BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LARIAT SUTURE DELIVERY DEVICE

    MDR report key: 2890715 · Received December 26, 2012

    Report

    Report Number
    3005802238-2012-00008
    Event Type
    Injury
    Date Received
    December 26, 2012
    Date of Event
    November 29, 2012
    Report Date
    December 26, 2012
    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

    ADDITIONAL 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 THE TENSURE SUTURE TIGHTENER. DUE TO PT ANATOMY, IT WAS NOTED THAT SOME DIFFICULTY WAS ENCOUNTERED TRYING TO ACCESS THE LAA WITH THE FINDRWIRZ GUIDE WIRES PRIOR TO LIGATION WITH THE LARIAT. THIS RESULTED IN SOME ADDITIONAL MANIPULATION OF THE DEVICES DURING THIS TIME, BUT WAS NOT BELIEVED TO BE RELATED TO THE REPORTED INCIDENT. HOWEVER, ONCE ACCESS TO THE LAA WAS ACHIEVED, THE REMAINDER OF THE LAA LIGATION PROCEDURE WITH THE LARIAT WAS UNREMARKABLE. THE EFFUSION WAS NOTED FOLLOWING THE INITIAL TIGHTENING OF THE SUTURE KNOT WITH THE TENSURE AND THE DECISION WAS MADE TO SEND THE PT TO SURGERY FOLLOWING THE DROP IN BLOOD PRESSURE. THE DISCUSSION THAT TOOK PLACE AMONG THE ATTENDING PHYSICIANS IS THAT ADDITIONAL PRESSURE MAY HAVE BEEN APPLIED TO THE TISSUE DURING TIGHTENING OF THE KNOT, WHICH MAY HAVE LED TO VERY FRIABLE LA TISSUE TO GIVE WAY AND TEAR. THE PHYSICIAN STATED THE LA WAS SO BIG THAT HE DOESN'T SEE HOW ANY DEVICE WOULD HAVE REACHED THE LA WALL TO CAUSE A TEAR. THERE WAS SOME DISCUSSION ABOUT THE POSSIBILITY THAT THE TIP OF THE LARIAT DURING TIGHTENING MAY HAVE CONTRIBUTED, BUT THE PHYSICIAN DOESN'T THINK SO. THE DEVICE WAS NOT RETURNED FOR EVAL AND THERE IS NO EVIDENCE TO SUGGEST THERE WAS A DEVICE MALFUNCTION. A REVIEW OF THE MFG RECORDS CONFIRMED THE DEVICE MET SPECIFICATIONS PRIOR TO SHIPMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LARIAT WAS USED TO LIGATE THE LAA ON AN (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 3MM DISTAL TO THE SUTURE SITE ON THE SUPERIOR PORTION OF THE LEFT ATRIUM NEAR THE COUMADIN RIDGE. 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 IN ANY WAY 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
    1 LARIAT SUTURE DELIVERY DEVICE REMOTE SUTURE DELIVERY DEVICE GAT SENTREHEART INC. NA 70512015

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention TENSURE SUTURE TIGHTENER| FINDRWIRE GUIDE WIRE SYSTEM