BEUDAMED
    FDA Adverse Event Injury Summary report: N

    Z-STENT DUA ANTI-REFLUX VALVE ESOPHAGEAL STENT

    MDR report key: 1991104 · Received February 11, 2011

    Report

    Report Number
    1037905-2011-00069
    Event Type
    Injury
    Date Received
    February 11, 2011
    Date of Event
    January 13, 2011
    Report Date
    January 13, 2011
    Manufacturer
    WILSON-COOK MEDICAL INC
    Product Code
    ESW
    PMA / PMN Number
    K920218
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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. ONE UNUSED PRODUCT FROM THE LOT NUMBER SAID TO BE INVOLVED WAS REMOVED FROM THE FINISHED GOODS INVENTORY TO CONDUCT AN INVESTIGATION. DURING OUR LABORATORY ANALYSIS OF THE UNUSED PRODUCT, THE STENT WAS LOADED INTO THE INTRODUCTION SYSTEM AND ADVANCED OVER A WIRE GUIDE. THE STENT DEPLOYED PROPERLY AND RESISTANCE WAS NOT ENCOUNTERED. THE STENT FULLY OPENED WITHOUT DELAY. THE OUTER DIAMETER OF THE STENT MEASURES WITHIN THE APPROPRIATE SPECIFICATIONS. A PRODUCT DISCREPANCY OR ANOMALY THAT COULD HAVE CONTRIBUTED TO THIS REPORTED OCCURRENCE WAS NOT OBSERVED DURING OUR EVALUATION OF THE UNUSED PRODUCT. THE DEVICE HISTORY RECORD FOR THE LOT NUMBER SAID TO BE INVOLVED WAS REVIEWED. A DISCREPANCY OR ANOMALY WAS NOT OBSERVED WITH THE PRODUCT THAT WAS RELEASED FOR DISTRIBUTION. A REVIEW OF THE TWELVE MONTH COMPLAINT HISTORY FOR THIS PRODUCT FAMILY WAS CONDUCTED. IN THE PAST TWELVE MONTHS, THERE HAVE BEEN NO OTHER SIMILAR OCCURRENCES. THEREFORE, THIS REPORT REPRESENTS AN ISOLATED OCCURRENCE. CONCLUSIONS: INFO PROVIDED WITH THIS REPORT INDICATES THE STRUCTURED AREA WAS DILATED TO 15MM. THE INSTRUCTIONS FOR USE FOR THE Z-STENT DUA ANTI-REFLUX VALVE ESOPHAGEAL STENT DIRECT THAT PRIOR TO ADVANCING THE INTRODUCTION SYSTEM INTO THE ESOPHAGUS, THE AREA TO BE STENTED SHOULD BE DILATED TO A MINIMUM OF 10MM AND A MAXIMUM OF 14MM. THE INSTRUCTIONS FOR USE CAUTION THAT IF THE AREA IS DILATED GREATER THAN 14MM, THE STENT MAY MIGRATE. STENT MIGRATION IS LISTED IN THE INSTRUCTIONS FOR USE AS A POTENTIAL COMPLICATION THAT CAN OCCUR WITH PLACEMENT OF AN ESOPHAGEAL PROSTHESIS. THE USER INDICATED THE APPEARANCE OF THE STENT SUGGESTED FULL WIDENING OF THE STENT DID NOT OCCUR WITHIN 2 TO 3 MINUTES. THE INSTRUCTIONS FOR USE CONTAIN THE FOLLOWING CAUTION: "TUMOR IMPINGEMENT MAY PREVENT STENT FROM IMMEDIATELY ACHIEVING MAXIMUM 18MM DIAMETER." PRIOR TO DISTRIBUTION, ALL Z-STENT DUA ANTI-REFLUX VALVE ESOPHAGEAL STENTS ARE SUBJECTED TO A VISUAL INSPECTION TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THAT THE LOT SAID TO BE INVOLVED MET ALL MANUFACTURING REQUIREMENTS PRIOR TO SHIPMENT. CORRECTIVE ACTION: NO CORRECTIVE ACTION WARRANTED AT THIS TIME BECAUSE THE INFO PROVIDED INDICATED THE PRODUCT WAS USED IN CONTRADICTION WITH THE INSTRUCTIONS FOR USE AND THE REPORT WAS UNABLE TO BE VERIFIED. THIS OBSERVATION REPRESENTS AN ISOLATED OCCURRENCE. CUSTOMER QUALITY ASSURANCE WILL CONTINUE TO MONITOR FOR COMPLAINT TRENDS.

    Description of Event or Problem · 1

    DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD), THE PHYSICIAN PLANNED TO PLACE A COOK Z-STENT DUA ANTI-REFLUX VALVE ESOPHAGEAL STENT IN THE ESOPHAGUS. DIFFICULTY WAS ENCOUNTERED DURING ADVANCEMENT OF THE ENDOSCOPE THROUGH THE STRICTURE. THE STRICTURE WAS DILATED TO 13MM AND THEN DILATED TO 15MM. THE PHYSICIAN POSITIONED THE WIRE GUIDE AND BEGAN TO ADVANCE THE STENT AND INTRODUCTION SYSTEM UNIT OVER THE WIRE GUIDE. WHEN THE STENT AND INTRODUCTION SYSTEM WERE IN THE DESIRED LOCATION, THE SENT WOULD NOT DEPLOY. THE PHYSICIAN DETERMINE THE TIP OF THE WIRE GUIDE WAS LOCATED AT THE WALL OF THE STOMACH AND NOT AT THE ANTRUM. THE STENT AND INTRODUCTION SYSTEM WERE REMOVED FROM THE PT AND THE ENDOSCOPE WAS ADVANCED TO ADJUST THE POSITION THE WIRE GUIDE. WITH THE WIRE GUIDE POSITIONED AT THE ANTRUM OF THE STOMACH, THE ENDOSCOPE WAS REMOVED. THE STENT AND INTRODUCTION SYSTEM WERE ADVANCED OVER THE WIRE GUIDE AGAIN. THE LOCKING KEY WAS REMOVED FROM THE INTRODUCTION SYSTEM AND STENT DEPLOYMENT WAS ATTEMPTED. THE PUSHING CATHETER OF THE INTRODUCTION SYSTEM WOULD NOT PUSH THE STENT OUT OF THE INTRODUCTION SYSTEM. MULTIPLE ATTEMPTS WERE MADE BUT STENT DEPLOYMENT WAS NOT SUCCESSFUL. THE STENT AND INTRODUCTION SYSTEM WERE REMOVED FROM THE PT. A KINK WAS OBSERVED IN THE PRODUCTION SYSTEM. THE INNER CATHETER OF THE INTRODUCTION SYSTEM WAS ADVANCED BEYOND THE KINK. THE STENT AND INTRODUCTION SYSTEM WERE ADVANCED OVER THE WIRE GUIDE AGAIN. THE STENT SUCCESSFULLY DEPLOYED FROM THE INTRODUCTION SYSTEM. THE PHYSICIAN REMOVED THE INTRODUCTION SYSTEM AND ADVANCED THE ENDOSCOPE TO THE LOCATION OF THE STENT FOR ENDOSCOPIC OBSERVATION OF STENT PLACEMENT POSITION. THE STENT REPORTEDLY DEPLOYED APPROX 4 TO 5CM ABOVE THE STRICTURE'S LOCATION. THE APPEARANCE OF THE STENT SUGGESTED FULL WIDENING OF THE STENT DID NOT OCCUR WITHIN 2 TO 3 MINUTES. BY ENDOSCOPIC VIEW, THE PHYSICIAN OBSERVED THE STENT MOVE INTO THE STOMACH. THE PHYSICIAN IS NOT SURE BUT INDICATED COMPRESSION OF THE STENT BY ONE END OF THE STRICTURE COULD HAVE CAUSED THE STENT TO MIGRATE. THE STENT WAS SURGICALLY REMOVED VIA LAPAROSCOPY. SEVERAL ATTEMPTS WERE MADE IN AN ATTEMPT TO COLLECT ADDITIONAL INFO REGARDING THIS OCCURRENCE. THE COMPLAINANT DID NOT SPECIFY IF THE PT EXPERIENCED ANY ADVERSE EFFECTS DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 Z-STENT DUA ANTI-REFLUX VALVE ESOPHAGEAL STENT ESW, PROSTHESIS, ESOPHAGEAL ESW WILSON-COOK MEDICAL INC W2957208

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Required Intervention OLYMPUS (B)(4) ENDOSCOPE| COOK SAVARY-GILLIARD WIRE GUIDE