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 Problems Nausea (1970); Tachycardia (2095); Confusion/ Disorientation (2553)

Event Date 02/12/2021

Event Type  Injury  

Event Description

It was reported that the ventricular assist device (vad) patient was dazed, nauseous and had ventricular tachycardia (vt) episodes.The ventricular assist device (vad) exhibited a low flow alarm and suction events and the patient was admitted to the intensive care unit (icu).The vad lavare cycle was deactivated and the patient's symptoms were managed with medication.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: the ventricular assist device (vad) (b)(4) was not returned for evaluation.The reported low flow and suction events were confirmed via review of the controller log files which intermittent suction events logged within the analyzed period and six (6) low flow alarms were logged since (b)(6) 2021.Information provided by the site revealed that, in addition to the suction and low flow event, the ventricular assist device (vad) patient was dazed, nauseous and had ventricular tachycardia (vt) episodes.The patient was admitted to the intensive care unit (icu).The vad lavare cycle was deactivated and the patient's symptoms were managed with medication.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 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 inappropriate pump rotational speed.Per the instructions for use, cardiac arrhythmia and neurological dysfunction are known potential complications associated with the implantation of a vad.Based on review of past adverse events for this patient, it was noted that the patient had a history of neurological dysfunction.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: 14142687
• MDR Text Key: 289516881
• Report Number: 3007042319-2022-04734
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Reporter Country Code: SF
• 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: 04/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/31/2022
• Device Model Number: 1104
• Device Catalogue Number: 1104
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/12/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/15/2020
• 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: 61 YR
• Patient Sex: Male
• Patient Weight: 89 KG