BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ICAST COVERED STENT SYSTEM, 6MMX22MMX120CM

    MDR report key: 21923458 · Received April 28, 2025

    Report

    Report Number
    3011175548-2025-000003
    Event Type
    Injury
    Date Received
    April 28, 2025
    Date of Event
    March 18, 2025
    Report Date
    August 20, 2025
    Manufacturer
    ATRIUM MEDICAL CORPORATION
    Product Code
    PRL
    UDI-DI
    00650862426229
    PMA / PMN Number
    P120003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 0

    RELATED MDR'S: 3011175548-2025-0000036 AND 3011175548-2025-0000037. REPORT RECEIVED STATED THAT A FEMALE PATIENT OF APPROXIMATELY 78-YEARS-OLD UNDERWENT A RIGHT RENAL AND SMA STENTING PROCEDURE IN WHICH THE ICAST COVERED STENT FELL OFF THE BALLOON WHILE TRYING TO POSITION IT IN THE RIGHT RENAL AND SMA. THIS COMPLAINT IS ALSO RELATED TO COMPLAINTS (B)(6) AS BOTH THESE COMPLAINTS WERE ALSO ASSOCIATED WITH THE SAME PROCEDURE WITH THE SAME PATIENT. THE THREE STENTS WERE REPORTED TO HAVE DISLODGED DURING THE ONE PROCEDURE. THERE WERE NO SIMILARITIES IN THE PRODUCT SIZE OR PRODUCT LOT NUMBERS. ADDITIONAL INFORMATION PROVIDED STATED THAT THE PROCEDURE WAS FOR AN AORTIC ANEURISM REPAIR WITH THE INTENDED TARGET BEING THE RIGHT RENAL ARTERY AND THE SUPERIOR MESENTERIC ARTERY (SMA). THE ENDOGRAFT USED IN THE PROCEDURE WAS A COOK ZENITH ALPHA ENDOGRAFT. THE SHEATH USED IN THE CASE WAS A 7FR COOK HIGH FLEX ANSEL INTRODUCER SHEATH. IT WAS REPORTED THAT THERE WAS MINIMAL CALCIFICATION, AND THAT THE VESSEL TAKE OFF ANGLE OFF THE AORTA WAS NOT KNOWN. NO OPERATIVE NOTES OR FLUOROSCOPIC IMAGES WERE PROVIDED FROM THE PROCEDURE. THE ICAST DEVICES NOR THE SHEATH WERE NOT RETURNED FOR EVALUATION, AND NO PICTURES WERE PROVIDED. THEREFORE, THE COMPLAINT CANNOT BE CONFIRMED. A REVIEW OF THE DEVICE HISTORY RECORDS WAS CONDUCTED FOR THE ICAST COVERED STENT LOT. THE REVIEW FOUND THAT THE PRODUCT MET ALL QUALITY AND PERFORMANCE REQUIREMENTS AND THAT THERE WERE NO NON-CONFORMANCES. THERE IS NO INDICATION THAT A DESIGN, MANUFACTURING SPECIFICATION, TEST METHOD, MANUFACTURING PROCESS, EQUIPMENT OR RAW MATERIAL WAS THE CAUSE OF THE COMPLAINT. A RECURRING LOT NUMBER QUERY WAS CONDUCTED FOR L/N 512796 AND THERE HAVE BEEN NO OTHER COMPLAINTS RELATED TO THIS COMPLAINT DESCRIPTION FOR THIS PRODUCTION LOT OF FINISHED GOODS. AN HISTORICAL REVIEW OF CAPA AND NCR¿S WAS CONDUCTED, WHICH DID NOT IDENTIFY ANY ISSUES DIRECTLY RELATED TO THE COMPLAINT. A COMPLAINT HISTORY REVIEW DID IDENTIFY SEVERAL RELATED COMPLAINTS INVOLVING STENT DISLODGEMENT, WHICH NONE OF THEM WERE FOUND TO BE RELATED TO THE STENT. MOST CASES INVOLVE ATTEMPTS TO PULL BACK THE ICAST DEVICE INTO THE INTRODUCER SHEATH PUSHING THE STENT OFF THE BALLOON. A RISK REVIEW FOUND THAT THE RISK MANAGEMENT DOCUMENTS FOR THIS PRODUCT ADEQUATELY ADDRESS THE REPORTED DEFECT AND THE SEVERITY AND ANTICIPATED OCCURRENCE LEVEL ARE APPROPRIATE. BASED ON THE INFORMATION PROVIDED THERE IS NO EVIDENCE TO CONCLUDE THAT THE DEVICE WAS FAULTY OR MANUFACTURED IMPROPERLY. GIVEN THAT THERE WERE 3 SEPARATE SIZE CATHETERS AND PRODUCT LOT NUMBERS HAD THE STENTS DISLODGE OFF THE BALLOON DURING HIS PROCEDURE, IT SUGGESTS THAT THERE MAY BE A TECHNIQUE ISSUE USED BY THE PHYSICIAN. IT IS VERY UNLIKELY THAT THE DEVICES STENT RETENTION OF THREE SEPARATE LOTS OF CATHETERS WERE PROBLEMATIC. THE LOTS IN QUESTION WERE BUILT MONTHS APART. THE MOST LIKELY SCENARIO IS THAT THE STENTS WERE ATTEMPTED TO BE WITHDRAWN BACK INTO THE INTRODUCER SHEATH DISLODGING THE STENT, HOWEVER THIS CANNOT BE CONFIRMED BASED ON THE INFORMATION PROVIDED. THERE ARE SPECIFIC INSTRUCTIONS WITHIN THE INSTRUCTIONS FOR USE (IFU) NOT TO PULL AN UNEXPANDED STENT BACK INTO THE INTRODUCER SHEATH.

    Additional Manufacturer Narrative · 0

    CORRECTION SECTION: H6 AND H11. A VISIT WITH THE PHYSICIAN WHO CONDUCTED THE PROCEDURE (B)(6) WAS HELD IN ORDER TO DISCUSS THE EVENTS RELATED TO THE CLINICAL PROCEDURE. BASED ON THE INFORMATION PROVIDED BY THE PHYSICIAN HE MENTIONED THE FACT THAT HE HAND CRIMPS THE STENTS WITH HIS FINGERS PRIOR TO USE TO ENSURE A GOOD CONNECTION OF THE STENT TO THE UNDERLYING BALLOON. THIS TECHNIQUE COULD ACTUALLY HAVE THE OPPOSITE EFFECT IN REGARD TO STENT RETENTION. THE INSTRUCTIONS FOR USE (IFU AW009603 ICAST COVERED STENT SYSTEM) IN THE WARNINGS AND CAUTIONS SECTION MENTION THE FOLLOWING: "DO NOT REMOVE, REPOSITION OR HAND CRIMP THE STENT." BASED ON THIS INFORMATION THE ROOT CAUSE WAS UPDATED TO USER ERROR.

    Description of Event or Problem · 0

    THE ICAST STENT FELL OFF THE BALLOON WHILE TRYING TO POSITION IT IN THE RIGHT RENAL AND SMA. THE STENTS WERE RECOVERED AND TAKEN OUT OF THE BODY BY SNARING THEM. NO ADVERSE OUTCOMES TO THE PATIENT.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1326490 ICAST COVERED STENT SYSTEM, 6MMX22MMX120CM ILIAC COVERED STENT, ARTERIAL PRL ATRIUM MEDICAL CORPORATION 42622 512796 00650862426229

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Female Required Intervention 7FR COOK HIGH FLEX ANSEL SHEATH| COOK ZENITH ALPHA 28-155