BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIPELINE VANTAGE WITH SHIELD TECHNOLOGY

    MDR report key: 21332917 · Received February 7, 2025

    Report

    Report Number
    2029214-2025-00333
    Event Type
    Malfunction
    Date Received
    February 7, 2025
    Date of Event
    November 20, 2021
    Report Date
    February 7, 2025
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    OUT
    Removal / Correction Number
    2029214-01-31-2025-001-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DOMINIK F VOLLHERBST, H SARUHAN CEKIRGE, ISIL SAATCI, FEYYAZ BALTACIOGLU, BARAN ONAL, OSMAN KOC, RIITTA RAUTIO, MATIAS SINISALO, ALE JANDRO TOMASELLO, PEDRO VEGA, MARIO MARTÍNEZ-GALDÁMEZ, JEREMY LYNCH; JOURNAL OF NEUROINTERVENT SURGERY; 2022; 0:1¿7; FIRST CLINICAL MULTICENTER EXPERIENCE WITH THE NEW PIPELINE VANTAGE FLOW DIVERTER; DOI:10.1136/NEURINTSURG-2021-018480 A.2. THIS VALUE IS THE AVERAGE 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. B.3. PLEASE NOTE THAT THIS DATE IS BASED OFF OF THE RECEIVED DATE OF THE ARTICLE AS THE EVENT DATES WERE NOT PROVIDED IN THE PUBLISHED LITERATURE 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.

    Description of Event or Problem · 0

    DOMINIK F VOLLHERBST, H SARUHAN CEKIRGE, ISIL SAATCI, FEYYAZ BALTACIOGLU, BARAN ONAL, OSMAN KOC, RIITTA RAUTIO, MATIAS SINISALO, ALE JANDRO TOMASELLO, PEDRO VEGA, MARIO MARTÍNEZ-GALDÁMEZ, JEREMY LYNCH; JOURNAL OF NEUROINTERVENT SURGERY; 2022; 0:1¿7; FIRST CLINICAL MULTICENTER EXPERIENCE WITH THE NEW PIPELINE VANTAGE FLOW DIVERTER; DOI:10.1136/NEURINTSURG-2021-018480 MEDTRONIC RECEIVED INFORMATION IN A LITERATURE ARTICLE THAT PATIENT'S TREATED WITH A PED3 PIPELINE HAD COMPLICATIONS. THE AIM OF THIS MULTICENTER STUDY WAS TO ASSESS THE PERIPROCEDURAL SAFETY AND FEASIBILITY, AS WELL AS THE SHORT-TERM EFFICACY, OF THE NEW PIPELINE VANTAGE (PV) FLOW DIVERTER (FD) FOR THE TREATMENT OF INTRACRANIAL ANEURYSMS. PATIENTS WITH INTRACRANIAL ANEURYSMS, WHO WERE TREATED WITH THE PV BETWEEN JANUARY 2020 AND JUNE 2020, WERE SYSTEMATICALLY REVIEWED. SIXTY PATIENTS WITH 70 ANEURYSMS WERE INCLUDED IN THIS STUDY. THE MEAN AGE OF THE PATIENTS WAS 53.9 YEARS. FORTY-ONE PATIENTS WERE FEMALE. THE PRE-, PERI- AND POST-PROCEDURAL ANTIPLATELET THERAPY, AS WELL AS THE TESTING OF THROMBOCYTE AGGREGATION RESPONSE, WERE PERFORMED ACCORDING TO THE RESPECTIVE INSTITUTIONAL STANDARDS. THE RECOMMENDED DELIVERY SYSTEMS ARE THE PHENOM 21 AND THE PHENOM 27 MICROCATHETER. RECAPTURING OR REPOSITIONING OF THE PV, BECAUSE OF SUBOPTIMAL POSITIONING OF THE INITIALLY IMPLANTED DEVICE, WAS PERFORMED IN 27.9% OF THE TREATMENTS. ADDITIONAL COILING WAS PERFORMED IN 18.6% FOR THE FOLLOWING REASONS: LARGE SIZE (46.2%), OPERATOR¿S CHOICE (30.8%), ACUTE PRE-INTERVENTIONAL ANEURYSMAL HEMORRHAGE (7.7%), AND IRREGULAR SHAPE (7.7%). IN-STENT BALLOON ANGIOPLASTY WAS PERFORMED TO ENHANCE THE VESSEL WALL APPOSITION IN 24.6%. THE EASE OF DEPLOYMENT WAS RATED ¿GOOD¿ OR ¿VERY GOOD¿ IN 88.5% OF THE CASES, WHILE IN 6.6% IT WAS RATED ¿INTERMEDIATE¿ , AND ¿POOR¿ IN ONLY 4.9%. VESSEL WALL APPOSITION WAS RATED ¿VERY GOOD¿ OR ¿GOOD¿ IN 95.1% AND ¿INTERMEDIATE¿ IN 4.9%, WHILE IT WAS NOT RATED ¿POOR¿ OR ¿VERY POOR¿ IN ANY CASE. PROCEDURAL TECHNICAL COMPLICATIONS OCCURRED IN 15 OUT OF 61 TREATMENTS (24.6%). THE MOST FREQUENT TECHNICAL COMPLICATION (12/15; 19.7% OF ALL TREATMENTS) WAS HANG-UP OF THE FD ON THE PUSHER WIRE AT THE PROXIMAL PART OF THE INTERFACE BETWEEN THE FD AND THE PUSHER WIRE, SO THAT THE FD COULD NOT BE RELEASED AS INTENDED. IN ALL OF THESE CASES, THE FD COULD BE FINALLY RELEASED BY APPLYING REPETITIVE GENTLE PUSH AND/OR PULL ON THE PUSHER WIRE. IN FOUR CASES, THE HANG-UP WAS SEVERE, SO THAT SEVERAL ATTEMPTS AND MORE FORCE WERE NECESSARY TO RELEASE THE FD. IN ONE OF THESE CASES, DURING THE TREATMENT OF AN 11 MM SIDEWALL ANEURYSM OF THE INTERNAL CAROTID ARTERY (ICA), THIS MANIPULATION LED TO A PULL BACK OF THE PV AT THE LEVEL OF THE NECK OF THE ANEURYSM, SO THAT A SECOND PV OF THE SAME SIZE HAD TO BE PLACED. IN ANOTHER TREATMENT, WITHOUT HANG-UP OF THE FD, THERE WAS INSUFFICIENT VESSEL WALL APPOSITION AT THE PROXIMAL PART OF THE PV AND A NEUROFORM ATLAS STENT WAS ADDITIONALLY IMPLANTED TO IMPROVE THE APPOSITION. THE OTHER TECHNICAL COMPLICATIONS WERE DISPLACEMENT OF THE FD WHEN NAVIGATING THE MICROCATHETER THROUGH IT, AND A HIGH RESISTANCE WHEN PUSHING THE FD THROUGH THE MICROCATHETER WHICH LED TO BREAKING OF THE PROXIMAL PART OF THE MICROCATHETER. ALL OF THESE TECHNICAL COMPLICATIONS WERE SUCCESSFULLY MANAGED AND DID NOT CAUSE ANY CLINICAL CONSEQUENCES. NO P ERIPROCEDURAL THROMBOTIC COMPLICATIONS OCCURRED. A NON-DEVICE RELATED PROCEDURAL SYMPTOMATIC COMPLICATION, AN ANAPHYLACTIC ALLERGIC REACTION, OCCURRED IN ONE TREATMENT (1.6%) AND WAS SUCCESSFULLY OVERCOME WITH MEDICAL TREATMENT. POST-PROCEDURAL SYMPTOMATIC COMPLICATIONS OCCURRED AFTER FOUR TREATMENTS (6.6%), OF WHICH ONLY ONE WAS DIRECTLY RELATED TO THE IMPLANTED FD. ONE PATIENT DEVELOPED SMALL BRAIN STEM AND MIDBRAIN INFARCTIONS, MOST LIKELY DUE TO THE OCCLUSION OF PERFORATOR ARTERIES, AFTER THE IMPLANTATION OF FIVE PVS INTO THE BASILAR AND POSTERIOR CEREBRAL ARTERY FOR THE TREATMENT OF A MULTISEGMENTAL ANEURYSMAL DISEASE, LEADING TO A STROKE (NATIONAL INSTITUTES OF HEALTH STROKE SCALE (NIHSS) 5). THE TWO OTHER COMPLICATIONS WERE A PUNCTURE SITE BLEEDING WHICH NEEDED SURGICAL INTERVENTION AND A URINARY TRACT INFECTION DURING THE HOSPITAL STAY WHICH RESOLVED AFTER ADMINISTRATION OF ANTIBIOTICS. DETERIORATION OF MRS (COMPARED WITH THE PRE-INTERVENTIONAL SCALE) WAS OBSERVED IN TWO PATIENTS. IN-STENT STENOSIS OR OCCLUSION WAS OBSERVED AFTER 13 TREATMENTS (21.3%) AND WAS GRADED AS ¿MILD¿ IN 12/13 CASES (92.3%). IN ONE CASE (1.6%), A COMPLETE, ASYMPTOMATIC OCCLUSION OF A PV IMPLANTED INTO THE MCA FOR THE TREATMENT OF A FUSIFORM MCA BIFURCATION ANEURYSM, WHICH WAS COMPLETELY OCCLUDED IN THE FOLLOW-UP IMAGING, WAS OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1248293 PIPELINE VANTAGE WITH SHIELD TECHNOLOGY INTRACRANIAL ANEURYSM FLOW DIVERTER OUT MICRO THERAPEUTICS, INC. DBA EV3 UNK-NV-PED3 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Female