BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERPRISE2 4MMX23MM

    MDR report key: 7763797 · Received August 8, 2018

    Report

    Report Number
    1226348-2018-00677
    Event Type
    Injury
    Date Received
    August 8, 2018
    Date of Event
    January 15, 2018
    Report Date
    July 17, 2018
    Manufacturer
    CODMAN AND SHURTLEFF, INC
    Product Code
    NJE
    UDI-DI
    10886704075356
    PMA / PMN Number
    H60001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MED PRODUCTS DUE TO CHARACTER LIMITATION: NEURON MAX 088 SHEATH, SIMMONS 2 120 CM SELECT CATHETER, NAVIEN 072 125 CM INTERMEDIATE CATHETER, PROWLER SELECT PLUS MICROCATHETER, SL-10 (STRYKER) ANGLED MICROCATHETER, ASAHI CHIKAI 0.014 MICROWIRE, SYNCHRO 2 SOFT 0.014 MICROWIRE, TARGET COILS, 7F SHEATH. INITIAL REPORTER OCCUPATION - CLINICAL RESEARCH MANAGER. COMPLAINT CONCLUSION: AS REPORTED BY A HEALTHCARE PROFESSIONAL, A (B)(6) MALE WITH A SIGNIFICANT HISTORY OF LIVER DISORDER AND TRANSPLANTATION PATIENT EXPERIENCED ANEURYSM RE-RUPTURE DURING COIL EMBOLIZATION USING A 4 MM X 23 MM ENTERPRISE 2 (ENF402312/10848579) STENT. THE PATIENT INITIALLY PRESENTED WITH HEADACHE, NECK PAIN, AND CONFUSION WITH OXYGEN SATURATION OF 90% ON ROOM AIR. THE PATIENT HAD A HISTORY OF THROMBOCYTOPENIA SECONDARY TO LIVER DISEASE AND HIS PLATELET COUNT WAS 31. THE PATIENT WAS ON LOVENOX FOR A HISTORY OF DEEP VEIN THROMBOSIS. AT THE OUTSIDE HOSPITAL, THE PATIENT¿S HIGHEST BLOOD PRESSURE WAS MEASURED AT 210 SYSTOLIC. COMPUTED TOMOGRAPHY (CT) SCAN REVEALED DIFFUSE SUBARACHNOID HEMORRHAGE IN THE BASAL CISTERNS WITH EXTENSION INTO THE LEFT GREATER THAN RIGHT SYLVIAN FISSURE, AS WELL AS INTRAVENTRICULAR HEMORRHAGE, ESPECIALLY IN THE THIRD VENTRICLE AND LEFT LATERAL VENTRICLE. THE PATIENT WAS GIVEN PROTAMINE FOR HISTORY OF LOVENOX USE AND ADMINISTERED A PLATELET TRANSFUSION. THE PATIENT WAS TRANSFERRED TO ANOTHER FACILITY FOR FURTHER MANAGEMENT. AT THE OUTSIDE HOSPITAL, THE PATIENT¿S HIGHEST BLOOD PRESSURE WAS MEASURED AT 210 SYSTOLIC. A RIGHT-SIDED HUMMINGBIRD EXTRAVENTRICULAR DRAIN WAS PLACED FOR HIS DEVELOPING HYDROCEPHALUS AND THE PATIENT UNDERWENT STENT-ASSISTED COILING OF A RUPTURED INFERIORLY PROJECTING WIDE-NECKED COMMUNICATING SEGMENT LEFT INTERNAL CAROTID ARTERY (ICA) ANEURYSM (MEASURING 5.0 X 6.8 MM WITH A 5.1 MM NECK) ON (B)(6) 2018. THE PARENT VESSEL MEASURED 4.4 MM PROXIMAL TO THE NECK AND 4.1 MM DISTALLY. UNDER ROADMAP GUIDANCE, A TRIAXIAL SYSTEM INCLUDING AN AMI CATHETER, PROWLER SELECT PLUS (UNK CATALOG & LOT) MICROCATHETER, AND SL-10 (STRYKER) MICROCATHETER, WAS ADVANCED INTO THE DISTAL ICA. THE SL-10 MICROCATHETER WAS UTILIZED TO ACCESS THE ANEURYSM. ATTEMPTS TO NAVIGATE PAST THE ANEURYSM WITH THE PROWLER SELECT PLUS MICROCATHETER WERE CHALLENGING. ULTIMATELY, THE ASAHI CHIKAI 0.014¿ MICROWIRE WAS ABLE TO BE TRACKED INTO THE LEFT MIDDLE CEREBRAL ARTERY ALONG THE WALL OF THE ANEURYSM, SUBSEQUENTLY REDUCING THE LOOP. THE MICROCATHETER WAS TRACKED INTO THE MIDDLE CEREBRAL ARTERY AND THE WIRE WAS REMOVED. A COMPETITOR COIL WAS ADVANCED TO THE TIP OF THE SL-10 MICROCATHETER. INTRAVENOUS (IV) HEPARIN (5000 BOLUS) WAS ADMINISTERED. THE ENTERPRISE 2 STENT WAS DEPLOYED ACROSS THE NECK OF THE ANEURYSM, WITH SOME MOVEMENT OF THE SL-10 MICROCATHETER. FOLLOW-UP ANGIOGRAPHY SHOWED PLACEMENT OF THE STENT ACROSS THE NECK OF THE ANEURYSM WITH DISTAL PORTION AND THE DISTAL ICA AND PROXIMAL PORTION NEAR THE OPHTHALMIC ARTERY. ALTHOUGH SOME SPASM WAS NOTED WITHIN THE DISTAL INTERNAL CAROTID ARTERY, THERE WAS NO EVIDENCE OF DISTAL EMBOLIZATION OR MALPOSITIONING. THE FIRST COIL WAS INTRODUCED INTO THE ANEURYSM AND THE COIL TRAVERSED THE WALL OF THE ANEURYSM INTO THE SUBARACHNOID SPACE. IV PROTAMINE WAS ADMINISTERED DUE TO THE INTRAOPERATIVE RUPTURE. ADDITIONAL COILS WERE PLACED IN THE SUBARACHNOID SPACE AND BACK INTO THE DOME OF THE ANEURYSM TO RAPIDLY SECURE THE RUPTURE. THE MICROCATHETER WAS ULTIMATELY DISPLACED INTO THE PARENT VESSEL, LEAVING A SMALL TAIL OF COIL WITHIN THE PARENT VESSEL. FOLLOW-UP ANGIOGRAPHY WAS PERFORMED, WHICH DEMONSTRATED NEAR OCCLUSION OF THE ANEURYSM. HEPARIN WAS AGAIN ADMINISTERED VIA IV, TITRATED TO ACTIVATING CLOTTING TIME (ACT) BETWEEN 250 AND 350. ADDITIONAL ATTEMPTS TO TRAVERSE THE STENT TO PLACE ADDITIONAL COILS WERE UNSUCCESSFUL. FOLLOW-UP ANGIOGRAPHY SHOWED OCCLUSION OF THE MAJORITY OF THE ANEURYSM WITH SOME MINIMAL FILLING WITHIN THE COIL PACK. A SMALL TAIL OF COIL PROTRUDED INTO THE PARENT VESSEL. THE ENTERPRISE STENT WAS PATENT. THE ANTERIOR CEREBRAL ARTERY AND MIDDLE CEREBRAL ARTERIES WERE PATENT. THERE WAS SOME VASOSPASM ALONG THE NON-CERENOVUS GUIDE CATHETER. 3-DIMENSIONAL ROTATIONAL ANGIOGRAPHY WAS PERFORMED TO DETERMINE THE RELATIONSHIP OF THE COIL/STENT TO THE PARENT VESSEL AND THERE WERE SOME COILS WITHIN THE LEFT TEMPORAL LOBE/SUBARACHNOID SPACE AND COILS WITHIN THE ANEURYSM. THE STENT WAS SEEN WITHIN THE PARENT VESSEL EXTENDING PROXIMALLY TO THE OPHTHALMIC ARTERY AND DISTALLY TO THE ICA TERMINUS. THERE WAS GOOD FLOW THROUGH THE STENT IN THE PARENT ARTERY. A CT SCAN OF THE HEAD WAS PERFORMED ON THE FOLLOWING DAY WHICH DEMONSTRATED THAT THE SUBARACHNOID HEMORRHAGE HAD INCREASED FROM PRIOR EXAM WITH STABLE APPEARING LEFT TO RIGHT-SIDED MIDLINE SHIFT. THE PATIENT HAD SUSTAINED A DEVASTATING INJURY AND REQUIRED ONGOING VENTILATORY AND CIRCULATORY SUPPORT WITH A POOR PROGNOSIS. A CHEST X-RAY ON (B)(6) 2018 REVEALED INCREASING AIRSPACE OPACIFICATIONS PREDOMINANTLY IN THE UPPER LOBES. AFTER A FAMILY MEETING ON (B)(6) 2018, THE DECISION WAS MADE TO WITHDRAW CARE. THE PATIENT SUBSEQUENTLY EXPIRED ON (B)(6) 2018. THE PRELIMINARY CAUSE OF DEATH WAS CARDIOVASCULAR COLLAPSE SECONDARY TO SUBARACHNOID HEMORRHAGE. ACCORDING TO THE PHYSICIAN, THE PATIENT'S DEATH WAS NOT RELATED TO THE PLACEMENT OF THE DEVICE. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE CAUSE OF DEATH WAS RESPIRATORY FAILURE AND IT WAS STATED THAT THE PATIENT WAS NOT PLACED ON VENTILATORY SUPPORT DUE TO THE ANEURYSM RE-RUPTURE. THE CAUSE OF THE RUPTURE WAS NOT CONSIDERED TO BE RELATED TO THE ENTERPRISE STENT. NON-CERENOVUS COILS WERE USED DURING THE PROCEDURE. THE PHYSICIAN FURTHER REPORTED THAT THE PATIENT HAD HEPATOCELLULAR CARCINOMA, END-STAGE LIVER DISEASE, AND COAGULOPATHY. NO FURTHER INFORMATION WAS PROVIDED. THE ENTERPRISE 2 STENT REMAINS IMPLANTED IN THE PATIENT AND IS THUS NOT AVAILABLE FOR EVALUATION. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING OR INSPECTION PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. ANEURYSM RUPTURE, HEMORRHAGE, AND DEATH ARE KNOWN POTENTIAL COMPLICATIONS RELATED TO THE USE OF THE ENTERPRISE 2 STENT AND STENT-ASSISTED COIL EMBOLIZATION PROCEDURES. ADDITIONAL INFORMATION PROVIDED FROM MEDICAL RECORDS AND THE HOSPITAL CONFIRMED THE CAUSE OF THE RE-RUPTURE TO BE RELATED TO THE NON-CERENOVUS COIL AND THE DEATH TO BE RELATED TO RESPIRATORY FAILURE. THE PATIENT WAS AT INCREASED RISK OF BLEEDING DUE TO THROMBOCYTOPENIA AND THE PATIENT HAD PRESENTED WITH A LOW O2 SATURATION AND WAS EXPERIENCING INCREASING AIRSPACE OPACIFICATIONS. THE MEDICAL RECORD REVEALED THERE WAS VASOSPASM RELATED TO THE ENTERPRISE STENT. VASOSPASM IS TIGHTENING OF THE MUSCLES IN THE VESSEL WALL. THIS CAN NARROW AND DECREASE OR EVEN PREVENT BLOOD FLOW DISTAL TO THE SPASM AND MAY OCCUR WHEN POSITIONING/ADVANCING THE DEVICES THROUGH THE VESSEL/ARTERIES AND IS USUALLY TREATED MEDICALLY. THIS IS A WELL KNOW POTENTIAL COMPLICATION WITH ANY INVASIVE PROCEDURE DURING WHICH DEVICES ARE INTRODUCED INTO VESSELS, INCLUDING THE ENTERPRISE 2 STENT. COIL PROTRUSION INTO NORMAL VESSELS ADJACENT TO THE ANEURYSM IS ALSO A KNOWN EVENT; HOWEVER, THE CONCOMITANT NON-CERENOVUS MICROCATHETER MAY HAVE CONTRIBUTED TO THIS EVENT. WIDE-NECK ANEURYSMS ARE PRONE TO COIL PROTRUSION. RECENT ADVANCEMENTS IN VASCULAR RECONSTRUCTION DEVICES AND COILS HAVE ALLOWED FOR THE APPLICATION OF COIL EMBOLIZATION FOR EVEN RELATIVELY WIDE-NECK ANEURYSMS. DESPITE TIGHT COIL PACKING, PROTRUSION OF COIL SEGMENTS OUT OF THE ANEURYSM AND INTO THE PARENT ARTERY STILL OCCURS. THE ROOT CAUSE OF THE EVENTS COULD NOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT IS POSSIBLE THAT PATIENT, PHARMACOLOGICAL, AND PROCEDURAL/CLINICAL FACTORS, INCLUDING VESSEL/ANEURYSM CHARACTERISTICS (I.E. NECK SIZE), DEVICE SELECTION, DEVICE MANIPULATION, AND CONCOMITANT DEVICES MAY HAVE CONTRIBUTED. AS PART OF THE POST MARKET SURVEILLANCE PROGRAM, INFORMATION FROM THIS COMPLAINT IS TRENDED FOR STATISTICAL SIGNALS AND CORRECTIVE/PREVENTIVE ACTION MAY BE TRIGGERED AT A LATER TIME. SINCE THERE WAS NO EVIDENCE TO SUGGEST THE EVENTS WERE RELATED TO A MANUFACTURING OR DESIGN ISSUE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. THE MANUFACTURER WILL SUBMIT A SUPPLEMENTAL REPORT IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.

    Description of Event or Problem · 1

    AS REPORTED BY A HEALTHCARE PROFESSIONAL, A (B)(6) MALE WITH A SIGNIFICANT HISTORY OF LIVER DISORDER AND TRANSPLANTATION PATIENT EXPERIENCED ANEURYSM RE-RUPTURE DURING COIL EMBOLIZATION USING A 4 MM X 23 MM ENTERPRISE 2 (ENF402312/10848579) STENT. THE PATIENT INITIALLY PRESENTED WITH HEADACHE, NECK PAIN, AND CONFUSION WITH OXYGEN SATURATION OF 90% ON ROOM AIR. THE PATIENT HAD A HISTORY OF THROMBOCYTOPENIA SECONDARY TO LIVER DISEASE AND HIS PLATELET COUNT WAS 31. THE PATIENT WAS ON LOVENOX FOR A HISTORY OF DEEP VEIN THROMBOSIS. AT THE OUTSIDE HOSPITAL, THE PATIENT¿S HIGHEST BLOOD PRESSURE WAS MEASURED AT 210 SYSTOLIC. COMPUTED TOMOGRAPHY (CT) SCAN REVEALED DIFFUSE SUBARACHNOID HEMORRHAGE IN THE BASAL CISTERNS WITH EXTENSION INTO THE LEFT GREATER THAN RIGHT SYLVIAN FISSURE, AS WELL AS INTRAVENTRICULAR HEMORRHAGE, ESPECIALLY IN THE THIRD VENTRICLE AND LEFT LATERAL VENTRICLE. THE PATIENT WAS GIVEN PROTAMINE FOR HISTORY OF LOVENOX USE AND ADMINISTERED A PLATELET TRANSFUSION. THE PATIENT WAS TRANSFERRED TO ANOTHER FACILITY FOR FURTHER MANAGEMENT. AT THE OUTSIDE HOSPITAL, THE PATIENT¿S HIGHEST BLOOD PRESSURE WAS MEASURED AT 210 SYSTOLIC. A RIGHT-SIDED HUMMINGBIRD EXTRAVENTRICULAR DRAIN WAS PLACED FOR HIS DEVELOPING HYDROCEPHALUS AND THE PATIENT UNDERWENT STENT-ASSISTED COILING OF A RUPTURED INFERIORLY PROJECTING WIDE-NECKED COMMUNICATING SEGMENT LEFT INTERNAL CAROTID ARTERY (ICA) ANEURYSM (MEASURING 5.0 X 6.8 MM WITH A 5.1 MM NECK) ON (B)(6) 2018. THE PARENT VESSEL MEASURED 4.4 MM PROXIMAL TO THE NECK AND 4.1 MM DISTALLY. UNDER ROADMAP GUIDANCE, A TRIAXIAL SYSTEM INCLUDING AN AMI CATHETER, PROWLER SELECT PLUS (UNK CATALOG AND LOT) MICROCATHETER, AND SL-10 (STRYKER) MICROCATHETER, WAS ADVANCED INTO THE DISTAL ICA. THE SL-10 MICROCATHETER WAS UTILIZED TO ACCESS THE ANEURYSM. ATTEMPTS TO NAVIGATE PAST THE ANEURYSM WITH THE PROWLER SELECT PLUS MICROCATHETER WERE CHALLENGING. ULTIMATELY, THE ASAHI CHIKAI 0.014¿ MICROWIRE WAS ABLE TO BE TRACKED INTO THE LEFT MIDDLE CEREBRAL ARTERY ALONG THE WALL OF THE ANEURYSM, SUBSEQUENTLY REDUCING THE LOOP. THE MICROCATHETER WAS TRACKED INTO THE MIDDLE CEREBRAL ARTERY AND THE WIRE WAS REMOVED. A COMPETITOR COIL WAS ADVANCED TO THE TIP OF THE SL-10 MICROCATHETER. INTRAVENOUS (IV) HEPARIN (5000 BOLUS) WAS ADMINISTERED. THE ENTERPRISE 2 STENT WAS DEPLOYED ACROSS THE NECK OF THE ANEURYSM, WITH SOME MOVEMENT OF THE SL-10 MICROCATHETER. FOLLOW-UP ANGIOGRAPHY SHOWED PLACEMENT OF THE STENT ACROSS THE NECK OF THE ANEURYSM WITH DISTAL PORTION AND THE DISTAL ICA AND PROXIMAL PORTION NEAR THE OPHTHALMIC ARTERY. ALTHOUGH SOME SPASM WAS NOTED WITHIN THE DISTAL INTERNAL CAROTID ARTERY, THERE WAS NO EVIDENCE OF DISTAL EMBOLIZATION OR MALPOSITIONING. THE FIRST COIL WAS INTRODUCED INTO THE ANEURYSM AND THE COIL TRAVERSED THE WALL OF THE ANEURYSM INTO THE SUBARACHNOID SPACE. IV PROTAMINE WAS ADMINISTERED DUE TO THE INTRAOPERATIVE RUPTURE. ADDITIONAL COILS WERE PLACED IN THE SUBARACHNOID SPACE AND BACK INTO THE DOME OF THE ANEURYSM TO RAPIDLY SECURE THE RUPTURE. THE MICROCATHETER WAS ULTIMATELY DISPLACED INTO THE PARENT VESSEL, LEAVING A SMALL TAIL OF COIL WITHIN THE PARENT VESSEL. FOLLOW-UP ANGIOGRAPHY WAS PERFORMED, WHICH DEMONSTRATED NEAR OCCLUSION OF THE ANEURYSM. HEPARIN WAS AGAIN ADMINISTERED VIA IV, TITRATED TO ACTIVATING CLOTTING TIME (ACT) BETWEEN 250 AND 350. ADDITIONAL ATTEMPTS TO TRAVERSE THE STENT TO PLACE ADDITIONAL COILS WERE UNSUCCESSFUL. FOLLOW-UP ANGIOGRAPHY SHOWED OCCLUSION OF THE MAJORITY OF THE ANEURYSM WITH SOME MINIMAL FILLING WITHIN THE COIL PACK. A SMALL TAIL OF COIL PROTRUDED INTO THE PARENT VESSEL. THE ENTERPRISE STENT WAS PATENT. THE ANTERIOR CEREBRAL ARTERY AND MIDDLE CEREBRAL ARTERIES WERE PATENT. THERE WAS SOME VASOSPASM ALONG THE NON-CERENOVUS GUIDE CATHETER. 3-DIMENSIONAL ROTATIONAL ANGIOGRAPHY WAS PERFORMED TO DETERMINE THE RELATIONSHIP OF THE COIL/STENT TO THE PARENT VESSEL AND THERE WERE SOME COILS WITHIN THE LEFT TEMPORAL LOBE/SUBARACHNOID SPACE AND COILS WITHIN THE ANEURYSM. THE STENT WAS SEEN WITHIN THE PARENT VESSEL EXTENDING PROXIMALLY TO THE OPHTHALMIC ARTERY AND DISTALLY TO THE ICA TERMINUS. THERE WAS GOOD FLOW THROUGH THE STENT IN THE PARENT ARTERY. A CT SCAN OF THE HEAD WAS PERFORMED ON THE FOLLOWING DAY WHICH DEMONSTRATED THAT THE SUBARACHNOID HEMORRHAGE HAD INCREASED FROM PRIOR EXAM WITH STABLE APPEARING LEFT TO RIGHT-SIDED MIDLINE SHIFT. THE PATIENT HAD SUSTAINED A DEVASTATING INJURY AND REQUIRED ONGOING VENTILATORY AND CIRCULATORY SUPPORT WITH A POOR PROGNOSIS. A CHEST X-RAY ON (B)(6) 2018 REVEALED INCREASING AIRSPACE OPACIFICATIONS PREDOMINANTLY IN THE UPPER LOBES. AFTER A FAMILY MEETING ON (B)(6) 2018, THE DECISION WAS MADE TO WITHDRAW CARE. THE PATIENT SUBSEQUENTLY EXPIRED ON (B)(6) 2018. THE PRELIMINARY CAUSE OF DEATH WAS CARDIOVASCULAR COLLAPSE SECONDARY TO SUBARACHNOID HEMORRHAGE. ACCORDING TO THE PHYSICIAN, THE PATIENT'S DEATH WAS NOT RELATED TO THE PLACEMENT OF THE DEVICE. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE CAUSE OF DEATH WAS RESPIRATORY FAILURE AND IT WAS STATED THAT THE PATIENT WAS NOT PLACED ON VENTILATORY SUPPORT DUE TO THE ANEURYSM RE-RUPTURE. THE CAUSE OF THE RUPTURE WAS NOT CONSIDERED TO BE RELATED TO THE ENTERPRISE STENT. NON-CERENOVUS COILS WERE USED DURING THE PROCEDURE. THE PHYSICIAN FURTHER REPORTED THAT THE PATIENT HAD HEPATOCELLULAR CARCINOMA, END-STAGE LIVER DISEASE, AND COAGULOPATHY. THE STENT REMAINS IMPLANTED IN THE PATIENT AND IS THUS NOT AVAILABLE FOR EVALUATION. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602427 ENTERPRISE2 4MMX23MM INTRACRANIAL NEUROVASCULAR STENT NJE CODMAN AND SHURTLEFF, INC 10848579 10886704075356

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention