BEUDAMED
    FDA Adverse Event Death Summary report: N

    COVERA PLUS VASCULAR COVERED STENT

    MDR report key: 17841624 · Received September 29, 2023

    Report

    Report Number
    9681442-2023-00331
    Event Type
    Death
    Date Received
    September 29, 2023
    Date of Event
    December 19, 2019
    Report Date
    June 15, 2024
    Manufacturer
    ANGIOMED GMBH & CO. MEDIZINTECHNIK KG
    Product Code
    PFV
    UDI-DI
    00801741135903
    PMA / PMN Number
    P170042
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H10: THE CATALOG NUMBER IDENTIFIED IN SECTION D4 HAS NOT BEEN CLEARED IN THE US BUT IS SIMILAR TO THE COVERA PLUS VASCULAR COVERED STENT SYSTEM PRODUCTS THAT ARE CLEARED IN THE US. THE PRO CODE AND 510 K NUMBER FOR THE COVERA PLUS VASCULAR COVERED STENT SYSTEM PRODUCTS ARE IDENTIFIED IN D2 AND G4. H10: MANUFACTURING REVIEW: THE LOT HISTORY RECORDS OF THIS LOT WERE REVIEWED WITH SPECIAL ATTENTION TO THE MANUFACTURING AND INSPECTION OF THIS PRODUCT AND THE PRODUCT WAS FOUND TO HAVE MET THE SPECIFICATION PRIOR TO SHIPMENT. BASED ON THE INFORMATION AVAILABLE IT IS NOT REASONABLY SUGGESTED THAT A MANUFACTURING PROCESS MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. INVESTIGATION SUMMARY: THE SAMPLE WAS NOT RETURNED FOR EVALUATION. THE STENT REMAINS IMPLANTED. NO X-RAY IMAGES WERE PROVIDED FOR REVIEW. PRE-DILATION AS WELL AS POST-DILATION WAS PERFORMED; THERE WAS NO REPORT OF ANY IRREGULARITIES OR COMPLICATIONS DURING INITIAL STENT PLACEMENT. BASED ON THE INFORMATION AVAILABLE, THE INVESTIGATION IS CLOSED WITH INCONCLUSIVE RESULT. A DEFINITE ROOT CAUSE FOR THE REPORTED EVENT COULD NOT BE DETERMINED. LABELING REVIEW: RELEVANT LABELING APPLICABLE FOR THIS PRODUCT WAS REVIEWED. THE INSTRUCTIONS FOR USE WAS FOUND TO SUFFICIENTLY ADDRESS THE POTENTIAL RISK; COMPLICATIONS AND ADVERSE EVENTS MAY INCLUDE COVERED STENT STENOSIS/THROMBOTIC OCCLUSION AS WELL AS STENOSIS/THROMBOTIC OCCLUSION OUTSIDE OF STENTED SEGMENT. REGARDING PRE AND POST-DILATION THE INSTRUCTIONS FOR USE STATES: "PRE-DILATE THE STENOSIS WITH A PTA BALLOON CATHETER OF APPROPRIATE LENGTH AND DIAMETER FOR THE LESION TO BE TREATED" AND "POST-DILATE THE COVERED STENT WITH AN ANGIOPLASTY BALLOON SIZED APPROPRIATELY AS TO ENSURE COMPLETE WALL APPOSITION TO THE REFERENCE VESSEL". REGARDING PROPER COVERED STENT DEPLOYMENT, THE INSTRUCTIONS FOR USE STATES: "DO NOT TOUCH THE DISTAL CATHETER ASSEMBLY (I.E., THE DARK BROWN CATHETER SEGMENT) DURING COVERED STENT DEPLOYMENT SINCE THIS MAY INTERFERE WITH COVERED STENT DEPLOYMENT AND MAY LEAD TO MISPLACEMENT." H10: D4 (EXPIRATION DATE: 08/2021). H11: SECTION A THROUGH F ¿ THE INFORMATION PROVIDED BY BD REPRESENTS ALL THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT/REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.

    Additional Manufacturer Narrative · 0

    H10: ADDITIONAL INFORMATION WAS RECEIVED, AND THE FILE WAS REASSESSED FOR REPORTABILITY AND DETERMINED TO BE REPORTABLE AS DEATH. H10: THE CATALOG NUMBER IDENTIFIED IN SECTION D4 HAS NOT BEEN CLEARED IN THE US BUT IS SIMILAR TO THE COVERA PLUS VASCULAR COVERED STENT SYSTEM PRODUCTS THAT ARE CLEARED IN THE US. THE PRO CODE AND 510 K NUMBER FOR THE COVERA PLUS VASCULAR COVERED STENT SYSTEM PRODUCTS ARE IDENTIFIED IN D2 AND G4. H10: MANUFACTURING REVIEW: THE LOT HISTORY RECORDS OF THIS LOT WERE REVIEWED WITH SPECIAL ATTENTION TO THE MANUFACTURING AND INSPECTION OF THIS PRODUCT AND THE PRODUCT WAS FOUND TO HAVE MET THE SPECIFICATION PRIOR TO SHIPMENT. BASED ON THE INFORMATION AVAILABLE IT IS NOT REASONABLY SUGGESTED THAT A MANUFACTURING PROCESS MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. INVESTIGATION SUMMARY: THE SAMPLE WAS NOT RETURNED FOR EVALUATION. THE STENT REMAINS IMPLANTED. NO X-RAY IMAGES WERE PROVIDED FOR REVIEW. PRE-DILATION AS WELL AS POST-DILATION WAS PERFORMED; THERE WAS NO REPORT OF ANY IRREGULARITIES OR COMPLICATIONS DURING INITIAL STENT PLACEMENT. REGARDING THE REPORTED DEATH OF THE PATIENT A CAUSE OF DEATH WAS NOT PROVIDED, AND THERE WAS NO REPORTED RELATIONSHIP BETWEEN THE DEATH OF THE PATIENT AND THE DEVICE OR THE PROCEDURE. BASED ON THE INFORMATION AVAILABLE, THE INVESTIGATION IS CLOSED WITH INCONCLUSIVE RESULT. NO DEVICE DEFICIENCY AND NO RELATIONSHIP OF THE CLINICAL EVENT TO THE DEVICE OR THE PROCEDURE WAS REPORTED. A DEFINITE ROOT CAUSE FOR THE REPORTED EVENT COULD NOT BE DETERMINED. LABELING REVIEW: THE RELEVANT LABELING APPLICABLE FOR THIS PRODUCT WAS REVIEWED. BASED ON THE INSTRUCTION FOR USE SUPPLIED WITH THIS PRODUCT THE COVERA PLUS VASCULAR COVERED STENT IS INDICATED FOR THE TREATMENT OF ATHEROSCLEROTIC LESIONS IN THE COMMON AND EXTERNAL ILIAC ARTERY. POTENTIAL COMPLICATIONS AND ADVERSE EVENTS WHICH MAY OCCUR WERE FOUND ADDRESSED, E.G., COVERED STENT STENOSIS/THROMBOTIC OCCLUSION, EMBOLISM, STENOSIS/THROMBOTIC OCCLUSION OUTSIDE OF STENTED SEGMENT. PREPARATION, DELIVERY SYSTEM INTRODUCTION AND COVERED STENT DEPLOYMENT WERE FOUND TO BE DESCRIBED IN DETAIL. H10: D4 (EXPIRATION DATE: 08/2021), G3, H6 (PATIENT). H11: B2, B3, B5, H1. H11: SECTION A THROUGH F ¿ THE INFORMATION PROVIDED BY BD REPRESENTS ALL THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT/REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.

    Description of Event or Problem · 0

    IT WAS REPORTED THROUGH THE RESULTS OF A CLINICAL TRIAL THAT TWO YEARS AND TWO DAYS POST STENT PLACEMENT IN THE RIGHT COMMON ILIAC ARTERY VIA AN IPSILATERAL APPROACH, THE PATIENT WAS DIAGNOSED WITH IN-STENT RESTENOSIS. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THROUGH THE RESULTS OF A CLINICAL TRIAL THAT POST A STENT GRAFT PLACEMENT IN THE RIGHT LEG COMMON ILIAC ARTERY, THE PATIENT HAD AN ADVERSE EVENT OF FALSE ANEURYSM IN THE RIGHT COMMON FEMORAL ARTERY. REPORTEDLY, THE ADVERSE EVENT WAS SUCCESSFULLY TREATED WITH THROMBUS REJECTION AND COMPRESSION DRESSING. IT WAS FURTHER REPORTED THAT APPROXIMATELY TWO YEARS AND TWO DAYS POST STENT PLACEMENT IN THE RIGHT COMMON ILIAC ARTERY VIA AN IPSILATERAL APPROACH, THE PATIENT WAS DIAGNOSED WITH IN-STENT RESTENOSIS AND NO INTERVENTIONS WERE REQUIRED. HOWEVER, FOUR YEARS, FIVE MONTHS AND FOUR DAYS POST STENT PLACEMENT, THE PATIENT WAS EXPIRED. THE CAUSE OF DEATH AND RELATIONSHIP OF THE DEATH TO THE DEVICE, PROCEDURE AND ARTERIOVENOUS ACCESS CIRCUIT WERE NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    316480 COVERA PLUS VASCULAR COVERED STENT VASCULAR COVERED STENT PFV ANGIOMED GMBH & CO. MEDIZINTECHNIK KG ANDV1841 00801741135903

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention| D CLOPIDOGREL