FDA Adverse Event Injury Summary report: N

HEARTMATE II LVAD

MDR report key: 2771873 · Received October 2, 2012

Report

Report Number: 2916596-2012-00930
Event Type: Injury
Date Received: October 2, 2012
Date of Event: September 4, 2012
Report Date: September 5, 2012
Manufacturer: THORATEC CORP.
Product Code: DSQ
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: OK, US
Reporter Occupation: BIOMEDICAL ENGINEER

Narratives

Additional Manufacturer Narrative · 1

THE EXPLANTED DEVICE WAS RETURNED TO THE MFR FOR EVAL AND IS CURRENTLY BEING ANALYZED. NO FURTHER INFO IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE DEVICE ANALYSIS IS COMPLETED.

Description of Event or Problem · 1

THE PT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). IT WAS REPORTED BY THE BIO MED THAT THE PT STARTED HAVING HIGH POWER AND HIGH PLASMA FREE HEMOGLOBIN 3-4 WEEKS POST-IMPLANT. THE PT HAD ADVANCED CT SCANNING WITH 3-D RECONSTRUCTION TO RULE OUT MECHANICAL OBSTRUCTION WITH PUMP SURGICAL PLACEMENT. THE PT ALSO WAS CHANGED OVER TO AGGRESSIVE PLATELET INHIBITION AND CHANGED FROM BABY ASPIRIN TO FULL ASPIRIN. HE WAS CHANGED OVER FROM PLAVIX TO BRYLENTA ALONG WITH HIGH INTERNATIONAL NORMALISED RATIO (INR) TARGET OF 3-3.5. PT CONTINUED TO HAVE INCREASED HEMOLYSIS AND INCREASED POWER CONSUMPTION AND WAS ADMITTED TO HOSP FOR PLACEMENT OF IV ANTICOAGULATION. PT WAS ORIGINALLY BTT AND HEMOLYSIS SLOWLY RESULTED AND DECISION WAS MADE TO LIST PT AS 1A STATUS DUE TO LVAD COMPLICATION, AWAITING HEART TRANSPLANT. HEMOLYSIS WAS KEPT TO MINIMUM LEVEL WITHOUT ANY RED BLOOD CELL DAMAGE WHILE AWAITING HEART TRANSPLANT. THE PT UNDERWENT ORTHOTOPIC TRANSPLANT ON (B)(6) 2012 AND THE LVAD WAS EXPLANTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	HEARTMATE II LVAD	DSQ: LEFT VENTRICULAR ASSIST DEVICE	DSQ	THORATEC CORP.	104911	112470

Patients

Seq	Age	Sex	Outcome	Treatment
1	66 YR		Required Intervention