MAUDE Adverse Event Report: MEDTRONIC; HEARTWARE

Catalog Number 1103

Device Problems Occlusion Within Device (1423); Insufficient Flow or Under Infusion (2182)

Patient Problem Death (1802)

Event Date 01/04/2019

Event Type  Death  

Event Description

Heartware pt implanted on (b)(6) 2018.Pt has a history of medication non-compliance; recently discharged from hosp on (b)(6) 2018 following hypoglycemia admission and also significant, recent admission (b)(6) 2018 for elevated ldh and splenic infarct 2/2 warfarin non-compliance.Pt presented to the vad clinic for post-discharge appt on (b)(6) 2019 complaining of intermittent fatigue and dizziness, but otherwise stated he felt fine.Vad interrogation revealed frequent low flow alarms, which started at noon that day.Flow was 0.5l/min, with no pulsatility noted.Vitals were stable.Vad hum auscultated.Inr sub-therapeutic, pt admitted to not "have" taken warfarin since discharge last admission.Pt admitted to cvicu for tpa.Overnight, several issues occurred.After receiving tpa bolus, pt became hypoxic and flushed.Bipap and supplemental o2 ordered as needed.Pt continued to experience multiple low flow alarms.Pt also became increasingly hypotensive, requiring inotropic and pressor support.Palliative care was consulted for end-of life decisions as pt is not a candidate for pump exchanged 2/2 non-compliance.Pt elected to be a dnr and declined any surgical intervention.Pt continued to decline throughout the day on (b)(6) 2019.Support was withdrawn per family request.Inotropes were stopped and pump was turned off.Pt was pronounced dead at 1534.

• Brand Name: MEDTRONIC
• Type of Device: HEARTWARE
• MDR Report Key: 8260711
• MDR Text Key: 133761248
• Report Number: 8260711
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/30/2023
• Device Catalogue Number: 1103
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/08/2019
• Distributor Facility Aware Date: 01/04/2019
• Device Age: 6 MO
• Event Location: Hospital
• Date Report to Manufacturer: 01/08/2019
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 61 YR
• Patient Weight: 80