BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 4103232 · Received September 19, 2014

    Report

    Report Number
    2024168-2014-06074
    Event Type
    Injury
    Date Received
    September 19, 2014
    Date of Event
    August 27, 2014
    Report Date
    August 27, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE STENT REMAINS IN THE PATIENT. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION. THE NC TREK REFERENCED IS BEING FILED UNDER A SEPARATE MANUFACTURING REPORT NUMBER.

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WAS NO REPORTED DEVICE MALFUNCTION AND THE PRODUCT WAS NOT RETURNED. THE REPORTED PATIENT EFFECTS OF ANGINA AND OCCLUSION, AS LISTED IN THE XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE (IFU), ARE KNOWN PATIENT EFFECTS THAT MAY BE ASSOCIATED WITH THE USE OF CORONARY STENTS. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURING, DESIGN OR LABELING. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. A CINE FILE, SENT WITH THE CASE WAS REVIEWED BY AN ABBOTT CLINICAL SPECIALIST. THE REVIEWER NOTED THE CINES SHOW ADDITIONAL PRE-DILATATION WITH A TREK RX 3.0 X 12 MM WAS DONE WITH REPORTED DISSECTION RELATED TO THIS ADDITIONAL PRE-DILATATION. NO DISSECTION WAS READILY APPRECIATED IN THE CINES RELATED TO ADDITIONAL PRE-DILATATION. A XIENCE XPEDITION RX 3.0 X 28 MM WAS PLACED IN THE PROXIMAL (BUT NOT OSTIAL) RCA. SOME SHADOWING INDICATING THE DISSECTION WAS NOTED IN THE CINES RELATED TO THE STENT PLACEMENT. THE FILLING OF THE STENT LOOKS GOOD BUT FLOW DISTAL TO THE STENT IS CLOSED OR VERY TIGHT. THERE IS SLOW AND INCOMPLETE FILLING OF THE DISTAL RCA. POST-DILATATION OF THE STENT IS SHOWN WITHOUT IMPROVEMENT IN FLOW. THE RCA WAS DILATED IN THE MID-DISTAL VESSEL PAST THE MAIN TORTUOSITY IN THE VESSEL. A DISSECTION IS READILY SEEN PROXIMAL TO THIS INFLATION. AN ADDITIONAL INFLATION WAS DONE MOVING PROXIMALLY IN THE RCA. ADDITIONAL PICTURES SHOWING THE POOR AND SLOW FLOW WERE RECORDED WITH SUBSEQUENT INFLATIONS. THE DISSECTION IS CLEAR IN THESE CINES AND IS NOTED TO BE FROM THE DISTAL STENT IN THE PROXIMAL RCA TO AROUND THE TORTUOSITY COVERING THE MID-RCA. STENTS WERE THEN PLACED IN THE DISTAL TO MID-RCA WHICH INCLUDED 2 2.75 X 38 MM XIENCE XPEDITION STENTS AND A 3.0 X 18 MM XIENCE XPEDITION WERE USED TO OPEN THE RCA AND COVER THE DISSECTION. POST-DILATATION WAS DONE POST PLACEMENT OF THE STENTS USING A NC TREK 3.5 X 15. THE RESULT WAS AN OPEN RCA VESSEL. THERE IS A SMALL DIAMETER STEP DOWN NOTED AT THE DISTAL EDGE OF THE MOST DISTAL STENT WITHIN THE RCA. THE REVIEWER CONCLUDED THE DISSECTION IS CONFIRMED. IT IS CONFIRMED THAT THE DISSECTION IS RELATED TO THE TREATMENT OF THE VESSEL UTILIZING ABBOTT VASCULAR PRODUCT. THE CAUSE OF THE DISSECTION MAY HAVE BEEN RELATED TO THE PRE-DILATATION ATTEMPTS ALTHOUGH THE DISSECTION IS NOT READILY APPRECIABLE UNTIL THE STENT PLACEMENT CINES. IT IS POSSIBLE THAT IT INITIATED WITH THE BALLOON DILATATION AND EXTENDED WITH THE FURTHER INTERVENTION OR MAY HAVE EXTENDED RELATED TO THE PRESSURE WITHIN THE VASCULATURE. THE PRESENCE OF CALCIFICATION MAY HAVE ALSO CONTRIBUTED TO THE PROPENSITY FOR DISSECTION.

    Description of Event or Problem · 1

    THE PROCEDURE WAS TO TREAT A MODERATELY TORTUOUS, MODERATELY CALCIFIED LESION IN THE MID RIGHT CORONARY ARTERY (MRCA). USING A FEMORAL ACCESS SITE, PRE-DILATATION WAS PERFORMED WITH A TREK 2.5X15 MM BALLOON CATHETER. THE PHYSICIAN THEN TRIED TO PASS THE 3.0X18 MM DEVICE; HOWEVER, SOME RESISTANCE WAS FELT AND IT WOULD NOT CROSS THROUGH THE EXACT BEND IN THE MRCA. THE 3.0X18 MM DEVICE WAS REMOVED AND ADDITIONAL DILATATION WAS PERFORMED WITH A TREK 3.0X12 MM. HOWEVER, BEFORE REINSERTION IT WAS DISCOVERED THE MRCA VESSEL DISSECTED. A XIENCE XPEDITION 3.0X28 MM WAS CHOSEN TO COVER THE DISSECTED LESION IN THE MRCA FOLLOWED BY POST DILATATION WITH A NC TREK 3.5X15 MM. AFTER STENTING IT WAS FOUND THAT THE WHOLE RCA PROXIMAL TO DISTAL LESION WAS CLOSED WITH NO FLOW AND THE PATIENT WAS EXPERIENCING CHEST PAIN. THE PHYSICIAN QUICKLY USED A XIENCE XPEDITION 48 TO IMPLANT FROM THE PROXIMAL TO THE DISTAL RCA BUT THE XIENCE XPEDITION 48 COULD NOT CROSS THROUGH. HENCE, 2 SHORTER XIENCE XPEDITIONS, A 2.75X38 OVERLAPPED WITH A XIENCE XPEDITION 3.0X18 MM TO COVER THE DISSECTION FROM THE PROXIMAL TO DISTAL RCA, FOLLOWED WITH A NC TREK 3.5X15 MM WITH A GOOD FINAL RESULT AND THE PATIENT WAS STABLE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    581657 XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 4012141

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention GUIDE CATH: JL 4 6F