BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTE INTEGRITY RX

    MDR report key: 3922170 · Received July 9, 2014

    Report

    Report Number
    9612164-2014-00759
    Event Type
    Malfunction
    Date Received
    July 9, 2014
    Date of Event
    June 9, 2014
    Report Date
    August 6, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P110013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: RESULTS: PATIENT CONDITION AFFECTED EFFECTIVENESS OF DEVICE (CALCIFIED WITH 90% STENOSIS). CAUSED BY ANOTHER DRUG/DEVICE (GUIDEWIRE DURING BACK LOADING THROUGH THE DISTAL TIP). DEFORMATION PROBLEM. RELATED TO OPERATIONAL CONTEXT. CONCLUSION: DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION (CALCIFIED WITH 90% STENOSIS). ANOTHER DEVICE CAUSED FAILURE (GUIDEWIRE DURING BACK LOADING THROUGH THE DISTAL TIP). OPERATIONAL CONTECT CONTRIBUTED TO EVENT. (B)(4)

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS: (BASED ON THE INFORMATION AVAILABLE NO ROOT CAUSE CAN BE DETERMINED). FAILURE TO FOLLOW INSTRUCTION (FORCED USED DURING PROCEDURE). INHERENT RISK OF PROCEDURE (BALLOON RUPTURE). NO RESULTS AVAILABLE SINCE NO EVALUATION PERFORMED (DEVICE EVALUATION IN PROGRESS). EVALUATION CONCLUSION: CONCLUSION NOT YET AVAILABLE- EVALUATION IN PROGRESS. UNABLE TO CONFIRM COMPLAINT (DEVICE EVALUATION IN PROGRESS). FAILURE TO FOLLOW INSTRUCTION (FORCED USED DURING PROCEDURE). KNOWN INHERENT RISK OF PROCEDURE (BALLOON RUPTURE). (BASED ON THE INFORMATION AVAILABLE NO ROOT CAUSE CAN BE DETERMINED). (B)(4).

    Description of Event or Problem · 1

    DURING AN ATTEMPT TO TREAT A LESION IN THE R-PDA THAT IS MODERATELY CALCIFIED WITH 90% STENOSIS USING A RESOLUTE INTEGRITY DEVICE; PHYSICIAN EXPERIENCED RESISTANCE WHILE ADVANCING THE DEVICE TO THE TARGET LESION WITH EXCESSIVE FORCE USED DUE TO VESSEL TORTUOUSITY. IT WAS REPORTED THAT THE BALLOON ONLY PARTIALLY INFLATED AND THEN BURST AT 10ATM. THE BALLOON ONLY INFLATED AT BOTH (PROXIMAL AND DISTAL) ENDS MAKING A BOWTIE UNDER FLUOROSCOPY. PHYSICIAN THEN ENCOUNTERED DIFFICULTY REMOVING THE DEVICE FROM PATIENT FOLLOWING STENT DEPLOYMENT. IT WAS REPORTED THAT THE PATIENT HAD A LARGE AORTIC ARCH, THIS LED TO NUMEROUS GUIDE CATHETERS AND LACK OF GUIDE SUPPORT DURING PROCEDURE, A GUIDELINER WAS ALSO USED. THERE WAS NO INJURY TO PATIENT.

    Description of Event or Problem · 1

    THE STENT HAD BEEN DEPLOYED AND WAS NOT RETURNED WITH THE DELIVERY SYSTEM. THE BALLOON FOLDS HAD BEEN PARTIALLY OPENED. THE BALLOON WAS INFLATED AND LIQUID WAS OBSERVED EXITING THROUGH THE DISTAL TIP, INDICATING AN INNER SHAFT LEAK. THE DISTAL SHAFT WAS CUT BACK IN ORDER TO EXAMINE THE INNER SHAFT. A SMALL HOLE WAS LOCATED ON THE INNER-DISTAL SHAFT, SLIGHTLY PROXIMAL TO THE PROXIMAL INNER SHAFT MARKER. THE MATERIAL AROUND THE LEAK SITE WAS PROTRUDING PROXIMALLY OUTWARDS. PROCEDURAL IMAGE REVIEW: REVIEW OF THE PROCEDURAL IMAGES RETURNED WITH THE DEVICE CONFIRMED THE "BOWTIE" APPEARANCE OF THE STENT UNDER FLUOROSCOPY INDICATING THE PRESENCE OF A LEAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401794 RESOLUTE INTEGRITY RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0006988649

    Patients

    Seq Age Sex Outcome Treatment
    1 00063 YR