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

Model Number 1104

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

Patient Problems Anemia (1706); Fatigue (1849); Hemorrhage/Bleeding (1888); Muscle Weakness (1967); Intra-Abdominal Hemorrhage (4479); Melena (4480); Stomach Ulceration (4488)

Event Date 02/01/2021

Event Type  Injury  

Manufacturer Narrative

Investigation of this event is pending and a supplemental report will be sent upon its completion.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient had suction alarms with low flows and was hospitalized with a intra-abdominal bleed accompanied with black stools, fatigue and weakness, which prevented the patient from walking.On admission the patient was subtherapeutic with an international normalized ratio (inr) of 4.4 and hemoglobin 3.8.The patient was diagnosed with an ulcer on his gastric bypass anastomosis which was clipped and patient was transfused 8-9 units of packed red blood cells (prbcs), in addition to vitamin k and medication.Anticoagulants were reduced and started with low dose of aspirin.The ventricular assist device (vad) remains in use.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

A supplemental report is being submitted for device evaluation.Product event summary: the ventricular assist device (vad) was not returned for evaluation.The reported low flow and suction events could not be confirmed via review of the controller log files since log files were not available for analysis.Information received from the site indicated that, in addition to the low flows and suctions, the patient experienced black stools, fatigue and weakness, which prevented the patient from walking.On admission the patient was subtherapeutic with an international normalized ratio (inr) of 4.4 and hemoglobin 3.8.The patient was diagnosed with an ulcer on his gastric bypass anastomosis which was clipped.The patient was treated with transfused 8-9 units of packed red blood cells (prbcs), vitamin k, medication, anticoagulants were reduced, and then started with low dose of aspirin.Based on the available information, there is no evidence to suggest that a device malfunction or performance issue caused or contributed to the reported event.Based on the risk documentation, possible causes of the reported low flow and suction 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.Per the instructions for use, bleeding is a known potential complication associated with the implantation of a vad.There is 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, including issues with an ulcer on his gastric bypass anastomosis, 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.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.

• Brand Name: HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP/DRIVELINE
• Type of Device: VENTRICULAR (ASSIST) BYPASS
• Manufacturer (Section D): HEARTWARE, INC.; 14400 nw 60th ave; miami lakes FL 33014
• MDR Report Key: 11325109
• MDR Text Key: 232199951
• Report Number: 3007042319-2021-01590
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• PMA/PMN Number: P100047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/30/2022
• Device Model Number: 1104
• Device Catalogue Number: 1104
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/10/2021
• Initial Date FDA Received: 02/12/2021
• Supplement Dates Manufacturer Received: 04/01/2021
• Supplement Dates FDA Received: 04/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 21 YR
• Patient Weight: 65