BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PALMAZ XL STENT PER 40 MM OUS

    MDR report key: 1603621 · Received February 9, 2010

    Report

    Report Number
    1016427-2010-00012
    Event Type
    Injury
    Date Received
    February 9, 2010
    Date of Event
    January 12, 2010
    Report Date
    January 14, 2010
    Manufacturer
    CORDIS CORPORATION
    Product Code
    FGE
    PMA / PMN Number
    K993091
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WHILE DEPLOYING A STENT IN THE AORTA, THE BALLOON ONLY INFLATED AT THE PROXIMAL END CAUSING THE STENT TO BE PUSHED OFF OF THE BALLOON AND DEPLOYED AT THE WRONG SPOT. AN ATTEMPT WITH A NEW STENT/BALLOON COMBINATION WAS TRIED, HOWEVER IT OCCURRED AGAIN. PER THE ACCOUNT, THE HAND CRIMPING PROCESS WAS PERFORMED PER SPECIFICATIONS. PER (B)(4) REPORT: REVIEW OF THE INVOLVED STENT ALONE PRODUCTION ROUTER INDICATED THE STENTS WERE PACKAGED IN COMPLIANCE WITH THE DEFINED PROCESS FLOW USING VALIDATED EQUIPMENT AND PROCESS PARAMETERS PER CORDIS DRAWING REQUIREMENTS. TRAINED OPERATORS PERFORMED ALL ROUTERS STEPS. 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-4426) 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 VALIDATED EQUIPMENT AND PROCESS PARAMETERS PER CORDIS DRAWING REQUIREMENTS. TRAINED OPERATORS PERFORMED ALL ROUTER STEPS, WHILE THE 98.6%, 91.2% 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) 2009 = 91.8%). AS PART OF THE STANDARD STENT MANUFACTURING PROCESS, ALL STENTS IN THE SUBJECT BATCHES 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 NNI SHIPPING CONTROL NUMBER IN QUESTION MEETS CORDIS DRAWING SPECIFIED PRODUCT RELEASE REQUIREMENTS. NO CORRECTIVE ACTIONS WILL BE OPENED AT THIS TIME. WITH THE LIMITED AMOUNT OF INFORMATION AVAILABLE AND WITHOUT THE 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, VESSEL CHARACTERISTICS AND PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    WHILE DEPLOYING A STENT IN THE AORTA THE BALLOON ONLY INFLATED AT THE PROXIMAL END CAUSING THE STENT TO BE PUSHED OFF OF THE BALLOON AND DEPLOYED AT THE WRONG SPOT. AN ATTEMPT WITH A NEW STENT/BALLOON COMBINATION WAS TRIED, HOWEVER IT OCCURRED AGAIN. PER THE ACCOUNT THE HAND CRIMPING PROCESS WAS PERFORMED PER SPECIFICATIONS. A SINGLE PHOTOCOPIED IMAGE OF THE ABDOMINAL AORTA IS SUBMITTED FOR REVIEW. AN AORTIC ENDOGRAFT IS IN PLACE. THERE IS A PALMAZ XL STENT ON A BALLOON CATHETER. THE BALLOON IS INFLATED BUT ONLY THE PROXIMAL END OF THE STENT HAS EXPANDED. THE STENT APPEARS TO HAVE SLIPPED OFF THE BALLOON CATHETER DURING BALLOON EXPANSION. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THESE LOTS PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. NO CORRECTIVE ACTIONS WILL BE OPENED AT THIS TIME. THIS COMPLAINT INVOLVES A PALMAZ XL STENT WHICH FAILED TO EXPAND/DEPLOY DURING TREATMENT OF A PROBABLE TYPE 1 ENDOLEAK OF A AAA ENDOGRAFT. FULL EVALUATION IS DIFFICULT DUE TO THE PAUCITY OF INFORMATION. IT APPEARS MOST LIKELY THAT THE CAUSE OF THE EVENT WAS INEFFECTIVE CRIMPING OF THE STENT ONTO THE BALLOON. WHEN USING LARGE STENTS, HAND CRIMPING IS VERY DIFFICULT AND ONLY EXPERIENCED OPERATORS CAN PERFORM HAND CRIMPING EFFECTIVELY. USING A CRIMPING TOOL IS RECOMMENDED FOR THESE TYPES OF STENTS. ALSO, BATHING THE BALLOON IN CONTRAST PRIOR TO CRIMPING CAN ALSO HELP SECURE THE STENT IN PLACE. I DO NOT BELIEVE THAT THIS REPRESENTS PRODUCT MALFUNCTION BUT RATHER IS TECHNICALLY/PROCEDURALLY RELATED.

    Additional Manufacturer Narrative · 1

    THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THE REPORTED EVENT. THE ASSOCIATED MFR REPORT NUMBER IS 1016427-2010-00013, 9610978-2010-00023, 9610978-2010-00024. ADD'L INFO WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB. RESULTS AS FOLLOWS: DATE: (B) (6) 2010; INRATIO: 3.11; LAB: 3.54.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON APRIL 8, 2010 THAT A NITINOL STONE RETRIEVAL BASKET WAS USED IN A URETEROSCOPY PROCEDURE PERFORMED ON (B) (6) 2007 (PATIENT AGE AND WEIGHT ARE UNAVAILABLE). ACCORDING TO THE COMPLAINANT, THE PATIENT EXPERIENCED PAIN FOR "AWHILE" IN HIS LEFT URETER AFTER A KIDNEY STONE WAS REMOVED. ON (B) (6) 2008 IT WAS DISCOVERED THAT A "PORTION" OF THE NITINOL BASKET WIRE HAD DETACHED FROM THE DEVICE AND REMAINED INSIDE THE PATIENT. IT IS UNKNOWN HOW THE BASKET WIRE WAS REMOVED. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    A PALMAZ XL STENT WAS SUPPOSED TO BE IMPLANTED INTO THE AORTA OF A FEMALE PT BY THE MEANS OF A MAXI LD BALLOON. WHEN INFLATING THE BALLOON, IT ONLY OPENED AT THE PROXIMAL END AND THE PARTIALLY EXTENDED STENT WAS PUSHED FROM THE BALLOON. THE BALLOON DIDN'T FORM A "DOG'S BONE" WHICH LED TO THE WRONG POSITIONING OF THE STENT. IT WAS ANCHORED IN THE WALL OF THE AORTA AND THE SECOND ATTEMPT WITH SIMILAR MATERIAL (A 2ND BALLOON AND STENT), THE SAME WRONG POSITIONING OCCURRED. THE PROCEDURE CLOSED WITHOUT SUCCESS. THE BALLOON AND STENT WERE PREPARED ACCORDING TO IFU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PALMAZ XL STENT PER 40 MM OUS ENDOVASCULAR SDS/STENTS (FGE) FGE CORDIS CORPORATION NA N0308323

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK MAXI LD BALLOON CATHETER