BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTWARE VENTRICULAR ASSIST SYSTEM - DRIVELINE

    MDR report key: 15725937 · Received November 4, 2022

    Report

    Report Number
    3007042319-2022-08137
    Event Type
    Injury
    Date Received
    November 4, 2022
    Date of Event
    October 28, 2022
    Report Date
    March 28, 2023
    Manufacturer
    HEARTWARE, INC.
    Product Code
    DSQ
    UDI-DI
    00888707003261
    PMA / PMN Number
    P100047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A SUPPLEMENTAL REPORT IS BEING SUBMITTED FOR ADDITIONAL INFORMATION. NEWLY RECEIVED INFORMATION PROVIDED THE LOT NUMBER OF THE DRIVELINE BOOT COVER. ADDITIONAL PRODUCTS: DRIVELINE BOOT COVER D4: LOT#: R024118 INVESTIGATION OF THIS EVENT IS PENDING AND A SUPPLEMENTAL REPORT WILL BE SENT UPON ITS COMPLETION. 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 · 0

    ADDITIONAL PRODUCT: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ DRIVELINE COVER, MODEL #: 1175/ CATALOG #: 1175. DEVICE AVAILABLE FOR EVALUATION: NO. LABELED FOR SINGLE USE: NO. (B)(4). INVESTIGATION OF THIS EVENT IS PENDING AND A SUPPLEMENTAL REPORT WILL BE SENT UPON ITS COMPLETION. ADDITIONAL INFORMATION HAS BEEN REQUESTED REGARDING THE LOT NUMBER OF THE BOOT COVER OF THE EVENT, BUT IT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT. IF ADDITIONAL INFORMATION IS RECEIVED, THE EVENT WILL BE UPDATED AND A SUPPLEMENTAL REPORT WILL BE SENT. 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.

    Additional Manufacturer Narrative · 0

    A SUPPLEMENTAL REPORT IS BEING SUBMITTED FOR DEVICE EVALUATION. PRODUCT EVENT SUMMARY: THE DRIVELINE CABLE ASSOCIATED WITH THE VENTRICULAR ASSIST DEVICE (VAD) AND THE DRIVELINE BOOT COVER WERE NOT RETURNED FOR EVALUATION. REVIEW OF THE PUMP¿S MANUFACTURING DOCUMENTATION AND DRIVELINE BOOT COVER INSPECTION RECORDS CONFIRMED THAT THE ASSOCIATED DEVICES MET ALL REQUIREMENTS FOR RELEASE ONSITE INSPECTION OF THE DRIVELINE CABLE, AS WELL AS VISUAL EVIDENCE PROVIDED BY THE SITE REVEALED THAT THE PREVIOUS DRIVELINE STRAIN RELIEF REPAIR WAS DAMAGED. VISUAL EVIDENCE PROVIDED BY THE SITE REVEALED DAMAGE TO THE DRIVELINE BOOT COVER. THE DAMAGED TO THE BOOT COVER LIKELY AFFECTED THE FUNCTIONALITY OF THE BOOT COVER. AS A RESULT, THE REPORTED EVENT WAS CONFIRMED. ADDITIONALLY, VISUAL EVIDENCE PROVIDED BY THE SITE REVEALED DISCOLORATION OF THE DRIVELINE SHEATH; THIS IS AN ADDITIONAL FINDING NOT RELATED TO THE REPORTED EVENT. A DRIVELINE STRAIN RELIEF REPAIR WAS PERFORMED TO MITIGATE THE REPORTED EVENT. OF NOTE, THE DRIVELINE BOOT COVER WAS REMOVED DURING THE SERVICING PROCEDURE. BASED ON HISTORICAL REVIEW OF SIMILAR EVENTS, THE MOST LIKELY ROOT CAUSE OF THE OBSERVED DRIVELINE SHEATH DISCOLORATION MAY BE ATTRIBUTED TO MULTIPLE FACTORS INCLUDING DESIGN ISSUES AND/OR EXPOSURE TO UV LIGHT. THE MOST LIKELY ROOT CAUSE OF THE DAMAGE TO THE PREVIOUS DRIVELINE STRAIN RELIEF REPAIR AND DRIVELINE BOOT COVER MAY BE ATTRIBUTED, BUT NOT LIMITED, TO WEAR AND/OR THE HANDLING OF THE DEVICES. ADDITIONAL PRODUCTS: D1: DRIVELINE COVER 1175- D4: R024118 H3: YES H6: FDA METHOD CODE(S): B14, B15, B17 H6: FDA RESULTS CODE(S): C07 H6: FDA CONCLUSION CODE(S): D11 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT NOTED THE STRAIN RELIEF CONNECTED TO THE DRIVELINE WAS SEPARATING AGAIN. THE PATIENT PREVIOUSLY HAD REPAIR PERFORMED ON THE SAME AREA. CLINICAL ENGINEERING PERFORMED THE REPAIR. THE STRAIN RELIEF WAS RETRACTED FROM THE CONNECTOR AND THE DRIVELINE COVER WAS REMOVED USING CUTTERS, AND NOTED THAT THE COVER WAS TOO LOOSE AROUND THE CONNECTOR. THE REPAIR WAS SUCCESSFUL AND THE PATIENT LEFT WITH NO DRIVELINE COVER. THE DRIVELINE REMAINS IN USE AND THE DRIVELINE COVER WAS REMOVED FROM SERVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2788291 HEARTWARE VENTRICULAR ASSIST SYSTEM - DRIVELINE VENTRICULAR (ASSISST) BYPASS DSQ HEARTWARE, INC. 1103 00888707003261

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male