HEARTWARE® VENTRICULAR ASSIST SYSTEM

MDR report key: 2883270 · Received December 21, 2012

Report

Report Number: 3007042319-2012-00002
Event Type: Injury
Date Received: December 21, 2012
Date of Event: November 25, 2012
Report Date: November 26, 2012
Manufacturer: HEARTWARE, INC
Product Code: DSQ
PMA / PMN Number: P100047
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: GM
Reporter Occupation: HEALTH PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

(B)(4): PRODUCT NOT AVAILABLE FOR RETURN.

Additional Manufacturer Narrative · 1

THE SITE HAS INDICATED THAT THE DEVICE IS NOT GOING TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION; HOWEVER, ATTEMPTS TO UNDERSTAND WHY THE PRODUCT IS NOT BEING RETURNED ARE ON-GOING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN THIRTY (30) DAYS OF RECEIPT. PRODUCT NOT AVAILABLE FOR RETURN.

Description of Event or Problem · 1

THIS EVENT INVOLVED A (B)(6) MALE PATIENT WITH A PAST MEDICAL HISTORY THAT INCLUDED INTERMITTENT ATRIAL FIBRILLATION WHO EXPERIENCED HIGH POWER EVENTS AFTER HEARTWARE LVAD IMPLANTATION. THE INITIAL HEARTWARE LVAD ((B)(4)) WAS IMPLANTED ELECTIVELY VIA THORACOTOMY APPROACH AND SURGERY WAS REPORTED TO HAVE BEEN ESSENTIALLY UNCOMPLICATED. THE PATIENT WAS DISCHARGED TO A REHABILITATION FACILITY TWO WEEKS LATER. POST-OPERATIVELY THE PATIENT EXPERIENCED POSITIVE CRP LEVELS (WITHOUT INFECTIOUS FOCUS) AND A DETERIORATION OF HIS HEART FAILURE. HE DEVELOPED PROGRESSIVE DYSPNEA AND HIGH LVAD POWER CONSUMPTION ALONG WITH HEMOLYSIS MARKERS. AT THE TIME OF THE EVENT, THE PATIENT'S MEDICATIONS INCLUDED ASPIRIN (100 MG), CLOPIDOGREL, PRASUGREL AND LOW MOLECULAR WEIGHT HEPARIN. THIS EVENT WAS TREATED WITH PUMP EXCHANGE WITH ANOTHER HEARTWARE LVAD ((B)(4)).

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	HEARTWARE® VENTRICULAR ASSIST SYSTEM	CIRCULATORY ASSIST SYSTEM	DSQ	HEARTWARE, INC

Patients

Seq	Age	Sex	Outcome	Treatment
1	64 YR		Hospitalization\| L\| R