ZILVER BILIARY SELF-EXPANDING METAL STENT
Report
- Report Number
- 3001845648-2020-00224
- Event Type
- Injury
- Date Received
- April 7, 2020
- Date of Event
- September 17, 2015
- Report Date
- October 16, 2020
- Manufacturer
- COOK IRELAND LTD
- Product Code
- FGE
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KR
- Reporter Occupation
- PHYSICIAN
Narratives
PMA/510(K) #: K182980. DEVICE EVALUATION: THE ZIB DEVICES OF UNKNOWN LOT NUMBER INVOLVED IN THIS COMPLAINT WERE NOT AVAILABLE FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT BASED INVESTIGATION WAS CONDUCTED. DOCUMENT REVIEW: PRIOR TO DISTRIBUTION ZIB DEVICES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. THESE INSPECTIONS AND FUNCTIONAL CHECKS ARE OUTLINED IN INTERNAL PROCEDURES IN PLACE AT CIRL. A REVIEW OF THE MANUFACTURING RECORDS FOR THE ZIB DEVICES COULD NOT BE PERFORMED AS THE LOT NUMBER IS UNKNOWN. IT SHOULD BE NOTED THAT THE INSTRUCTIONS FOR USE(IFU0040-6) STATES THE FOLLOWING: ¿THIS DEVICE IS NOT INTENDED TO BE DEPLOYED THROUGH THE WALL OF A PREVIOUSLY PLACED OR EXISTING METAL STENT.¿ THERE IS EVIDENCE TO SUGGEST THE USER DID NOT FOLLOW THE IFU. Y CONFIGURATION OF STENT-IN-STENT WAS OFF-LABEL USE. ROOT CAUSE REVIEW: A DEFINITIVE ROOT CAUSE OF OFF-LABEL USE WAS IDENTIFIED FROM THE AVAILABLE INFORMATION.Y CONFIGURATION OF STENT-IN-STENT WAS OFF-LABEL USE. STENT OCCLUSION OCCURRED AFTER STENT-IN-STENT DEPLOYMENT. SUMMARY: THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. ACCORDING TO THE INITIAL REPORTER, THE PATIENTS HAD OBSTRUCTIVE JAUNDICE RELATED TO BILIARY INTRADUCTAL METASTA-SIS OF ADVANCED GASTRIC CANCERS. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.
PMA/510(K) #: K182980. DEVICE EVALUATION: THE ZIB DEVICES OF UNKNOWN LOT NUMBER INVOLVED IN THIS COMPLAINT WERE NOT AVAILABLE FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT BASED INVESTIGATION WAS CONDUCTED. DOCUMENT REVIEW: PRIOR TO DISTRIBUTION ZIB DEVICES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. THESE INSPECTIONS AND FUNCTIONAL CHECKS ARE OUTLINED IN INTERNAL PROCEDURES IN PLACE AT CIRL A REVIEW OF THE MANUFACTURING RECORDS FOR THE ZIB DEVICES COULD NOT BE PERFORMED AS THE LOT NUMBER IS UNKNOWN. IT SHOULD BE NOTED THAT THE INSTRUCTIONS FOR USE (IFU0040-6) STATES THE FOLLOWING: ¿THE STENT HAS NOT BEEN DESIGNED TO INHIBIT TUMOR INGROWTH. TISSUE MAY GROW THROUGH STENTS.¿ THERE IS NO EVIDENCE TO SUGGEST THE USER DID NOT FOLLOW THE IFU (IFU0040-6) . ROOT CAUSE REVIEW: A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. A POSSIBLE ROOT CAUSE COULD BE ATTRIBUTED TO PATIENT PRE-EXISTING CONDITIONS. THE PATIENTS HAD OBSTRUCTIVE JAUNDICE RELATED TO BILIARY INTRADUCTAL METASTA-SIS OF ADVANCED GASTRIC CANCERS. SUMMARY: THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. ACCORDING TO THE INITIAL REPORTER, THE PATIENTS HAD OBSTRUCTIVE JAUNDICE RELATED TO BILIARY INTRADUCTAL METASTA-SIS OF ADVANCED GASTRIC CANCERS. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS. - ATTACHMENT: [(B)(6) 2016.PDF].
SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION.
THIS FOLLOW UP IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION. (B)(6) 2016 ¿ ¿BILIARY INTRADUCTAL METASTASIS FROM ADVANCED GASTRIC CANCER: RADIOLOGIC AND HISTOLOGIC CHARACTERISTICS, AND CLINICAL OUTCOMES OF PERCUTANEOUS METALLIC STENT PLACEMENT¿ OFF LABEL USE: PATIENTS WITH HILAR BILIARY OBSTRUCTIONS UNDERWENT BILATERAL STENTING VIA A SINGLE PERCUTANEOUS SITE AND USING STENT-IN-STENT DEPLOYMENT IN A T CONFIGURATION OR BILATERAL PERCUTANE-OUS SITES USING STENT-IN-STENT DEPLOYMENT IN A Y CONFIGURATION. WE INITIALLY ATTEMPTED TO USE THE T CONFIGURATION IN ALL PATIENTS WITH HILAR BILIARY OBSTRUCTION AS THIS TECHNIQUE DOES NOT REQUIRE AN ADDITIONAL CONTRALATERAL PUNCTURE. HOWEVER, WHEN NEGOTIAT-ING A GUIDE WIRE INTO THE CONTRALATERAL DUCT WAS NOT POSSIBLE, THE Y CONFIGURATION WAS EVENTUALLY USED. STENT OCCLUSION WAS OBSERVED IN FOUR (17 %) PATIENTS TREATED USING PTBD AND WITH AN ONSET DATE RANGING FROM 49¿278 DAYS (MEAN, 168 DAYS) FOLLOWING STENT PLACEMENT. THREE OCCLUSIONS WERE CAUSED BY SLUDGE INCRUSTATION AND ONE MOST LIKELY RESULTING FROM TUMOR OVERGROWTH. TWO PATIENTS WITH STENT OCCLUSION CAUSED BY SLUDGE INCRUSTATION UNDERWENT AN ADDITIONAL METALLIC STENT PLACEMENT, WHICH RESULTED IN GOOD INTERNAL DRAINAGE FOR TWO AND THREE MONTHS, RESPECTIVELY, PRIOR TO THEIR DEATHS. IN THE REMAINING TWO PATIENTS, ADDITIONAL STENT PLACEMENT WAS NOT PERFORMED DUE TO THE SEVERE DISEASE PROGRESSION. THE MEDIAN STENT PATENCY TIME WAS 156 DAYS.
PMA/510(K) #: K182980. INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.
LEE JY 2016: ¿BILIARY INTRADUCTAL METASTASIS FROM ADVANCED GASTRIC CANCER: RADIOLOGIC AND HISTOLOGIC CHARACTERISTICS, AND CLINICAL OUTCOMES OF PERCUTANEOUS METALLIC STENT PLACEMENT.¿ OFF LABEL USE: PATIENTS WITH HILAR BILIARY OBSTRUCTIONS UNDERWENT BILATERAL STENTING VIA A SINGLE PERCUTANEOUS SITE AND USING STENT-IN-STENT DEPLOYMENT IN A T CONFIGURATION OR BILATERAL PERCUTANE-OUS SITES USING STENT-IN-STENT DEPLOYMENT IN A Y CONFIGURATION. WE INITIALLY ATTEMPTED TO USE THE T CONFIGURATION IN ALL PATIENTS WITH HILAR BILIARY OBSTRUCTION AS THIS TECHNIQUE DOES NOT REQUIRE AN ADDITIONAL CONTRALATERAL PUNCTURE. HOWEVER, WHEN NEGOTIATING A GUIDE WIRE INTO THE CONTRALATERAL DUCT WAS NOT POSSIBLE, THE Y CONFIGURATION WAS EVENTUALLY USED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 396066 | ZILVER BILIARY SELF-EXPANDING METAL STENT | FGE CATHETER, BILIARY, DIAGNOSTIC - BILIARY STENT - METAL | FGE | COOK IRELAND LTD |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |