BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JOSTENT GRAFTMASTER

    MDR report key: 1952593 · Received January 7, 2011

    Report

    Report Number
    2024168-2011-00088
    Event Type
    Injury
    Date Received
    January 7, 2011
    Date of Event
    December 10, 2010
    Report Date
    December 14, 2010
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    HDE00001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    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. STENT: 3.5 X 19 MM GRAFTMASTER ((B)(4)/UNK), 3.0 X 18 MM RX VISION ((B)(4)). THE STENT REMAINS IN THE PATIENT. THE LOT NUMBER WAS PROVIDED. REVIEW OF THE DEVICE HISTORY RECORD IS FORTHCOMING. A FOLLOW-UP WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION. THE 3.5 X 19 MM GRAFTMASTER ((B)(4)/UNK), AND THE 3.0 X 18 MM RX VISION ((B)(4)), ARE EACH BEING FILED UNDER SEPARATE MFR NUMBERS.

    Additional Manufacturer Narrative · 1

    (B)(4). THE INABILITY TO CROSS A LESION CAN BE AFFECTED BY NUMEROUS FACTORS INCLUDING, BUT NOT LIMITED TO, PATIENT ANATOMICAL MORPHOLOGY, PATIENT DISEASE STATE, PRE-DILATATION STRATEGY, DEVICE PLACEMENT TECHNIQUE, DEVICE SIZE SELECTION, DAMAGE TO THE SDS OR THE STENT IMPLANT, INTERACTIONS WITH OTHER DEVICES, AND ACCESSORY DEVICE SUPPORT. ALTHOUGH NO PATIENT ANATOMICAL INFORMATION WAS PROVIDED, THE FAILURE TO ADVANCE IS NOT GENERALLY ASSOCIATED WITH A PRODUCT QUALITY DEFICIENCY AND WAS LIKELY RELATED TO CIRCUMSTANCES OF THE PROCEDURE. FURTHERMORE, POTENTIAL FACTORS THAT CAN CONTRIBUTE TO STENT DISLODGEMENT WITHIN THE BODY INCLUDE, BUT ARE NOT LIMITED TO, IMPROPER OR INADEQUATE CRIMPING AT THE TIME OF MANUFACTURE, POSITIVE PRESSURE DURING PRODUCT PREPARATION, NEGATIVE PRESSURE DURING SHEATH REMOVAL, FORCED SHEATH REMOVAL, HANDLING OF THE STENT DURING PRODUCT PREPARATION, AN INTERACTION WITH THE PATIENT ANATOMY, OR FROM AN INTERACTION WITH A PREVIOUSLY IMPLANTED STENT AND/OR ACCESSORY DEVICES. SINCE THERE WAS NO REPORT OF ANY DAMAGE OBSERVED TO THE SDS OR STENT IMPLANT PRIOR TO THE PROCEDURE, THIS MAY SUGGEST THAT A PRODUCT DEFICIENCY DID NOT CONTRIBUTE TO THE DIFFICULTIES EXPERIENCED. RETURN OF THE GRAFTMASTER MAY HAVE ULTIMATELY AIDED THE INVESTIGATION IN DETERMINING A CAUSE FOR THE REPORTED COMPLAINT. IT IS POSSIBLE THAT THE STENT INTERACTED WITH THE LESION AND/OR THE IMPLANTED VISION STENT DURING ATTEMPTED ADVANCEMENT SUCH THAT UPON REMOVAL, THE STENT BECAME DISRUPTED ON THE BALLOON AND DISLODGED, THOUGH THIS CANNOT BE CONFIRMED. THE ADDITIONAL THERAPY/NON-SURGICAL TREATMENT APPEARS TO BE A SECONDARY EFFECT OF THE REPORTED FAILURE TO ADVANCE AND STENT DISLODGEMENT AS THE DEVICE WAS UNABLE TO FULLY TREAT THE PERFORATION. PROLONGED BALLOON INFLATIONS WERE ULTIMATELY PERFORMED TO SUCCESSFULLY TREAT THE PERFORATION. A REVIEW OF THE FINISHED PRODUCT DEVICE HISTORY RECORD DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT AND ALL LOT RELEASE TESTING MET MANUFACTURING CRITERIA. BASED ON THE INFORMATION RECEIVED FROM THE COMPLAINT, THE REPORTED FAILURE TO ADVANCE APPEARS TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE. HOWEVER, WITHOUT THE PRODUCT TO EXAMINE, A DEFINITIVE CAUSE FOR THE REPORT STENT DISLODGEMENT CANNOT BE DETERMINED. TO ENSURE THIS TYPE OF OCCURRENCE IS NOT A RESULT OF A POTENTIAL MANUFACTURING DEFICIENCY, ALL STENT DELIVERY SYSTEMS ARE 100% VISUALLY INSPECTED FOR CATHETER DAMAGE, STENT DAMAGE AND PROPER STENT PLACEMENT. A SAMPLING OF UNITS IS ALSO DESTRUCTIVELY TESTED TO VERIFY PRODUCT QUALITY, INCLUDING STENT DISLODGEMENT FORCE AS WELL AS PROPER GUIDE WIRE AND GUIDING CATHETER MOVEMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE DEPLOYMENT OF AN RX VISION STENT IN THE MID LEFT ANTERIOR DESCENDING ARTERY (LAD), A LONG PERFORATION OCCURRED. AN ATTEMPT WAS MADE TO TREAT THE PERFORATION WITH A 3.0 X 12 MM GRAFTMASTER STENT; HOWEVER, IT WOULD NOT CROSS AND DURING REMOVAL OF THE DEVICE THE STENT DISLODGED FROM THE BALLOON AT THE PROXIMAL END OF THE PERFORATION AND WAS DEPLOYED SUCCESSFULLY. A 3.5 X 19 MM GRAFTMASTER WAS USED IN AN ATTEMPT TO CROSS TO TREAT THE DISTAL END OF THE PERFORATION; HOWEVER, IT ALSO WOULD NOT CROSS. THE REMAINING UNTREATED PART OF THE PERFORATION WAS SUCCESSFULLY TREATED WITH PROLONGED BALLOON INFLATIONS. THE PATIENT IS REPORTED TO BE STABLE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JOSTENT GRAFTMASTER CORONARY STENT GRAFT MAF AV-TEMECULA-CT 472569

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention CONCOMITANT MEDICAL DEVICES