BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LARIAT SUTURE DELIVERY DEVICE

    MDR report key: 2960251 · Received February 8, 2013

    Report

    Report Number
    3005802238-2013-00002
    Event Type
    Injury
    Date Received
    February 8, 2013
    Date of Event
    January 10, 2013
    Report Date
    February 8, 2013
    Manufacturer
    SENTREHEART INC.
    Product Code
    GAT
    PMA / PMN Number
    K090385
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L INFO WAS PROVIDED BY THE SENTREHEART REP WHO ATTENDED THE CASE. DURING THIS LAA LIGATION PROCEDURE, THE LARIAT WAS BEING USED WITH THE FINDRWIRZ GUIDE WIRE SYSTEM AND TENSURE SUTURE TIGHTENER. THE PT WAS NOTED TO HAVE AN EXTREMELY LARGE AND DILATED LEFT ATRIUM. ONCE ACCESS TO THE LAA WAS ACHIEVED, THE REMAINDER OF THE LAA LIGATION PROCEDURE WITH THE LARIAT WAS UNREMARKABLE. AN EFFUSION WAS NOTED FOLLOWING THE INITIAL TIGHTENING OF THE SUTURE KNOT WITH THE TENSURE SUTURE TIGHTENER AND THE DECISION WAS MADE TO SEND THE PT TO SURGERY FOLLOWING A DROP IN BLOOD PRESSURE. THE PHYSICIAN NOTED THIS WAS A SIMILAR EVENT TO A PREVIOUS PT WHO ALSO HAD A DILATED LEFT ATRIUM. HE DOES NOT BELIEVE THAT THE DEVICE ITSELF CAUSED THE LACERATION, BUT THAT MAY BE THE MANIPULATION OF THE DEVICES AND TISSUE DURING TIGHTENING CAUSED THE FRIABLE LEFT ATRIAL TISSUE TO TEAR. THE PT THEN RECOVERED NORMALLY WITH NO FURTHER SEQUELAE. THE DEVICE WAS NOT RETURNED FOR EVALUATION AND THERE IS NO EVIDENCE TO SUGGEST THERE WAS A DEVICE MALFUNCTION. A REVIEW OF MFG RECORDS CONFIRMED THE DEVICE MET SPECIFICATIONS PRIOR TO SHIPMENT.

    Description of Event or Problem · 1

    THE LARIAT WAS USED TO LIGATE THE LAA ON A (B)(6) FEMALE WITH AN EXTREMELY LARGE LEFT ATRIUM. FOLLOWING A SUCCESSFUL LIGATION, AN EFFUSION WAS OBSERVED ON BOTH ECHO AND FLUORO. PERICARDIOCENTESIS WAS THEN PERFORMED TO MANAGE THE EFFUSION, BUT WAS FOLLOWED BY A SUDDEN DROP IN BLOOD PRESSURE. THE PHYSICIAN THEN DECIDED TO SEND THE PT TO SURGERY. THE SURGEON PERFORMED A MEDIAN STERNOTOMY AND REPORTED A LACERATION OF THE LEFT ATRIUM 2MM DISTAL TO THE SUTURE SITE ON THE SUPERIOR PORTION OF THE LEFT ATRIUM. THE LACERATION WAS SUBSEQUENTLY SUTURED AND THE BLEEDING RESOLVED. THE SURGEON COMMENTED THAT THE LAA WAS LIGATED AND INTACT AND THAT THE LACERATION WAS NOT CAUSED BY THE SUTURE. THE PHYSICIAN NOTED THAT HE DID NOT BELIEVE THE INCIDENT WAS RELATED TO A DEVICE MALFUNCTION. PT WAS REPORTED STABLE THE FOLLOWING DAY AND EXPECTED TO RECOVER NORMALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    53513 LARIAT SUTURE DELIVERY DEVICE REMOTE SUTURE DELIVERY DEVICE GAT SENTREHEART INC. NA 70512015

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention FINDRWIRE GUIDE WIRE SYSTEM| TENSURE SUTURE TIGHTENER