BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOEHENDRA STENT RETRIEVER

    MDR report key: 10063327 · Received May 15, 2020

    Report

    Report Number
    1037905-2020-00221
    Event Type
    Injury
    Date Received
    May 15, 2020
    Date of Event
    October 13, 2017
    Report Date
    April 19, 2020
    Manufacturer
    COOK ENDOSCOPY
    Product Code
    FGE
    PMA / PMN Number
    K161203
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    SHIN, S., JANG, S. ET AL. (2017). PANCREATIC PERFORATION CAUSED BY THE SOEHENDRA RETRIEVAL DEVICE IN A PATIENT WITH CHRONIC PANCREATITIS. GASTROINTESTINAL INTERVENTION, 6, 187-190. AN EMDR REPORT WAS INITIALLY SENT ON 05/15/2020, BASED ON THE INFORMATION STATED IN THE ARTICLE THAT THE SOEHENDRA STENT RETRIEVER POSSIBLY CONTRIBUTED TO THE PANCREATIC PERFORATION. ADDITIONAL INFORMATION WAS RECEIVED ON 05/21/2020 FROM THE AUTHOR THAT STATED THAT THE GUIDEWIRE WAS MOST LIKELY TO CAUSE OR CONTRIBUTE TO THE PERFORATION. BASED ON THE ADDITIONAL INFORMATION, THIS INCIDENT NO LONGER MEETS THE REPORTING CRITERIA OF AN FDA MDR REPORT.

    Description of Event or Problem · 0

    THIS CORRECTION FOLLOW UP REPORT IS BEING SUBMITTED TO CANCEL THE INITIAL REPORT SUBMITTED RELATING TO THIS EVENT. REFERENCE THE ADDITIONAL INFORMATION SECTION FOR THIS JUSTIFICATION.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: COOK MEDICAL ZIMMON PANCREATIC STENT (SPSOF-7-10), GUIDE WIRE (UNKNOWN MAKE OR MODEL). SHIN, S., JANG, S. ET AL. (2017). PANCREATIC PERFORATION CAUSED BY THE SOEHENDRA RETRIEVAL DEVICE IN A PATIENT WITH CHRONIC PANCREATITIS. GASTROINTESTINAL INTERVENTION, 6, 187-190. THE INVESTIGATION IS ONGOING. A FOLLOW UP REPORT WILL BE SENT UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    COOK ENDOSCOPY WAS NOTIFIED OF THIS EVENT INVOLVING A SOEHENDRA STENT RETRIEVER. PLEASE SEE BELOW FOR RELEVANT EXCERPTS OF THIS ARTICLE. "DILATING THE STRICTURE BY DRILLING USING A SOEHENDRA® RETRIEVAL DEVICE (7 FR; COOK MEDICAL) WAS SUCCESSFUL, AND AN ERPD PLASTIC STENT (7 FR/10 CM, SINGLE PIGTAIL; COOK MEDICAL) WAS INSERTED INTO THE MAIN PANCREATIC DUCT ALONG THE GUIDE WIRE. HOWEVER, THE PATIENT COMPLAINED OF PERSISTENT ABDOMINAL PAIN AFTER THE PROCEDURE. AT THIS TIME, HIS BLOOD RESULTS WERE AS FOLLOWS: C-REACTIVE PROTEIN 10 MG/L, TOTAL BILIRUBIN 2.5 MG/DL, ALKALINE PHOSPHATASE 391 IU/L, ASPARTATE AMINOTRANSFERASE/ALANINE AMINOTRANSFERASE 324/401 IU/L, GAMMA GLUTAMYL TRANSFERASE 694 IU/L, AMYLASE 174 IU/L, AND LIPASE 82 U/L. WE PERFORMED A SECOND ERCP AND INSERTED AN ENDOSCOPIC RETROGRADE BILIARY DRAINAGE (ERBD) STENT BECAUSE OF SUSPICION OF A COMMON BILE DUCT OBSTRUCTION BY ACUTE AGGRAVATION OF CHRONIC PANCREATITIS (FIG. 3). HOWEVER, THE PATIENT CONTINUED TO COMPLAIN OF ABDOMINAL PAIN. HE UNDERWENT ABDOMINAL CT, WHICH SHOWED LOCALIZED PERITONITIS WITH PNEUMOPERITONEUM IN THE RETROPERITONEUM, LIKELY DUE TO PERFORATION BY THE ERPD STENT. AN EMERGENCY OPERATION WAS PERFORMED, DURING WHICH WE FOUND THAT THE HEAD PORTION OF THE PANCREAS WAS PUNCTURED BY THE ERPD STENT (FIG. 4). THEREFORE, A TOTAL PANCREATECTOMY WAS PERFORMED. THE PATIENT RECOVERED AFTER THE OPERATION AND WAS DISCHARGED. HE HAS SINCE BEEN MONITORED ON AN OUTPATIENT BASIS." THE IMAGES PROVIDED IN THE ARTICLE WERE ANALYZED AND IT IS CONCLUDED THAT AFTER THE WIRE WAS IN PLACE THE STENT RETRIEVAL AND PLASTIC STENT FOLLOW THE WIRE PATH. THE IMAGES SHOWS THAT THE PLASTIC STENT WAS STILL IN THE SAME LOCATION THAT THE PHYSICIAN LEFT IT IN DURING THE INITIAL PROCEDURE. THIS POTENTIALLY INDICATES THAT THE PERFORATION HAPPED BEFORE THE ACTUAL STENT WAS EVER INTRODUCED. THIS SUGGEST THE SOEHENDRA STENT RETRIEVER POSSIBLY CONTRIBUTED TO THE PERFORATION (SUBJECT OF REPORT). IT WAS NOT PUBLISHED IN THE ARTICLE IF A SECTION OF THE DEVICE REMAINED INSIDE THE PATIENT'S BODY. THE PATIENT REQUIRED A TOTAL PANCREATECTOMY DUE TO PANCREATIC PERFORATION. HE WAS DISCHARGED AND WAS MONITORED ON AN OUTPATIENT BASIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    525506 SOEHENDRA STENT RETRIEVER FGE STENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS FGE COOK ENDOSCOPY

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention ENDOSCOPE (UNKNOWN MANUFACTURER)