BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABSOLUTE PRO .035 SELF EXPANDING STENT SYSTEM

    MDR report key: 17607824 · Received August 23, 2023

    Report

    Report Number
    2024168-2023-09211
    Event Type
    Injury
    Date Received
    August 23, 2023
    Date of Event
    August 3, 2023
    Report Date
    October 27, 2023
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    FGE
    PMA / PMN Number
    K072708
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED FOR ANALYSIS. THE REPORTED PHYSICAL RESISTANCE / STICKING AND THE REPORTED DIFFICULT OR DELAYED ACTIVATION WERE UNABLE TO BE REPLICATED IN A TESTING ENVIRONMENT DUE TO THE CONDITION OF THE RETURNED DEVICE. IT SHOULD BE NOTED THE ABSOLUTE PRO .035 PERIPHERAL SELF-EXPANDING STENT SYSTEM INSTRUCTIONS FOR USE (IFU) STATES: THE ABSOLUTE PRO .035 PERIPHERAL SELF-EXPANDING STENT SYSTEM IS INTENDED FOR THE STENTING OF PERIPHERAL ARTERIES AS AN ADJUNCT TO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) AND FOR THE PALLIATION OF MALIGNANT STRICTURES IN THE BILIARY TREE. A REVIEW OF THE LOT HISTORY RECORD IDENTIFIED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY IDENTIFIED NO OTHER INCIDENTS FROM THIS LOT. AS THERE WAS NO DAMAGE NOTED TO THE DEVICE DURING THE INSPECTION PRIOR TO USE, THE INVESTIGATION DETERMINED THE REPORTED DIFFICULTIES APPEAR TO BE RELATED TO DEVIATION OF THE INSTRUCTIONS FOR USE AND SUBSEQUENT CIRCUMSTANCES OF THE PROCEDURE AS IT IS LIKELY THAT DURING ADVANCEMENT (AGAINST THE INSTRUCTIONS FOR USE IN THE CEREBRAL VENOUS SINUSES) INTERACTION WITH THE HEAVILY TORTUOUS AND MILDLY CALCIFIED ANATOMY RESULTED IN PREVENTING THE SHAFT LUMENS FROM MOVING FREELY RESULTING IN THE REPORTED PHYSICAL RESISTANCE / STICKING DIFFICULTIES (RESISTANCE WAS FELT TO BE TOO HIGH TO CONTINUE THE RELEASE OF THE STENT) AND THE REPORTED DIFFICULT/DELAYED ACTIVATION/DEPLOYMENT DIFFICULTIES. INTERACTION WITH ANATOMY/OTHER DEVICES AND MANIPULATION OF THE DEVICE BY DISASSEMBLING THE HANDLE RESULTED IN THE NOTED MULTIPLE DEVICE DAMAGES. THE TREATMENT(S) APPEARS TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING. D4: CATALOG NUMBER/ LOT NUMBER UPDATED FROM 1012536-40 / 3011161 TO 1012839-60 / 3051862.

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION IS STILL PENDING AT THIS TIME. RESULTS AND CONCLUSIONS WILL BE PROVIDED IN THE FINAL REPORT. H6: DEVICE CODE 1494- INCORRECT ANATOMY.

    Description of Event or Problem · 0

    SUBSEQUENTLY, AFTER THE INITIAL WAS FILED IT WAS NOTED THE CORRECT SIZE OF THE ABSOLUTE PRO IN THIS PROCEDURE WAS A 6.0X60MM. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY TORTUOUS, MILDLY CALCIFIED CEREBRAL VENOUS SINUSES LESION. THE LESION WAS PRE-DILATATED WITH A 5X40MM ARMADA 35 AT 8 ATMOSPHERES. AS NO OTHER STENT WAS AVAILABLE A 8.0X40MM ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM (SESS) WAS CHOSEN. DURING HALFWAY OF DEPLOYMENT OF THE SESS RESISTANCE WAS FELT TO BE TOO HIGH TO CONTINUE THE RELEASE OF THE STENT. THE HANDLE WAS DISASSEMBLED, THE PURPLE STABILITY SHEATH AND PART OF YELLOW DISTAL RETRACTION SHEATH WERE MANUALLY PULLED OUT. AN ENDOSCOPIC FOREIGN BODY FORCEPS WAS USED TO CLAMP REMAINING PART OF DISTAL RETRACTION GUIDE SHEATH. THE OPERATOR PULLED OUT THE REMAINING DISTAL RETRACTION GUIDE SHEATH BY FORCEPS, THE OTHER PART OF STENT WAS RELEASED. THE HEAD SEGMENT AND SLOT TUBE WERE WITHDRAWN WITH DISTAL GUIDE SHEATH UNDER FLUOROSCOPY. A 6X30MM VIATRAC BALLOON WAS USED FOR POST DILATATION AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1138407 ABSOLUTE PRO .035 SELF EXPANDING STENT SYSTEM SELF EXPANDING PERIPHERAL STENT SYSTEM FGE ABBOTT VASCULAR 3051862
    2009201 ABSOLUTE PRO .035 SELF EXPANDING STENT SYSTEM SELF EXPANDING PERIPHERAL STENT SYSTEM FGE ABBOTT VASCULAR 3051862

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention 6X30MM VIATRAC BALLOON