BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN

    MDR report key: 7824853 · Received August 28, 2018

    Report

    Report Number
    2210968-2018-75506
    Event Type
    Injury
    Date Received
    August 28, 2018
    Report Date
    August 17, 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). CITATION: INTERACTIVE CARDIOVASCULAR AND THORACIC SURGERY 15 (2012) 377¿381, DOI:10.1093/ICVTS/IVS151, ADVANCE ACCESS PUBLICATION: 23 MAY 2012. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: "TITLE: A BIORESORBABLE OSTEOSYNTHESIS DEVICE CAN INDUCE AN EARLIER STERNAL FUSION AFTER MEDIAN STERNOTOMY" AUTHORS: TOMOHIRO TSUNEKAWA, AKIHIKO USUI, HIDEKI OSHIMA, SHINNICHI MIZUTANI, YOSHIMORI ARAKI, NORITAKA OKADA AND YUICHI UEDA. CITATION: INTERACTIVE CARDIOVASCULAR AND THORACIC SURGERY 15 (2012) 377¿381, DOI:10.1093/ICVTS/IVS151, ADVANCE ACCESS PUBLICATION: 23 MAY 2012. THE AIM OF THIS STUDY WAS TO EXAMINE THE IMPACT OF THE BIORESORBABLE OSTEOSYNTHESIS STERNAL PIN (SUPER FIXSORB 30) ON STERNAL HEALING AFTER MEDIAN STERNOTOMY. THERE WERE 63 PATIENTS (AGE; MEAN: 67.1 ± 9.85 YEARS, RANGE 38¿83 YEARS, 47 MALES AND 16 FEMALES) WHO UNDERWENT AORTIC SURGERY THROUGH MEDIAN STERNOTOMY BETWEEN JANUARY 2006 AND MARCH 2009. THE SUBJECTS INCLUDED 49 PATIENTS WITH ATHEROSCLEROTIC ANEURYSMS AND 14 WITH AORTIC DISSECTIONS. FIFTY-EIGHT PATIENTS HAD ASCENDING AORTA AND TOTAL AORTIC ARCH REPLACEMENTS, AND FIVE PATIENTS HAD ASCENDING AORTA AND HEMI-AORTIC ARCH REPLACEMENTS. A FULL MEDIAN STERNOTOMY WAS CLOSED WITH NUMBER-5 ETHIBOND NON-ABSORBABLE BRAIDED POLYESTER SUTURES (ETHICON, INC., (B)(4)) WITH OR WITHOUT SUPER FIXSORB 30 STERNAL PINS. THE PATIENTS WERE DIVIDED INTO TWO GROUPS ACCORDING TO THE APPLICATION OF THE PIN FOR STERNAL CLOSURE (GROUP A: WITH THE PIN; GROUP B: WITHOUT THE PIN). STERNAL PINS WERE UTILIZED IN 36 PATIENTS FOR STERNAL REINFORCEMENT IN ADDITION TO THE STANDARD CLOSURE OF THE STERNUM WITH ETHIBOND SUTURES (GROUP A), AND 27 RECEIVED NO PINS WITH THE STANDARD ETHIBOND STERNAL CLOSURE (GROUP B). TWO PATIENTS WERE TRANSFERRED BACK TO THE OPERATING ROOM FOR POSTOPERATIVE BLEEDING. TWO STERNAL DEHISCENCES (5.6%) IN GROUP A AND FOUR DEHISCENCES (14.8%), IN GROUP B WERE OBSERVED ON THE DISCHARGE CT SCANS. DURING THE FOLLOW-UP, ANOTHER 2 DEHISCENCES OCCURRED IN GROUP B. THERE WERE 5 DISPLACEMENTS (18.5%) OBSERVED IN GROUP B AT DISCHARGE. DURING THE FOLLOW-UP, 2 MORE DISPLACEMENTS WERE OBSERVED IN GROUP B. IN CONCLUSION, THE USE OF THE SUPER FIXSORB 30 STERNAL PIN REDUCED ANTERIOR¿POSTERIOR STERNAL DISPLACEMENT AND FACILITATED EARLIER STERNAL FUSION. THE STERNAL PIN MAY PROMOTE OSTEOGENESIS OF THE STERNAL BONE AROUND IT AND CONTRIBUTE TO EARLIER STERNAL FUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    666189 ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN SUTURE, NONABSORBABLE, SYNTHETIC GAT ETHICON INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention