BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1241089 · Received November 21, 2008

    Report

    Report Number
    2024168-2008-01217
    Event Type
    Injury
    Date Received
    November 21, 2008
    Date of Event
    October 23, 2008
    Report Date
    October 24, 2008
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: QUALITY ASSURANCE ANALYSIS REVEALED THAT THE SDS WAS RETURNED WITHOUT BLOOD VISIBLE. THERE WAS CONTRAST VISIBLE IN THE INFLATION LUMEN. THE BALLOON WAS TIGHTLY FOLDED. THERE WERE CRIMP MARKS VISIBLE ON THE BALLOON BETWEEN THE MARKERS. THE TIP WAS STRETCHED DISTAL TO THE CLEAR GAP FOR A LENGTH OF 3 MM. THERE WERE NO KINKS OR DAMAGE NOTED TO THE INNER MEMBER. THERE WERE TWO KINKS IN THE HYPOTUBE 31 CM AND 67 CM DISTAL TO THE STRAIN RELIEF TUBING. THERE WAS NO OTHER DAMAGE NOTED TO THE SDS. THE TIP SEAL LENGTH WAS MEASURED AND MET MANUFACTURING CRITERIA. PRODUCT PERFORMANCE ENGINEERING REVIEWED THE INCIDENT INFORMATION. POTENTIAL CAUSES FOR STENT DISLODGEMENT INSIDE THE BODY, AS OBSERVED IN PAST INCIDENTS, MAY INCLUDE INTERACTION OF THE STENT WITH THE LESION, ACCESSORY DEVICES AND/OR PREVIOUSLY IMPLANTED STENTS. IN THIS CASE, IT IS POSSIBLE INTERACTION WITH THE LESION AND/OR PREVIOUSLY IMPLANTED STENT MAY HAVE LED TO THE REPORTED DIFFICULTY CROSSING AND DIFFICULTY REMOVING THE DEVICE. ADDITIONALLY, INTERACTION WITH THE PREVIOUSLY EXPANDED STENT COMBINED WITH THE NEGATIVE PRESSURE APPLIED DURING REMOVAL LIKELY CONTRIBUTED TO THE REPORTED STENT DISLODGEMENT. ANALYSIS OF THE RETURNED SDS FOUND CRIMP MARKS VISIBLE ON THE TIGHTLY FOLDED BALLOON BETWEEN THE MARKERS, INDICATING THE STENT WAS INITIALLY CRIMPED ON THE BALLOON IN THE CORRECT LOCATION AND THE BALLOON WAS NOT INFLATED. IN ADDITION, ANALYSIS FOUND THE TIP STRETCHED DISTAL TO THE CLEAR GAP. THIS TYPE OF DAMAGE IS CONSISTENT WITH THE REPORTED RESISTANCE AND COULD BE A RESULT OF INTERACTION BETWEEN THE ANATOMY, PREVIOUSLY IMPLANTED STENT, AND/OR ACCESSORIES DURING THE ATTEMPTED POSITIONING AND RETRACTION OF THE DEVICE. THE DAMAGE TO THE DEVICE LIKELY OCCURRED DURING THE PROCEDURE, AS NO DAMAGE WAS REPORTED AS BEING NOTED DURING THE INSPECTION PRIOR TO USE. ALTHOUGH IT WAS STATED THAT THE PREVIOUSLY IMPLANTED STENT WAS FROM A SEPARATE PROCEDURE PERFORMED ONE MONTH PRIOR, THE PRODUCT INSTRUCTIONS FOR USE (IFU) DOES WARNS, "ALTHOUGH THE SAFETY AND EFFECTIVENESS OF TREATING MORE THAN ONE VESSEL PER CORONARY ARTERY WITH XIENCE V STENTS HAS NOT BEEN ESTABLISHED, IF THIS IS PERFORMED, PLACE THE STENT IN THE DISTAL LESION BEFORE THE PROXIMAL LESION IN ORDER TO MINIMIZE DISLODGEMENT RISK INCURRED BY TRAVERSING THROUGH DEPLOYED STENT." IN ADDITION, IT WAS REPORTED THAT NEGATIVE PRESSURE WAS APPLIED AFTER THE SDS BECAME STUCK AND THE IFU ALSO STATES, "DO NOT INDUCE NEGATIVE PRESSURE ON THE DELIVERY SYSTEM PRIOR TO PLACING THE STENT ACROSS THE LESION. THIS MAY CAUSE DISLODGEMENT OF THE STENT FROM THE BALLOON." AND "SHOULD ANY RESISTANCE BE FELT AT ANY TIME DURING EITHER LESION ACCESS OR REMOVING THE DELIVERY SYSTEM POST-STENT IMPLANTATION, THE SDS AND THE GUIDING CATHETER SHOULD BE REMOVED AS A SINGLE UNIT. FAILURE TO FOLLOW THESE STEPS AND/OR APPLYING EXCESSIVE FORCE TO THE DELIVERY SYSTEM CAN POTENTIALLY RESULT IN LOSS OR DAMAGE TO THE STENT AND/OR DELIVERY SYSTEM COMPONENTS." ANALYSIS OF THE RETURNED DEVICE ALSO FOUND TWO KINKS NOTED IN THE HYPOTUBE DISTAL TO THE STRAIN RELIEF TUBING. ALTHOUGH THERE WAS NO MENTION OF KINKS IN THE INCIDENT REPORT, THE KINKS LIKELY OCCURRED AS A RESULT OF THE PROCEDURAL ATTEMPT TO CROSS THE LESION OR FROM HANDLING OF THE DEVICE DURING PACKING/SHIPPING BACK TO ABBOTT FOR EVALUATION. HOWEVER, THE KINKS DO NOT APPEAR TO BE RELATED TO OR TO HAVE CONTRIBUTED TO THE REPORTED ISSUES. TO HELP ENSURE THESE TYPES OF EVENTS ARE NOT THE RESULT OF A MANUFACTURING ISSUE, ALL SDS ARE INSPECTED FOR PROPER STENT PLACEMENT, STENT DAMAGE AND CRIMPED STENT OUTER DIAMETER. ADDITIONALLY, PRIOR TO LOT RELEASE, A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED TO VERIFY STENT DISLODGEMENT FORCE. THE LOT HISTORY RECORDS FOR THIS DEVICE WERE REVIEWED, AND THERE WERE NO NONCONFORMING MATERIAL RECORDS ISSUED FOR THE LOT THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT. IN ADDITION, ALL ONLINE TESTING FOR THE LOT IN QUESTION MET STENT IMPLANT SECURITY CRITERIA, WHICH WOULD INDICATE THE UNIT HAD AN ADEQUATE CRIMP. ALL LOT RELEASE TESTING MET SPECIFICATION INCLUDING TESTING FOR STENT PLACEMENT, CRIMPED STENT OUTER DIAMETER AND STENT DISLODGEMENT FORCE. THE PROFILE DIMENSIONS ON ALL SDS ARE CONFIRMED BY VISUAL AND DIMENSIONAL CHECKS ON THE MANUFACTURING LINE BEFORE RELEASE. ADDITIONALLY, A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED TO VERIFY STENT DISLODGEMENT FORCE. THIS MDR IS CONSIDERED CLOSED BY THE PRODUCT PERFORMANCE GROUP.

    Description of Event or Problem · 1

    REPORTING STATUS: SERIOUS INJURY - MEDICAL INTERVENTION / PERMANENT IMPAIRMENT. REPORTING RATIONALE: DISLODGED STENT REMAINS IN PATIENT. DEVICE ISSUE: STENT DISLODGEMENT. IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE MID RCA. THE LESION WAS PRE-DILATED AND THE XIENCE WAS ABLE TO CROSS THROUGH ANOTHER STENT IN THE OSTIUM OF THE RCA (IMPLANTED 1 MONTH PRIOR), BUT COULD NOT CROSS THE MID SECTION OF THE TARGET LESION. THE STENT DELIVERY SYSTEM (SDS) WAS RETRACTED, BUT THE STENT BECAME STUCK INSIDE THE PREVIOUSLY IMPLANTED STENT. NEGATIVE PRESSURE WAS APPLIED AND THE STENT DISLODGED. A 2.0 BALLOON WAS INSERTED INSIDE THE DISLODGED STENT AND DILATED, DEPLOYING THE STENT INSIDE THE PREVIOUSLY IMPLANTED STENT. A NON-COMPLIANT BALLOON WAS USED TO POST DILATE THE STENT. NO FURTHER ATTEMPTS WERE MADE TO TREAT THE LESION IN THE MID RCA. ANGIOGRAPHIC RESULTS WERE GOOD. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM NIQ ABBOTT VASCULAR-CARDIAC THERAPIES NA 7110761

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention| S