BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STENT, CORONARY

    MDR report key: 14644023 · Received June 9, 2022

    Report

    Report Number
    1820334-2022-01025
    Event Type
    Injury
    Date Received
    June 9, 2022
    Report Date
    October 12, 2022
    Manufacturer
    COOK INC
    Product Code
    MAF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT WAS AN UNSPECIFIED COOK GIANTURCO STENT. THE ARTICLES REFERENCED IN THE LITERATURE REVIEW INVOLVE STUDIES PUBLISHED PRIOR TO 2017; THEREFORE, IT IS ASSUMED THAT THE DEVICE(S) WILL NOT BE RETURNED. COMMON NAME & PRODUCT CODE = UNAVAILABLE AS THE DEVICE LOT NUMBER, RPN, AND GPN ARE UNKNOWN. PMA/510(K) NUMBER = UNAVAILABLE AS THE DEVICE LOT NUMBER, RPN, AND GPN ARE UNKNOWN. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803 AND IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT CONTAINED HEREIN IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED, THAT A DEATH OR SERIOUS INJURY OCCURRED, NOR THAT ANY COOK DEVICE CAUSED, CONTRIBUTED TO, OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNCHANGED, OR UNAVAILABLE. SUMMARY OF EVENT: AS REPORTED IN THE LITERATURE BY LEON ET AL. (2022), A LITERATURE REVIEW OF RETROSPECTIVE STUDIES INVOLVING PERCUTANEOUS STENT PLACEMENT FOR THE PALLIATIVE TREATMENT OF MALIGNANT SUPERIOR VENA CAVA SYNDROME WAS CONDUCTED. THE PEER-REVIEWED ARTICLES WERE PUBLISHED BETWEEN 1991 AND 2017. ACUTE STENT THROMBOSIS WAS NOTED IN FOUR PATIENTS WHO RECEIVED THE UNKNOWN GIANTURCO STENT. NO ADVERSE EFFECTS WERE NOTED. NO INTERVENTIONS WERE DISCUSSED. THE LITERATURE REVIEW MENTIONS ONE DEATH (CARDIAC ARREST FROM A LARGE HEMOPTYSIS) THAT OCCURRED DURING A STUDY IN WHICH MULTIPLE STENTS, ONE OF WHICH WAS AN UNSPECIFIED GIANTURCO, WERE USED (REPORTED UNDER PATIENT IDENTIFIER 365782) . THE LITERATURE REVIEW NOTES STENT MIGRATION OF THE GIANTURCO STENT, REPORTED UNDER PATIENT IDENTIFIER 365783. REFERENCE FOR LITERATURE ARTICLE: LEON ET AL., 2022. LITERATURE REVIEW OF PERCUTANEOUS STENTING FOR PALLIATIVE TREATMENT OF MALIGNANT SUPERIOR VENA CAVA SYNDROME (SVCS). ACADEMIC RADIOLOGY, 29(4), S110-120. HTTPS://DOI.ORG/10.1016/J.ACRA.2021.08.016 INVESTIGATION EVALUATION: REVIEWS OF THE INSTRUCTIONS FOR USE (IFU) AND QUALITY CONTROL PROCEDURES WERE CONDUCTED DURING THE INVESTIGATION. THE COOK DEVICE WAS NOT RETURNED FOR INVESTIGATION. A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. A DEVICE MASTER RECORD (DMR) REVIEW WAS PERFORMED, AND DEVICE QUALITY CONTROL PROCEDURES ASSOCIATED WITH THE COMPLAINT WERE IDENTIFIED. COOK HAS CONCLUDED THAT SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO IDENTIFY FAILURE MODES PRIOR TO DISTRIBUTION. THE LOT NUMBER AND RPN ARE UNKNOWN; THEREFORE, COOK WAS NOT ABLE TO PERFORM A DEVICE HISTORY RECORD REVIEW. COOK REVIEWED THE INSTRUCTIONS FOR USE (IFU) FOR THE POSSIBLE DEVICES. ALL IFUS INDICATE THAT THE DEVICES ARE NOT INTENDED FOR INTRAVASCULAR USE. THE INFORMATION PROVIDED UPON REVIEW OF THE JOURNAL ARTICLE, DMR, AND POSSIBLE IFUS SUGGESTS THAT THERE IS EVIDENCE THE DEVICE WAS MANUFACTURED TO SPECIFICATION. THERE IS NO EVIDENCE OF NON-CONFORMING DEVICES IN-HOUSE OR IN THE FIELD. BASED ON THE INFORMATION PROVIDED AND THE RESULTS OF THE INVESTIGATION, COOK HAS CONCLUDED THE PATIENTS¿ CONDITION CONTRIBUTED TO THIS EVENT. THROMBUS FORMATION IS COMMONLY ASSOCIATED WITH SUPERIOR VENA CAVA SYNDROME. THE STENT WAS USED IN THE VASCULAR SYSTEM, WHICH IS OFF-LABEL USE FOR THIS DEVICE. THE RISK ANALYSIS FOR THIS FAILURE MODE WAS REVIEWED AND NO ADDITIONAL ESCALATION WAS REQUIRED. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED AND COOK WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803 AND IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT CONTAINED HEREIN IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED, THAT A DEATH OR SERIOUS INJURY OCCURRED, NOR THAT ANY COOK DEVICE CAUSED, CONTRIBUTED TO, OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

    Description of Event or Problem · 0

    AS REPORTED IN THE LITERATURE BY LEON ET AL. (2022), A LITERATURE REVIEW OF RETROSPECTIVE STUDIES INVOLVING PERCUTANEOUS STENT PLACEMENT FOR THE PALLIATIVE TREATMENT OF MALIGNANT SUPERIOR VENA CAVA SYNDROME WAS CONDUCTED. THE PEER-REVIEWED ARTICLES WERE PUBLISHED BETWEEN 1991 AND 2017. ACUTE STENT THROMBOSIS WAS NOTED IN FOUR PATIENTS WHO RECEIVED THE UNKNOWN GIANTURCO STENT. NO ADVERSE EFFECTS WERE NOTED. NO INTERVENTIONS WERE DISCUSSED. THE LITERATURE REVIEW MENTIONS ONE DEATH (CARDIAC ARREST FROM A LARGE HEMOPTYSIS) THAT OCCURRED DURING A STUDY IN WHICH MULTIPLE STENTS, ONE OF WHICH WAS AN UNSPECIFIED GIANTURCO, WERE USED (REPORTED UNDER PATIENT IDENTIFIER (B)(6)) . THE LITERATURE REVIEW NOTES STENT MIGRATION OF THE GIANTURCO STENT, REPORTED UNDER PATIENT IDENTIFIER (B)(6). REFERENCE FOR LITERATURE ARTICLE: LEON ET AL., 2022. LITERATURE REVIEW OF PERCUTANEOUS STENTING FOR PALLIATIVE TREATMENT OF MALIGNANT SUPERIOR VENA CAVA SYNDROME (SVCS). ACADEMIC RADIOLOGY, 29(4), S110-120. HTTPS://DOI.ORG/10.1016/J.ACRA.2021.08.016.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION HAS BEEN RECEIVED SINCE THE LAST REPORT WAS SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2195575 STENT, CORONARY MAF COOK INC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Life Threatening| O