BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PALMAZ XL STENT PER 40MM UNMOUNTED

    MDR report key: 1952482 · Received January 7, 2011

    Report

    Report Number
    1016427-2011-00005
    Event Type
    Injury
    Date Received
    January 7, 2011
    Report Date
    December 13, 2010
    Manufacturer
    CORDIS CORPORATION
    Product Code
    FGE
    PMA / PMN Number
    K993091
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS NOT AVAILABLE FOR ANALYSIS.ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS FROM RECEIPT.

    Additional Manufacturer Narrative · 1

    THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THIS ADVERSE EVENT IN WHICH ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 9610978-2011-00029 AND 1016427-2011-00005. THE BALLOON DID NOT FULLY EXPAND WHEN THE BALLOON WAS INFLATED. IT WAS CONFIRMED THAT THE PHYSICIAN DID VASCULAR REPAIR BY SUTURE DUE TO THE REMOVAL OF THE STENT BECAUSE THE STENT WAS PARTIALLY EXPANDED. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS FROM RECEIPT.

    Additional Manufacturer Narrative · 1

    THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THIS ADVERSE EVENT IN WHICH ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 9610978-2011-00029 AND 1016427-2011-00005. WHEN ATTEMPTING TO DEPLOY A STENT FOR REPAIR OF A TYPE I ENDO LEAK INSIDE OF A AAA DEVICE THE BALLOON DID NOT FULLY INFLATE AND THE PARTIALLY EXPANDED STENT DISLODGED AND MOVED DOWNSTREAM TO THE BIFURCATION. IT WAS SURGICALLY REMOVED. (B)(4). 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 SUBJECT BATCH WAS PACKAGED AND LABELED PER THE VALIDATED PROCESS. THE SUBJECT BATCH PASSED ALL LABELING VERIFICATIONS AND WAS FOUND ACCEPTABLE FOR THE VALIDATED BACTERIAL ENDOTOXINS TESTING. RECEIVING INSPECTION RECORDS INDICATE THAT THE RAW TUBING LOT OF (10149, ST-4957 & ST-4970) USED TO MANUFACTURE THE STENT LOST INVOLVED IN THE SHIPMENTS WERE INSPECTED AND ACCEPTED TO CORDIS M-S013 DIMENSIONAL AND METALLURGICAL REQUIREMENTS. REVIEW OF ALL INVOLVED STENT PRODUCTION ROUTERS INDICATED THE STENTS WERE PROCESSED IN COMPLIANCE WITH THE DEFINED PROCESS FLOW USING PROCESS PARAMETERS PER CORDIS DRAWING REQUIREMENTS. TRAINED OPERATORS PERFORMED ALL ROUTER STEPS, WHILE THE 90.4% OVERALL YIELD THROUGH ALL MANUFACTURING AND INSPECTION PROCESSES FOR THE SUBJECT BATCHES WERE NORMAL TO HISTORICAL P4014 EXTRA LARGE RESULTS FOR THE SAME PERIOD ((B)(6) 2009 - (B)(6) 2010 = 90.4%). AS PART OF THE STANDARD STENT MANUFACTURING PROCESS, ALL STENTS IN THE SUBJECT BATCH WERE DIRECTLY MONITORED FOR VISUAL ATTRIBUTE, WALL THICKNESS, STENT FEATURES, AND OVERALL LENGTH. ALL ACCEPTED STENTS CONFORMED TO 100% COMPARATOR INSPECTION OF OVERALL LENGTH, AND WALL THICKNESS, ALONG WITH 100% VISUAL ATTRIBUTE INSPECTION THROUGH 40X MICROSCOPE INSPECTION. ALL (B)(4) FINISHED STENT DOCUMENTATION INDICATES THAT ALL STENTS SHIPPED UNDER THE SUBJECT (B)(4) SHIPPING CONTROL NUMBER IN QUESTION MEETS CORDIS DRAWING SPECIFIED PRODUCT RELEASE REQUIREMENTS. BASED ON THE LACK OF INFORMATION AND THE INABILITY TO ASSIGN OR DETERMINE ROOT CAUSE NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. (B)(4). 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. REVIEW OF LOT 15105620 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. NO UNITS WERE REJECTED DURING THE FINAL ASSEMBLY OF THIS LOT. NO OTHER ISSUES WERE NOTED THAT WERE CONSIDERED POTENTIALLY RELATED TO THE REPORTED COMPLAINT. NO NONCONFORMANCE RECORDS WERE ISSUED FOR THIS LOT. NO EXCURSIONS WERE FOUND FOR LOT 15105620. LEAK AND BURST TEST RESULTS WERE REVIEWED AND NO ANOMALIES WERE FOUND DURING MANUFACTURING PROCESS OF THIS LOT. BASED ON THE LACK OF INFORMATION AND THE INABILITY TO ASSIGN OR DETERMINE ROOT CAUSE NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. WITH THE LIMITED AMOUNT OF INFORMATION AVAILABLE AND WITHOUT RETURN OF THE PRODUCT FOR ANALYSIS OR FILMS OF THE EVENT IT IS NOT POSSIBLE TO DRAW A CLINICAL CONCLUSION BETWEEN THE DEVICE AND THE EVENT. HOWEVER, PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. BASED ON THE LACK OF INFORMATION AND THE INABILITY TO ASSIGN OR DETERMINE ROOT CAUSE NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    AFTER COMPLETING ENDOVASCULAR ANEURYSM REPAIR SURGERY, THE PHYSICIAN FOUND A TYPE I ENDOLEAK. THE PHYSICIAN USED A PALMAZ STENT OVER A MAXI LD BALLOON; HOWEVER, THE STENT WAS "LOST" WHEN THE BALLOON WAS INFLATED. THE PROBLEM OCCURRED DURING USE ON THE PATIENT. THERE WAS NO ADVERSE EVENT. THE DEVICE WAS DISCARDED; THEREFORE, WILL NOT BE RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    AFTER COMPLETING ENDOVASCULAR ANEURYSM REPAIR SURGERY, THE PHYSICIAN FOUND A TYPE I ENDOLEAK. THE PHYSICIAN USED A PALMAZ STENT OVER A MAXI LD BALLOON; HOWEVER, THE STENT WAS "LOST" WHEN THE BALLOON WAS INFLATED. THE PROBLEM OCCURRED DURING USE ON THE PATIENT. THE DEVICE WAS DISCARDED; THEREFORE, WILL NOT BE RETURNED FOR ANALYSIS. THE TARGET LESION WAS LOCATED IN THE MID AORTA. THE LESION WAS DESCRIBED AS 3CM IN LENGTH WITH NO CALCIFICATION. IT WAS REPORTED THAT THE STENT BECAME DISLODGED AND MIGRATED TO THE BIFURCATION. THE STENT WAS REMOVED FROM THE PATIENT. THERE WAS PATIENT INJURY REPORTED AS "VASCULAR AT FEMORAL SITE DISSECT AND TRAUMA". TREATMENT INCLUDED VASCULAR REPAIR BY SUTURE. THE DEVICE WAS STORED PER THE INSTRUCTIONS FOR USE. THERE WAS NO DAMAGE NOTED WITH THE PACKAGING OR THE DEVICE PRIOR TO USE. THE DEVICE PREPPED NORMALLY. ULTRAVIST/BAYER CONTRAST MEDIA WAS USED. THE CONTRAST TO SALINE RATIO WAS 50:50. THE SAME INDEFLATOR WAS USED WITH OTHER DEVICES. THERE WAS NO DIFFICULTY TRACKING THE DEVICE TO THE LESION. THERE WAS NO DIFFICULTY INFLATING THE BALLOON. NO EXCESSIVE FORCE WAS APPLIED WITH THE DEVICE AT ANY TIME DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PALMAZ XL STENT PER 40MM UNMOUNTED ENDOVASCULAR SDS/STENTS (FGE) FGE CORDIS CORPORATION NA N1209303

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR MAXI LD BALLOON.