BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JOSTENT GRAFTMASTER

    MDR report key: 2081818 · Received May 9, 2011

    Report

    Report Number
    2024168-2011-03291
    Event Type
    Injury
    Date Received
    May 9, 2011
    Date of Event
    March 24, 2011
    Report Date
    April 14, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    HDE00001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. GUIDE WIRE: CHOICE, WHISPER, SYNCHRO. GUIDE CATH: 8F FR 3.5. STENT: PROMUS 3.0X12. EMBOLIC PROTECTION: PROXIS. ABOVE RATED BURST PRESSURE. THE DEVICE REMAINS IN THE PATIENT. BALLOON MATERIAL RUPTURES CAN BE AFFECTED BY NUMEROUS FACTORS INCLUDING, BUT IS NOT LIMITED TO, BALLOON DAMAGE DURING MANUFACTURING, MATERIALS, HANDLING, LESION CALCIFICATION AND TORTUOSITY, AN INTERACTION WITH A PREVIOUSLY IMPLANTED STENT, INSUFFICIENT PREPARATION PRIOR TO USE OR FROM INTERACTIONS WITH OTHER DEVICES. IN THIS CASE, SINCE THERE WAS NO REPORT OF ANY LEAKS NOTED DURING PREPARATION FOR USE, THIS MAY INDICATE THAT THE BALLOON WAS NOT DAMAGED PRIOR TO THE PROCEDURE. THE LESION WAS HEAVILY TORTUOUS AND 90% STENOSED, WHICH MAY HAVE CONTRIBUTED TO THE REPORTED DIFFICULTY. HOWEVER, IT WAS ALSO REPORTED THAT THE GRAFTMASTER WAS INFLATED TO 18 ATMOSPHERES (ATM), WHICH IS ABOVE THE RATED BURST PRESSURE OF 16 ATM. IT SHOULD BE NOTED THAT THE GRAFTMASTER OTW INSTRUCTIONS FOR USE (IFU) STATES: THE RATED BURST PRESSURE (RBP) FOR A 3.0MM DIAMETER IS 16 ATM. THEREFORE, IT IS POSSIBLE THAT THE OVER-INFLATION OF THE DEVICE CONTRIBUTED TO THE REPORTED BALLOON RUPTURE. TO ENSURE THIS TYPE OF DAMAGE IS NOT A RESULT OF A POTENTIAL PRODUCT RELATED DEFICIENCY, ALL CATHETERS ARE VISUALLY INSPECTED AND LEAK TESTED DURING THE MANUFACTURING PROCESS. BRADYCARDIA AND EMBOLISM ARE KNOWN ADVERSE EVENTS LISTED IN THE GRAFTMASTER OTW IFU. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS AND THE RELATIONSHIP, IF ANY, TO THE DEVICES COULD NOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURE OR DESIGN. THE REPORTED BALLOON RUPTURE IS MOST LIKELY RELATED TO OVER-INFLATION OF THE BALLOON; HOWEVER, A DEFINITIVE CAUSE OF THE REPORTED PATIENT EFFECTS COULD NOT BE DETERMINED. A REVIEW OF THE FINISHED DEVICE LOT HISTORY RECORDS DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT AND THERE HAVE BEEN NO RELATED INCIDENTS REPORTED FOR THIS LOT. ADDITIONALLY, ON-LINE TEST DATA FOR THIS LOT SHOWS ALL UNITS PASSED THE MANUFACTURING CRITERIA. THIS SUGGESTS THAT THERE ARE NO LOT SPECIFIC PRODUCT QUALITY DEFICIENCIES. THIS TYPE OF REPORTED EVENT WILL CONTINUE TO BE MONITORED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN ANEURYSM IN THE STENOSED RIGHT CORONARY ARTERY (RCA) WITH HEAVY TORTUOSITY. PRE-DILATATION WAS PERFORMED, AND THE MID LESION WAS STENTED WITH A 3 X 12 PROMUS. A NON-ABBOTT EMBOLIC PROTECTION DEVICE WAS PLACED THROUGH THE ANEURYSM. THE PATIENT WAS ISCHEMIC THROUGHOUT THIS TIME, AS THE EMBOLIC PROTECTION SYSTEM LIMITED ANY FLOW TO THE RCA. AN ATTEMPT WAS MADE TO ADVANCE THE 3.5 X 16 GRAFTMASTER; HOWEVER, THE DEVICE DID NOT FIT THROUGH THE EMBOLIC PROTECTION DEVICE AND WAS EXCHANGED FOR A 3.0 X 16 GRAFTMASTER. THE GRAFTMASTER SUCCESSFULLY CROSSED THE LESION; HOWEVER, DURING THE FIRST INFLATION, AT 18 ATMOSPHERES FOR 30 SECONDS, THE BALLOON RUPTURED. THE STENT WAS IMPLANTED AND SUCCESSFULLY TREATED THE ANEURYSM. IT WAS NOTED THAT AN AIR EMBOLISM OCCURRED AS A RESULT OF INTRODUCTION OF AIR INTO THE EMBOLIC PROTECTION DEVICE, RESULTING IN SUBSEQUENT HEARTBLOCK. THE HEARTBLOCK WAS TREATED WITH ATROPINE. POST-DILATATION WAS PERFORMED. TWO ADDITIONAL PROMUS STENTS WERE IMPLANTED. THE PATIENT WAS IN NORMAL SINUS RHYTHM WITHOUT HEARTBLOCK, AND TIMI FLOW III. THE PATIENT CONDITION IS STABLE, AND THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED. THOUGH REQUESTED, 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 639595

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention (B)(4)