BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANTA V12 COVERED STENT

    MDR report key: 11458424 · Received March 11, 2021

    Report

    Report Number
    3011175548-2021-00273
    Event Type
    Malfunction
    Date Received
    March 11, 2021
    Report Date
    December 11, 2022
    Manufacturer
    ATRIUM MEDICAL CORPORATION
    Product Code
    NIO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ARTICLE REVIEWED: CUCURUZ ET AL. 2020. MIDTERM OUTCOME OF RENAL FUNCTION AFTER BRANCHED THORACOABDOMINAL AORTIC ANEURYSM REPAIR. J VASC SURG; 71:1119 -27. THE SUBJECT ARTICLE IS A SINGLE-CENTER RETROSPECTIVE COHORT STUDY OF A PROSPECTIVE REGISTRY OF PATIENTS WITH TAAA, TREATED WITH STANDARD OR CUSTOM-MADE ENDOVASCULAR BRANCHED STENT GRAFTS BETWEEN JULY 2007 AND NOVEMBER 2016. THE AIM OF THIS STUDY WAS TO INVESTIGATE THE INCIDENCE AND IMPACT OF ACUTE AND CHRONIC KIDNEY DYSFUNCTION AFTER BRANCHED ENDOVASCULAR AORTIC ANEURYSM REPAIR (BEVAR) PERIOPERATIVELY AND DURING FOLLOW-UP. THIS COMPLAINT IS BASED ON INFORMATION FOUND WITHIN A ARTICLE/LITERATURE REVIEW. THERE WAS NO PRODUCT THAT WAS AVAILABLE FOR EVALUATION, THEREFORE A DEVICE EVALUATION COULD NOT BE CONDUCTED AND THE COMPLAINT CANNOT BE CONFIRMED. THE AUTHOR OF THE ARTICLE DID NOT REPORT ANY MAJOR ADVERSE PATIENT EFFECTS AS RESULT OF THIS EVENT. A DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE PERFORMED AS THE DEVICE PRODUCT PART NUMBER AND LOT NUMBER WAS NOT PROVIDED WITHIN THE ARTICLE. ATTEMPTS TO OBTAIN THE DEVICE LOT INFORMATION WAS CONDUCTED BUT UNSUCCESSFUL. THE HAZARDOUS SITUATION/HARM IS ADDRESSED IN THE RISK FILE AND IS OPERATING WITHIN ITS RISK PROFILE. THERE WAS NO EVIDENCE WITHIN THE ARTICLE THAT THE DEVICE WAS THE CAUSE OF THE REPORTED EVENT. THE COMPLAINT HISTORY REVIEW DID NOT IDENTIFY AN ADVERSE TREND, THEREFORE NO ESCALATION TO CAPA PROCESS IS REQUIRED. CONCLUSION: THE INSTRUCTIONS FOR USE CLEARLY STATES THAT POTENTIAL ADVERSE EFFECTS OF ADVANTA V12 BALLOON-EXPANDABLE STENT INCLUDE, BUT MAY BE NOT LIMITED TO: INADEQUATE IMPLANTATION OR INTIMAL TRAUMA, RESTENOSIS OF STENTED LESION, STENT MISPLACEMENT, MIGRATION OR DEFORMATION, SYSTEMIC EMBOLIZATION OR THROMBOEMBOLIC EPISODES. ALTHOUGH POSTOPERATIVE ACUTE KIDNEY INJURY WAS OBSERVED IN 36% OF PATIENTS TREATED WITH BRANCHED ENDOVASCULAR AORTIC ANEURYSM REPAIR FOR TAAA, 10 PATIENTS WITH AKI HAD POSTOPERATIVE DIALYSIS AND CUMULATIVE RISK FOR DIALYSIS POSTOPERATIVELY WAS 6.7%, HOWEVER CONSIDERING THE STUDY DESIGN, THE FACT THAT 4 PATIENTS RECOVERED WITHOUT DIALYSIS, THAT STAGED PROCEDURES DECREASE THE RISK OF AKI AFTER BEVAR AND SIGNIFICANTLY INCREASED LEVELS OF CREATININE AND THAT AFTER 2 YEARS OF FOLLOW-UP RENAL FUNCTION WAS RESTORED IN MORE THAN 85% OF PATIENTS, ONE CAN INFER THAT THE GETINGE¿S ADVANTA V12 BALLOON EXPANDABLE COVERED STENTS PERFORMED AS EXPECTED. AUTHORS DO NOT ATTRIBUTE ADVERSE EVENTS TO ANY PARTICULAR TYPE OF BRIDGING STENTS. H3 OTHER TEXT : PRODUCT NOT RETURNED.

    Description of Event or Problem · 0

    N/A

    Additional Manufacturer Narrative · 1

    ON COMPLETION OF THE INVESTIGATION A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    RECEIVED AN ARTICLE: CUCURUZ, B. E. (2020). MIDTERM OUTCOME OF RENAL FUNCTION AFTER BRANCHED THORACOABDOMINAL AORTIC ANEURYSM REPAIR. JOURNAL OF VASCULAR SURGERY, 1119-1127. PURPOSE: TO INVESTIGATE THE INCIDENCE AND IMPACT OF ACUTE AND CHRONIC KIDNEY DYSFUNCTION AFTER BRANCHED ENDOVASCULAR AORTIC ANEURYSM REPAIR (BEVAR) PERIOPERATIVELY AND DURING FOLLOW-UP. METHOD: PATIENTS WITH A THORACOABDOMINAL AORTIC ANEURYSM WERE TREATED WITH BEVAR WERE EVALUATED. CONCLUSION: PREVENTION OF ACUTE KIDNEY INJURY USING STAGED PROCEDURES, EARLY INTERVENTIONS FOR RENAL SIDE BRANCH COMPLICATIONS, AND REGULAR SURVEILLANCE IS RECOMMENDED DURING AND AFTER BEVAR TO IMPROVE OUTCOMES. PER THE ARTICLE PRODUCT PROBLEMS INCLUDED KINKING (DEFORMATION).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    365106 ADVANTA V12 COVERED STENT STENT, ILIAC NIO ATRIUM MEDICAL CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention