BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPHIRION DEEP PTA BALLOON CATHETER

    MDR report key: 12614836 · Received October 12, 2021

    Report

    Report Number
    9612164-2021-03910
    Event Type
    Injury
    Date Received
    October 12, 2021
    Date of Event
    June 24, 2013
    Report Date
    January 31, 2022
    Manufacturer
    MEDTRONIC MEXICO
    Product Code
    DQY
    PMA / PMN Number
    K052791
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    AGE OR DATE OF BIRTH: AVERAGE AGE. SEX: MAJORITY GENDER. EVENT DATE: DATE OF ARTICLE PUBLICATION DRUG-ELUTING BALLOON IN PERIPHERAL INTERVENTION FOR BELOW THE KNEE ANGIOPLASTY EVALUATION (DEBATE-BTK) A RANDOMIZED TRIAL IN DIABETIC PATIENTS WITH CRITICAL LIMB ISCHEMIA CIRCULATION (2013) 128:615¿621 10.1161/CIRCULATIONAHA.113.001811. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS SUBMITTED WHICH AIMED TO INVESTIGATE THE EFFICACY OF A PACLITAXEL DRUG-ELUTING BALLOONS VERSUS CONVENTIONAL PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) FOR THE REDUCTION OF RESTENOSIS IN DIABETIC PATIENTS WITH CRITICAL LIMB ISCHEMIA UNDERGOING ENDOVASCULAR INTERVENTION OF BELOW-THE-KNEE ARTERIES. RESULTS REPORTED FROM THE DRUG-ELUTING BALLOON IN PERIPHERAL INTERVENTION FOR BELOW THE KNEE ANGIOPLASTY EVALUATION (DEBATE-BTK). 132 PATIENTS WITH 158 LESIONS IN 143 LIMBS WERE INCLUDED IN THE STUDY. THE ARTICLE REPORTED DEBATE STUDY WAS CARRIED OUT FOR ALL CONSECUTIVE DIABETIC PATIENTS WITH CLI UNDERGOING ANGIOGRAPHY OF AT LEAST ONE BELOW THE KNEE VESSEL, WERE SCREENED FOR ENROLMENT. MEDTRONIC'S INPACT AMPHIRION DEB AND AMPHIRION DEEP PTA WERE USED IN THE STUDY. THE STUDY WAS DIVIDED INTO TWO GROUPS, DEB VS PTA. THE LESIONS WERE RANDOMLY ASSIGNED TO ONE OF THE TWO STUDY ARMS. NO MAJOR ADVERSE EVENT OCCURRED IN THE HOSPITAL. IT WAS REPORTED THAT EIGHT PATIENTS DIED DURING FOLLOW UP; CAUSES OF DEATH INCLUDED SUDDEN DEATH, RESPIRATORY FAILURE, STROKE, HEART FAILURE AND SEPSIS. FIVE PATIENTS HAD WORSENING OF PRE-EXISTING RENAL FAILURE, TWO PATIENTS HAD MAJOR STROKE, TWO PATIENTS HAD CONGESTIVE HEART FAILURE. AMPUTATION, RESTENOSIS, AND OCCLUSION WERE REPORTED FOR OTHER PATIENTS. THERE IS NO ESTABLISHED OR SUSPECTED CAUSAL RELATIONSHIP BETWEEN THE DEVICE(S) AND THE DEATH EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1513742 AMPHIRION DEEP PTA BALLOON CATHETER CATHETER, PERCUTANEOUS DQY MEDTRONIC MEXICO

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male Required Intervention