BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTEGE GPS SELF-EXPANDING STENT SYSTEM 035 STANDARD

    MDR report key: 10541068 · Received September 16, 2020

    Report

    Report Number
    2183870-2020-00295
    Event Type
    Injury
    Date Received
    September 16, 2020
    Date of Event
    July 1, 2020
    Report Date
    February 24, 2021
    Manufacturer
    COVIDIEN
    Product Code
    FGE
    PMA / PMN Number
    K050725
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED 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. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    JOURNAL TITLE: UNDERSIZED STENTGRAFT PLACEMENT FOR TRAUMATIC DESCENDING AORTA RUPTURE, AND WHAT IS NEXT? JOURNAL: THE AMERICAN JOURNAL OF CASE REPORTS YEAR: 2020 REF: DOI: 10.12659/AJCR.926299. DATE OF EVENT: DATE OF PUBLICATION. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THIS ARTICLE PRESENTS A CASE REPORT FOR A PATIENT WHO WAS ADMITTED FOLLOWING A CAR ACCIDENT PRESENTING SYMPTOMS OF ISCHEMIC SHOCK. AMONG MULTIPLE INJURIES, A TRAUMATIC DESCENDING AORTA RUPTURE WAS DIAGNOSED. THE PATIENT WAS DIAGNOSED WITH TRAUMA TO THE HEAD WITH INTRACRANIAL HEMATOMA AND MAXILLOFACIAL FRACTURES, LUNG AND LIVER CONTUSION, MULTIPLE FRACTURES OF THE RIBS, AND LEFT PNEUMOTHORAX AND PELVIC FRACTURES. THE CTA REVEALED AN AORTIC ISTHMUS RUPTURE AS A MAJOR LIFE-THREATENING BLEEDING SOURCE. THIS EXAM ALSO REVEALED AN AORTIC PSEUDOANEURYSM WITH ASSOCIATED POSTERIOR MEDIASTINAL HEMATOMA AND MULTIFOCAL PULMONARY CONTUSION. PREOPERATIVE ANALYSIS OF THE CHEST CTA INDICATED A 15×10-MM AREA OF FOCAL DAMAGE TO THE MEDIAL ASPECT OF THE DESCENDING AORTA, LOCATED RIGHT UNDERNEATH THE ISTHMUS, AND AN ASSOCIATED 60-MM PSEUDOANEURYSM. THE AORTIC ARCH WAS 12-12.5 MM IN DIAMETER AND LOCATED DISTALLY TO THE DISRUPTION. AS AN INTRACRANIAL HAEMORRHAGE WAS DETECTED, IT WAS DETERMINED STANDARD SYSTEMIC ANTICOAGULATION TO BE HIGH RISK FOR THE PATIENT. HENCE, THE PROCEDURE WAS PERFORMED WITHOUT HEPARIN ADMINISTRATION. THE AVAILABLE STENT GRAFT SIZES WERE REPORTED TO BE APPROXIMATELY 30% LARGER THAN THE PATIENT¿S AORTA SIZE. AUTONOMIC VASOCONSTRICTION OF THE AORTA CAUSED BY THE HAEMORRHAGIC SHOCK MADE PREOPERATIVE MEASURING OF THE MAIN ARTERY DIFFICULT. IT WAS DECIDED TO IMPLANT A BALLOON-EXPANDABLE COVERED STENT. FEMORAL ACCESS WAS OBTAINED, AND A PIGTAIL CATHETER WAS ADVANCED THROUGH THE FEMORAL ARTERY, RETROGRADE INTO THE ASCENDING AORTA. THIS WAS FOLLOWED BY AN ANGIOGRAM. USING CTA AND THE INTRAOPERATIVE ANGIOGRAM, A NON-MEDTRONIC BALLOON-EXPANDABLE COVERED STENT (14/80 MM STENT GRAFT) WAS IMPLANTED. THE STENT WAS LOCKED IN PLACE AND THE NEXT ANGIOGRAM INDICATED PROPER PROXIMAL AND DISTAL WALL APPOSITION AT THE HEIGHT OF THE PSEUDOANEURYSM. A BIRD¿S BEAK DEFORMITY WAS NOTED AND, TRYING TO AVOID STENT GRAFT COLLAPSE, THE PHYSICIAN ADDED A PROTÉGÉ GPS 14/16 MM SELF-EXPANDABLE STENT TO COVER THE DISTAL PART OF THE AORTIC ARCH AND THE PROXIMAL PART OF THE IMPLANTED COVERED STENT. HOWEVER, THE REPAIR REVEALED A TYPE-I ENDOLEAK. IT WAS REALIZED THAT THE BALLOON-EXPANDABLE COVERED STENT COULD NOT FIT INTO THE CURVE OF THE DISTAL SEGMENT OF THE AORTIC ARCH. BLINDSIDED BY THE SECOND FAILURE AND LEFT WITH NO ALTERNATIVES, A NON-MEDTRONIC ILIAC STENT GRAFT (15/16×93 MM) WAS USED USING A CONTRALATERAL LIMB STANDARD FOR ABDOMINAL AORTIC ANEURYSM REPAIR. THIS PARTIALLY COVERED THE LEFT SUBCLAVIAN ARTERY OSTIUM. THIS REQUIRED ACCESS VIA THE ILIAC ARTERY SINCE THE SHORT SHAFT OF THIS EQUIPMENT WAS NOT TAILORED FOR THIS PART OF THE ARTERIAL TREE. NEXT, THE RIGHT COMMON ILIAC ARTERY WAS EXPOSED, AND FROM THIS LEVEL IT WAS POSSIBLE TO REACH THE AFOREMENTIONED POSITION, EXPAND THE STENT GRAFT, AND FINALLY ACHIEVE THE TOTAL EXCLUSION OF THE AORTIC DISRUPTION. TO FINISH THE PROCEDURE, A BILATERAL CHEST DRAINAGE WAS PERFORMED. AFTER THAT, THE PATIENT WAS REFERRED TO THE DEPARTMENT OF GENERAL SURGERY, WHERE, DUE TO LIVER INJURY, HE UNDERWENT DRAINAGE LAPAROTOMY IN TWO STAGES: FIRST, LIVER PACKING AS A DAMAGE-CONTROL SURGERY; AND SECOND, REMOVAL OF GAUZE AFTER 4 DAYS. THE PELVIC FRACTURES WERE MANAGED CONSERVATIVELY. NO NEUROSURGICAL INTERVENTION WAS NEEDED. THE PATIENT SPENT 30 DAYS IN THE INTENSIVE CARE UNIT (ICU). AFTER 30 DAYS, THE CTA WAS REPEATED. THE RESULTS REVEALED THAT THE DIAMETERS OF THE STENTS AND STENT GRAFT DEPLOYED WERE UNDERSIZED. FORTUNATELY, NONE OF THE ELEMENTS MIGRATED, BUT THE DIAMETER OF THE AORTA WAS 20-22 MM, RESULTING IN THE OCCURRENCE OF TYPE-IA AND -IB ENDOLEAKS. A DECISION WAS MADE TO REMOVE THE THREE STENTS (I.E., TWO STENTS AND THE STENT GRAFT) VIA AN ENDOVASCULAR APPROACH, AND TO DEPLOY A THORACIC STENT GRAFT IN THE SAME SESSION. THE LEFT ILIAC ARTERY WAS DISSECTED RETROPERITONEALLY, AND A 14FR NON-MEDTRONIC 80-CM SHEATH WAS DEPLOYED. A NON-MEDTRONIC (EN SNARE ENDOVASCULAR SNARE SYSTEM) 18-30 MM ENDOVASCULAR LOOP ALLOWED FOR REMOVAL OF ALL THE STENTS AT THE SAME TIME. THE STENTS WERE PULLED THROUGH TO THE REGION OF AORTIC BIFURCATION. THEN, AFTER CLAMPING OF THE AORTA AND COMMON ILIAC ARTERIES, IT WAS POSSIBLE TO SAFELY REMOVE THE STENTS THROUGH A 10-MM INCISION IN THE DISTAL PART OF THE ABDOMINAL AORTA, JUST UNDER THE AORTIC BIFURCATION. NEXT THE PHYSICIAN ANASTOMOSED AN 8/150-MM NON-MEDTRONIC CONDUIT END-TO-SIDE TO THIS INCISION WITH A PROLENE 5/0 RUNNING SUTURE. THIS ARTIFICIAL PASSAGEWAY ENABLED SAFE IMPLANTATION OF A NON-MEDTRONIC 24/105-MM THORACIC STENT GRAFT. THE FINAL ANGIOGRAPHY CONFIRMED A TOTAL EXCLUSION OF THE PSEUDOANEURYSM. THE VASCULAR CONDUIT WAS CUT, LEAVING A 1-CM STUMP WHICH WAS LIGATED WITH PROLENE 2/0 SUTURE. SEVEN DAYS AFTER THIS PROCEDURE, THE PATIENT WAS DISCHARGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1004773 PROTEGE GPS SELF-EXPANDING STENT SYSTEM 035 STANDARD CATHETER, BILIARY, DIAGNOSTIC FGE COVIDIEN

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Required Intervention