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

Model Number 1103

Device Problems Device Contamination with Chemical or Other Material (2944); Pumping Problem (3016)

Patient Problems Hemolysis (1886); Thrombus (2101)

Event Date 05/19/2020

Event Type  Injury  

Manufacturer Narrative

This device is used for treatment not diagnosis.The ventricular assist system is indicated for use as a bridge to cardiac trans plantation and destination therapy in patients who are at risk of death from refractory end-stage left ventricular heart failure.The system is designed for in-hospital and out-of-hospital settings.Additional information has been requested regarding the date of implant, patient weight, and laboratory data of the event, but it was not available at the time of this report.If additional information is received, the event will be updated and a supplemental report will be sent.Additional products: brand name: heartware ventricular assist system ¿ outflow graft , medical device: model #: 1125 / catalog #: 1125 / expiration date: unk / lot#: 1415164, udi #:(b)(4).Device available for evaluation? no.Device: mfg date: unk.Labeled for single use? yes.(b)(4).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 was hospitalized for hemolysis and thrombus.The ventricular assist device (vad) exhibited low flows due to thrombus in the inflow cannula and thrombus compressing the outflow graft (ofg).If was further reported that foreign material/contamination was visible in the ofg and vad.The vad and the ofg were exchanged.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) and the outflow graft were returned for evaluation.Information received from the site indicated that the patient experienced hemolysis, low flows due to outflow graft compression, and thrombus.The patient underwent a ventricular assist device (vad) exchange procedure.Visual evidence provided by the site revealed foreign material within the pump and the outflow graft.As a result, the reported outflow graft compression event was confirmed.The reported low flow event could not be confirmed via review of the controller log files since log files were not available for analysis.Failure analysis of the returned outflow graft revealed that the returned segment passed visual examination.Failure analysis of the returned pump revealed that the device passed visual examination and dimensional verification.Post-explant functional analysis on the returned pump was not possible since the driveline was too short to be able to splice the driveline and then conduct functional testing.Inter nal pathological report revealed evidence of thrombus within the pump.As a result, the reported thrombus event was confirmed.Per the hvad instructions for use, device thrombus is a known potential complication associated with the implantation of an hvad pump.There is no evidence that the patient had a history of thrombus events.There is no evidence to suggest that a device malfunction caused or contributed to the reported event.Based on the investigation conducted and the risk documentation, possible causes of the reported low flow event may be attributed 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 are possible patient, pharmacological and procedural factors that may have contributed to this event.Additional products: d1: outflow graft d4: lot #: 1415164 d10: yes, return date: 17-jun-2020 h3: yes dev rtn to mfr? yes h6: fda method code(s): 10, 4112 h6: fda results code(s): 213 h6: fda conclusion code(s): 22, 4310 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP
• Type of Device: VENTRICULAR (ASSIST) BYPASS
• Manufacturer (Section D): HEARTWARE, INC.; 14400 nw 60th ave; miami lakes FL 33014
• MDR Report Key: 10108829
• MDR Text Key: 193311076
• Report Number: 3007042319-2020-03386
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00888707002639
• UDI-Public: 00888707002639
• 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,health
• Type of Report: Initial,Followup
• Report Date: 08/18/2020

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: 11/30/2019
• Device Model Number: 1103
• Device Catalogue Number: 1103
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2020
• Initial Date Manufacturer Received: 05/19/2020
• Initial Date FDA Received: 06/02/2020
• Supplement Dates Manufacturer Received: 08/18/2020
• Supplement Dates FDA Received: 08/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DTBA1D4 ICD, 4135 LEAD, 0292 LEAD, 4549 LEAD; DTBA1D4 ICD, 4135 LEAD, 0292 LEAD, 4549 LEAD
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 67 YR