BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SECURESTRAP 5MM ABSORBABLE STRAP FIXATION DEVICE

    MDR report key: 3221222 · Received July 11, 2013

    Report

    Report Number
    2210968-2013-12855
    Event Type
    Injury
    Date Received
    July 11, 2013
    Date of Event
    November 3, 2011
    Report Date
    June 24, 2013
    Manufacturer
    ETHICON INC.
    Product Code
    GDW
    PMA / PMN Number
    K093845
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A HERNIA REPAIR SURGICAL PROCEDURE ON (B)(6) 2011 AND ABSORBABLE TACKERS WERE USED ALONG WITH TRANSORAL FUNDOPLICATION AND ENDOGASTIC SOLUTIONS ESOPHYX CARTRIDGE IMPLANT ADDITIONALLY DUE TO PARAESOPHAGEAL HERNIA. IT WAS REPORTED THAT THE PATIENT UNDERWENT LAPAROTOMY FOR EVALUATION ON (B)(6) 2011, ALONG WITH EMERGENCY CORONARY BYPASS GRAFT X1, AND SAPHENOUS VEIN GRAFT TO THE POSTERIOR DESCENDING ARTERY DUE TO PERFORATION. IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION: USER ERROR CAUSED THE EVENT. IT IS STATED IN THE CONTRAINDICATIONS SECTION OF THE IFU: THIS DEVICE SHOULD NOT BE USED IN TISSUES THAT HAVE DIRECT ANATOMIC RELATIONSHIP TO MAJOR VASCULAR STRUCTURES. THIS WOULD INCLUDE THE DEPLOYMENT OF FASTENERS IN THE DIAPHRAGM IN THE VICINITY OF THE PERICARDIUM, AORTA, OR INFERIOR VENA CAVA DURING DIAPHRAGMATIC HERNIA REPAIR.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A LAPAROSCOPIC PARAESOPHAGEAL HIATAL REPAIR WITH BIOLOGIC MESH ON (B)(6) 2011 AND ABSORBABLE TACKERS WERE USED TO FIXATE THE MESH. THE SURGEON PERFORATED THE POSTERIOR DESCENDING CORONARY ARTERY WITH A TACKER WHILE ATTEMPTING TO REINFORCE THE DIAPHRAGM WITH THE BIOLOGIC MESH. THE PATIENT BECAME HEMODYNAMICALLY UNSTABLE ON (B)64 )2011 AND EXPERIENCED PERICARDIAC TAMPONADE AS A RESULT OF THE PERFORATION OF THE CORONARY ARTERY. HE UNDERWENT AN EMERGENCY SURGERY TO ADDRESS THE VASCULAR INJURY. NO ADDITIONAL INFORMATION WAS PROVIDED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319753 SECURESTRAP 5MM ABSORBABLE STRAP FIXATION DEVICE STAPLE, IMPLANTABLE GDW ETHICON INC. UNK DKZ762

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention BIOLOGIC MESH