BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVERFLEX+ SELF-EXPANDING PERIPHERAL STENT SYSTEM STANDARD

    MDR report key: 5748694 · Received June 24, 2016

    Report

    Report Number
    2183870-2016-00457
    Event Type
    Injury
    Date Received
    June 24, 2016
    Date of Event
    January 1, 2015
    Report Date
    May 29, 2016
    Manufacturer
    COVIDIEN
    Product Code
    NIP
    PMA / PMN Number
    K060057
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AVERAGE AGE. MAJORITY GENDER. ¿ APPROXIMATE DATE OF PUBLICATION JOURNAL ARTICLE OUTCOMES OF ENDOVASCULAR TREATMENT FOR PATIENTS WITH TASC II D FEMOROPOPLITEAL OCCLUSIVE DISEASE: A SINGLE CENTER STUDY GUO ET AL. BMC CARDIOVASCULAR DISORDERS (2015) 15:44 DOI 10.1186/S12872-015-0025-1 GUO ET AL. BMC CARDIOVASCULAR DISORDERS (2015) 15:44. 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

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    FROM JANUARY 2011 TO MARCH 2013, 53 PATIENTS WITH 58 LIMBS INVOLVING TASC II D FEMOROPOPLITEAL LESIONS WERE RETROSPECTIVELY ENROLLED IN THIS STUDY. OF THESE LIMBS, 30 WERE LIFESTYLE-LIMITING CLAUDICATION (RUTHERFORD CATEGORY 2/3), 17 WERE REST PAIN (RUTHEFORD CATEGORY 4), AND 11 WERE GANGRENE (RUTHERFORD CATEGORY 5). PATIENTS WHO HAD EXPERIENCED ANY ENDOVASCULAR OR BYPASS PROCEDURES PRIOR TO THIS STUDY AND PATIENTS WITH OCCLUSION OF ILIAC OR COMMON FEMORAL ARTERY WERE EXCLUDED. THREE TYPES OF NITINOL SELF-EXPANDING STENTS: PROTEG EVERFLEX (EV3 INC., USA), LIFESTENT (BARD INC, USA), AND SMART CONTROL (CORDIS CORPORATION) WERE USED ACCORDING TO OPERATOR DISCRETION. NO MAJOR COMPLICATIONS LIKE DEATH, CARDINAL INFARCTION, ACUTE RENAL FAILURE OR AMPUTATION WERE OCCURRED DURING OPERATIONS. BUT THERE WERE 6 (11.1 %) MINOR COMPLICATIONS, INCLUDING TWO HAEMATOMAS AT THE PUNCTURE SITE (3.7 %), ONE ACUTE RENAL INSUFFICIENCY (1.9 %), ONE CONTRAST MEDIA INDUCED-ENCEPHALOPATHY (1.9 %), AND 2 ANGINAS (3.7 %). FORTUNATELY, ALL THESE MINOR COMPLICATIONS WERE CURED, AND NO FURTHER TREATMENT WAS NEEDED. THERE WERE 2 PATIENTS DIED DURING THE FOLLOW-UP, ONE FROM CARDIAC INFARCTION AT THE 7TH MONTH, AND THE OTHER FROM CANCER AT THE 13TH MONTH. THE SYMPTOMS OF REST PAIN OCCURRED IN 16 LIMBS ALSO TRANSITED INTO MILD TO MODERATE CLAUDICATION BUT ONE LIMB REMAINED TO PRESENT WITH REST PAIN. THE SYMPTOMS OF GANGRENE NE TRANSITED INTO MILD TO MODERATE CLAUDICATION IN 10 LIMBS AND INTO REST PAIN IN 1 LIMB. DURING THE FOLLOW-UP PERIOD, 8 LIMBS EXPERIENCED RESTENOSIS AND 4 OCCLUSIONS. TEN (7 RE-STENOSIS AND 3 OCCLUSIONS) OCCURRED WITHIN 1-2 YEARS AND 2 OCCURRED (1 RE-STENOSIS AND 1 OCCLUSIONS) WITHIN 2-3 YEARS. THE PRIMARY PATENCY RATES AT 1, 2 AND 3 YEARS WERE 63 %, 12 % AND 12 %, RESPECTIVELY. REINTERVENTION WAS PERFORMED FOR ALL LIMBS SUFFERING FROM IN-STENT-RE-STENOSIS (ISR) DURING THE FOLLOW-UP PERIOD AND THE VESSELS WERE SUCCESSFULLY REVASCULARIZED BUT 2 LIMBS IN 2 PATIENTS. OF THESE 2 PATIENTS WHO SUFFERED A SLIGHT REST PAIN, ONE WAS TECHNICALLY FAILED AND RECEIVED AN ORAL DRUG MEDICATION SINCE THIS PATIENT HAD NO VESSEL RUNOFF THAT SURGERY BYPASS WAS UNSUITABLE. PALLIATIVE TREATMENT WAS CARRIED OUT FOR THE OTHER PATIENTS DUE TO SEVERE AND LIFE-THREATENING COMORBIDITIES. FOUR PATIENTS RECEIVED AT LEAST 2 REINTERVENTIONS DURING THE FOLLOW-UP PERIOD AND UNTIL NOW TARGET LESIONS STILL REMAIN UNOBSTRUCTED. ASSISTED PRIMARY PATENCY RATES AT 1, 2 AND 3 YEARS WERE 77 %, 31 % AND 31 %, RESPECTIVELY. THE 4 PATIENTS WITH OCCLUSIONS UNDERWENT A CDT (CATHETER DIRECTED THROMBOLYSIS) RE-INTERVENTION AND SUBSEQUENT PTA (PERCUTANEOUS TRANSLUMINAL ANGIOGRAPHY). NO FURTHER STENT IMPLANTATION WAS NEEDED. THE SECONDARY PATENCY RATE WAS 93 % AT 1 YEAR, 54 % AT 2 YEAR AND STILL 54 % AT 3 YEAR. DURING THE FOLLOW-UP, NO MAJOR AMPUTATION WAS OCCURRED. FIVE PATIENTS (9.3 %) UNDERWENT TOE DISSECTION DUE TO TOE GANGRENE AND ACHIEVED A QUICK WOUND HEALING AFTER INTERVENTION. CONCLUSION ENDOVASCULAR TREATMENT FOR TASC II D LESIONS IS SAFE AND CAN BE EFFECTIVELY PERFORMED WITH ACCEPTABLE HEMODYNAMIC IMPROVEMENT. THOUGH RE-STENOSIS IS VERY COMMON, CLOSE SURVEILLANCE AND REPEATED INTERVENTION CAN RESOLVE THIS PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    402789 EVERFLEX+ SELF-EXPANDING PERIPHERAL STENT SYSTEM STANDARD STENT, SUPERFICIAL FEMORAL ARTERY NIP COVIDIEN

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention