BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOTUS INTRODUCER SET

    MDR report key: 4992690 · Received August 11, 2015

    Report

    Report Number
    3004193842-2015-00019
    Event Type
    Injury
    Date Received
    August 11, 2015
    Date of Event
    April 1, 2015
    Report Date
    July 29, 2015
    Manufacturer
    CREGANNA MEDICAL ALSO D/B/A CREGANNA-TACTX MEDICAL
    Product Code
    DYB
    PMA / PMN Number
    K140338
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE REVIEW COULD NOT CONFIRM THE REPORTED COMPLAINT AS THE DEVICE WAS NOT RECEIVED FOR REVIEW. A REVIEW OF THE MANUFACTURING DOCUMENTATION DID NOT IDENTIFY ANY ANOMALY WHICH COULD CONTRIBUTE TO THE REPORTED EVENT. LHR FOR LOT 221688 WAS REVIEWED ON THE 08 AUG 2016. NO OBSERVATIONS WERE IDENTIFIED WHICH COULD POTENTIALLY CONTRIBUTE TO THE REPORTED EVENT. DEVIATIONS AND NCRS SPECIFIC TO PRODUCTION OF THIS LOT WERE ALSO REVIEWED AND NO ISSUES WERE FOUND. IT WAS CONFIRMED THAT TRAINING RECORDS FOR ALL OPERATORS WERE UP-TO-DATE. A SIMILAR COMPLAINT REVIEW WAS COMPLETED FOR LOT # 221688. COMPLAINT LOT-PC15-014 AND LOT-PC15-023 DETAIL AN 'AS REPORTED CLASSIFICATION' OF 'PATIENT - VESSEL DISSECTION' WHICH IS SIMILAR TO THIS COMPLAINT LOT-PC15-031. THE LOT SIZE SHIPPED FOR LOT # 221688 IS 275 DEVICES. VESSEL DISSECTION IS AN ANTICIPATED PROCEDURAL COMPLICATION AS DETAILED WITHIN THE IFU. A REVIEW OF THE CLINICAL EVALUATION REPORT (CER13607) CONFIRMED THAT VESSEL DISSECTION IS COMMON WITH THESE DEVICES. SEE BELOW EXTRACT FROM CER13607; AVAILABLE TRANSCATHETER VALVES REQUIRE LARGE INTRODUCER SHEATHS, WHICH ARE A RISK FOR MAJOR VASCULAR COMPLICATIONS LARGE SHEATHS CAN ALSO CAUSE MAJOR VASCULAR COMPLICATIONS VESSEL DISSECTION WITH LARGE SHEATHS AND CATHETERS IS A RISK. FROM THE INFORMATION AVAILABLE, THERE IS NOTHING TO INDICATE THAT THE DEVICE WAS NOT USED PER THE DIRECTIONS FOR USE/PRODUCT LABEL. 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 AN 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. WE WILL CONTINUE TO MONITOR OCCURRENCE RATES PER THE RISK DOCUMENTATION. BASED ON THE ABOVE CONCLUSION NO FURTHER ESCALATION OR CORRECTIVE ACTION IS REQUIRED AT THIS TIME. WE WILL CONTINUE TO MONITOR FOR THESE COMPLAINT TYPES.

    Additional Manufacturer Narrative · 1

    THE PURPOSE OF (B)(6) IS TO COLLECT REAL WORLD CLINICAL AND DEVICE PERFORMANCE OUTCOMES DATA WITH THE LOTUS VALVE SYSTEM USED IN ROUTINE CLINICAL PRACTICE TO DEMONSTRATE THAT THE COMMERCIALLY AVAILABLE LOTUS VALVE SYSTEM IS A SAFE AND EFFECTIVE TREATMENT FOR PATIENTS WITH SEVERE CALCIFIC AORTIC STENOSIS. DEVICE REVIEW COULD NOT CONFIRM THE REPORTED COMPLAINT AS THE DEVICE WAS NOT RECEIVED FOR REVIEW. A REVIEW OF THE MANUFACTURING DOCUMENTATION COULD NOT BE PERFORMED AS THE BATCH NUMBER IS UNKNOWN. A SIMILAR COMPLAINT BATCH REVIEW COULD NOT BE PERFORMED AS THE BATCH NUMBER IS NOT KNOWN. FROM THE INFORMATION AVAILABLE, THERE IS NOTHING TO INDICATE THAT THE DEVICE WAS NOT USED PER THE DIRECTIONS FOR USE/PRODUCT LABEL. 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 AN 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. WE WILL CONTINUE TO MONITOR OCCURRENCE RATES PER THE RISK DOCUMENTATION. BASED ON THE ABOVE CONCLUSION NO FURTHER ESCALATION OR CORRECTIVE ACTION IS REQUIRED AT THIS TIME. WE WILL CONTINUE TO MONITOR FOR THESE COMPLAINT TYPES.

    Description of Event or Problem · 1

    "RESPOND (B)(6) (DISSECTION OF FEMORAL ARTERY). PROCEDURE SUMMARY: THE SUBJECT WAS ENROLLED INTO THE RESPOND STUDY ON (B)(6) 2015. PRIOR TO THE INDEX PROCEDURE, HEPARIN OR OTHER ANTICOAGULANT WAS GIVEN AND THE SUBJECT RECEIVED A LOADING DOSE OF 600 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. THERE WAS CORRECT POSITIONING OF A SINGLE PROSTHETIC HEART VALVE INTO THE PROPER ANATOMICAL LOCATION AND NEITHER REPOSITIONING NOR RETRIEVAL WAS ATTEMPTED. EVENT DESCRIPTION: DISSECTION OF FEMORAL ARTERY (001): ON (B)(6) 2015, DURING INDEX PROCEDURE, DISSECTION WAS NOTED IN THE FEMORAL ARTERY. PER ANSWERED QUERY, SITE CONFIRMED THAT THE DISSECTION WAS CAUSED BY THE LOTUS INTRODUCER. VARC SEVERITY: MINOR. THE SUBJECT WAS TREATED WITH PTA WITHOUT STENTING. ON (B)(6) 2015, THE EVENT WAS CONSIDERED TO BE RECOVERED/ RESOLVED. POTENTIAL RELATIONSHIP TO STUDY PROCEDURE PER INVESTIGATOR: RELATED HB DROP (002): ON (B)(6) 2015, 2 DAYS POST INDEX PROCEDURE, THE SUBJECT'S HEMOGLOBIN DROPPED FROM 11.8 G/DL TO 9 G/DL. VARC BLEEDING CLASSIFICATION: MAJOR. THE SUBJECT WAS TREATED WITH BLOOD TRANSFUSION. ON (B)(6) 2015, THE EVENT WAS CONSIDERED TO BE RECOVERED/ RESOLVED. POTENTIAL RELATIONSHIP TO STUDY PROCEDURE PER INVESTIGATOR: RELATED"

    Description of Event or Problem · 1

    (B)(6) (DISSECTION OF FEMORAL ARTERY). PROCEDURE SUMMARY: THE SUBJECT WAS ENROLLED INTO (B)(6) ON (B)(6)-2015. PRIOR TO THE INDEX PROCEDURE, HEPARIN OR OTHER ANTICOAGULANT WAS GIVEN AND THE SUBJECT RECEIVED A LOADING DOSE OF 600 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. THERE WAS CORRECT POSITIONING OF A SINGLE PROSTHETIC HEART VALVE INTO THE PROPER ANATOMICAL LOCATION AND NEITHER REPOSITIONING NOR RETRIEVAL WAS ATTEMPTED. EVENT DESCRIPTION: DISSECTION OF FEMORAL ARTERY (001): ON (B)(6)-2015, DURING INDEX PROCEDURE, DISSECTION WAS NOTED IN THE FEMORAL ARTERY. PER ANSWERED QUERY, SITE CONFIRMED THAT THE DISSECTION WAS CAUSED BY THE LOTUS INTRODUCER. VARC SEVERITY: MINOR. THE SUBJECT WAS TREATED WITH PTA WITHOUT STENTING. (B)(6)-2015, THE EVENT WAS CONSIDERED TO BE RECOVERED/ RESOLVED. POTENTIAL RELATIONSHIP TO STUDY PROCEDURE PER INVESTIGATOR: RELATED HB DROP (002): ON (B)(6)-2015, 2 DAYS POST INDEX PROCEDURE, THE SUBJECT'S HEMOGLOBIN DROPPED FROM 11.8 G/DL TO 9 G/DL. VARC BLEEDING CLASSIFICATION: MAJOR. THE SUBJECT WAS TREATED WITH BLOOD TRANSFUSION. ON (B)(6)-2015, THE EVENT WAS CONSIDERED TO BE RECOVERED/ RESOLVED. POTENTIAL RELATIONSHIP TO STUDY PROCEDURE PER INVESTIGATOR: RELATED"

    Description of Event or Problem · 1

    "RESPOND (B)(6) (DISSECTION OF FEMORAL ARTERY); PROCEDURE SUMMARY: THE SUBJECT WAS ENROLLED INTO THE (B)(6) STUDY ON (B)(6) 2015. PRIOR TO THE INDEX PROCEDURE, HEPARIN OR OTHER ANTICOAGULANT WAS GIVEN AND THE SUBJECT RECEIVED A LOADING DOSE OF 600 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. THERE WAS CORRECT POSITIONING OF A SINGLE PROSTHETIC HEART VALVE INTO THE PROPER ANATOMICAL LOCATION AND NEITHER REPOSITIONING NOR RETRIEVAL WAS ATTEMPTED. EVENT DESCRIPTION: DISSECTION OF FEMORAL ARTERY (001): ON (B)(6) 2015, DURING INDEX PROCEDURE, DISSECTION WAS NOTED IN THE FEMORAL ARTERY. PER ANSWERED QUERY, SITE CONFIRMED THAT THE DISSECTION WAS CAUSED BY THE LOTUS INTRODUCER. VARC SEVERITY: MINOR. THE SUBJECT WAS TREATED WITH PTA WITHOUT STENTING. (B)(6) 2015, THE EVENT WAS CONSIDERED TO BE RECOVERED/ RESOLVED. POTENTIAL RELATIONSHIP TO STUDY PROCEDURE PER INVESTIGATOR: RELATED HB DROP (002): ON (B)(6) 2015, 2 DAYS POST INDEX PROCEDURE, THE SUBJECT'S HEMOGLOBIN DROPPED FROM 11.8 G/DL TO 9 G/DL. VARC BLEEDING CLASSIFICATION: MAJOR. THE SUBJECT WAS TREATED WITH BLOOD TRANSFUSION. ON (B)(6) 2015, THE EVENT WAS CONSIDERED TO BE RECOVERED/ RESOLVED. POTENTIAL RELATIONSHIP TO STUDY PROCEDURE PER INVESTIGATOR: RELATED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    523398 LOTUS INTRODUCER SET INTRODUCER CATHETER DYB CREGANNA MEDICAL ALSO D/B/A CREGANNA-TACTX MEDICAL NTR20 221688

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention