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

Model Number 1104

Device Problems Increase in Suction (1604); Pumping Problem (3016)

Patient Problem High Blood Pressure/ Hypertension (1908)

Event Date 12/16/2019

Event Type  Injury  

Event Description

It was reported that the ventricular assist device (vad) exhibited multiple low flow alarms and frequent suction events.The patient was hospitalized for right heart catheterization to evaluate if the patient¿s blood pressure was contributing to the vad flow and suction events.The vad speed was adjusted, and patient was given antihypertensive medication.The vad flow increased with the lowering of the patient¿s blood pressure.The 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 (b)(4) due to an fda audit observation.Product event summary: ventricular assist device (vad) (b)(4) was not returned for evaluation.Review of the available autologs report revealed intermittent suction events within the analyzed period and 350 low flow alarms were logged since 12-dec-2019.As a result, the reported low flow and suction event was confirmed.Information received from the site indicated that the vad exhibited multiple low flow alarms and frequent suction events.The patient was hospitalized for right heart catheterization to evaluate if the patient¿s blood pressure was contributing to the vad flow and suction events.The vad speed was adjusted, and patient was given antihypertensive medication.The vad flow increased with the lowering of the patient¿s blood pressure.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 and suction events 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 an inappropriate pump rotational speed.Per the instructions for use, hypertension is known potential complications associated with the implantation of a vad.There was no evidence that the patient had a history of similar adverse 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 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: 14408726
• MDR Text Key: 291735496
• Report Number: 3007042319-2022-05108
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P100047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/31/2020
• Device Model Number: 1104
• Device Catalogue Number: 1104
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/12/2020
• Date Device Manufactured: 10/16/2018
• 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): Hospitalization; Required Intervention
• Patient Age: 56 YR
• Patient Sex: Male
• Patient Weight: 42 KG