)(6) 2020, 5019 adapter  implanted (b)(6) 2020 heartware ventricular assist system ¿ outflow graft d4: model #: 1125 / catalog #:  1125 / expiration date: / serial or lot#:(b)(6).Mfg date:  h5: yes h6: the codes present in section h6 correspond to components/products that comprise the reported event.Investigation of this event is pending and a supplemental report will be sent upon its completion.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

Event Description

It was reported that the ventricular assist device (vad) patient was experienced non-ischemic cardiomyopathy, morbid obesity, immune thrombocytopenic purpura (itp) requiring intravenous immunoglobulin (ivig), persistent atrial fibrillation (af), diabetes melletes, hypertension, obstructive sleep apnea, gastrointestinal bleed (gib) and frequent hospital admissions who presents with left lower and right lower extremity pain and swelling.Patient has had recent prolonged hospital admissions requiring ongoing medications, with end stage decompensated biventricular heart failure and hepatic encephalopathy.The ventricular assist device (vad) eroded into the patient's chest and there was an outflow graft obstruction, and the patient experienced coagulopathy, vasalgia, requiring massive transfusions, worsening right ventricle (rv) failure, and wer placed on a competitor's product extracorporeal membrane oxygenation (ecmo) right vad.  it was also reported that the patient experienced cardiogenic shock,  acute on chronic left ventricular systolic heart failure, respiratory insufficiency that required a tracheotomy, thrombocytopenia ,  acute kidney injury on a chronic kidney disease, volume overload,  pulmonary hemorrhage, adrenal insufficiency, septic shock and wounds.The vad was exchanged. no further patient complications have been reported as a result of this event.

• 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: 18960759
• MDR Text Key: 338377516
• Report Number: 3007042319-2024-01310
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00888707002639
• UDI-Public: 00888707002639
• 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: Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/31/2019
• Device Model Number: 1103
• Device Catalogue Number: 1103
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/14/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/31/2017
• 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
• Treatment: CD1357-40Q ICD, LDA220Q LEAD
• Patient Outcome(s): Life Threatening; Required Intervention; Hospitalization
• Patient Age: 35 YR
• Patient Sex: Female