HMS PLUS INSTRUMENT

Description of Event or Problem

A LITERATURE REVIEW WAS CONDUCTED OF A STUDY THAT AIMED TO DETERMINE WHETHER ACTIVATED CLOTTING TIME (ACT)-GUIDED HEPARINISATION WAS SUPERIOR TO THE CONVENTIONAL ADMINISTRATION OF A SINGLE 5,000 IU HEPARIN BOLUS IN REDUCING THROMBOEMBOLIC COMPLICATIONS AND MORTALITY, WITHOUT INCREASING THE RISK OF BLEEDING IN PATIENTS UNDERGOING ELECTIVE OPEN ABDOMINAL AORTIC ANEURYSM (AAA) REPAIR. PATIENTS SCHEDULED FOR ELECTIVE OPEN REPAIR OF AN ABDOMINAL AORTIC OR ILIAC ANEURYSM WERE RECRUITED BETWEEN 16 MARCH 2020 AND 18 OCTOBER 2023. PARTICIPANTS WERE RANDOMLY ASSIGNED IN A 1:1 RATIO TO RECEIVE EITHER ACT-GUIDED HEPARINISATION, CONSISTING OF AN INITIAL HEPARIN DOSE OF 100 IU/KG WITH A TARGET ACT OF 200 SECONDS, OR THE STANDARD TREATMENT CONSISTING OF A SINGLE INTRAVENOUS BOLUS OF 5,000 IU OF HEPARIN. FOLLOWING RANDOMISATION, 149 PATIENTS RECEIVED ACT-GUIDED HEPARINISATION. THE MEAN PATIENT AGE WAS 69 YEARS, THE MEAN BODY MASS INDEX (BMI) WAS 27 KG/M², AND THE MAJORITY OF PARTICIPANTS WERE MALE. THE MEDTRONIC HAEMOSTASIS MANAGEMENT SYSTEM (HMS) PLUS WAS USED FOR ALL PATIENTS. ONE PATIENT REACHED AN ACT OF 500 SECONDS FOLLOWING THE INITIAL HEPARIN DOSE, WHICH WAS ATTRIBUTED TO AN HMS PLUS MEASUREMENT FAILURE. COMPLICATIONS REPORTED IN PATIENTS WITH A PEAK ACT >250 SECONDS INCLUDED THROMBOEMBOLIC EVENTS, BLEEDING, AND DEATH. BASED ON THE AVAILABLE INFORMATION, THESE ADVERSE EVENTS MAY HAVE BEEN ATTRIBUTED TO THE MEDTRONIC HMS PLUS; HOWEVER, THE STUDY DID NOT ESTABLISH THAT THEY WERE CAUSED BY THE DEVICE.

Additional Manufacturer Narrative

NOTE ON B.3: EARLIEST DATE OF PUBLICATION USED FOR DATE OF EVENT LITERATURE CITATION: AUTHORS: VINCENT JONGKIND, THOMAS A.H. STEUNENBERG, LILIANE C. ROOSENDAAL, MAX HOEBINK, JAN D. BLANKENSTEIJN, MARK J.W. KOELEMAY, ROGIER H.J. KROPMAN, CLARK J. ZEEBREGTS, JAN VAN SCHAIK, JAN M.M. HEYLIGERS, ROBERT H. GEELKERKEN, MAURICE E.N. PIERIE, MICHEL M.P.J. REIJNEN, SUSAN M. LEMSON, RIGO HOENCAMP, JOEP A.W. TEIJINK, MARKUS G. STEINBAUER, RUTGER J. HISSINK, SEBASTIAN DEBUS, HESSEL C.J.L. BUSCHER, BRAM FIOOLE, SUSAN VAN DIEREN, ARNO M. WIERSEMA, ACTION-1 INVESTIGATORS. ACTIVATED CLOTTING TIME GUIDED HEPARINISATION DURING OPEN ABDOMINAL AORTIC ANEURYSM REPAIR (ACTION-1): A RANDOMISED, MULTICENTRE, SINGLE BLIND, SUPERIORITY TRIAL. EUROPEAN JOURNAL OF VASCULAR AND ENDOVASCULAR SURGERY 2025 - 70, 3 (295-305). DOI.ORG/10.1016/J.EJVS.2025.07.027. NO UNIQUE DEVICE IDENTIFIER (SERIAL/LOT) NUMBERS WERE PROVIDED; WITHOUT THIS INFORMATION IT COULD NOT BE DETERMINED WHETHER THESE OBSERVATIONS HAVE BEEN PREVIOUSLY REPORTED. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.