BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PALMAZ GENESIS AMIIA

    MDR report key: 4113245 · Received September 24, 2014

    Report

    Report Number
    9616099-2014-00629
    Event Type
    Injury
    Date Received
    September 24, 2014
    Date of Event
    September 11, 2014
    Report Date
    September 18, 2014
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    FGE
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDENDUM (15-OCT-2014): ADDITIONAL INFORMATION/CLARIFICATION WAS PROVIDED BY THE AFFILIATE. THE STENT FULLY DEPLOYED AND THEN MIGRATED. THE STENT WAS SUCCESSFULLY REMOVED FROM THE PATIENT. NO PIECE OF THE STENT OR SDS REMAINED IN THE PATIENT. THE STENT DID NOT DISLODGE FROM THE BALLOON BEFORE THE STENT WAS FULLY DEPLOYED. THE STENT DID NOT JUMP DURING DEPLOYMENT. THE PRODUCT WAS STORED AND HANDLED ACCORDING TO THE IFU. THE DEVICE WAS INSPECTED AND PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE. THE STENT WAS PROPERLY MOUNTED ON THE SYSTEM WHEN INSPECTED PRIOR TO USE. THERE WAS NOTHING UNUSUAL WAS NOTED ABOUT THE SDS PRIOR TO USE. DURING PREPARATION OF THE DEVICE, THE STENT WAS NOT MANIPULATED. PRIOR TO INSERTING THE SDS IN THE CATHETER, THE BALLOON WAS NOT INFLATED OR PARTIALLY INFLATED. NEGATIVE PRESSURE WAS APPLIED TO THE SDS. THE INFLATION DEVICE WAS IN NEUTRAL POSITION WHEN THE SYSTEM WAS BEING ADVANCED/WITHDRAWN. AN AGURU GUIDE WIRE WAS USED FOR THE PROCEDURE (UNKNOWN SIZE). CLARIFICATION: DURING DELIVERY OF THE SECOND STENT, THE AGURU GUIDEWIRE SLIPPED OUT (DROPPED OUT OF THE STENT), AND THEN THE FIRST STENT WAS MOVED BACK TO THE DISTAL SIDE AND STOPPED AROUND THE COMMON ILIAC ARTERY. THERE WAS NO DIFFICULTY ADVANCING THE DEVICE TO THE TARGET LESION. ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 1

    COMPLAINT CONCLUSION: DURING A STENT GRAFTING PROCEDURE IN THE LEFT RENAL ARTERY, IT WAS REPORTED THAT A 6.0X18 142CM PALMAZ GENESIS AMIIA STENT WAS DEPLOYED AND THE STENT SLIPPED TOWARD THE ABDOMINAL AORTA SIDE AND IT WAS JUST HANGING ON THE RENAL ARTERY. THE PHYSICIAN THEN TRIED TO PLACE ANOTHER NEW PALMAZ GENESIS (THE SAME SIZE) IN THE DISTAL RENAL ARTERY TO FIX THE FIRST STENT. HOWEVER, DURING DELIVERY OF THE SECOND STENT, A GUIDEWIRE SLIPPED OUT, AND THEN THE FIRST STENT WAS MOVED BACK TO THE DISTAL SIDE AND STOPPED AROUND THE COMMON ILIAC ARTERY. THEREFORE, THE FIRST STENT WAS WITHDRAWN INTO THE 20F SHEATH INTRODUCER BY USING A SNARE CATHETER AND WAS REMOVED FROM THE PATIENT SUCCESSFULLY. THE STENT GRAFT WAS IMPLANTED AS SCHEDULED. THE PROCEDURE WAS FINISHED SUCCESSFULLY. THE TARGET LESION WAS NOT TORTUOUS WITH 50% STENOSIS. THE BALLOON INFLATED NORMALLY DURING DEPLOYMENT. THERE WAS NO INJURY TO THE PATIENT AS A RESULT OF THE COMPLICATION. PROCEDURAL FILMS ARE NOT AVAILABLE. THE DEVICE WAS CLINICALLY USED AND WILL NOT BE RETURNED FOR ANALYSIS. REVIEW OF LOT 16024208 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. THE REPORTED STENT MIGRATION COULD NOT BE CONFIRMED AS THE DEVICE WAS NOT RETURNED FOR ANALYSIS NOR WERE PROCEDURAL FILMS PROVIDED FOR REVIEW. THE EXACT CAUSE COULD NOT BE DETERMINED. BASED ON THE INFORMATION AVAILABLE FOR REVIEW, FACTORS CONTRIBUTION THE DIFFICULTY EXPERIENCED BY THE CUSTOMER COULD NOT BE DETERMINED. NEITHER THE INFORMATION AVAILABLE FOR REVIEW, NOR THE DHR SUGGEST THAT THERE IS A DESIGN OR MANUFACTURING RELATED ISSUE; THEREFORE, NO CORRECTIVE ACTION WILL BE TAKEN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    ADDITIONAL DETAILS WERE PROVIDED BY THE AFFILIATE. THE TARGET LESION WAS NOT TORTUOUS WITH 50% STENOSIS. THE BALLOON INFLATED NORMALLY DURING DEPLOYMENT. THERE WAS NO INJURY TO THE PATIENT AS A RESULT OF THE COMPLICATION. PROCEDURAL FILMS ARE NOT AVAILABLE. ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS NOT AVAILABLE FOR TESTING AND EVALUATION. ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    DURING A STENT GRAFTING PROCEDURE, IT WAS REPORTED THAT A 6.0X18 142CM PALMAZ GENESIS AMIIA STENT WAS DEPLOYED AND THE STENT SLIPPED TOWARD THE ABDOMINAL AORTA SIDE AND IT WAS JUST HANGING ON THE RENAL ARTERY. THE PHYSICIAN THEN TRIED TO PLACE ANOTHER NEW PALMAZ GENESIS (THE SAME SIZE) IN THE DISTAL RENAL ARTERY TO FIX THE FIRST STENT. HOWEVER, DURING DELIVERY OF THE SECOND STENT, A GUIDEWIRE SLIPPED OUT, AND THEN THE FIRST STENT WAS MOVED BACK TO THE DISTAL SIDE AND STOPPED AROUND THE COMMON ILIAC ARTERY. THEREFORE, THE FIRST STENT WAS WITHDRAWN INTO THE 20F SHEATH INTRODUCER BY USING A SNARE CATHETER AND WAS REMOVED FROM THE PATIENT SUCCESSFULLY. THE STENT GRAFT WAS IMPLANTED AS SCHEDULED. THE PROCEDURE WAS FINISHED SUCCESSFULLY. THE DEVICE WAS CLINICALLY USED AND WILL NOT BE RETURNED FOR ANALYSIS. FOR PLACEMENT OF A STENT GRAFT IN THE AORTA, THE PALMAZ GENESIS STENT WAS DELIVERED TO THE LEFT RENAL ARTERY AND THE STENT WAS DEPLOYED. HOWEVER, THE STENT SLIPPED TOWARD ABDOMINAL AORTA SIDE AND IT WAS JUST HANGING ON THE RENAL ARTERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    593233 PALMAZ GENESIS AMIIA ENDOVASCULAR SDS/STENTS (FGE) FGE CORDIS DE MEXICO NA 16024208

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention| S