BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 2000452 · Received February 18, 2011

    Report

    Report Number
    2953200-2011-00460
    Event Type
    Injury
    Date Received
    February 18, 2011
    Report Date
    January 21, 2011
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P070027
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION, RESULTS: (LOT NUMBER, IMPLANT AND EXPLANT DATE WERE NOT PROVIDED), (ENDOLEAK, DEATH, ANEURYSM ENLARGEMENT). CONCLUSION: (LOT NUMBER, IMPLANT AND EXPLANT DATE WERE NOT PROVIDED), (J VASC SURG 2010; 52; 1435-41). NONE OF THE EVENTS IN THIS ARTICLE MATCH EVENT INFORMATION ALREADY KNOWN TO MEDTRONIC. THE PHYSICIAN WAS CONTACTED AND REQUESTED TO PROVIDE SPECIFIC INFORMATION RELATED TO EACH EVENT RELATED TO ANEURX DEVICES, SUCH AS THE LOT NUMBER, IMPLANT DATE, AND EXPLANT DATE. NO REPLY HAS BEEN RECEIVED FROM THE PHYSICIAN.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED THE FOLLOWING JOURNAL ARTICLE WHICH IS SUMMARIZED AS FOLLOWS: MIDTERM RESULTS OF ADJUNCTIVE NECK THERAPIES PERFORMED DURING ELECTIVE INFRARENAL AORTIC ANEURYSM (J VASC SURG 2010; 52: 1435-41. OBJECTIVE: THIS STUDY EVALUATED THE DURABILITY OF ADJUNCTIVE ENDOVASCULAR NECK PROCEDURES, INCLUDING AORTIC CUFFS, PALMAZ STENTS, AND HIGH-PRESSURE BALLOON ANGIOPLASTY, AT MANAGING INTRAOPERATIVE PROXIMAL NECK COMPLICATIONS DURING ENDOVASCULAR AORTIC ANEURYSM REPAIR (EVAR). METHODS: THIS WAS A SINGLE-CENTER RETROSPECTIVE REVIEW OF EVARS; 174 PATIENTS WERE STUDIED INCLUDING THOSE WITH ANEURX (REF MFR# 2953200-2011-00459) OR TALENT DEVICES. THE PRIMARY OUTCOME VARIABLE STUDIED WAS SURVIVAL FREE OF A GRAFT-RELATED EVENT (GRE). THESE OUTCOME VARIABLES WERE ASSESSED RELATIVE TO THE PREOPERATIVE ANATOMIC NECK VARIABLES (NECK LENGTH, DIAMETER, DEGREE OF ANGULATION, DEGREE OF CIRCUMFERENTIAL THROMBUS, AND PRESENCE OF CONICITY), PROCEDURAL VARIABLES (MANUFACTURING TYPE OF GRAFT, USE OF A PALMAZ STENT), AND PATIENT CHARACTERISTICS (AGE AND PRESENCE OF MEDICAL COMORBIDITIES). RESULTS: A TOTAL OF 174 EVARS PERFORMED BETWEEN (B)(6) 2005 AND (B)(6) 2007 WERE EVALUATED. THERE WERE 56 ADJUNCTIVE PROCEDURES PERFORMED, WITH A 97% PRIMARY-ASSISTED EXCLUSION RATE. THE ADJUNCTIVE PROCEDURES TO PLACE CUFFS OR PALMAZ STENTS WERE DUE TO TYPE I ENDOLEAKS AND MIGRATION (INACCURATE DELIVERY) AT IMPLANT. PATIENTS WHO RECEIVED AN ADJUNCTIVE THERAPY HAD SIMILAR FREEDOM FROM A GRE COMPARED WITH EVARS THAT DID NOT REQUIRE ADJUNCTIVE THERAPY. SUBSET ANALYSIS IDENTIFIED A SIGNIFICANT ASSOCIATION BETWEEN PALMAZ STENT PLACEMENT AT THE TIME OF EVAR AND DECREASED FREEDOM FROM GRES. ABOUT 14 DEATHS, 5 AAA ENLARGEMENTS, AND 3 ACUTE TYPE I ENDOLEAKS WERE REPORTED IN THE STUDY. THERE WERE 56 PATIENTS WITH ADJUNCTIVE PROCEDURES, THE AORTIC NECKS IN THE STUDY WERE 16.2 +/- 10.5 MM LONG, 24.9 +/- 3.7MM IN DIAMETER, 45 +/- 22.7 DEG. ANGULATED; FOR THE 118 PATIENTS WITHOUT ADJUNCTIVE PROCEDURES, THE AORTIC NECKS IN THE STUDY WERE 21.9 +/- 10.4 MM LONG, 24.4 +/- 3.7MM IN DIAMETER, 37.2 +/- 20.6 DEG. ANGULATED. CONCLUSIONS: MIDTERM RESULTS SUGGEST THAT ADJUNCTIVE THERAPIES TO MANAGE INTRAOPERATIVE PROXIMAL NECK COMPLICATIONS DO NOT COMPROMISE DURABILITY. THE SUBSET OF PATIENTS REQUIRING AORTIC NECK PALMAZ STENT PLACEMENT AT THE TIME OF EVAR ARE AMONG THOSE AT HIGHEST RISK FOR SUBSEQUENT GRE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TALENT ABDOMINAL STENT GRAFT SYSTEM MIH MEDTRONIC CARDIOVASCULAR NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Death| R