BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENUMBRA COIL 400

    MDR report key: 5333824 · Received December 29, 2015

    Report

    Report Number
    3005168196-2015-01356
    Event Type
    Injury
    Date Received
    December 29, 2015
    Date of Event
    September 3, 2015
    Report Date
    December 2, 2015
    Manufacturer
    PENUMBRA, INC.
    Product Code
    HCG
    UDI-DI
    00814548011783
    PMA / PMN Number
    K120330
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR EVALUATION. WITHOUT THE RETURN OF THE DEVICE, THE ROOT CAUSE OF THE PROBLEM CANNOT BE DETERMINED. THE MANUFACTURING RECORDS FOR THIS LOT WERE REVIEWED AND DID NOT REVEAL ANY OUTSTANDING DISCREPANCIES, DESIGN, OR QUALITY CONCERNS. REFERENCES: AGNOLI AL. VASCULAR ANOMALIES AND SUBARACHNOID HAEMORRHAGE ASSOCIATED WITH PERSISTING EMBRYONIC VESSELS. ACTA NEUROCHIR (WIEN) 1982; 60: 183-199. LIE TA. CONGENITAL ANOMALIES OF THE CAROTID ARTERIES. AMSTERDAM, EXCERPTA MED FOUNDATION, 1968, 76-83. BOHMFALK GL, STORY JL. ANEURYSMS OF THE PERSISTENT HYPOGLOSSAL ARTERY. NEUROSURGERY 1977; 1: 291-296. WAGA S, MOROOKA Y, KOJIMA T. ANEURYSM ON A PERSISTENT HYPOGLOSSAL ARTERY. ACTA NEUROCHIR (WIEN) 1981; 59: 71-78. KOBAYASHI H, MUNEMOTO S, HAYASHI M, ET AL. ASSOCIATION OF PERSISTENT HYPOGLOSSAL ARTERY, MULTIPLE INTRACRANIAL ANEURYSMS, AND POLYCYSTIC DISEASE. SURG NEUROL 1984; 21: 258-260. MURAYAMA Y, FUJIMOTO N, MATSUMOTO K. BILATERAL PERSISTENT PRIMITIVE HYPOGLOSSAL ARTERIES ASSOCIATED WITH A LARGE RUPTURED ANEURYSM ON ONE SIDE. SURG NEUROL 1985; 24: 498-502. PERSISTENT PRIMITIVE HYPOGLOSSAL ARTERY 1 NO SHINKEI GEKA 1988; 16: 421-426. DUFFILL J, LANG DA, DWYER GN. SUBARACHNOID HAEMORRHAGE IN A CHILD FROM AN ANEURYSM OF A PERSISTENT PRIMITIVE HYPOGLOSSAL ARTERY. BR J NEUROSURG 1996; 10: 607-610. PERSISTENT PRIMITIVE HYPOGLOSSAL ARTERY 2001; 10: 481-486. TEO M, BHATTACHARYA J, SUTTNER N. PERSISTENT HYPOGLOSSAL ARTERY-AN INCREASED RISK FOR INTRACRANIAL ANEURYSMS? BR J NEUROSURG 2012; 26: 891-892. KANEMATSU M, SATOH K, NAKAJIMA N, ET AL. RUPTURED ANEURYSM ARISING FROM A BASILAR ARTERY FENESTRATION AND ASSOCIATED WITH A PERSISTENT PRIMITIVE HYPOGLOSSAL ARTERY. CASE REPORT AND REVIEW OF THE LITERATURE. J NEUROSURG 2004; 101: 532-535. BALTSAVIAS GM, CHOURMOUZI D, TASIANAS N, ET AL. RUPTURED ANEURYSM OF A PERSISTENT PRIMITIVE HYPOGLOSSAL ARTERY TREATED BY ENDOVASCULAR APPROACH-CASE REPORT AND LITERATURE REVIEW. SURG NEUROL 2007; 68: 338-343, DISCUSSION 343. BAPURAJ JR, OJILI V, KHANDELWAL N, ET AL. BASILAR ARTERY ANEURYSM TREATED WITH COIL EMBOLIZATION VIA PERSISTENT PRIMITIVE HYPOGLOSSAL ARTERY. AUSTRALAS RADIOL 2007; 51: 340-343. BALDI S, ZANDER T, RABELLINO M, ET AL. STENT-ASSISTED COIL EMBOLIZATION OF A WIDE-NECK ANEURYSM OF A PERSISTENT PRIMITIVE HYPOGLOSSAL ARTERY. CARDIOVASC INTERVENT RADIOL 2009; 32: 352-355. JNET 2009; 3: 187-191. PERSISTENT PRIMITIVE HYPOGLOSSAL ARTERY JNET 2012; 6: 127-132. DE CARO R, PARENTI A, MUNARI PF. THE PERSISTENT PRIMITIVE HYPOGLOSSAL ARTERY: A RARE ANATOMIC VARIATION WITH FREQUENT CLINICAL IMPLICATIONS. ANN ANAT 1995; 177: 193-198. THE DEVICE WAS IMPLANTED IN THE PATIENT.

    Description of Event or Problem · 1

    THE FOLLOWING IS BASED ON A LITERATURE REVIEW OF AN ARTICLE ENTITLED: A CASE OF MULTIPLE UNRUPTURED CEREBRAL ANEURYSM ASSOCIATED WITH PERSISTENT PRIMITIVE HYPOGLOSSAL ARTERY, WHICH WAS PUBLISHED IN THE JOURNAL OF NEUROENDOVASCULAR THERAPY ON SEPTEMBER 03, 2015: ON (B)(6) 2012, THE PATIENT WAS UNDERGOING A BALLOON-ASSISTED COIL EMBOLIZATION IN THE RIGHT INTERNAL CAROTID ARTERY (ICA) USING PENUMBRA COIL 400 COILS (PC400 COILS). DURING THE PROCEDURE, THE PHYSICIAN PLACED ANOTHER MANUFACTURER'S BALLOON CATHETER IN THE NECK OF THE ANEURYSM AND THEN DELIVERED TWENTY-SEVEN PC400 COILS INTO THE ANEURYSM USING A PX SLIM DELIVERY MICROCATHETER (PX SLIM). AN ANGIOGRAPHY WAS PERFORMED, WHICH REVEALED THAT PART OF THE TWENTY-SEVENTH PC400 COIL WAS FLOATING AND PROTRUDING OUT FROM THE ANEURYSM INTO THE RIGHT ICA. THE PHYSICIAN ADVANCED ANOTHER MANUFACTURER'S MICROCATHETER INTO THE RIGHT MIDDLE CEREBRAL ARTERY AND THEN PLACED A STENT IN ORDER TO PRESS THE FLOATING PC400 COIL ONTO THE TARGET BLOOD VESSEL SO THAT THE STENT CAN COVER THE NECK OF THE ANEURYSM. THE FINAL ANGIOGRAPHY REVEALED NO ABNORMALITIES IN THE CEREBRAL ARTERIES AND THE PATIENT WAS DISCHARGED ONE WEEK AFTER THE PROCEDURE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    856075 PENUMBRA COIL 400 HCG, KRD HCG PENUMBRA, INC. F30181 00814548011783

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention