MAUDE Adverse Event Report: ABBOTT LABORATORIES (FORMALLY SJM AND THORATEC) HEARTMATE II

Device Problems Signal Artifact/Noise (1036); Occlusion Within Device (1423)

Patient Problems Hemolysis (1886); Thrombus (2101)

Event Date 11/22/2017

Event Type  Injury  

Event Description

Pt with previous admissions on (b)(6) 2017 for a subocclusive lvad thrombus as evidenced by a positive ramp echo's and elevated ldh.Pt's status changed to 1a on the unos transplant waiting list (b)(6) 2017 due to hemolysis and thrombus.Pt admitted again on (b)(6) 2017 due to an ldh of 910.Bivalirudin was initiated.Despite bivalirudin infusing the ldh remained elevated, peak ldh was 1383 on (b)(6) 2017.Urine studies with evidence of hemolysis on (b)(6) 2017 with a rise in the pt's creatinine.Ramp echo on (b)(6) 2017 showed the aov remained open at 11400 rpms.A cardiac morphology ct was performed on (b)(6) 2017 which showed decreased hounsfield unit attenuation in the outflow portion of the lvad, there was also some linear streaking suggestive of beam hardening artifact, a thrombus could not be ruled out.The decision was made to exchange the hm ii lvad which occurred on (b)(6) 2017.Surgery went well, the surgeon was able to identify a thrombus on the inflow side of the pump, on the inflow stator.The pt is doing well and is currently recovering on our telemetry unit.

• Brand Name: HEARTMATE II
• Type of Device: HEARTMATE II
• Manufacturer (Section D): ABBOTT LABORATORIES (FORMALLY SJM AND THORATEC); pleasanton CA 94588
• MDR Report Key: 7078741
• MDR Text Key: 93755242
• Report Number: MW5073693
• 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: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• 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): Hospitalization; Required Intervention
• Patient Age: 63 YR
• Patient Weight: 117