BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENUMBRA SMART COIL

    MDR report key: 6732435 · Received July 21, 2017

    Report

    Report Number
    3005168196-2017-01275
    Event Type
    Injury
    Date Received
    July 21, 2017
    Date of Event
    March 31, 2017
    Report Date
    July 1, 2017
    Manufacturer
    PENUMBRA, INC.
    Product Code
    HCG
    PMA / PMN Number
    K160832
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    PLEASE NOTE THAT THE FOLLOWING SECTIONS WERE INCORRECTLY REPORTED ON THE INITIAL MFR REPORT AND IS BEING CORRECTED ON THIS FOLLOW-UP #02 MFR REPORT 3005168196-2017-01275: 1.SECTION B. BOX 1. ADVERSE EVENT AND/OR PRODUCT PROBLEM. 2.SECTION B. BOX 5. DESCRIBE EVENT OR PROBLEM. 3.SECTION H. BOX 6. PATIENT CODE 1 UPDATED FROM 2199 TO 2135. 4.SECTION H. BOX 6. CONCLUSION CODE 1 UPDATED FROM 67 TO 22. 5.SECTION H. BOX 6. CONCLUSION CODE 2 UPDATED FROM 95 TO 4315. THE PRODUCT WAS NOT RETURNED FOR EVALUATION. WITHOUT THE RETURN OF THE DEVICE, THE ROOT CAUSE OF THE PROBLEM CANNOT BE DETERMINED. POTENTIAL ADVERSE EVENTS IN THE LABELING WITH THE PENUMBRA SMART COIL SYSTEM INCLUDE, BUT ARE NOT LIMITED TO DISSECTION, OR PERFORATION, COIL HERNIATION INTO PARENT VESSEL, THROMBOSIS, DISTAL EMBOLIZATION, EMBOLI, EMBOLIC STROKE AND OTHER CEREBRAL ISCHEMIC EVENTS, VESSEL SPASM, INCLUDING DEATH. THEREFORE, IT WAS DETERMINED THAT THE REPORTED ADVERSE EVENT WAS AN ANTICIPATED COMPLICATION. THE MANUFACTURING RECORDS FOR THIS LOT WERE REVIEWED AND DID NOT REVEAL ANY OUTSTANDING DISCREPANCIES, DESIGN, OR QUALITY CONCERNS.

    Description of Event or Problem · 0

    THE PATIENT UNDERWENT A COIL EMBOLIZATION PROCEDURE IN THE RIGHT ANTERIOR COMMUNICATING ARTERY (ACOM) USING PENUMBRA SMART COILS (SMART COILS). IT WAS REPORTED THAT SMALL AMOUNT OF COIL HERNIATION WAS NOTED THROUGH THE ANEURYSM''S DOME SUGGESTING THAT THERE WAS AN INTRACRANIAL PERFORATION OF THE ANEURYSM. HOWEVER THERE ARE NO CLINICAL SIGNS OF PERFORATION AND THE CONTROL ANGIOGRAPHY DEMONSTRATED NO EXTRAVASATION OF CONTRAST. THE VESSEL PERFORATION WAS REPORTED TO BE AN ADVERSE EVENT RELATED TO THE SMART COIL.

    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 PRODUCT LOT NUMBER WAS NOT PROVIDED, THEREFORE, THE MANUFACTURING RECORDS COULD NOT BE REVIEWED. THE DEVICE IS IMPLANTED IN THE PATIENT.

    Additional Manufacturer Narrative · 1

    PLEASE NOTE THAT ADDITIONAL INFORMATION WAS PROVIDED ON 27-MAR-2018 AND THEREFORE, THE FOLLOWING SECTIONS ARE BEING UPDATED: THE MANUFACTURING RECORDS FOR THIS LOT WERE REVIEWED AND DID NOT REVEAL ANY OUTSTANDING DISCREPANCIES, DESIGN, OR QUALITY CONCERNS.

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT A COIL EMBOLIZATION PROCEDURE IN THE RIGHT ANTERIOR COMMUNICATING ARTERY (ACOM) USING PENUMBRA SMART COILS (SMART COILS). IT WAS REPORTED THAT SMALL AMOUNT OF COIL HERNIATION WAS NOTED THROUGH THE ANEURYSM'S DOME SUGGESTING THAT THERE WAS AN INTRACRANIAL PERFORATION OF THE ANEURYSM. HOWEVER THERE ARE NO CLINICAL SIGNS OF PERFORATION AND THE CONTROL ANGIOGRAPHY DEMONSTRATED NO EXTRAVASATION OF CONTRAST. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    512394 PENUMBRA SMART COIL HCG, KRD HCG PENUMBRA, INC. F72191

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Other