BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN PILLCAM PATENCY CAPSULE

    MDR report key: 19495329 · Received June 9, 2024

    Report

    Report Number
    9710107-2024-00087
    Event Type
    Injury
    Date Received
    June 9, 2024
    Report Date
    June 9, 2024
    Manufacturer
    GIVEN IMAGING LTD., YOQNEAM
    Product Code
    NEZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    PLEASE CITE THIS ARTICLE AS: BLANCO-VELASCO G, RAMOS-GARCÍA J, SOLÓRZANO-PINEDA OM, MARTÍNEZ-CAMACHO C, MURCIO-PÉREZ E, HERNÁNDEZMON DRAGÓN OV. SEGURIDAD Y EFICACIA DE LA CÁPSULA PATENCY. REV GASTROENTEROL MÉX. 2023;88:132---135. * CORRESPONDING AUTHOR AT: AV. CUAUHTÉMOC 330, COLONIA DOCTORES, ALCALDÍA CUAUHTÉMOC, C.P. 06720 MEXICO CITY, MEXICO. TEL.: +52 5556276900; EXTENSION 21317 AND 21318. E-MAIL ADDRESS: [email protected] (G. BLANCO-VELASCO). 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

    ACCORDING TO THE LITERATURE, A RETROSPECTIVE OBSERVATIONAL STUDY WAS CONDUCTED THAT INCLUDED ALL THE PATIENTS WITH CONFIRMED CROHN¿S DISEASE THAT WERE ADMINISTERED A PATENCY CAPSULE, WITHIN THE TIME FRAME OF JANUARY 2019 AND DECEMBER 2020. ALL THE PATIENTS FASTED FOR 8 H PRIOR TO CAPSULE INGESTION. NO PREPARATION WITH LAXATIVES OR PROKINETICS WAS CARRIED OUT. THE PATIENTS WERE GIVEN AN APPOINTMENT 30 H POST-CAPSULE INGESTION. IF THE CAPSULE WAS EXPELLED IN A BOWEL MOVEMENT DURING THE 30 H PERIOD, IT HAD TO BE COLLECTED OR PHOTOGRAPHED, TO EVALUATE ITS PHYSICAL INTEGRITY. IF THAT WAS NOT POSSIBLE, A PLAIN ABDOMINAL X-RAY IN TWO POSITIONS WAS TAKEN, TO VERIFY THE LOCATION OF THE CAPSULE IN THE GASTROINTESTINAL TRACT. THE DIAGNOSTIC YIELD, SENSITIVITY, SPECIFICITY, POSITIVE PREDICTIVE VALUE, AND NEGATIVE PREDICTIVE VALUE WERE EVALUATED, IN RELATION TO CAPSULE ENDOSCOPY AND DOUBLE-BALLOON ENDOSCOPY FINDINGS. COMPLICATIONS ASSOCIATED WITH THE PATENCY CAPSULE WERE ALSO IDENTIFIED THIRTY PATIENTS WERE INCLUDED, IN WHOM THE PATENCY CAPSULE HAD 83% SENSITIVITY, 100% SPECIFICITY, 100% POSITIVE PREDICTIVE VALUE, AND 96% NEGATIVE PREDICTIVE VALUE, WITH A DIAGNOSTIC YIELD OF 96.7%.THERE WAS ONE COMPLICATION (3.3%) AND IT RESOLVED SPONTANEOUSLY. THE CAPSULE IDENTIFIED PREDICTIVE DATA OF SMALL BOWEL STRICTURE IN 5 PATIENTS. IN 3 OF THOSE CASES, A PLAIN ABDOMINAL X-RAY SHOWED CAPSULE RETENTION IN THE SMALL BOWEL, 30 HOURS POST-INGESTION, AND IN ONE CASE, A DEFORMED CAPSULE WAS EXPELLED IN A BOWEL MOVEMENT, WITHIN THE FIRST 30 HOURS. IN THE REMAINING CASE, THE PATIENT WENT TO THE EMERGENCY SERVICE 6 HOURS POST-INGESTION, WITH SIGNS OF BOWEL OBSTRUCTION THAT WERE THEN CONFIRMED THROUGH A PLAIN ABDOMINALX-RAY. TWELVE HOURS AFTER SYMPTOM ONSET, THE PATIENT EXPELLED A DEFORMED CAPSULE IN A BOWEL MOVEMENT, SPONTANEOUSLY RESOLVING THE SITUATION. THE STRICTURE THAT CAUSED THE RETENTION WAS IN THE JEJUNUM AND THE VIDEO CAPSULE WAS EXPELLED IN A BOWEL MOVEMENT 27 DAYS POST-INGESTION. THE PATIENT WAS ASYMPTOMATIC DURING THE TIME THE CAPSULE WAS RETAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2123794 UNKNOWN PILLCAM PATENCY CAPSULE SYSTEM, IMAGING, GASTROINTESTINAL, WIRELESS, C NEZ GIVEN IMAGING LTD., YOQNEAM UNKNOWN PILLCAM PATENCY CAPSULE

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Female Other