BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT

    MDR report key: 730275 · Received June 16, 2006

    Report

    Report Number
    6000093-2006-01116
    Event Type
    Malfunction
    Date Received
    June 16, 2006
    Date of Event
    May 17, 2006
    Report Date
    May 18, 2006
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    Product Code
    NIQ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS VERIFIED THE DIFFICULTY STATED IN THE COMPLAINT. THE RETURNED CATHETER EXHIBITED A FRACTURE OF THE HYPOTUBE LOCATED 17.8 CENTIMETERS DISTALLY FROM THE EDGE OF THE STRAIN RELIEF. THE CATHETER ALSO EXHIBITED TWO SHAFT KINKS LOCATED 16.3 AND 19.9 CENTIMETERS DISTALLY FROM THE EDGE OF THE STRAIN RELIEF. MICROSCOPIC EXAMINATION OF THE FRACTURE FACE REVEALED EVIDENCE THAT THE HYPOTUBE HAD BEEN SEVERELY KINKED AT THE FRACTURE SITE. FURTHER EXAMINATION OF THE FRACTURE SITE DID NOT REVEAL ANY INHERENT MATERIAL DISCREPANCIES THAT WOULD HAVE CONTRIBUTED TO THIS INCIDENT. MICROSCOPIC EXAMINATION OF THE MATERIAL SURROUNDING THE SHAFT KINKS DID NOT REVEAL ANY INHERENT DEFICIENCIES THAT WOULD HAVE CONTRIBUTED TO THE INCIDENT. IT WAS NOT POSSIBLE TO DETERMINE HOW OR WHEN THE KINKS OCCURRED. THE CAUSE OF THE ORIGINAL KINKS OR THE SUBSEQUENT FRACTURE COULD NOT BE DETERMINED. THE SHOP FLOOR PAPERWORK (SFP) FOR TOP ASSEMBLY BATCH 8184713 WAS REVIEWED AND NO ISSUES OR DISCREPANCIES WERE FOUND WHICH COULD POTENTIALLY RELATE TO THIS COMPLAINT. THE SFP REVIEW CONFIRMS THAT THIS DEVICE MET MATERIAL, ASSEMBLY, AND PERFORMANCE SPECIFICATIONS. THERE ARE NO SIMILAR COMPLAINTS OF THIS NATURE RELATED TO THIS BATCH NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CORONARY ARTERY DRUG ELUTING STENTING TREATMENT PROCEDURE, THE SHAFT FRACTURED. THE TARGET LESION WAS LOCATED IN A SEGMENT OF THE MID LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. THE PATIENT PRESENTED WITH ANGINA PECTORIS BEFORE THE PROCEDURE. DURING ADVANCEMENT OF A 2.75X16MM TAXUS LIBERTE' DRUG ELUTING STENT, THE SHAFT FRACTURED PROXIMALLY. THE PHYSICIAN USED A CLIPPING RETRIEVAL DEVICE TO RETRIEVE THE REMAINING DISTAL PART OF THE STENT DELIVERY SYSTEM (SDS). THE SDS WAS ENTIRELY REMOVED FROM THE PATIENT. ANOTHER TAXUS LIBERTE' STENT WAS IMPLANTED, AND THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED. THIS PRODUCT IS ONLY OUS APPROVED, BUT IT IS SIMILAR TO A MARKETED US DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT DRUG COATED STENT NIQ BOSTON SCIENTIFIC CORP. 2.75X16MM 8184713

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR