BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYPERGLIDE

    MDR report key: 17367121 · Received July 20, 2023

    Report

    Report Number
    2029214-2023-01151
    Event Type
    Injury
    Date Received
    July 20, 2023
    Date of Event
    August 5, 2021
    Report Date
    August 3, 2023
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    MJN
    PMA / PMN Number
    K091458
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G2: CITATION: AUTHORS: DODIER, P., WANG, W.-T., HOSMANN, A., HIRSCHMANN, D., MARIK, W., FRISCHER, J. M., GRUBER, A., RÖSSLER, K., <(>&<)> BAVINZSKI, G.. COMBINED STANDARD BYPASS AND PARENT ARTERY OCCLUSION FOR MANAGEMENT OF GIANT AND COMPLEX INTERNAL CAROTID ARTERY ANEURYSMS.. JOURNAL OF NEUROINTERVENTIONAL SURGERY 14(6):593-598 2022. DOI:10.1136/NEURINTSURG-2021-017673 A.2. THIS VALUE IS THE MEDIAN AGE OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. A.3. THIS VALUE REFLECTS THE GENDER OF THE MAJORITY OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. EARLIEST DATE OF PUBLICATION USED FOR DATE OF EVENT NO UNIQUE DEVICE IDENTIFIER (SERIAL/LOT) NUMBERS WERE PROVIDED; WITHOUT THIS INFORMATION IT COULD NOT BE DETERMINED WHETHER THESE OBSERVATIONS HAVE BEEN PREVIOUSLY REPORTED. WITHOUT RETURN OF THE PRODUCT NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE CLINICAL OBSERVATIONS. 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 · 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.

    Description of Event or Problem · 0

    DODIER P, WANG W-T, HOSMANN A, ET AL. COMBINED STANDARD BYPASS AND PARENT ARTERY OCCLUSION FOR MANAGEMENT OF GIANT AND COMPLEX INTERNAL CAROTID ARTERY ANEURYSMS. JOURNAL OF NEUROINTERVENTIONAL SURGERY. 2022;14(6):593-598. DOI:10.1136/NEURINTSURG-2021-017673 MEDTRONIC LITERATURE REVIEW FOUND A REPORT OF PATIENT COMPLICATIONS IN ASSOCIATION WITH THE HYPERGLIDE BALLOON. THE PURPOSE OF THIS ARTICLE WAS TO INVESTIGATE THE SAFETY AND EFFICACY OF MICROSURGICAL REVASCULARIZATION COMBINED WITH PARENT ARTERY OCCLUSION (PAO) IN GIANT AND COMPLEX INTERNAL CAROTID ARTERY (ICA) ANEURYSMS. BETWEEN 1998 AND 2017, 41 PATIENTS WITH 47 GIANT AND COMPLEX ICA ANEURYSMS WERE TREATED BY AN A PRIORI PLANNED COMBINED TREATMENT ST RATEGY. THE MEDIAN AGE WAS 57 YEARS AND THERE WERE 30 FEMALES AND  11 MALES. PRIOR TO PAO, A BALLOON TEST OCCLUSION (BTO) OF THE DISEASED ICA WAS PERFORMED. A BALLOON CATHETER (MAGIC B1, BALT; HYPERGLIDE, MEDTRONIC; OR SCEPTER XC BALLOON, MICROVENTION) WAS POSITIO NED IN COAXIAL FASHION VIA A GUIDING CATHETER (ENVOY OR VISTA BRITE; CORDIS) PROXIMALLY ADJACENT TO THE ANEURYSM. PRIOR TO BALLOON INFLATION, 4000¿5000IU OF HEPARIN WAS ADMINISTERED. CONTRAST MEDIUM INJECTION CONFIRMED SUFFICIENT INFLATION AND FLOW ARREST. PATIENTS WERE CONTINUOUSLY MONITORED AND TESTED FOR A TOTAL DURATION OF 25¿30MIN WITH SIMPLE MOTOR AND LANGUAGE TASKS AND EXAMINED FOR NEUROCOGNITIVE IMPAIRMENT. IF A HYPOTENSIVE CHALLENGE TEST WAS DEEMED NECESSARY, A DECREASE IN SYSTOLIC BLOOD PRESSURE OF APPROXIMATELY 20MMHG WAS TARGETED FOR A SHORT DURATION OF TIME (5MIN). ONCE STABLE NEUROLOGY WAS DOCUMENTED, LOOSE COILING OF THE ANEURYSM SAC AND ENDOVASCULAR PAO WERE PERFORMED WITH DETACHABLE BALLOONS, COILS, OR A COMBINATION OF BOTH. RECENTLY, FLOW-BLOCKING VASCULAR PLUGS WERE ALSO PLACED (UNO, NEUROVASCULAR EMBOLIZATION SYSTEM, REVERSE MEDICAL) BELOW THE PETROUS ICA AFTER COILING THE DISEASED SEGMENT. THE ARTICLE DOES NOT STATE ANY TECHNICAL ISSUES DURING USE OF THE HYPERGLIDE BALLOON. THE FOLLOWING INTRA- OR POST-PROCEDURAL OUTCOMES WERE NOTED: ONE PROCEDURE (1/41, 2%) WAS ABORTED DUE TO THROMBOSIS OF THE DONOR VESSEL, POSSIBLY RELATED TO VESSEL INJURY DURING PREPARATION. -BTO WAS PERFORMED IN A MEDIAN OF 2DAYS (RANGE: 1¿57 DAYS) AFTER BYPASS IN 36 PATIENTS (36/40, 90%). OF THESE, BTO WAS WELL TOLERATED BY 89% OF PATIENTS (32/36) AND WAS FOLLOWED BY PERMANENT ICA OCCLUSION. FOUR PATIENTS (4/36, 11%) DEVELOPED NEUROLOGICAL SYMPTOMS AND BTO WAS IMMEDIATELY ABORTED IN THE FIRST ATTEMPT. IN TWO OF THEM, THE ICA WAS SUCCESSFULLY OCCLUDED AFTER NEGATIVE BTO AT A SECOND ATTEMPT, 24HOURS AND 21 DAYS LATER. -PAO WITHOUT BTO WAS SUCCESSFULLY PERFORMED UNDER GENERAL ANESTHESIA IN THE REMAINING FOUR PATIENTS WITH LUXURIANT BYPASS FLOW (4/40, 10%). IN THREE OF THEM, OCCLUSION WAS ACHIEVED BY ENDOVASCULAR MEANS, AND IN ONE, SURGICALLY (HUNTERIAN CLIP LIGATION, 1/40, 2%), DUE TO DIFFICULT VASCULAR ACCESS. PAO WAS PERFORMED BY EVT IN ALL OTHER CASES (37/40, 92%). HENCE, A COMBINED TREATMENT WAS EXECUTED, AS PLANNED, IN 38 PATIENTS (38/40, 95%). IN THE REMAINING TWO PATIENTS, SUCCESSFUL EVT WITH A STENT/COIL CONSTRUCT WAS USED AFTER POOR BYPASS FILLING IN ONE AND AFTER SPEECH ARREST DURING BTO IN ANOTHER. PATENCY WAS CONFIRMED IN 92% OF PATIENTS (36/39) OR 93% OF ALL ANASTOMOSES (66/71) -COMPLETE OCCLUSION (RAYMOND I) WAS DOCUMENTED IN 95% OF PATIENTS (35/37) AT THE LAST FOLLOW-UP. RESIDUAL FILLING WAS EVIDENT ON CON TROL-ANGIOGRAPHY IN TWO PATIENTS ONLY (2/37, 5%). IN ONE PATIENT (1/37, 3%) A RECANALIZED ICA WAS DIAGNOSED 2 MONTHS AFTER PAO. RETREATMENT BY SURGICAL ICA LIGATION LED TO TOTAL ANEURYSM OBLITERATION. -AT LAST FOLLOW-UP, 97% OF PATIENTS (36/37) PRESENTED WITH EXCELLENT OR GOOD CLINICAL OUTCOMES (MEDIAN MRS: 0, RANGE: 0¿2). IN ONE PATIENT, POOR OUTCOME WAS ATTRIBUTED TO WATERSHED INFARCTION AND POSTOPERATIVE HEMIPARESIS FURTHER COMPLICATED BY SEVERE CARDIAC DISEASE -IN FOUR PATIENTS SYMPTOMS REMAINED UNCHANGED. -1 PATIENT EXPERIENCED PERIPROCEDURAL HYGROMA AND HAD REVISION SURGERY -THERE WERE 4 ISCHEMIC EVENTS; 1 PERMANENT STROKE, 2 TRANSIENT NEUROLOGICAL DEFICITS (TIA), AND AN ASYMPTOMATIC INFARCTION -2 PATIENTS HAD PULMONARY EMBOLISM AND DEEP-VEIN THROMBOSIS -DELAYED COMPLICATIONS INCLUDED ISCHEMIC EVENTS OF 1 DELAYED COIL PERMEATION, ICA REPERMEATION, TIA REQUIRING REVISION, AND 2 CASES OF WOUND NECROSIS.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT NO MEDTRONIC PRODUCTS WERE USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1704251 HYPERGLIDE CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY MJN MICRO THERAPEUTICS, INC. DBA EV3 UNK-NV-HYPERGLIDE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Female Required Intervention