BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTWARE VENTRICULAR ASSIST SYSTEM - SEWING RING

    MDR report key: 7495463 · Received May 8, 2018

    Report

    Report Number
    3007042319-2018-01800
    Event Type
    Malfunction
    Date Received
    May 8, 2018
    Date of Event
    April 16, 2018
    Report Date
    August 22, 2022
    Manufacturer
    HEARTWARE, INC.
    Product Code
    DSQ
    UDI-DI
    00888707002639
    PMA / PMN Number
    P100047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REGULATORY REPORT IS BEING SUBMITTED AS PART OF A RETROSPECTIVE REVIEW AND REMEDIATION PER D00595825 DUE TO AN FDA AUDIT OBSERVATION. UPDATED SECTIONS: - G. ALL MANUFACTURERS MFR CONTACT FIRST NAME: UPDATED FROM "ANNE" TO "PAULA" - G. ALL MANUFACTURERS LAST NAME: UPDATED FROM "SCHILLING" TO "BIXBY" - G. ALL MANUFACTURERS EMAIL: UPDATED FROM "[email protected]" TO "[email protected]" - G. ALL MANUFACTURERS PHONE NUMBER: UPDATED FROM "+1(763)505-2036" TO "17635055378" CORRECTED SECTIONS: -B5 DESC EVT PROBLEM: CORRECTED TO INCLUDE SEVERE RIGHT HEART FAILURE AND INTERVENTION. - H6 PATIENT CODES (IME/ANNEX E), IMF (ANNEX F) HEALTH IMPACT, DEVICE CODES (FDD/ANNEX A): CORRECTED TO INCLUDE NEW ANNEX CODES THAT REFLECT THE REPORTED EVENT. -H10 ADDT MANUFACTURER FOR MDR: CORRECTED TO INCLUDE ALL THE INFORMATION IN THE PRODUCT EVENT SUMMARY PRODUCT EVENT SUMMARY: SEWING RING ASSOCIATED WITH (B)(6) WITH LOT NUMBER R022174 WAS RETURNED FOR EVALUATION. THE REPORTED EVENT OF SEWING RING DAMAGE WAS CONFIRMED VIA VISUAL INSPECTION, WHICH REVEALED THAT THE POLYESTER WAS PARTIALLY DETACHED FROM THE METAL RING. SUPPLEMENTAL TESTING REVEALED EVIDENCE OF THE SECOND PASS OF SILICONE BUT FAILED TO IDENTIFY TRACES OF SILICONE OF THE FIRST PASS AS PER MANUFACTURING SPECIFICATIONS. FURTHER EXAMINATION FAILED TO IDENTIFY SEWING PROCESS ON ONE END OF THE POLYESTER THAT SECURES AND ENCAPSULATES THE FELT TO THE SEWING RING. REVIEW OF THE MANUFACTURING AND INSPECTION RECORDS CONFIRMED THAT THE SEWING RING MET ALL REQUIREMENTS PRIOR TO RELEASE. BASED ON THIS INVESTIGATION, THE MOST LIKELY ROOT CAUSE OF THE SEWING RING DAMAGE MAY BE ATTRIBUTED TO DEVIATIONS FROM PROCEDURE DURING THE MANUFACTURING PROCESS. CAPA PR391998 IS INVESTIGATING SEWING RING DAMAGE/LEAKING ASSOCIATED WITH SEPARATION OF THE POLYESTER. EVEN THOUGH THIS CAPA IS CLOSED, THE SEWING RING FALLS WITHIN THE BOUNDS OF THIS CAPA. INFORMATION PROVIDED BY THE SITE INDICATED THAT THE PATIENT HAD SEVERE RIGHT HEART FAILURE AT THE TIME OF IMPLANT WHICH CONTINUED TO WORSEN. THE PATIENT WAS PLACED ON CONTINUOUS VENO-VENOUS HEMOFILTRATION (CVVH) AND EVENTUALLY ON DIALYSIS. BASED ON THE AVAILABLE INFORMATION, THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. PER THE INSTRUCTIONS FOR USE, RIGHT VENTRICULAR FAILURE IS A KNOWN POTENTIAL COMPLICATION ASSOCIATED WITH THE IMPLANTATION OF A VAD. 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 IS 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 · 0

    PRODUCT EVENT SUMMARY: SEWING RING ASSOCIATED WITH HW31004 WITH LOT NUMBER R022174 WAS RETURNED FOR EVALUATION. THE REPORTED EVENT OF SEWING RING DAMAGE WAS CONFIRMED VIA VISUAL INSPECTION, WHICH REVEALED THAT THE POLYESTER WAS PARTIALLY DETACHED FROM THE METAL RING. SUPPLEMENTAL TESTING REVEALED EVIDENCE OF THE SECOND PASS OF SILICONE BUT FAILED TO IDENTIFY TRACES OF SILICONE OF THE FIRST PASS AS PER MANUFACTURING SPECIFICATIONS. FURTHER EXAMINATION FAILED TO IDENTIFY SEWING PROCESS ON ONE END OF THE POLYESTER THAT SECURES AND ENCAPSULATES THE FELT TO THE SEWING RING. REVIEW OF THE MANUFACTURING AND INSPECTION RECORDS CONFIRMED THAT THE SEWING RING MET ALL REQUIREMENTS PRIOR TO RELEASE. BASED ON THIS INVESTIGATION, THE MOST LIKELY ROOT CAUSE OF THE SEWING RING DAMAGE MAY BE ATTRIBUTED TO DEVIATIONS FROM PROCEDURE DURING THE MANUFACTURING PROCESS. MEDTRONIC, INC. (MEDTRONIC) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. 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 IN THE TIME ALLOTTED AND HAS PROVIDED AS MUCH INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC OR ITS EMPLOYEES 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 REPORTING PURSUANT TO PART 803. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE IT 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 FURTHER REPORTED THAT THE PATIENT HAD SEVERE RIGHT HEART FAILURE AT THE TIME OF IMPLANT WHICH CONTINUED TO WORSEN. THE PATIENT WAS PLACED ON CONTINUOUS VENO-VENOUS HEMOFILTRATION (CVVH) AND EVENTUALLY ON DIALYSIS.

    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 AND DESTINATION THERAPY 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. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE VENTRICULAR ASSIST DEVICE (VAD) IMPLANT PROCEDURE THE SEWING RING WAS DAMAGED. UPON ATTACHING THE SEWING RING AND PRIOR TO PLACING THE PUMP, THE PHYSICIAN REPORTED THAT BLOOD WAS LEAKING FROM IN BETWEEN FELT AND METAL ON THE SEWING RING. THE PHYSICIAN STATED IT WAS AS IF THERE WAS NOT ENOUGH GLUE CONNECTING THE TWO PIECES AND THE MATERIAL FELT SOFTER AND DISCOLORED . THE SEWING RING WAS REMOVED AND REPLACED WITH A NEW SEWING RING. THE VAD WAS IMPLANTED AND REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    337928 HEARTWARE VENTRICULAR ASSIST SYSTEM - SEWING RING VENTRICULAR (ASSISST) BYPASS DSQ HEARTWARE, INC. 1153 00888707002639

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Male Other 1103 VAD