BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN

    MDR report key: 7621645 · Received June 20, 2018

    Report

    Report Number
    2210968-2018-73595
    Event Type
    Injury
    Date Received
    June 20, 2018
    Report Date
    May 29, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    GAT
    PMA / PMN Number
    K946173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. DOES THE SURGEON BELIEVE THAT ETHICON PRODUCTS INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS AS DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCTS USED IN THIS PROCEDURE? CITATION: VASCULAR, 2017, VOL. 25(3) 234¿241; DOI: 10.1177/1708538116665268 [(B)(4).PDF].

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: "TITLE: RESULTS OF OPEN PARARENAL ABDOMINAL AORTIC ANEURYSM REPAIR: SINGLE CENTRE SERIES AND POOLED ANALYSIS OF LITERATURE" AUTHORS: GUUS W VAN LAMMEREN, C¸ AGDA¸S U¨ NLU¨, SJOERD VERSCHOOR, ERIC P VAN DONGEN, JAN WILLE, ERIC DWM VAN DE PAVOORDT, DEBBIE AB DE VRIES-WERSON AND JEAN-PAUL PM DE VRIES; CITATION: VASCULAR, 2017, VOL. 25(3) 234¿241; DOI: 10.1177/1708538116665268. THE AIM OF THIS RETROSPECTIVE ANALYSIS. BETWEEN 2005 AND 2014, ELECTIVE OPEN PARARENAL ABDOMINAL AORTIC ANEURYSM REPAIRS WERE PERFORMED. A TOTAL OF 214 CONSECUTIVE PATIENTS UNDERWENT ELECTIVE OPEN PARARENAL ABDOMINAL AORTIC ANEURYSM REPAIR. MEAN AGE WAS 69.8 (7.1) YEARS, 82.7% (177/214) WERE MEN, AND MEAN ABDOMINAL AORTIC ANEURYSM DIAMETER WAS 62 (11) MM. DURING THE PROCEDURE, AFTER AORTOTOMY BACK BLEEDING LUMBAR ARTERIES AND THE INFERIOR MESENTERIC ARTERY WERE LIGATED WITH NON-ABSORBABLE ETHIBOND SUTURES. BASED ON EXTENSION OF THE ANEURYSM, TUBE GRAFT OR BIFURCATED GRAFTS WERE IMPLANTED, USING END-TO-END ANASTOMOSIS WITH NON-ABSORBABLE PROLENE SUTURES. ALL PATIENTS WERE MONITORED IN THE INTENSIVE CARE OR MEDIUM CARE UNIT DURING THE FIRST 24 H AFTER SURGERY; THEREAFTER, THEY WERE TRANSFERRED TO THE SURGICAL WARD IF NO COMPLICATIONS OCCURRED. REBLEEDING (N=8) AND BOWEL ISCHEMIA (N=5) WERE REPORTED THAT BOTH REQUIRED SURGERY. IN CONCLUSION, OPEN PARARENAL AAA REPAIR RESULTS IN ACCEPTABLE PERIOPERATIVE MORBIDITY AND MORTALITY, AND A LOW SECONDARY INTERVENTION RATE IN COMPARISON WITH F-EVAR. EXPERTISE WITH OPEN REPAIR STILL REMAINS ESSENTIAL FOR TREATMENT OF PARARENAL AAA IN THE NEAR FUTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    464867 ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN SUTURE, NONABSORBABLE, SYNTHETIC GAT ETHICON INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention