BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM

    MDR report key: 2842963 · Received November 21, 2012

    Report

    Report Number
    2024168-2012-07387
    Event Type
    Malfunction
    Date Received
    November 21, 2012
    Date of Event
    September 27, 2012
    Report Date
    September 27, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. GUIDE WIRE: BALANCE MIDDLEWEIGHT. GUIDE CATH: EBU4 6F. (B)(4). THOUGH THE DEVICE ABSORB BIORESORBABLE VASCULAR SCAFFOLD (BVS) SYSTEM IS NOT APPROVED FOR SALE IN THE U.S., IT USES A DELIVERY SYSTEM WHICH IS SIMILAR TO A DEVICE SOLD IN THE U.S. THE PRODUCT LISTED THE PMA#, IS BASED ON THE PREDICATE DEVICE (XIENCE V STENT SYSTEM) THAT IS DETERMINED TO BE SAME AND SIMILAR TO THE DELIVERY SYSTEM OF THIS DEVICE. EVALUATION SUMMARY: THE COMPLAINT DEVICE WAS RETURNED FOR ANALYSIS. THE REPORTED KINK IN THE SHAFT WAS CONFIRMED AND A 3MM TEAR IN THE GUIDE WIRE EXIT NOTCH WAS NOTED. THE REPORTED FAILURE TO ADVANCE COULD NOT BE REPLICATED IN A TESTING ENVIRONMENT AS IT WAS BASED ON OPERATIONAL CIRCUMSTANCES. BASED ON THE VISUAL AND DIMENSIONAL ANALYSIS OF THE DEVICE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. A REVIEW OF THE COMPLAINT HISTORY OF THE REPORTED LOT DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. IT SHOULD BE NOTED THAT THE ABSORB BVS INSTRUCTIONS FOR USE (IFU) STATES: AN UNEXPANDED SCAFFOLD MAY BE RETRACTED INTO THE GUIDING CATHETER ONE TIME ONLY. AN UNEXPANDED SCAFFOLD SHOULD NOT BE REINTRODUCED INTO THE ARTERY ONCE IT HAS BEEN PULLED BACK INTO THE GUIDING CATHETER. SUBSEQUENT MOVEMENT IN AND OUT THROUGH THE DISTAL END OF THE GUIDING CATHETER SHOULD NOT BE PERFORMED, AS THE SCAFFOLD MAY BE DAMAGED OR DISLODGED DURING RETRACTION BACK INTO THE GUIDING CATHETER. ADDITIONALLY, THE IFU STATES: SHOULD ANY RESISTANCE BE FELT AT ANY TIME DURING WITHDRAWAL OF THE ABSORB BVS SYSTEM, THE ENTIRE SYSTEM SHOULD BE REMOVED AS A SINGLE UNIT. THE RE-INSERTION AND ADDITIONAL FORCE USED DURING THE PROCEDURE, LIKELY CONTRIBUTED TO THE SCAFFOLD DAMAGE (STRETCHED/BENT STRUTS) AND KINK IN THE SHAFT. HOWEVER, THE IMPROPER USE DID NOT LIKELY CONTRIBUTE TO THE TORN GUIDE WIRE EXIT NOTCH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY CALCIFIED MID-DISTAL CIRCUMFLEX (CX) LESION WITHOUT TORTUOUSITY. THE MID AND DISTAL CX WERE PRE-DILATED WITH A 2.5 X 20 MM TREK, BUT THE LESION REMAINED A LITTLE HARD. ADDITIONAL PRE-DILATATION WAS PERFORMED WITH A 2.75 X 12 MM NON-COMPLIANT (NC) BALLOON. THE 2.5 X 18 ABSORB BIORESORBABLE VASCULAR SCAFFOLD (BVS) WAS ADVANCED, BUT COULD NOT CROSS THE LESION AND WAS REMOVED. THE LESION WAS PRE-DILATED AGAIN WITH THE SAME NC BALLOON. THE BVS WAS ADVANCED AGAIN, BUT STILL COULD NOT CROSS THE LESION AND THE HYPOTUBE BECAME BENT WHEN EXTRA FORCE WAS APPLIED. THE BVS WAS REMOVED FROM THE PATIENT WITHOUT ISSUE. A NEW 2.5 X 18 MM BVS WAS ADVANCED, BUT ALSO COULD NOT CROSS THE LESION. A 2ND GUIDE WIRE WAS USED PARALLEL TO THE INITIAL GUIDE WIRE, BUT THE BVS STILL COULD NOT PASS THE LESION. THE LESION WAS AGAIN PRE-DILATED AND THE 2.5 X 18 BVS WAS ADVANCED AGAIN IN AN ATTEMPT TO REACH THE LESION, BUT THE HYPOTUBE BECAME BENT WHEN EXTRA FORCE WAS APPLIED. IT WAS REMOVED FROM THE ANATOMY WITHOUT ISSUE. A 2.5 X 18 BARE METAL STENT (BMS) WAS ADVANCED SUCCESSFULLY AND IMPLANTED IN THE DISTAL CX. A 3.0 X 30 MM BMS WAS IMPLANTED PROXIMALLY, OVERLAPPING THE PREVIOUS ONE. ALTHOUGH THE PROCEDURE WAS LONGER THAN USUAL, IT WAS NOT CONSIDERED A CLINICALLY SIGNIFICANT DELAY AND THERE WERE NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED. RETURN DEVICE ANALYSIS OF THE FIRST ABSORB DELIVERY SYSTEM REVEALED A TEAR IN THE SHAFT AT THE GUIDE WIRE EXIT NOTCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 2070561

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR