BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1952442 · Received January 7, 2011

    Report

    Report Number
    9616099-2011-00016
    Event Type
    Injury
    Date Received
    January 7, 2011
    Date of Event
    December 13, 2010
    Report Date
    December 13, 2010
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A MALE PATIENT EXPERIENCED RECURRENT RESTENOSIS POST IMPLANTATION OF A CYPHER STENT. DURING RE-PCI, ANOTHER CYPHER STENT HAD TRACKING DIFFICULTY THROUGH PREVIOUSLY DEPLOYED STENTS AND DISLODGED. HOWEVER, THE STENT WAS FINALLY DEPLOYED AT THE TARGET SITE SUCCESSFULLY. PAST MEDICAL HISTORY WAS UNKNOWN. THE TARGET LESION WAS AN ISR OF AN UNKNOWN CYPHER (DETAILS UNKNOWN) IMPLANTED IN THE PROXIMAL LAD. THIS UNKNOWN CYPHER WAS PREVIOUSLY TREATED WITH TWO PROMUS STENTS (SIZE UNKNOWN) IMPLANTED IN THE PROXIMAL TO MID LAD WITH OVERLAP. SIX MONTHS AFTER THIS RE-PCI, THERE IS ISR IN THE PROXIMAL TO MID LAD. THE VESSEL WAS NOT CALCIFIED, BUT WAS MODERATELY TORTUOUS. THERE WAS 90% STENOSIS. RADIAL APPROACH WAS CHOSEN FOR THE PROCEDURE. PRE-DILATION WAS CONDUCTED AND THEN CYPHER SELECT+ (2.5/18MM) WAS BEING DELIVERED TO THE MID LAD, BUT THE DISTAL TIP OF THE CYPHER SELECT+ BECAME STUCK AT THE PROXIMAL LAD DUE TO FLEXION. THEREFORE, THE PHYSICIAN TRIED TO ADVANCE THE CYPHER SELECT+ FURTHER BY PUSHING BACK AND FORTH, BUT IT WOULD NOT ADVANCE FURTHER AND COULD NOT REACH THE TARGET LESION IN THE MID LAD FOR DEPLOYMENT. IN ORDER TO EXCHANGE THE GUIDING CATHETER, THE PHYSICIAN TRIED TO RETRIEVE THE CYPHER SELECT+ FROM THE PATIENT BUT THE STENT DISLODGED AT THE LMT ON THE GUIDEWIRE (RUNTHROUGH), WHICH WAS INSERTED TO THE DISTAL PORTION OF THE VESSEL. THE GUIDING CATHETER REMAINED ENGAGED IN THE TARGET VESSEL PROPERLY. THE PHYSICIAN TRIED TO COLLECT THE DISLODGED STENT BY SNARE. BECAUSE THE SNARE MOVED THE DISLODGED STENT TO THE TARGET LESION IN THE PROXIMAL LAD, A BALLOON (TAZUNA 1.25MM) WAS INSERTED AND THE DISLODGED STENT WAS SUCCESSFULLY DEPLOYED IN THE PROMUS STENT AT THE PROXIMAL LAD. THE PROCEDURE WAS FINISHED SUCCESSFULLY WITH THE IMPLANT OF THE 2.5X18MM CYPHER SELECT+ IN THE PROXIMAL LAD TARGET SITE AND WITH POBA ONLY IN THE MID LAD. THE PROCEDURE WAS FINISHED SUCCESSFULLY. ADDITIONAL TREATMENT FOR THE MID LAD WAS NOT SCHEDULED. THERE WAS NO PATIENT INJURY REPORTED. THE PATIENT WAS IN STABLE CONDITION AFTER THE PROCEDURE. THE PRODUCT WAS CLINICALLY USED AND THE SDS WILL BE RETURNED FOR ANALYSIS. THE PHYSICIAN DID NOT INDICATE ANY ANOMALIES PRIOR TO USE. THE PRODUCTS REMAIN IMPLANTED IN THE PATIENT AND ARE THUS NOT AVAILABLE FOR EVALUATION. A REVIEW OF THE MANUFACTURING RECORDS FOR THE UNKNOWN CYPHER COULD NOT BE CONDUCTED WITHOUT A LOT NUMBER. ONE NON-STERILE CYPHER SELECT + (B)(4) 2.50 X 18MM WAS RECEIVED COILED INSIDE A PLASTIC BAG. THE STENT WAS NOT RECEIVED. THE SDS PRESENTED NO DAMAGES, THE BALLOON WAS RECEIVED FOLDED AND BUMPING AND CRIMPING MARKS COULD BE OBSERVED ON IT. DIMENSIONAL ANALYSIS FOR CROSSING PROFILE COULD NOT BE PERFORMED DUE TO THE RECEIVED CONDITION OF THE UNIT. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. THE REPORTED DISLODGE FAILURE WAS CONFIRMED SINCE THERE IS NO EVIDENCE THAT THE BALLOON WAS INFLATED. THE EXACT CAUSE OF THE FAILURES EXPERIENCED BY THE CUSTOMER COULD NOT BE DETERMINED. NEITHER THE DHR REVIEW NOR THE PRODUCT ANALYSIS SUGGESTS THAT THE REPORTED FAILURES AND STENT DAMAGES COULD BE RELATED TO THE MANUFACTURING PROCESS OF THE UNIT. THEREFORE, NO CORRECTIVE OR PREVENTIVE ACTIONS WILL BE TAKEN. RESTENOSIS IS A KNOWN POTENTIAL ADVERSE EVENT FOLLOWING STENT IMPLANTATION AND IS OFTEN ASSOCIATED WITH THE PROGRESSION OF CARDIOVASCULAR DISEASE. PATIENTS WHO ARE KNOWN TO BE AT HIGH-RISK FOR RESTENOSIS INCLUDE THOSE WITH DIABETES, LONG LESIONS, SMALL VESSELS, BIFURCATIONS, AND RESTENOTIC LESIONS. DIFFICULTY TRACKING A PRODUCT THROUGH AN ANATOMICAL STRUCTURE IS A KNOWN PROCEDURAL OCCURRENCE. THIS TYPE OF DIFFICULTY OCCURRING DURING THE CLINICAL USE OF THE DEVICE IS USUALLY ADDRESSED BY MODIFICATION IN TECHNIQUE OR SUBSTITUTION WITH ANOTHER DEVICE. TRACKING DIFFICULTY IS MOST COMMONLY RELATED TO THE PATIENT'S ANATOMY, VESSEL CHARACTERISTICS, OPERATOR'S TECHNIQUE AND APPROPRIATE DEVICE SELECTION. FACTORS SUCH AS TORTUOUS VESSELS, CALCIFIED LESIONS OR AN INCREASED DIFFICULTY TO TRACK THE PRODUCT THROUGH AN EXISTING STENT MAY CONTRIBUTE TO IT. THE IFU INDICATES THAT SHOULD ANY RESISTANCE BE FELT AT ANY TIME DURING EITHER LESION ACCESS OR REMOVAL OF THE SDS PRE-STENT IMPLANTATION, THE SYSTEM SHOULD BE REMOVED AS A SINGLE UNIT. WHEN REMOVING THE SDS AS A SINGLE UNIT, DO NOT RETRACT THE DELIVERY SYSTEM INTO THE GUIDING CATHETER OR SHEATH. FAILURE TO FOLLOW STENT/SDS REMOVAL INSTRUCTIONS AND/OR APPLYING EXCESSIVE FORCE TO THE STENT DELIVERY SYSTEM CAN POTENTIALLY RESULT IN LOSS OR DAMAGE TO THE STENT AND/OR SDS COMPONENTS. BASED ON THE INFORMATION AVAILABLE, THERE ARE POSSIBLE VESSEL LESION CHARACTERISTICS (RESTENOTIC LESION, TORTUOUS) AND PROCEDURAL FACTORS (TRACKING DIFFICULTY) THAT MAY HAVE CONTRIBUTED TO THESE EVENTS.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: GUIDING CATHETER: MACH1 7F JL, BALLOON CATHETER: TAZUNA, MAVERICK. THIS PRODUCT IS DISTRIBUTED OUTSIDE THE UNITED STATES. HOWEVER, IT IS SIMILAR TO THE US DISTRIBUTED DRUG-ELUTING STENTS. THE PRODUCT HAS BEEN RECEIVED FOR EVALUATION. HOWEVER, THE ENGINEERING ANALYSIS IS NOT YET COMPLETE. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    THE PATIENT'S AGE WAS UNKNOWN, BUT WAS A MALE. THE TARGET LESION WAS THE PROXIMAL TO MID LAD. THE LESION WAS AN ISR OF A CYPHER (DETAILS UNKNOWN) IMPLANTED IN THE PROX LAD WHICH WAS TREATED WITH TWO PROMUS STENTS (SIZE UNKNOWN) IMPLANTED AT PROX TO MID LAD WITH OVERLAP IN (B)(6) 2010 THAT LATER RESTENOSED. THE VESSEL WAS NOT CALCIFIED, BUT WAS MODERATELY TORTUOUS. THERE WAS 90% STENOSIS. RADIAL APPROACH WAS CHOSEN FOR THE PROCEDURE. PRE-DILATION WAS CONDUCTED AND THEN CYPHER SELECT+ (2.5/18MM) WAS BEING DELIVERED TO THE MID LAD, BUT THE DISTAL TIP OF THE CYPHER SELECT+ BECAME STUCK AT THE PROX LAD DUE TO FLEXION. THEREFORE THE PHYSICIAN TRIED TO ADVANCE THE CYPHER SELECT+ FURTHER BY PUSHING BACK AND FORTH, BUT IT WOULD NOT ADVANCE FURTHER AND COULD NOT REACH THE TARGET LESION IN THE MID LAD FOR DEPLOYMENT. IN ORDER TO EXCHANGE THE GUIDING CATHETER, THE PHYSICIAN TRIED TO RETRIEVE THE CYPHER SELECT+ FROM THE PATIENT BUT THE STENT DISLODGED AT THE LMT ON THE GUIDEWIRE (RUNTHROUGH), WHICH WAS INSERTED TO THE DISTAL PORTION OF THE VESSEL. THE GUIDING CATHETER REMAINED ENGAGED IN THE TARGET VESSEL PROPERLY. THE PHYSICIAN TRIED TO COLLECT THE DISLODGED STENT BY SNARE. BECAUSE THE SNARE MOVED THE DISLODGED STENT TO AROUND THE PROX LAD, A BALLOON (TAZUNA 1.25MM) WAS INSERTED AND THE DISLODGED STENT WAS SUCCESSFULLY DEPLOYED USING THE BALLOON IN THE PROMUS STENT AT THE PROX LAD. THE PROCEDURE WAS FINISHED SUCCESSFULLY WITH THE IMPLANT OF THE CYPHER SELECT+ AT THE PROX LAD AND WITH POBA ONLY IN THE MID LAD. ADDITIONAL TREATMENT FOR THE MID LAD WAS NOT SCHEDULED. THERE WAS NO PATIENT INJURY REPORTED. THE PATIENT WAS IN STABLE CONDITION AFTER THE PROCEDURE. THE PRODUCT WAS CLINICALLY USED AND THE SDS WILL BE RETURNED FOR ANALYSIS. THE PHYSICIAN DID NOT INDICATE ANY ANOMALIES PRIOR TO USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CYPHER SIROLIMUS-ELUTING CORONARY STENT DRUG-ELUTING STENT (NIQ) NIQ CORDIS DE MEXICO NA 15168678

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention GUIDEWIRE: RUNTHROUGH