BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTWARE VENTRICULAR ASSIST SYSTEM - OUTFLOW GRAFT

    MDR report key: 6138170 · Received December 1, 2016

    Report

    Report Number
    3007042319-2016-04280
    Event Type
    Injury
    Date Received
    December 1, 2016
    Date of Event
    November 10, 2016
    Report Date
    August 19, 2021
    Manufacturer
    HEARTWARE, INC
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    A SUPPLEMENTAL REPORT IS BEING SUBMITTED FOR ADDITIONAL INFORMATION AND CORRECTION. CORRECTION H6: PATIENT IME CODE(S) E1001, E0717, E2338 WERE ADDED. ADDITIONAL PRODUCTS: D4: SERIAL #: (B)(6), UDI #: (B)(4). H6: PATIENT IME CODE(S): E1001, E0717, E2338 H6: IMF CODE(S): F08, F1203, F1903, F2203 H6: IMG CODE(S): G04105 H6: FDA DEVICE CODE(S): A1412 INVESTIGATION OF THIS EVENT IS COMPLETED AND THE FILE WILL BE CLOSED. IF NEW INFORMATION IS RECEIVED, THE FILE WILL BE RE-OPENED AND A SUPPLEMENTAL WILL BE SUBMITTED. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN PROVIDED THAT PROVIDES DETAILS ABOUT THE EVENT. IT STATES THAT THE PATIENT BECAME MORE INTOLERANT OF ACTIVITY AND HAD DYSPNEA ON EXERTION. THE PATIENT COMPLAINED OF ABDOMINAL BLOATING AND DISTENTION AND EDEMA TO HIS LOWER EXTREMITIES. IT WAS NOTED ON HIS DEVICE INTERROGATIONS THAT HIS FLOWS HAVE BEEN GRADUALLY DROPPING AND HE HAD 5 EPISODES IN THE LAST MONTH WHERE THEY DROPPED BELOW 2 L/MIN. A BILATERAL HEART CATH WAS PERFORMED WITH HEMODYNAMICALLY SIGNIFICANT STENOSIS INVOLVING THE ANASTOMOSIS OF THE LVAD OUTFLOW GRAFT TO THE ASCENDING AORTA FOUND. BEST COURSE OF ACTION AT THIS TIME WAS TO UP-LIST PATIENT ON THE TRANSPLANT LIST. INFORMATION PROVIDED ABOUT THE SURGICAL IMPLANT STATES THAT GORTEX WAS PLACED OVER THE ENTIRE HEART AND NOTHING WAS MENTIONED SPECIFICALLY ABOUT THE OUTFLOW GRAFT. THE OUTFLOW GRAFT (B)(4) AND PUMP (B)(4) WERE NOT RETURNED FOR EVALUATION. REVIEW OF THE MANUFACTURING RECORDS CONFIRMED THAT THE ASSOCIATED DEVICES MET ALL REQUIREMENTS PRIOR TO RELEASE. LOG FILE ANALYSIS FROM (B)(6) 2016 REVEALED NORMAL PUMP PARAMETERS AND INTERMITTENT SUCTION. IMAGING OF THE OUTFLOW GRAFT BY THE SITE REVEALED STENOSIS OF THE OUTFLOW GRAFT NEAR THE ANASTOMOSIS SITE, CONFIRMING THE REPORTED EVENT. THERE IS NO EVIDENCE TO SUGGEST THAT A DEVICE MALFUNCTION CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE MOST LIKELY ROOT CAUSE OF THE DECREASE IN FLOW AND PULSATILITY CAN BE ATTRIBUTED TO THE CONFIRMED STENOSIS OF THE OUTFLOW GRAFT NEAR THE ANASTOMOSIS SITE. HEARTWARE WILL SUBMIT A SUPPLEMENTAL REPORT WHEN NEW FACTS ARISES WHICH MATERIALLY ALTERS INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT NOT DIAGNOSIS. THE VENTRICULAR ASSIST SYSTEM IS INDICATED FOR USE AS A BRIDGE TO CARDIAC TRANSPLANTATION IN PATIENTS WHO ARE AT RISK OF DEATH FROM REFRACTORY END-STAGE LEFT VENTRICULAR HEART FAILURE. THE SYSTEM IS DESIGNED FOR IN-HOSPITAL AND OUT-OF-HOSPITAL SETTINGS. THE INSTRUCTIONS FOR USE (IFU) AND PATIENT MANUAL PROVIDE CLEAR INSTRUCTIONS TO MEDICAL PERSONNEL ON PROPER USAGE AND PLACEMENT OF THE HVAD SYSTEM IN ADDITION TO APPROPRIATE HVAD PUMP PARAMETERS. MOREOVER, THE IFU PROVIDES INSTRUCTION TO FURTHER EDUCATE THE PATIENT ABOUT PRODUCT SAFETY, ALARM MANAGEMENT, AND ANTICOAGULATION RECOMMENDATIONS; ADDITIONAL GUIDELINES INSTRUCT BOTH THE USER AND MEDICAL PERSONNEL ON HOW TO RECOGNIZE LOW FLOW ALARMS, THE POTENTIAL CAUSES OF THESE ALARMS, AND THE POTENTIAL COURSES OF ACTION. HEARTWARE WILL SUBMIT A SUPPLEMENTAL REPORT IF NEW FACTS ARISES WHICH MATERIALLY ALTERS INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.

    Additional Manufacturer Narrative · 1

    ASSOCIATED DEVICE: (B)(4), EXP; 06/30/2016, MFR DATE; 06/30/2014, (B)(4). HEARTWARE WILL SUBMIT A SUPPLEMENTAL REPORT WHEN NEW FACTS ARISES WHICH MATERIALLY ALTERS INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT BEGAN HAVING CLINICAL ISSUES IN (B)(6) 2016 WHERE A PULSATILITY AND FLOW DROP WERE SEEN ON THE LOG FILES. AN RADIOGRAPH WAS DONE WHICH REVEALED AN OUTFLOW GRAFT OBSTRUCTION NEAR THE ANASTOMOSIS SITE TO THE ASCENDING AORTA, CAUSING 80 MM PRESSURE GRADIENT FROM GRAFT TO AORTA. THE CAUSE AT THIS TIME IS UNKNOWN. HOWEVER, PATIENT HAS BEEN UPLISTED TO STATUS 1A ON THE CARDIAC TRANSPLANT LIST AND THE CAUSE MAY BE INVESTIGATED DURING TRANSPLANT WHEN PATIENT'S NATIVE HEART AND VAD ARE EXAMINED. THE PATIENT IS CURRENTLY AWAITING TRANSPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    788877 HEARTWARE VENTRICULAR ASSIST SYSTEM - OUTFLOW GRAFT CIRCULATORY ASSIST SYSTEM, PRODUCT CODE, PRODUCT CODE DSQ HEARTWARE, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| L| R