BEUDAMED
    FDA Adverse Event Death Summary report: N

    SAVARY-GILLIARD DILATOR SET

    MDR report key: 9221503 · Received October 22, 2019

    Report

    Report Number
    1037905-2019-00637
    Event Type
    Death
    Date Received
    October 22, 2019
    Date of Event
    September 26, 2007
    Report Date
    September 11, 2019
    Manufacturer
    COOK ENDOSCOPY
    Product Code
    KNQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    USAGE OF DEVICE IS UNKNOWN. PIOTET, E., ESCHER, A., & MONNIER, P. (2007). ESOPHAGEAL AND PHARYNGEAL STRICTURES: REPORT ON 1,862 ENDOSCOPIC DILATATIONS USING THE SAVARY-GILLIARD TECHNIQUE. EUROPEAN ARCHIVES OF OTO-RHINO-LARYNGOLOGY, 265(3), 357¿364. DOI: 10.1007/S00405-007-0456-0. INVESTIGATION EVALUATION: A PRODUCT EVALUATION WAS NOT PERFORMED IN RESPONSE TO THIS REPORT BECAUSE THE PRODUCT SAID TO BE INVOLVED WAS NOT PROVIDED TO COOK FOR EVALUATION. THE REPORT COULD NOT BE CONFIRMED. THE DEVICE HISTORY RECORD FOR THE LOT NUMBER SAID TO BE INVOLVED COULD NOT BE REVIEWED BECAUSE A LOT NUMBER WAS NOT PROVIDED. INVESTIGATION CONCLUSION: WE COULD NOT CONDUCT A COMPLETE INVESTIGATION BECAUSE THE PRODUCT SAID TO BE INVOLVED WAS NOT RETURNED FOR EVALUATION. A DEFINITIVE CAUSE FOR THE REPORTED OBSERVATION COULD NOT BE DETERMINED. THE INSTRUCTIONS FOR USE INCLUDE THE FOLLOWING POTENTIAL COMPLICATIONS "POTENTIAL COMPLICATIONS ASSOCIATED WITH UPPER GASTROINTESTINAL ENDOSCOPY AND ESOPHAGEAL DILATION INCLUDE, BUT ARE NOT LIMITED TO: PERFORATION, HEMORRHAGE, ASPIRATION, FEVER, INFECTION, ALLERGIC REACTION TO MEDICATION, HYPOTENSION, RESPIRATORY DEPRESSION, OR ARREST, CARDIAC ARRHYTHMIA OR ARREST. " PRIOR TO DISTRIBUTION, ALL SAVARY-GILLIARD DILATORS ARE SUBJECTED TO A VISUAL INSPECTION TO ENSURE DEVICE INTEGRITY. CORRECTIVE ACTION IS NOT WARRANTED AT THIS TIME BASED ON THE QUALITY ENGINEERING RISK ASSESSMENT. QUALITY ASSURANCE WILL CONTINUE TO MONITOR FOR COMPLAINT TRENDS AND REASSESS THE RISK ASSESSMENT RESULTS AS POST MARKET FEEDBACK CONTINUES TO BECOME AVAILABLE.

    Description of Event or Problem · 0

    COOK ENDOSCOPY WAS NOTIFIED OF EVENTS THAT OCCURRED WITH SEVEN (7) SAVARY-GILLIARD DILATOR SETS. PLEASE SEE BELOW FOR RELEVANT EXCERPTS OF THIS ARTICLE. "OUR DATABASE WAS REVIEWED TO ASSESS NUMBER AND ETIOLOGIES OF THE PHARYNGEAL AND ESOPHAGEAL STRICTURES NECESSITATING DILATATION IN OUR DEPARTMENT BETWEEN JANUARY 1, 1963 AND DECEMBER 31, 2005. DILATATIONS WITH THE SAVARY-GILLIARD DILATORS HAVE BEEN EXCLUSIVELY USED IN OUR CLINIC SINCE 1980, RATHER THAN USING THE MALONEY DILATORS OR THE EDER- PUESTOW OLIVES, EXCEPT FOR SOME CASES OF ACHALASIA THAT WERE MANAGED BY BALLOON DILATATION. THE SAVARY-GILLIARD SET INCLUDED A METALLIC GUIDE-WIRE AND POLYVINYL CHLORIDE BOUGIES, RANGING FROM 5 TO 18 MM IN DIAMETER. THE PROCEDURE HAS BEEN DESCRIBED IN DETAIL ELSEWHERE [26], AND WAS ALWAYS PERFORMED UNDER FLUOROSCOPY. . . SEVERE COMPLICATIONS INCLUDED ESOPHAGEAL PERFORATION IN 34 PATIENTS (1.83%), ALL BUT ONE PRESENTING WITH MALIGNANT STRICTURES, AND MASSIVE BLEEDING WAS DOCUMENTED IN TWO PATIENTS (0.11%). THE MORTALITY RATE WAS 0.38, 0.09% IN BENIGN AND 0.81% IN MALIGNANT STRICTURES, RESPECTIVELY, WITH DEATH OCCURRING IN SEVEN PATIENTS SECONDARY TO PERFORATION [SUBJECT OF THIS REPORT]. OUR OVERALL COMPLICATION RATE WAS 1.93, 0.18% FOR BENIGN AND 4.58% FOR MALIGNANT STRICTURES, RESPECTIVELY. . . .ESOPHAGEAL PERFORATION REPRESENTS THE PRIMARY SEVERE COMPLICATION OF DILATATION, WITH RAPID PROGRESSION TO SEPSIS,MEDIASTINITIS AND DEATH. RAPID DIAGNOSIS AND AGGRESSIVE TREATMENT ARE REQUIRED. . . ALL CASES OF DEATH SECONDARY TO DILATATION OCCURRED IN THE GROUP OF ESOPHAGEAL PERFORATIONS WITH A FATAL EVOLUTION IN SEVEN PATIENTS. THE OVERALL MORTALITY RATE WAS THUS 0.38, 0.09% FOR BENIGN AND 0.81% FOR MALIGNANT STRICTURES, RESPECTIVELY.¿ IT WAS NOT PUBLISHED IN THE ARTICLE IF A SECTION OF THE DEVICE REMAINED INSIDE THE PATIENTS' BODY. THE ARTICLE INDICATES IN CASES OF PERFORATION RAPID DIAGNOSIS AND AGGRESSIVE TREATMENT ARE REQUIRED FOR PERFORATIONS. THEREFORE, IT IS ASSUMED AN ADDITIONAL PROCEDURE WAS REQUIRED. THE SEVEN PATIENTS EXPIRED SECONDARY TO PERFORATIONS.

    Additional Manufacturer Narrative · 1

    USAGE OF DEVICE IS UNKNOWN. PIOTET, E., ESCHER, A., & MONNIER, P. (2007). ESOPHAGEAL AND PHARYNGEAL STRICTURES: REPORT ON 1,862 ENDOSCOPIC DILATATIONS USING THE SAVARY-GILLIARD TECHNIQUE. EUROPEAN ARCHIVES OF OTO-RHINO-LARYNGOLOGY, 265(3), 357¿364. DOI: 10.1007/S00405-007-0456-0. THIS INVESTIGATION IS ON-GOING. ONCE COMPLETE, A FOLLOW-UP EMDR REPORT WILL BE PROVIDED.

    Description of Event or Problem · 1

    COOK ENDOSCOPY WAS NOTIFIED OF EVENTS THAT OCCURRED WITH SEVEN (7) SAVARY-GILLIARD DILATOR SETS. PLEASE SEE BELOW FOR RELEVANT EXCERPTS OF THIS ARTICLE. "OUR DATABASE WAS REVIEWED TO ASSESS NUMBER AND ETIOLOGIES OF THE PHARYNGEAL AND ESOPHAGEAL STRICTURES NECESSITATING DILATATION IN OUR DEPARTMENT BETWEEN JANUARY 1, 1963 AND DECEMBER 31, 2005. DILATATIONS WITH THE SAVARY-GILLIARD DILATORS HAVE BEEN EXCLUSIVELY USED IN OUR CLINIC SINCE 1980, RATHER THAN USING THE MALONEY DILATORS OR THE EDER- PUESTOW OLIVES, EXCEPT FOR SOME CASES OF ACHALASIA THAT WERE MANAGED BY BALLOON DILATATION. THE SAVARY-GILLIARD SET INCLUDED A METALLIC GUIDE-WIRE AND POLYVINYL CHLORIDE BOUGIES, RANGING FROM 5 TO 18 MM IN DIAMETER. THE PROCEDURE HAS BEEN DESCRIBED IN DETAIL ELSEWHERE [26], AND WAS ALWAYS PERFORMED UNDER FLUOROSCOPY. . . SEVERE COMPLICATIONS INCLUDED ESOPHAGEAL PERFORATION IN 34 PATIENTS (1.83%), ALL BUT ONE PRESENTING WITH MALIGNANT STRICTURES, AND MASSIVE BLEEDING WAS DOCUMENTED IN TWO PATIENTS (0.11%). THE MORTALITY RATE WAS 0.38, 0.09% IN BENIGN AND 0.81% IN MALIGNANT STRICTURES, RESPECTIVELY, WITH DEATH OCCURRING IN SEVEN PATIENTS SECONDARY TO PERFORATION [SUBJECT OF THIS REPORT]. OUR OVERALL COMPLICATION RATE WAS 1.93, 0.18% FOR BENIGN AND 4.58% FOR MALIGNANT STRICTURES, RESPECTIVELY. . . .ESOPHAGEAL PERFORATION REPRESENTS THE PRIMARY SEVERE COMPLICATION OF DILATATION, WITH RAPID PROGRESSION TO SEPSIS,MEDIASTINITIS AND DEATH. RAPID DIAGNOSIS AND AGGRESSIVE TREATMENT ARE REQUIRED. . . ALL CASES OF DEATH SECONDARY TO DILATATION OCCURRED IN THE GROUP OF ESOPHAGEAL PERFORATIONS WITH A FATAL EVOLUTION IN SEVEN PATIENTS. THE OVERALL MORTALITY RATE WAS THUS 0.38, 0.09% FOR BENIGN AND 0.81% FOR MALIGNANT STRICTURES, RESPECTIVELY.¿ IT WAS NOT PUBLISHED IN THE ARTICLE IF A SECTION OF THE DEVICE REMAINED INSIDE THE PATIENTS' BODY. THE ARTICLE INDICATES IN CASES OF PERFORATION RAPID DIAGNOSIS AND AGGRESSIVE TREATMENT ARE REQUIRED FOR PERFORATIONS. THEREFORE, IT IS ASSUMED AN ADDITIONAL PROCEDURE WAS REQUIRED. THE SEVEN PATIENTS EXPIRED SECONDARY TO PERFORATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1016138 SAVARY-GILLIARD DILATOR SET KNQ, DILATOR, ESOPHAGEAL KNQ COOK ENDOSCOPY UNKKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Death