BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONYX FRONTIER

    MDR report key: 17448147 · Received August 3, 2023

    Report

    Report Number
    9612164-2023-03514
    Event Type
    Malfunction
    Date Received
    August 3, 2023
    Date of Event
    April 26, 2023
    Report Date
    August 14, 2023
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    UDI-DI
    00763000511616
    PMA / PMN Number
    P160043
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT ANALYSIS #290984193:THE CORONARY ANGIOGRAMS WITH CONTRAST INJECTION CONFIRM THE TARGET LESION IN THE LAD. THE VESSEL WAS PRE -DILATED FOLLOWED BY STENT D EPLOYMENT. THE STENT WAS POST DILATED THROUGH OUT THE NEWLY DEPLOYED STENT LENGTH. CONTRAST INJECTION INTO THE LAD APPEARS TO SHOW THAT THE VESSEL DIAMETER IS LARGER THAN THE PORTION OF THE DISTAL VESSEL WHERE NO STENT WAS DEPLOYED. CASE UPLOADED TO MEDIDATA 04-JULY-2023 BY ELLEN HEGARTY. PATIENT NAME: (B)(6) # 29301098 PRODUCT ANALYSIS #290879487:DEVICE DECONTAMINATED WITH CIDEX-OPA. THE STENT DID NOT RETURN FOR ANALYSIS AS IT WAS IMPLANTED IN THE PATIENT. A FLATTENED SECTION WAS EVIDENT ON THE DISTAL SHAFT. THE INNER MEMBER WAS STRETCHED AND BUNCHED. THE BALLOON FOLDS RETURNED EXPANDED. NEGATIVE PREP. AND INFLATION TESTING COULD NOT BE PERFORMED DUE TO STRETCHING AND BUNCHING OF THE INNER MEMBER. NO DEFORMATION EVIDENT TO THE DISTAL TIP. MARKER BAND SPACING MEASURED APPROX. 34.11MM WHICH WAS WITHIN SPEC. OF MINIMUM 33.86MM AND MAXIMUM 34.36MM. NO OTHER DEFORMATION EVIDENT TO THE REMAINDER OF THE DEVICE. RULER CALIBRATION NUMBER (802290). 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

    ADDITIONAL INFORMATION: ANNEX D CODE. 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.

    Description of Event or Problem · 0

    AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT TO TREAT A NON-TORTUOUS, MODERATELY CALCIFIED LESION WITH 65% STENOSIS IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. ARTERY DIAMETER WAS 3.5MM AND LESION LENGTH 28MM. THE DEVICE WAS INSPECTED WITH NO ISSUES. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. THE LESION WAS PRE-DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED. THE STENT WAS INFLATED TO 13 ATM. IT WAS REPORTED THAT UPON DEPLOYMENT, WHILE THE BALLOON WAS INFLATED, THAT THE STENT LOOKED LARGER THAN THE EXPECTED 3.5MM DIAMETER, AND WHILE ON FLUOROSCOPY THE BALLOON APPEARED TO INCREASE IN DIAMETER BEYOND THE 3.50MM EXPECTED AT 13 ATM. POST STENT DEPLOYMENT INTRAVASCULAR ULTRASOUND (IVUS) WAS PERFORMED. THE RESULTING IVUS SHOWED A 4.2MM INNER DIAMETER OF THE DEPLOYED STENT. AN NON-MEDTRONIC INDEFLATOR WAS USED. THE SAME INFLATION DEVICE WAS USED PREVIOUSLY ON OTHER DEVICES WITH NO ISSUES. THERE WAS NO ADDITIONAL INTERVENTION NEEDED OR PERFORMED. A 6F GUIDE CATHETER WAS ALSO USED DURING THE PROCURE TO WHICH THERE IS NO COMPLAINT. THE PATIENT IS ALIVE WITH NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    285306 ONYX FRONTIER CORONARY DRUG-ELUTING STENT NIQ MEDTRONIC IRELAND ONYXNG35034UX 0011593484 00763000511616

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male