BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 DRUG-ELUTING CORONARY STENT

    MDR report key: 753519 · Received June 21, 2006

    Report

    Report Number
    6000089-2006-01231
    Event Type
    Injury
    Date Received
    June 21, 2006
    Date of Event
    May 18, 2006
    Report Date
    May 23, 2006
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVAL, THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE AND WE ARE NOT ABLE TO DETERMINE THE ROOT CAUSE OF THIS EVENT. THE MANUFACTURING RECORDS FOR TOP ASSEMBLY BATCH 8030855 HAVE BEEN REVIEWED AND NO ISSUES OR DISCREPANCIES WERE FOUND. THIS RECORD'S REVIEW CONFIRMS THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY, AND PERFORMANCE SPECIFICATIONS. SHOULD FURTHER RELEVANT INFO BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE FILED.

    Description of Event or Problem · 1

    SAME AS MANUFACTURER'S REPORT # 6000093-2006-01131, 6000089-2006-01230, 6000089-2006-01232. TAP. IT WAS REPORTED THAT 142 DAYS AFTER IMPLANTATION OF A 3.0X32MM, 2.5X20MM, AND TWO (2) 2.5X8MM TAXUS EXPRESS2 DRUG ELUTING STENTS, AN IN-STENT RESTENOSIS OCCURRED. DURING THE INITIAL PROCEDURE, THE TARGET LESION WAS LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD). A PRE-INTERVENTION IN-STENT STENOSIS OF 99% WITH "COMPETITIVE FLOW" AT THE DISTAL END OF THE VESSEL WAS REPORTED. THE LESION WAS PRE-DILATED WITH A 2.0X15MM MAVERICK BALLOON THAT WAS INFLATED MULTIPLE TIMES TO 18 ATMS AT THE ANASTOMOTIC SITE OF THE LAD AND THE LEFT INTERNAL MAMMARY ARTERY (LIMA) RESULTING IN A 30% DIFFUSE RESIDUAL STENOSIS. A 2.5X20MM TAXUS STENT WAS DEPLOYED DISTALLY IN THE MID LAD, "JUST PRIOR TO THE ANASTOMOTIC SITE OF THE LIMA," RESULTING IN 0% RESIDUAL STENOSIS. A PERSISTENT STENOTIC LESION WAS NOTED AT THE DISTAL END OF THE PREVIOUSLY PLACED STENT AND A 2.5X8MM TAXUS STENT WAS DEPLOYED. IN THE PROXIMAL LAD, A 3.0X32MM TAXUS STENT WAS DEPLOYED, OVERLAPPING THE OTHER STENTS AND COVERING THE PROXIMAL AND OSTIAL LAD RESULTING IN 0% RESIDUAL STENOSIS. A PERSISTENT STENOTIC AREA PRIOR TO THE ANASTOMOTIC SITE WAS NOTED. SUBSEQUENTLY, A 2.5X8MM TAXUS STENT WAS DEPLOYED "JUST DISTAL TO THE OTHERS." IT WAS REPORTED THAT THIS STENT DID "IMPINGE SLIGHTLY ON THE ANASTOMOTIC SITE WITH THE LIMA." A POST-INTERVENTION RESIDUAL STENOSIS OF 0% WAS REPORTED. IT WAS REPORTED THAT "THERE WAS GREAT FLOW NOTED DOWN THE ENTIRE LAD AFTER THE PROCEDURE WITH GOOD FLOW NOTED IN THE DISTAL LAD AS WELL." IT WAS REPORTED THAT THE LESION WAS NOT CALCIFIED NOR WAS THE VESSEL TORTUOUS. THE PATIENT RECEIVED ASPIRIN BEFORE THE PROCEDURE; INTEGRILIN AND HEPARIN DURING; AND PLAVIX, ASPIRIN, METOPROLOL, IMDUR, LESCOL, GLYBURIDE AND ATIVAN AFTER. PATIENT COMPLICATIONS WERE REPORTED AS "NONE." THE PATIENT'S DISCHARGE CONDITION WAS REPORTED AS "GOOD." THE PATIENT PRESENTED 142 DAYS AFTER THE INITIAL PROCEDURE WITH CHEST PAIN AND AN IN-STENT RESTENOSIS IN THE PROXIMAL LAD. A PRE-INTERVENTION RESTENOSIS OF 70% WAS REPORTED. PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) WAS PERFORMED WITH A 2.5X20MM BALLOON. A 3.5X23MM CYPHER STENT WAS DEPLOYED IN THE LESION. A POST-INTERVENTION STENOSIS OF 0% WAS REPORTED. THE PATIENT RECEIVED INTEGRILIN AND HEPARIN DURING THE PROCEDURE AND WAS CONTINUED ON ASPIRIN AND PLAVIX AFTER THE PROCEDURE. COMPLICATIONS WERE REPORTED AS "NONE." THE PATIENT'S CONDITION WAS REPORTED AS "SATISFACTORY/GOOD."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS EXPRESS2 DRUG-ELUTING CORONARY STENT DRUG COATED STENT NIQ BOSTON SCIENTIFIC 3.0X32MM 8030855

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Other