BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP

    MDR report key: 12253182 · Received July 30, 2021

    Report

    Report Number
    3007042319-2021-05530
    Event Type
    Injury
    Date Received
    July 30, 2021
    Date of Event
    July 23, 2021
    Report Date
    October 4, 2021
    Manufacturer
    HEARTWARE, INC.
    Product Code
    DSQ
    UDI-DI
    00888707002639
    PMA / PMN Number
    P100047
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    A SUPPLEMENTAL REPORT IS BEING SUBMITTED FOR DEVICE EVALUATION. PRODUCT EVENT SUMMARY: THE VAD WAS RETURNED FOR EVALUATION. VARIOUS ANALYSES WERE CONDUCTED AND REVIEWED IN ORDER TO EVALUATE THE PE RFORMANCE OF THE DEVICE IN RELATION TO THE REPORTED EVENT. REVIEW OF THE MANUFACTURING RECORDS CONFIRMED THAT THE ASSOCIATED PUMP MET ALL REQUIREMENTS PRIOR TO RELEASE. FAILURE ANALYSIS OF THE RETURNED PUMP REVEALED THAT THE DEVICE PASSED FUNCTIONAL TESTING. DIMENSIONAL VERIFICATION REVEALED THAT THE FRONT AND REAR HOUSING DISC CURVATURES WERE FOUND TO BE DEVIATING FROM SPECIFICATIONS. GIVEN THAT THE PUMP MET SPECIFICATIONS PRIOR TO RELEASE, THESE DEVIATIONS WERE LIKELY A RESULT OF THE CLINICAL CHALLENGE TO THE PUMP, AND, BASED ON THE NULL IMPACT ON THE WET TEST POWER CONSUMPTION, THESE DEVIATIONS ARE NOT EXPECTED TO IMPACT PUMP PERFORMANCE. VISUAL EXAMINATION REVEALED ABRASIONS ON THE LOWER HOUSING CERAMIC SURFACE AND ON THE INFERIOR SURFACE OF THE IMPELLER. THESE MECHANICAL ABRASIONS OF THE LOWER HOUSING CERAMIC SURFACE AND MATCHING SURFACE OF THE IMPELLER ARE INDICATIVE THAT AN EXTERNAL FACTOR SUCH AS THROMBUS MAY HAVE FORCED THE IMPELLER AGAINST THE REAR HOUSING WITH SUFFICIENT STRENGTH TO OVERCOME THE REAR PRELOAD OF THE MAGNETIC SPRING/SUSPENSION SYSTEM. INTERNAL PATHOLOGICAL REPORT REVEALED NO EVIDENCE OF THROMBUS WITHIN THE DEVICE. LOG FILE ANALYSIS REVEALED AN INCREASE IN POWER CONSUMPTION STARTING (B)(6) 2021, LEADING TO PARAMETERS ABOVE NORMAL OPERATING RANGE, AND ONE HIGH WATT ALARM LOG GED ON 23/JUL/2021. AS A RESULT, THE REPORTED HIGH POWER EVENT WAS CONFIRMED. BASED ON THE HISTORICAL REVIEW OF SIMILAR HIGH POWER EVENTS AND THE INVESTIGATION CONDUCTED, THE MOST LIKELY ROOT CAUSE OF THE HIGH POWER EVENT CAN BE ATTRIBUTED TO EXTERNAL FACTORS SUCH AS THROMBUS FORMATION/INGESTION. POSSIBLE CLINICAL FACTORS THAT MAY HAVE CONTRIBUTED TO THIS EVENT INCLUDE THE PATIENT¿S PRE-EXISTING HISTORY AND RELATED COMORBIDITIES, THE PROGRESSION OF THEIR UNDERLYING DISEASE, ISSUES RELATED TO THE THERAPEUTIC USE OF ANTICOAGULANT AND ANTIPLATELET MEDICATIONS AND THE PATIENT'S COMPLEX POST-OPERATIVE COURSE. THERE ARE POSSIBLE PATIENT, PHARMACOLOGICAL AND PROCEDURAL FACTORS THAT MAY HAVE CONTRIBUTED TO THIS EVENT. 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

    INVESTIGATION OF THIS EVENT IS PENDING AND A SUPPLEMENTAL REPORT WILL BE SENT UPON ITS COMPLETION. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VENTRICULAR ASSIST DEVICE (VAD) EXHIBITED HIGH POWER CONSUMPTION AND HIGH WATT ALARMS. THE PATIENT PRESENTED WITH DARK URINE AND ELEVATED LACTATE DEHYDROGENASE (LDH). THE VAD WAS EXCHANGED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1151496 HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP VENTRICULAR (ASSISST) BYPASS DSQ HEARTWARE, INC. 1103 00888707002639

    Patients

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