BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOTUS INTRODUCER SET

    MDR report key: 4898164 · Received July 3, 2015

    Report

    Report Number
    3004193842-2015-00016
    Event Type
    Injury
    Date Received
    July 3, 2015
    Date of Event
    June 16, 2015
    Report Date
    June 29, 2015
    Manufacturer
    CREGANNA MEDICAL DEVICES
    Product Code
    DYB
    PMA / PMN Number
    K140338
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6).

    Additional Manufacturer Narrative · 1

    THIS ADVERSE EVENT IS PART OF CLINICAL STUDY REPRISE III 0763R3029. DEVICE REVIEW COULD NOT CONFIRM THE REPORTED COMPLAINT AS THE DEVICE WAS NOT RECEIVED FOR REVIEW. A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR LOT# 253853 DID NOT HIGHLIGHT ANY ANOMALY WHICH COULD CONTRIBUTE TO THIS REPORTED EVENT. FROM THE INFORMATION AVAILABLE, THERE IS NOTHING TO INDICATE THAT THE DEVICE WAS NOT USED PER THE DIRECTIONS FOR USE/PRODUCT LABEL. AS OF 07/20/2015 TWO FURTHER COMPLAINTS HAVE BEEN OPENED IN RELATION TO LOT# 253853. THE ROOT CAUSE COULD NOT BE DETERMINED AND DEVICES WERE NOT RETURNED FOR BOTH COMPLAINTS LOT-PC15-016 AND LOT-PC15-017. THE REPORTED EVENTS ARE NOT SIMILAR TO THIS COMPLAINT (LOT-PC15-028) AND THEREFORE NO TREND CAN BE IDENTIFIED. THE MOST PROBABLE ROOT CAUSE CLASSIFICATION CODE ASSIGNED TO THIS COMPLAINT IS "ANTICIPATED PROCEDURAL COMPLICATION" WHERE ANALYSIS OF ALL AVAILABLE INFORMATION DETERMINED THAT THE REPORTED EVENT IS ANTICIPATED PROCEDURAL COMPLICATION AS DETAILED WITHIN THE IFU. BASED ON A REVIEW OF THE FMEAS, VESSEL DISSECTION AS A REPORTED CLASSIFICATION IS NOT A NEW OR UNANTICIPATED FAILURE MODE. NO UPDATES ARE REQUIRED FOR RISK DOCUMENTATION BASED ON THIS COMPLAINT. CREGANNA MEDICAL WILL CONTINUE TO MONITOR OCCURRENCE RATES PER THE RISK DOCUMENTATION. THIS IS CONSIDERED THE FINAL REPORT.

    Description of Event or Problem · 1

    THE SUBJECT WAS RANDOMIZED INTO THE (B)(6) STUDY ON (B)(6)2015. THE INDEX PROCEDURE WAS PERFORMED ON (B)(6) 2015. PRIOR TO THE INDEX PROCEDURE, HEPARIN OR OTHER ANTICOAGULANT WAS GIVEN AND THE SUBJECT RECEIVED A LOADING DOSE OF 300 MG OF CLOPIDOGREL. A LOTUS INTRODUCER WAS PLACED AND THEN THE AORTIC VALVE WAS TREATED WITH BALLOON VALVULOPLASTY AND SUBSEQUENT DEPLOYMENT OF A 23 MM LOTUS VALVE. SUCCESSFUL REPOSITIONING OF THE LOTUS VALVE INVOLVED PARTIAL RESHEATHING OF THE LOTUS VALVE IN THE DELIVERY SYSTEM CATHETER AND DEPLOYMENT INTO A MORE ACCURATE POSITION WITHIN THE AORTIC ANNULUS. RETRIEVAL WAS NOT ATTEMPTED. EVENT DESCRIPTION: RIGHT EXTERNAL ILIAC PERFORATION (001) / RIGHT COMMON ILIAC DISSECTION (002). ON (B)(6) 2015, DURING THE INDEX PROCEDURE, RIGHT EXTERNAL ILIAC ARTERY PERFORATION AND RIGHT COMMON ILIAC ARTERY DISSECTION OCCURRED. THE RIGHT EXTERNAL ILIAC ARTERY PERFORATION WAS TREATED WITH A 7MM BALLOON AND AN "8X100 VIABAHN STENT" FOLLOWED BY POST DILATATION WITH A 6MM BALLOON. THE SUBJECT ALSO UNDERWENT BLOOD TRANSFUSION. OF NOTE, PER SITE CONFIRMATION THE "LOUTS INTRODUCER" SHEATH WAS RESPONSIBLE FOR THE RIGHT COMMON ILIAC ARTERY DISSECTION. THE VARC CLASSIFICATION FOR THE BLEEDING EVENT WAS LIFE-THREATENING OR DISABLING. THE VARC CLASSIFICATION FOR VASCULAR COMPLICATION WAS MAJOR. ON (B)(6) 2015, THE EVENT RIGHT COMMON ILIAC DISSECTION (002) WAS CONSIDERED TO BE RESOLVED. AT THE TIME OF REPORTING, THE EVENT RIGHT EXTERNAL ILIAC PERFORATION (001) WAS CONSIDERED RECOVERING/ RESOLVING. POTENTIAL RELATIONSHIP TO STUDY PROCEDURE PER INVESTIGATOR (FOR 001 AND 002); RELATED. ADJUDICATION RESULTS: EVENT 1: RIGHT EXTERNAL ILIAC PERFORATION . ADJUDICATION RESULTS: PENDING. EVENT 2: RIGHT EXTERNAL ILIAC PERFORATION. ADJUDICATION RESULTS: PENDING. EVENT 3: RIGHT COMMON ILIAC DISSECTION. ADJUDICATION RESULTS: NO CEC ADJUDICATION RESULTS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    433951 LOTUS INTRODUCER SET INTRODUCER CATHETER DYB CREGANNA MEDICAL DEVICES J840MTR19- 253953

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R