BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1920506 · Received December 13, 2010

    Report

    Report Number
    9616099-2010-00942
    Event Type
    Malfunction
    Date Received
    December 13, 2010
    Date of Event
    October 15, 2010
    Report Date
    October 18, 2010
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT MET MDR REPORTABILITY CRITERIA ON 11/30/2010, WHEN IT WAS DISCOVERED, VIA REVIEW OF A PROCEDURE CD BY AN INDEPENDENT PHYSICIAN, THAT THE PATIENT HAD A STENT FRACTURE. CYPHER SELECT PRODUCT (CRA/CRB/CJB) IS NOT DISTRIBUTED IN THE US; HOWEVER, IT IS SIMILAR TO US DISTRIBUTED CYPHER PRODUCT (CXS). THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THIS ADVERSE EVENT IN WHICH ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 9616099-2010-00941 AND 9616099-2010-00942. A (B)(6) MALE PATIENT EXPERIENCED A STENT FRACTURE WITH SEPARATION, ANEURYSM, AND A RESTENOSIS APPROXIMATELY FOUR YEARS AFTER IMPLANTATION OF TWO CYPHER STENTS. THE PATIENT HAD TWO OVERLAPPING CYPHER SELECT + STENTS IMPLANTED IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD). THE PATIENT HAD COMPLAINED OF CHEST PAIN AND A REPEAT ANGIOGRAM REVEALED AN ANEURYSM IN THE MID PORTION OF THE PROXIMAL STENT AND A RESTENOSIS OF APPROXIMATELY 80% IN THE STENT THAT HAD BEEN IMPLANTED DISTALLY. THE PATIENT DID NOT EXPERIENCE A MYOCARDIAL INFARCT OR OTHER INJURY AS A RESULT OF THE ANEURYSM/RESTENOSIS. THE PATIENT CURRENTLY HAS CHEST PAIN AND THE PHYSICIAN HAS INDICATED THAT HE MAY VERY LIKELY SEND THE PATIENT FOR BYPASS SURGERY. PROCEDURE FILMS WERE REVIEWED BY AN INDEPENDENT PHYSICIAN. HE REPORTED THAT THERE APPEARS TO BE A STENT FRACTURE IN THE MID PORTION OF THE STENTED SEGMENT WHERE THERE WAS APPROXIMATELY 2MM DISPLACEMENT OF FRAGMENTS AND SEVERE IN-STENT RESTENOSIS AT THAT LOCATION. IN THE PROXIMAL PORTION OF THE STENTED SEGMENT, ANEURYSMAL FORMATION WAS NOTED. THE PRODUCTS REMAIN IMPLANTED IN THE PATIENT AND ARE THUS NOT AVAILABLE FOR EVALUATION. A REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE CONDUCTED WITHOUT A LOT NUMBER. WHILE NOT OBSERVED IN THE (B)(4) CLINICAL TRIALS THAT SUPPORTED THE CYPHER STENT PMA, STENT FRACTURES ARE UNCOMMON EVENTS BUT HAVE BEEN OBSERVED IN LONG STENTED SEGMENTS INCLUDING THOSE IN WHICH OVERLAPPING STENTS HAVE BEEN USED. THEY HAVE BEEN OBSERVED IN CORONARY SEGMENTS THAT UNDERGO SIGNIFICANT MOTION, PARTICULARLY IN AREAS WITH SEVERE ANGULATION, TORTUOSITY AND CALCIFICATION. IN THE CYPHER STENT, THEY HAVE BEEN REPORTED MOST OFTEN IN CERTAIN LESION SUBGROUPS IN WHICH SAFETY AND EFFECTIVENESS HAVE NOT BEEN ESTABLISHED. RECENTLY, SES FRACTURE HAS BEEN RECOGNIZED AS A NEW POTENTIAL MECHANISM OF RESTENOSIS. POSSIBLE DISPOSING FACTORS OF STENT FRACTURE ARE LONG LESIONS WITH OVERLAPPING STENTS AND CORONARY SEGMENTS THAT UNDERGO SIGNIFICANT MOTION, PARTICULARLY IN AREAS WITH SEVERE ANGULATION, TORTUOSITY AND CALCIFICATION. IN THIS CASE, THE VESSEL/LESION CHARACTERISTICS WERE NOT REPORTED. THEREFORE IT IS NOT KNOWN WHAT FACTORS MAY HAVE CONTRIBUTED TO THE STENT FRACTURE REPORTED. AN INVESTIGATION WAS CONDUCTED SURROUNDING THE INCREASE IN CYPHER STENT FRACTURE COMPLAINTS. AS A RESULT OF THAT INVESTIGATION LABELING CHANGES RELATED TO STENT FRACTURES WERE MADE. ADDITIONAL INVESTIGATION IS ONGOING. A CAUSE OF CORONARY ARTERY ANEURYSM FORMATION AFTER PCI HAS BEEN IDENTIFIED AS EXCESSIVE USE OF OVERSIZED BALLOONS OR HIGH-PRESSURE INFLATION OF THE BALLOON, RESULTING IN INTIMAL AND MEDIAL TEARING WITH CONTINUOUS WEAKENING AND STRETCHING OF THE ARTERY. THE EXACT MECHANISM OF ANEURYSM FORMATION AFTER DES IMPLANTATION IS STILL UNKNOWN. HOWEVER, CLINICAL REPORTS SUGGEST SEVERAL POTENTIAL CAUSES, INCLUDING REACTION TO STENT MATERIAL (STAINLESS STEEL COMPOSED OF IRON, NICKEL AND CHROMIUM), DRUG EFFECTS AND HYPERSENSITIVITY TO THE DRUG ELUTING POLYMERS. ANOTHER POSSIBLE MECHANISM MAY BE RELATED TO A STENT FRACTURE IN WHICH THE STRUT IN COMBINATION WITH OTHER MECHANISMS, COULD PROBABLY EXPLAIN ANEURYSM FORMATION. BASED ON THE LIMITED INFORMATION AVAILABLE FOR REVIEW, IT IS NOT POSSIBLE TO DRAW A CONCLUSION ABOUT A CLINICAL RELATIONSHIP BETWEEN THE DEVICES AND THE EVENTS AND NO DETERMINATION REGARDING POTENTIAL CONTRIBUTING FACTORS COULD BE MADE.

    Description of Event or Problem · 1

    A PATIENT EXPERIENCED A STENT FRACTURE WITH SEPARATION, ANEURYSM, AND A RESTENOSIS APPROXIMATELY FOUR YEARS AFTER STENT IMPLANTATION. THE PATIENT HAD TWO OVERLAPPING CYPHER SELECT + STENTS IMPLANTED IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD). THE PATIENT HAD COMPLAINED OF CHEST PAIN AND A REPEAT ANGIOGRAM REVEALED AN ANEURYSM IN THE MID PORTION OF THE PROXIMAL STENT AND A RESTENOSIS OF APPROXIMATELY 80% IN THE STENT THAT HAD BEEN IMPLANTED DISTALLY. THE PATIENT DID NOT EXPERIENCED A MYOCARDIAL INFARCT OR OTHER INJURY AS A RESULT OF THE ANEURYSM/RESTENOSIS. THE PATIENT CURRENTLY HAS CHEST PAIN AND THE PHYSICIAN HAS INDICATED THAT HE MAY VERY LIKELY SEND THE PATIENT FOR BYPASS SURGERY. PROCEDURE FILMS WERE REVIEWED BY AN INDEPENDENT PHYSICIAN. HE REPORTED THAT THERE WAS STENT FRACTURE IN THE MID PORTION OF THE STENTED SEGMENT, WHERE THERE WAS APPROXIMATELY 2MM DISPLACEMENT OF FRAGMENTS AND SEVERE IN-STENT RESTENOSIS AT THAT LOCATION. IN THE PROXIMAL PORTION OF THE STENTED SEGMENT, ANEURYSMAL FORMATION WAS NOTED.

    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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| R