MAUDE Adverse Event Report: HEARTWARE INC. HVAD PUMP IMPLANT KIT; VENTRICULAR (ASSIST) BYPASS

Model Number 1103

Device Problems Obstruction of Flow (2423); Material Deformation (2976); Mechanics Altered (2984); Scratched Material (3020)

Patient Problems Stroke/CVA (1770); Cognitive Changes (2551); Convulsion/Seizure (4406); Heart Failure/Congestive Heart Failure (4446)

Event Date 12/02/2021

Event Type  Death  

Event Description

(b)(6) patient developed pump thrombus, leading to death.Detail of note: pump analysis says 'external factors' deformed the pump, causing the impeller to make contact with rear housing.Treatment summary: the patient was admitted for ventricular assist device (vad) high power and suspected thrombus.In addition, the patient was showing signs and symptoms of heart failure and their international normalized ratio (inr) was 2.6.The patient was given 2 doses of tissue plasminogen activator (tpa) to treat the thrombus.After the tpa treatment, the patient experienced changes in mental status and a hemorrhagic stroke.The patient continued to decline neurologically, and an electroencephalogram (eeg) showed continuous seizing.The decision was made to withdraw care and the patient subsequently passed away.Device analysis: analysis of the pump revealed the device did not pass visual inspection or dimensional verification.Visual examination revealed abrasions on the lower housing ceramic surface and on the inferior surface of the impeller.These mechanical abrasions of the lower housing ceramic surface and matching surface of the impeller are indicative that an external factor may have forced the impeller against the rear housing which led to scoring marks observed during visual inspection.Dimensional verification revealed the front and rear housing disc curvatures were found to be deviating from specifications.

• Brand Name: HVAD PUMP IMPLANT KIT
• Type of Device: VENTRICULAR (ASSIST) BYPASS
• Manufacturer (Section D): HEARTWARE INC.; 8200 coral sea street ne; mvs46; moundsview MN 55112
• MDR Report Key: 15093562
• MDR Text Key: 296487813
• Report Number: 15093562
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: 1103
• Device Catalogue Number: 1103
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/18/2022
• Device Age: 4 YR
• Event Location: Hospital
• Date Report to Manufacturer: 07/25/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 25550 DA
• Patient Sex: Male
• Patient Weight: 64 KG