FDA Adverse Event Death Summary report: N

ABBOTT

MDR report key: 7296021 · Received February 19, 2018

Report

Report Number
7296021
Event Type
Death
Date Received
February 19, 2018
Date of Event
February 8, 2018
Report Date
February 15, 2018
Product Code
DSQ
Adverse Event
Yes
Report Source
User Facility report
Reporter Location
SC, US
Reporter Occupation
NURSE

Narratives

Description of Event or Problem · 1

ON (B)(6) 2018 - PATIENT WAS IMPLANTED WITH A HM3. ON (B)(6) 2018 A BAT WAS CALLED BECAUSE IT WAS DISCOVERED THAT THE PATIENT WAS UNABLE TO MOVE HIS LEFT SIDE EXTREMITIES AFTER SEDATION WAS TURNED OFF. PATIENT WENT DOWN FOR A STAT HEAD CT. THE CT REVEALED AN OCCLUSION OF THE RIGHT ICA AND PROXIMAL MCA. A PERFUSION STUDY REVEALED A SMALL CORE INFARCT WITH A LARGE PENUMBRA INVOLVING THE RIGHT MCA TERRITORY. HE WAS IMMEDIATELY TAKEN TO SPECIALS FOR INTERVENTION. NEURO WAS ON BOARD. PATIENT'S INR AT THIS TIME WAS 1.6 DESPITE PATIENT BEING OFF ANTICOAGULATION. HE WAS ON ASPIRIN 325. AT THIS TIME, SPEED WAS 5000 RPMS, EPI 10 MCGS, LEVO OFF AND MAPS IN 70S - 80S. THROMBECTOMY WAS PERFORMED IN SPECIALS. PATIENT WAS TAKEN BACK TO ROOM. AT THIS TIME, THERE WAS CEREBRAL ATROPHY, BUT NO EVIDENCE OF MASS HEMORRHAGE OR EARLY SIGNS OF ISCHEMIA. IN LATE AFTERNOON OF SAME DAY, PATIENT'S NEURO STATUS CHANGED. HE BECAME NONREACTIVE AND OBTUNDED. STAT HEAD CT WAS PERFORMED AGAIN AND REVEALED A HEMORRHAGIC CONVERSION AND VENTRICULAR HEMORRHAGE WITH HYDROCEPHALUS AND DIFFUSE CEREBRAL EDEMA. IT INCLUDED A 7 CM DIAMETER INTRAPARENCHYMAL HEMATOMA INFARCT. LATER THAT EVENING THE VAD COORDINATOR WAS INFORMED THE PATIENT WAS NOT RESPONDING TO LEVO OR VASOPRESSIN AND BECAME MORE HYPOTENSIVE. MAP WAS 50. NP ARRIVED AT BEDSIDE TO SPEAK WITH FAMILY AND THEIR OPTIONS. END OF LIFE WAS DISCUSSED. DURING THE DISCUSSION WITH FAMILY, THE PATIENT'S RHYTHM CHANGED TO ASYSTOLE AND THEN A WIDE COMPLEX WITH A RATE OF 85. PATIENT'S FAMILY DECIDED TO WITHDRAW CARE ONCE THE MONITOR CONVERTED TO COMPLETE ASYSTOLE. PATIENT DID HAVE AICD. CARE WAS WITHDRAWN AND LVAD WAS TURNED OFF BY COORDINATOR AT BEDSIDE. PATIENT'S TIME OF DEATH WAS 2220.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
124838 ABBOTT HEARTMATE III DSQ

Patients

Seq Age Sex Outcome Treatment
0 61 YR Death| L
1 61 YR Death| L