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

Model Number 1103

Device Problems Obstruction of Flow (2423); Pumping Problem (3016)

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Date 12/28/2019

Event Type  Injury  

Event Description

It was reported that the ventricular assist device (vad) exhibited low flows which triggered alarms.The patient was hospitalized as there was concern for pump thrombosis or outflow graft occlusion.Information received indicated that there was no obstruction per computed tomography angiography (cta) and the low flows were due to the patient's condition.It was further reported that the patient experienced hypotension.The patient¿s fluid status was optimized, and their medical management was adjusted.The patient was discharged after two weeks.The ventricular assist device (vad) and outflow graft remain 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 (b)(4) due to an fda audit observation.Additional products: brand name: heartware ventricular assist system ¿ outflow graft, model #: 1125/ catalog #: 1125/ expiration date: 31-jul-2022 / lot#: 16329217-0283 udi #: (b)(4).Device available for evaluation: no.Device manufacture date: mfg date: 31-jul-2020, labeled for single use: yes.(b)(4).Product event summary: ventricular assist device (vad) hw30714 and the associated outflow graft (lot 16329217-0283) were not returned for evaluation.The reported low flow event was confirmed through log file analysis which revealed 24 low flow alarms logged since (b)(6) 2019.Information received from the site indicated that there was no obstruction per computed tomography angiography (cta) and the low flows were due to the patient's condition.It was further reported that the patient experienced hypotension.The patient¿s fluid status was optimized, and their medical management was adjusted.Based on the available information, the device may have caused or contributed to the reported event.Based on the risk documentation, possible causes of the reported low flow event may be attributed to multiple factors including but not limited to thrombus at the inflow cannula/outflow graft, constriction at the outflow graft, poor vad filling, and/or inappropriate pump rotational speed.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 is 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: 14402463
• MDR Text Key: 293445063
• Report Number: 3007042319-2022-05095
• 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,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2022
• 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: 01/08/2020
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 58 YR
• Patient Sex: Male