BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EU 4.5X28MM STENT 12 MM DW TIP

    MDR report key: 16087867 · Received January 3, 2023

    Report

    Report Number
    3008114965-2023-00003
    Event Type
    Malfunction
    Date Received
    January 3, 2023
    Date of Event
    December 19, 2022
    Report Date
    February 2, 2023
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    NJE
    PMA / PMN Number
    H60001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). COMPLAINT CONCLUSION: AS REPORTED BY THE FIELD, DURING A STENT ASSIST COIL EMBOLIZATION TO TREAT A MIDDLE CEREBRAL ARTERY STENOSIS, AN EU 4.5X28MM STENT 12 MM DW TIP (ENC452812, 7002191) WAS PLANNED TO DELIVERED TO LESION POSITION THROUGH A PROWLER SELECT PLUS MICROCATHETER (606S255X, LOT UNKNOWN). THE PHYSICIAN ENCOUNTERED A LOT OF RESISTANCE WHEN DELIVERING THE STENT INTO THE MICROCATHETER (MC). THE DOCTOR RETRACTED MICROCATHETER AND STENT AND OBSERVED THE MICROCATHETER SHAPE. THERE WAS NO CREASE ON THE MICROCATHETER. THEN, THE MICROCATHETER AND STENT WERE PUSHED INTO THE GUIDE CATHETER AGAIN. THERE WAS STILL A LOT OF RESISTANCE DURING PROCESS OF DELIVERING THE STENT. A NEW STENT WAS SWITCHED TO COMPLETE THE SURGERY SMOOTHLY. THE MICROCATHETER WAS NOT REPLACED. THERE WAS NO PATIENT INJURY REPORT. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE INTRODUCER WAS FULLY SEATED AND SECURED IN THE HUB. THEY WERE ABLE TO TORQUE THE DEVICE. THERE WAS NO EVIDENCE OF PHYSICAL MATERIAL WITHIN THE DEVICE. THE REPLACEMENT STENT WAS OF THE SAME SIZE AS THE ORIGINAL ONE. NO EXCESSIVE FORCE WAS USED WITH THE DEVICE. THERE WERE NO PROCEDURAL DELAYS DUE TO THE EVENT. A NON-STERILE EU 4.5X28MM STENT 12 MM DW TIP WAS RECEIVED CONTAINED IN THE DECONTAMINATION POUCH. UPON RECEIVING THE DEVICE, A VISUAL INSPECTION WAS PERFORMED, AND IT WAS NOTED THAT THE STENT WAS ALREADY DETACHED FROM THE UNIT. THE DELIVERY WIRE AND THE INTRODUCER WERE RETURNED FOR EVALUATION; BOTH WERE FOUND TO BE IN GOOD CONDITION (I.E., NO KINKS, NO FRACTURES, OR SEPARATIONS). THE STENT COMPONENT WAS INSPECTED UNDER MAGNIFICATION, AND IT WAS FOUND THAT TWO OF THE DISTAL STRUTS WERE BENT. THE STENT DETACHMENT WAS NOT ORIGINALLY DOCUMENTED IN THE COMPLAINT AND THE EXACT TIME WHEN THIS CONDITION OCCURRED COULD NOT BE DETERMINED, HOWEVER, BASED ON THE INFORMATION AVAILABLE, IT IS LIKELY THAT THIS OCCURRED ONCE THE STENT WAS REMOVED FROM THE MICROCATHETER OUTSIDE OF THE PATIENT¿S BODY. THEREFORE, THIS FINDING DOES NOT HAVE A CLEAR RELATIONSHIP WITH THE ISSUE REPORTED. THE ISSUE DOCUMENTED THAT THERE WAS RESISTANCE WHEN DELIVERING THE STENT INTO THE MICROCATHETER COULD NOT BE EVALUATED THROUGH FUNCTIONAL TESTING SINCE THE STENT WAS ALREADY DEPLOYED; HOWEVER, THIS CONDITION REASONABLY SUGGESTS THAT THE ENTERPRISE INTRODUCER WAS NOT FULLY SEATED IN THE HUB OF THE MICROCATHETER, AND WHEN THE HEALTHCARE PROFESSIONAL TRIED TO ADVANCE THE STENT, THIS PREMATURELY DEPLOYED IN THE Y CONNECTOR, CAUSING THE STENT COMPONENT TO BECOME BENT AND TO BE UNABLE TO ADVANCE FURTHER. IT IS POSSIBLE THAT THE STENT INADVERTENTLY BECAME DAMAGED DURING THE ADVANCEMENT. BASED ON THIS, THE CUSTOMER COMPLAINT WAS ABLE TO BE CONFIRMED; HOWEVER, THERE IS NO INDICATION THAT THE ISSUE REPORTED IN THE COMPLAINT RESULTS FROM A DEFECT INHERENTLY RELATED TO THE DEVICE. LAKE REGION MEDICAL PERFORMED A REVIEW OF THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTION, AND PACKAGING OF LOT 7002191. THE HISTORICAL RECORD INDICATES THIS PRODUCT WAS FINAL INSPECTION TESTED AT LAKE REGION MEDICAL AND WAS DETERMINED TO BE ACCEPTABLE. IT SHOULD BE NOTED THAT MULTIPLE FACTORS COULD CAUSE PRODUCT FAILURE. THE INSTRUCTIONS FOR USE (IFU) DO CONTAIN THE FOLLOWING RECOMMENDATIONS: ¿ DO NOT APPLY UNDUE FORCE IF RESISTANCE IS ENCOUNTERED AT ANY POINT DURING STENT MANIPULATION. WITHDRAW THE UNIT AND ADVANCE TO A NEW ONE. AS PART OF THE CERENOVUS QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. AS PART OF THE POST MARKET SURVEILLANCE PROGRAM, INFORMATION FROM THIS COMPLAINT IS TRENDED TO IDENTIFY STATISTICAL SIGNALS FOR CONSIDERATION OF FURTHER CORRECTION ACTION. SINCE THERE WAS NO EVIDENCE TO SUGGEST THE EVENT WAS RELATED TO A MANUFACTURING OR DESIGN ISSUE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT #: (B)(4). INFORMATION REGARDING PATIENT WEIGHT, HEIGHT, MEDICAL HISTORY, RACE, AND ETHNICITY WAS NOT REPORTED. INITIAL REPORTER PHONE: (B)(6). THE DEVICE IS AVAILABLE TO BE RETURNED FOR EVALUATION AND TESTING. HOWEVER, IT HAS NOT BEEN RECEIVED TO DATE. IF THE DEVICE RETURNS, A DEVICE INVESTIGATION WILL BE PERFORMED. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803 (AND/OR PART 4, AS APPLICABLE). THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY CERENOVUS, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, CERENOVUS, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THE COMPLAINT AND THE ASSOCIATED MANUFACTURER REPORT NUMBER IS 3008114965-2023-00004. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.

    Description of Event or Problem · 0

    AS REPORTED BY THE FIELD, DURING A STENT ASSIST COIL EMBOLIZATION TO TREAT A MIDDLE CEREBRAL ARTERY STENOSIS, AN EU 4.5X28MM STENT 12 MM DW TIP (CATALOG #: ENC452812, LOT #: 7002191) WAS PLANNED TO BE DELIVERED TO THE LESION POSITION THROUGH A PROWLER SELECT PLUS MICROCATHETER (606S255X, LOT UNKNOWN). THE PHYSICIAN ENCOUNTERED A LOT OF RESISTANCE WHEN DELIVERING THE STENT INTO THE MICROCATHETER (MC). THE DOCTOR RETRACTED THE MICROCATHETER AND STENT AND OBSERVED THE MICROCATHETER SHAPE. THERE WAS NO CREASE ON THE MICROCATHETER. THEN, THE MICROCATHETER AND STENT WERE PUSHED INTO THE GUIDE CATHETER AGAIN. THERE WAS STILL A LOT OF RESISTANCE DURING PROCESS OF DELIVERING THE STENT. A NEW STENT WAS SWITCHED TO COMPLETE THE SURGERY SMOOTHLY. THE MICROCATHETER WAS NOT REPLACED. THERE WAS NO PATIENT INJURY REPORT. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE INTRODUCER WAS FULLY SEATED AND SECURED IN THE HUB. THEY WERE ABLE TO TORQUE THE DEVICE. THERE WAS NO EVIDENCE OF PHYSICAL MATERIAL WITHIN THE DEVICE. THE REPLACEMENT STENT WAS OF THE SAME SIZE AS THE ORIGINAL ONE. NO EXCESSIVE FORCE WAS USED WITH THE DEVICE. THERE WERE NO PROCEDURAL DELAYS DUE TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    139379 EU 4.5X28MM STENT 12 MM DW TIP INTRACRANIAL NEUROVASCULAR STENT NJE MEDOS INTERNATIONAL SARL 7002191

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown PROWLER SELECT PLUS 150/5CM