BEUDAMED
    FDA Adverse Event Death Summary report: N

    CONFIDA BRECKER CURVE GUIDEWIRE

    MDR report key: 3843164 · Received June 2, 2014

    Report

    Report Number
    2025587-2014-00342
    Event Type
    Death
    Date Received
    June 2, 2014
    Date of Event
    May 6, 2014
    Report Date
    September 22, 2014
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    DQX
    PMA / PMN Number
    K132623
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SUBSEQUENTLY CORRECTED INFORMATION WAS OBTAINED THAT THE PATIENT'S IMPLANT DATE WAS (B)(6) 2014 AND DEATH DATE WAS (B)(6) 2014.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THA THE DEVICE WAS NOT AVAILABLE FOR RETURN. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND THE INVESTIGATION CONTINUES. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: NO EVAL EXPLAIN CODE.

    Additional Manufacturer Narrative · 1

    BASED ON THE ADDITIONAL INFORMATION RECEIVED, THE TYPE OF REPORTABLE EVENT STATUS HAS BEEN CHANGED TO DEATH. THE PROVIDED DATE OF DEATH IS INCORRECT, AS IT PRECEDES THE EVENT DATE. THE CORRECT DATE HAS BEEN REQUESTED; A SUPPLEMENTAL REPORT WILL BE FILED WHEN ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    INVESTIGATION CONCLUSION: EFFUSION IS A KNOWN EFFECT THAT CAN OCCUR AFTER CARDIAC PROCEDURES. WITHOUT THE RETURN OF THE GUIDEWIRE FOR EVALUATION, WE ARE UNABLE TO CONCLUSIVELY DETERMINE THE CAUSE FOR THIS EVENT WITH THE LIMITED INFORMATION AVAILABLE. REVIEW OF THE DEVICE HISTORY RECORD WAS CONDUCTED AND SHOWED THE DEVICE MET ALL MANUFACTURING SPECIFICATIONS FOR PRODUCT RELEASED TO DISTRIBUTION.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT FOLLOWING THE DEPLOYMENT OF A TRANSCATHETER BIOPROSTHETIC VALVE, SIGNIFICANT AND RAPID ONSET HYPOTENSION WAS NOTED, AND A CARDIAC EFFUSION SUBSEQUENTLY WAS LOCATED AT THE APEX OF THE LEFT VENTRICLE. THE PHYSICIAN SUSPECTED THAT THIS GUIDEWIRE HAD CAUSED A 0.5 CENTIMETER LACERATION TO THE APEX OF THE LEFT VENTRICLE DURING OR JUST AFTER DEPLOYMENT OF THE VALVE. THE HEART WAS DRAINED VIA PERICARDIOCENTESIS BUT THIS DID NOT ALLEVIATE THE CONDITION. A SURGICAL TEAM REPAIRED THE LACERATION BY SEWING A TEFLON PATCH INTO PLACE. THE PATIENT WAS ADMITTED TO AN INTENSIVE THERAPY UNIT FOR RECOVERY. NO SUBSEQUENT ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    SUBSEQUENTLY IT WAS REPORTED THAT THE PATIENT PASSED AWAY FOLLOWING THE PROCEDURE. THE PHYSICIAN REPORTED THAT THE CAUSE OF DEATH WAS DUE TO THE COMPLICATIONS ORIGINALLY CAUSED BY THE GUIDEWIRE LACERATION (PHYSICAL TRAUMA OF HAVING THE CHEST SURGICALLY OPENED TO REPAIR THE LACERATION AND THE PROLONGATION OF THE PROCEDURE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321589 CONFIDA BRECKER CURVE GUIDEWIRE WIRE, GUIDE, CATHETER DQX MEDTRONIC HEART VALVES DIVISION GWBC30 91400189

    Patients

    Seq Age Sex Outcome Treatment
    1 00081 YR Death| R