BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 4468850 · Received January 30, 2015

    Report

    Report Number
    3003742446-2015-00011
    Event Type
    Injury
    Date Received
    January 30, 2015
    Date of Event
    January 30, 2009
    Report Date
    March 23, 2015
    Manufacturer
    CORDIS CORPORATION
    Product Code
    NIQ
    PMA / PMN Number
    P020026
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS ONE OF THREE EVENTS ASSOCIATED WITH THE PATIENT AND ARE ASSOCIATED MANUFACTURER REPORT NUMBERS: 3003742446-2015-00010, 3003742446-2015-00011, & 3003742446-2015-00001. GTIN NUMBER = (B)(4). THE PRODUCT REMAINS IMPLANTED AND IS THUS NOT AVAILABLE FOR ANALYSIS. ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT. CONCOMITANT MEDICATIONS: ASPIRIN325 MG/ONCE A DAY (UU/UUU/1994 - ONG); CLONAZEPAM (RESTLESS LEG SYNDROME) 0.5 MG/ONCE A DAY (UU/UUU/1994 - ONG); CLOPIDOGREL 75MG/ONCE A DAY- (UU/UUU/1994 - ONG); FUROSEMIDE- 20MG/ONCE A DAY- (UU/UUU/1994 - ONG); HYDROXYZINE-TREATMENT FOR ITCHING-25MG/TWICE A DAY- (UU/UUU/2005 - ONG); LISINOPRIL-10MG/ONCE A DAY-(UU/UUU/1994 - ONG).

    Additional Manufacturer Narrative · 1

    THIS IS ONE OF THREE EVENTS ASSOCIATED WITH THE PATIENT AND ARE ASSOCIATED MANUFACTURER REPORT NUMBERS: 3003742446-2015-00010, 3003742446-2015-00011, & 3003742446-2015-00001. COMPLAINT CONCLUSION: A PATIENT CALLED FOR MEDICAL INFORMATION AND ADDITIONALLY REPORTED ADVERSE EVENTS. ON (B)(6) 2004, THE PATIENT HAD A CYPHER STENT PLACED IN AN UNKNOWN "CIRC" "MAIN ARTERY", FOLLOWING THE PATIENT PRESENTING WITH BACK PAIN BETWEEN THE SHOULDER BLADES, "FOR 90 SOMETHING PERCENT" BLOCKAGE OF AN UNKNOWN VESSEL. ON (B)(6) 2007, THE CONSUMER EXPERIENCED "88% AND 90 SOMETHING PERCENT BLOCKAGE " IN THE CIRC, , AFTER PRESENTING WITH BACK PAIN BETWEEN THE SHOULDER BLADES, AND AS TREATMENT THE PATIENT HAD 2 "LIBERTE STENTS" PLACED THE CIRC . PATIENT WAS "IN THE HOSPITAL LESS THAN 24 HOURS STAYED OVERNIGHT". PHYSICIAN IS AWARE AND EVENT RESOLVED. HE STATED THAT THE LIBERTE STENTS WERE IMPLANTED IN THE ¿CIRC¿, AS WELL AS THE CYPHER STENT. HE STATED THAT HE IS UNSURE IF MORE THAN ONE CYPHER STENT WAS PLACED BACK IN 2004. HE ALSO WAS UNSURE IF THERE WAS RESTENOSIS OF THE CYPHER STENT IN 2007, OR IF THERE WAS AN ENTIRELY NEW LESION. MEDICAL RECORDS WERE PROVIDED BY THE PHYSICIAN. APPROXIMATELY 5 YEARS AFTER CYPHER STENT PLACEMENT, THE PATIENT HAD A LEFT HEART CATHETERIZATION, SELECTIVE CORONARY ANGIO, SELECTIVE LV ANGIO, AND A RADI-WIRE LESION ASSESSMENT OF THE CIRCUMFLEX. THE INDICATION WAS CHEST PAIN, AN ABNORMAL STRESS TEST, AND CAO. ANGIO FINDINGS INCLUDED A RIGHT DOMINANT SYSTEM, MILD PLAQUING PRESENT IN THE LEFT MAIN CORONARY ARTERY (LMCA), THE LAD HAS DIFFUSION LUMINAL IRREGULARITIES, AND THE MID TO DISTAL CIRCUMFLEX HAD MULTIPLE STENTS WITH 70 AND 60% AREAS OF IN-STENT RESTENOSIS PRESENT. RADI-WIRE WAS UTILIZED FOR LESION ASSESSMENT. FFR OF 0.89 WAS OBTAINED. THE RCA WAS OCCLUDED IN THE MID PORTION AND THE L>R COLLATERALS TO THE DISTAL RCA WERE VISUALIZED. THE (B)(6)-YEAR-OLD MALE PATIENT HAS A MEDICAL HISTORY OF HEART ATTACK 1994 SHOWED ON EKG IN EMERGENCY ROOM (TREATMENT BALLOON PLACED IN UNKNOWN VESSEL) FOLLOWING PAIN IN CHEST UP INTO THE JAW AND LEFT ARM, HYPERTENSION, HIGH CHOLESTEROL, SLEEP APNEA (SINCE 80'S), SMOKING, GERD, AND PEPTIC ULCER DISEASE. THE CYPHER STENT REMAINS IMPLANTED AND IS, THEREFORE, NOT UNAVAILABLE FOR ANALYSIS. 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. RESTENOSIS IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH CORONARY ARTERY STENTING. PATIENTS WHO ARE KNOWN TO BE AT HIGH-RISK FOR RESTENOSIS AND THROMBOSIS INCLUDE THOSE WITH DIABETES, LONG LESIONS, SMALL VESSELS, BIFURCATIONS, AND RESTENOTIC LESIONS. REVIEW OF THE INFORMATION PROVIDED SUGGESTS THAT THERE ARE POSSIBLE PATIENT FACTORS (SPECIFICALLY DIABETES), VESSEL/LESION CHARACTERISTICS (RESTENOTIC, LONG LESION) AND PROCEDURAL FACTORS THAT MAY HAVE CONTRIBUTED TO THIS EVENT. REVIEW OF THE AVAILABLE INFORMATION SUGGESTS THAT PATIENT FACTORS AND/OR VESSEL/LESION CHARACTERISTICS MAY HAVE CONTRIBUTED TO THE EVENT. THERE IS NO EVIDENCE TO SUGGEST THAT THE EVENT IS RELATED TO THE DESIGN OR MANUFACTURING PROCESS OF THE DEVICE. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN.

    Description of Event or Problem · 1

    A PATIENT CALLED FOR MEDICAL INFORMATION AND ADDITIONALLY REPORTED ADVERSE EVENTS. ON (B)(6)2004, THE PATIENT HAD A CYPHER STENT PLACED IN AN UNKNOWN "CIRC" "MAIN ARTERY", FOLLOWING THE PATIENT PRESENTING WITH BACK PAIN BETWEEN THE SHOULDER BLADES, "FOR 90 SOMETHING PERCENT" BLOCKAGE OF AN UNKNOWN VESSEL. ON (B)(6) 2007, THE CONSUMER EXPERIENCED "88% AND 90 SOMETHING PERCENT BLOCKAGE " IN THE CIRC, , AFTER PRESENTING WITH BACK PAIN BETWEEN THE SHOULDER BLADES, AND AS TREATMENT THE PATIENT HAD 2 "LIBERTE STENTS" PLACED THE CIRC . PATIENT WAS "IN THE HOSPITAL LESS THAN 24 HOURS STAYED OVERNIGHT". PHYSICIAN IS AWARE AND EVENT RESOLVED. HE STATED THAT THE LIBERTE STENTS WERE IMPLANTED IN THE ¿CIRC¿, AS WELL AS THE CYPHER STENT. HE STATED THAT HE IS UNSURE IF MORE THAN ONE CYPHER STENT WAS PLACED BACK IN 2004. HE ALSO WAS UNSURE IF THERE WAS RESTENOSIS OF THE CYPHER STENT IN 2007, OR IF THERE WAS AN ENTIRELY NEW LESION. MEDICAL RECORDS WERE PROVIDED BY THE PHYSICIAN. APPROXIMATELY 5 YEARS AFTER CYPHER STENT PLACEMENT, THE PATIENT HAD A LEFT HEART CATHETERIZATION, SELECTIVE CORONARY ANGIO, SELECTIVE LV ANGIO, AND A RADI-WIRE LESION ASSESSMENT OF THE CIRCUMFLEX. THE INDICATION WAS CHEST PAIN, AN ABNORMAL STRESS TEST, AND CAO. ANGIO FINDINGS INCLUDED A RIGHT DOMINANT SYSTEM, MILD PLAQUING PRESENT IN THE LEFT MAIN CORONARY ARTERY (LMCA), THE LAD HAS DIFFUSION LUMINAL IRREGULARITIES, THE MID TO DISTAL CIRCUMFLEX HAD MULTIPLE STENTS WITH 70 AND 60% AREAS OF IN-STENT RESTENOSIS PRESENT. RADI-WIRE WAS UTILIZED FOR LESION ASSESSMENT. FFR OF 0.89 WAS OBTAINED. THE RCA WAS OCCLUDED IN THE MID PORTION AND THE L>R COLLATERALS TO THE DISTAL RCA WERE VISUALIZED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    71724 CYPHER SIROLIMUS-ELUTING CORONARY STENT DRUG-ELUTING STENT (NIQ) NIQ CORDIS CORPORATION X1103171

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| L| R