ZILVER 635 SELF-EXPANDING BILIARY STENT
Report
- Report Number
- 3001845648-2022-00541
- Event Type
- Malfunction
- Date Received
- August 18, 2022
- Date of Event
- December 22, 2021
- Report Date
- June 13, 2023
- Manufacturer
- COOK IRELAND LTD
- Product Code
- FGE
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
510K: K182980.INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.
510K: K182980. DEVICE EVALUATION: THE DEVICE EVALUATION COULD NOT BE COMPLETED AS THE DEVICE OR PHOTOGRAPHIC EVIDENCE OF THE DEVICE WAS NOT RETURNED FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT-BASED INVESTIGATION WAS CONDUCTED. THIS FILE IS RELATED TO (B)(4) AND IT WAS CREATED FROM THE JOURNAL ARTICLE REF. ATT. ¿AN2021 HIGHLIGHTED.PDF¿. LAB EVALUATION ¿ N/A. DOCUMENT REVIEW: PRIOR TO DISTRIBUTION ALL ZIB DEVICES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL INSPECTION TO ENSURE DEVICE INTEGRITY. IT SHOULD BE NOTED THAT THE INSTRUCTIONS FOR USE (IFU0040) STATES THE FOLLOWING: ¿STANDARD TECHNIQUES FOR PLACEMENT OF PERCUTANEOUS TRANSHEPATIC BILIARY DRAINAGE CATHETERS AND METAL STENTS SHOULD BE EMPLOYED¿. THERE IS EVIDENCE TO SUGGEST THE USER DID NOT FOLLOW THE IFU. THERE IS EVIDENCE TO SUGGEST THAT THE CUSTOMER DID NOT FOLLOW THE LABEL. IMAGE REVIEW: AN IMAGE WAS NOT RETURNED FOR EVALUATION. ROOT CAUSE REVIEW: A DEFINITIVE ROOT CAUSE OF OFF LABEL USE CAN BE CONCLUDED BASED ON THE INFORMATION PROVIDED. FROM THE INFORMATION PROVIDED IT IS KNOWN THAT THE STENTS WERE USED IN CONJUNCTION WITH IODINE-125 SEED STRANDS. THERE ARE NO INSTRUCTIONS CONTAINED WITHIN THE IFU FOR USING IODINE-125 SEED STRANDS WITH THESE DEVICES. AS PER MEDICAL ADVISOR INPUT ¿USING ZIB STENT IN CONJUNCTION WITH IODINE SEED STRAND IS CONSIDERED OFF-LABEL USE. SUMMARY: THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. THE COMPLAINT WAS RAISED FROM LITERATURE PAPER AN ET AL 2021 ¿ ¿SELF-EXPANDABLE METALLIC STENT WITH IODINE-125 SEED STRAND IN MALIGNANT BILIARY OBSTRUCTION: A SELF-MADE DELIVERY SYSTEM AND NOVEL IMPLANTATION METHOD¿. ACCORDING TO THE INITIAL REPORTER, THE DEVICE WAS USED OFF LABEL IN 58 CASES WITH NO ADVERSE EVENTS REPORTED. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.
510K: K182980. DEVICE EVALUATION: THE DEVICE EVALUATION COULD NOT BE COMPLETED AS THE DEVICE OR PHOTOGRAPHIC EVIDENCE OF THE DEVICE WAS NOT RETURNED FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT-BASED INVESTIGATION WAS CONDUCTED. THIS FILE IS RELATED TO (B)(4) (3001845648-2022-00542) AND IT WAS CREATED FROM THE ATTACHED JOURNAL ARTICLE. DOCUMENT REVIEW: PRIOR TO DISTRIBUTION ALL ZIB DEVICES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL INSPECTION TO ENSURE DEVICE INTEGRITY. IT SHOULD BE NOTED THAT THE INSTRUCTIONS FOR USE (IFU0040) STATES THE FOLLOWING: ¿STANDARD TECHNIQUES FOR PLACEMENT OF PERCUTANEOUS TRANSHEPATIC BILIARY DRAINAGE CATHETERS AND METAL STENTS SHOULD BE EMPLOYED¿. THERE IS EVIDENCE TO SUGGEST THE USER DID NOT FOLLOW THE IFU OR LABEL. ROOT CAUSE REVIEW: A DEFINITIVE ROOT CAUSE OF THE USER NOT READING OR FOLLOWING THE INSTRUCTIONS FOR USE HAS BEEN DETERMINED. FROM THE INFORMATION PROVIDED IT IS KNOWN THAT THE STENTS WERE USED IN CONJUNCTION WITH IODINE-125 SEED STRANDS. THERE ARE NO INSTRUCTIONS CONTAINED WITHIN THE IFU FOR USING IODINE-125 SEED STRANDS WITH THESE DEVICES. SUMMARY: THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. THE COMPLAINT WAS RAISED FROM LITERATURE PAPER AN ET AL 2021. ACCORDING TO THE INITIAL REPORTER, THE DEVICE WAS USED IN CONJUNCTION WITH IODINE SEED STRANDS IN 58 PATIENTS WITH NO ADVERSE EVENTS REPORTED. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.
PMA 510K #K182980. OFF LABEL USE COMPLAINTS ARE CONSIDERED TO BE UNFORESEEN MISUSE. IT IS UNKNOWN HOW THE DEVICE WILL FUNCTION OUTSIDE OF ITS INTENDED USE. TRENDING WILL MONITOR IF ANY FUTURE INVESTIGATION IS REQUIRED. DEVICE EVALUATION THE DEVICE EVALUATION COULD NOT BE COMPLETED AS THE DEVICE OR PHOTOGRAPHIC EVIDENCE OF THE DEVICE WAS NOT RETURNED FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT-BASED INVESTIGATION WAS CONDUCTED. MANUFACTURING RECORDS REVIEW PRIOR TO DISTRIBUTION ALL ZIB DEVICES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL INSPECTION TO ENSURE DEVICE INTEGRITY. MANUFACTURING RECORDS REVIEW COULD NOT BE COMPLETED AS THE LOT NUMBER IS UNKNOWN. INSTRUCTIONS FOR USE AND LABEL IT SHOULD BE NOTED THAT THE INSTRUCTIONS FOR USE (IFU0040) STATES THE FOLLOWING: ¿THE ZILVER 518 AND 635 BILIARY STENT HAS BEEN DESIGNED FOR USE IN PALLIATION OF MALIGNANT NEOPLASMS IN THE BILIARY TREE¿. THERE IS EVIDENCE TO SUGGEST THE USER DID NOT FOLLOW THE IFU OR LABEL. IMAGE REVIEW AN IMAGE WAS NOT RETURNED FOR EVALUATION. ROOT CAUSE ANALYSIS DEFINITIVE ROOT CAUSE WAS ESTABLISHED. THE USER HAS NOT COMPLIED WITH THE REQUIREMENTS OF THE IFU WITH RESPECT TO THE INTENDED USE OF THE DEVICE. FROM THE INFORMATION PROVIDED IT IS KNOWN THAT THE IODINE SEED STRANDS WERE PLACED BETWEEN THE BILIARY WALL AND THE STENT WHICH HAS NOT BEEN INDICATED FOR IN THE INTENDED USE STATEMENT OF THE IFU. ADDITIONALLY, IODINE MAY CAUSE ADVERSE EVENTS WHICH WOULD NOT BE LISTED IN OUR IFU CONFIRMATION OF COMPLAINT IS CONFIRMED BASED ON CUSTOMER AND/OR REP TESTIMONY. SUMMARY OF INVESTIGATION THE COMPLAINT WAS RAISED FROM LITERATURE PAPER AN ET AL 2021 ¿ ¿SELF-EXPANDABLE METALLIC STENT WITH 125I SEED STRAND IN MALIGNANT BILIARY OBSTRUCTION: A SELF-MADE DELIVERY SYSTEM AND NOVEL IMPLANTATION METHOD¿. ACCORDING TO THE INITIAL REPORTER, THE DEVICE WAS USED IN CONJUNCTION WITH IODINE SEED STRANDS IN 58 PATIENTS WITH NO ADVERSE EVENTS REPORTED. INVESTIGATION FINDINGS CONCLUDE A DEFINITIVE ROOT CAUSE OF OFF LABEL USE. COMPLAINT IS CONFIRMED BASED ON CUSTOMER AND/OR REP TESTIMONY. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.
510K: K182980 INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.
AN ET AL 2021 ¿SELF-EXPANDABLE METALLIC STENT WITH 125I SEED STRAND IN MALIGNANT BILIARY OBSTRUCTION: A SELF-MADE DELIVERY SYSTEM AND NOVEL IMPLANTATION METHOD¿. STENTS AND 125I SEEDS. SELF-EXPANDABLE STENTS [E-LUMINEXX, (C. R. BARD, INC., KARLSRUHE, GERMANY), ZILVER (COOK, IRELAND, LTD., LIMERICK, IRELAND), EPIC (BOSTON SCIENTIFIC, GALWAY, IRELAND)] WITH DIAMETERS RANGING FROM 6 TO 8 MM AND LENGTHS OF 40¿100 MM WERE USED IN THIS STUDY. THE 125I SEEDS (BEIJING ATOM HI-TECH CO., LTD., BEIJING, CHINA) WITH A DIAMETER OF 0.8 MM AND LENGTH OF 4.5±0.5 MM WERE USED. PROCEDURE: FIRST, THE 125I SEED STRAND WAS DELIVERED THROUGH THE BRANCH PASSAGE OF THE Y-CONNECTOR, AND THE SELF-EXPANDING STENT WAS THEN FOLLOWED FROM THE MAIN PASSAGE, RIGHT BEHIND THE STRAND IN THE CATHETER. SECOND, THE STRAND WAS PUSHED BY THE STENT AND THEN DELIVERED TO THE TARGET POSITION. THE SUTURE (LONG ENOUGH TO EXTEND FROM THE OBSTRUCTION TO THE Y-CONNECTOR) FROM THE BRANCH PASSAGE OF THE Y-CONNECTOR WAS GRASPED BY THE OPERATOR IN CASE OF TRANSLOCATION. THIRD, THE STRAND WAS KEPT AT THE TARGET POSITION, THEN THE CATHETER WAS RETRACTED TO EXPOSE THE WHOLE STENT, AND THE STENT WAS PUSHED TO THE TARGET POSITION PARALLEL TO THE STRAND (STRAND SUTURE WAS STILL GRASPED). FOURTH, CHOLANGIOGRAPHY WAS PERFORMED TO RECONFIRM THE STRAND AND STENT. THEN, THE STENT WAS RELEASED, AND THE STRAND WAS COMPRESSED IMMEDIATELY BETWEEN THE STENT AND THE OBSTRUCTIVE BILE DUCT WALL. FIFTH, CHOLANGIOGRAPHY WAS PERFORMED AGAIN TO EVALUATE THE DISTRIBUTION, AND THE GUIDE WIRE AND CATHETER WERE WITHDRAWN (SUTURE WAS CLIPPED, AND THE RESIDUAL REMAINED IN THE PUNCTURE TRACT). THIS FILE WILL CAPTURE: OFF LABEL USE: IODINE SEED STRAND INSERTION. 58 PATIENTS WITH NO REPORTED ADVERSE EFFECTS.
SUPPLEMENTAL FOLLOW-UP REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION AND AN UPDATE TO THE INVESTIGATION CONCLUSIONS ON THE 16-DEC-2022.
THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON THE 13-APR-2023.
THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO CONFIRMATION FROM MEDICAL AFFAIRS ON (B)(6) 2023 THAT THE USE OF IODINE SEED STRAND INSERTION IS OFF LABEL USE AND UPDATES TO THE COMPLETION OF THE INVESTIGATION ON (B)(6) 2023
SUPPLEMENTAL CORRECTION REPORT IS BEING SUBMITTED TO CAPTURE BELOW UPDATES MADE ON 14-MAR-2023: 1. BRIEF DESCRIPTION-- CHANGED FROM: AN ¿ ¿OFF LABEL USE: IODINE SEED STRAND INSERTION¿ CHANGED TO: AN ¿ ¿USER ERROR: IODINE SEED STRAND INSERTION¿ 2. DESCRIPTION OF EVENT-- CHANGED FROM: AN ET AL 2021 ¿ ¿SELF-EXPANDABLE METALLIC STENT WITH 125I SEED STRAND IN MALIGNANT BILIARY OBSTRUCTION: A SELF-MADE DELIVERY SYSTEM AND NOVEL IMPLANTATION METHOD¿. STENTS AND 125I SEEDS SELF-EXPANDABLE STENTS [E-LUMINEXX, (C. R. BARD, INC., KARLSRUHE, GERMANY), ZILVER (COOK, IRELAND, LTD., LIMERICK, IRELAND), EPIC (BOSTON SCIENTIFIC, GALWAY, IRELAND)] WITH DIAMETERS RANGING FROM 6 TO 8 MM AND LENGTHS OF 40¿100 MM WERE USED IN THIS STUDY. THE 125I SEEDS (BEIJING ATOM HI-TECH CO., LTD., BEIJING, CHINA) WITH A DIAMETER OF 0.8 MM AND LENGTH OF 4.5±0.5 MM WERE USED. PROCEDURE: FIRST, THE 125I SEED STRAND WAS DELIVERED THROUGH THE BRANCH PASSAGE OF THE Y-CONNECTOR, AND THE SELF-EXPANDING STENT WAS THEN FOLLOWED FROM THE MAIN PASSAGE, RIGHT BEHIND THE STRAND IN THE CATHETER. SECOND, THE STRAND WAS PUSHED BY THE STENT AND THEN DELIVERED TO THE TARGET POSITION. THE SUTURE (LONG ENOUGH TO EXTEND FROM THE OBSTRUCTION TO THE Y-CONNECTOR) FROM THE BRANCH PASSAGE OF THE Y-CONNECTOR WAS GRASPED BY THE OPERATOR IN CASE OF TRANSLOCATION. THIRD, THE STRAND WAS KEPT AT THE TARGET POSITION, THEN THE CATHETER WAS RETRACTED TO EXPOSE THE WHOLE STENT, AND THE STENT WAS PUSHED TO THE TARGET POSITION PARALLEL TO THE STRAND (STRAND SUTURE WAS STILL GRASPED). FOURTH, CHOLANGIOGRAPHY WAS PERFORMED TO RECONFIRM THE STRAND AND STENT. THEN, THE STENT WAS RELEASED, AND THE STRAND WAS COMPRESSED IMMEDIATELY BETWEEN THE STENT AND THE OBSTRUCTIVE BILE DUCT WALL. FIFTH, CHOLANGIOGRAPHY WAS PERFORMED AGAIN TO EVALUATE THE DISTRIBUTION, AND THE GUIDE WIRE AND CATHETER WERE WITHDRAWN (SUTURE WAS CLIPPED, AND THE RESIDUAL REMAINED IN THE PUNCTURE TRACT). THIS FILE WILL CAPTURE: USER ERROR: IODINE SEED STRAND INSERTION 58 PATIENTS WITH NO REPORTED ADVERSE EFFECTS CHANGED TO: AN ET AL 2021 ¿ ¿SELF-EXPANDABLE METALLIC STENT WITH 125I SEED STRAND IN MALIGNANT BILIARY OBSTRUCTION: A SELF-MADE DELIVERY SYSTEM AND NOVEL IMPLANTATION METHOD¿. STENTS AND 125I SEEDS SELF-EXPANDABLE STENTS [E-LUMINEXX, (C. R. BARD, INC., KARLSRUHE, GERMANY), ZILVER (COOK, IRELAND, LTD., LIMERICK, IRELAND), EPIC (BOSTON SCIENTIFIC, GALWAY, IRELAND)] WITH DIAMETERS RANGING FROM 6 TO 8 MM AND LENGTHS OF 40¿100 MM WERE USED IN THIS STUDY. THE 125I SEEDS (BEIJING ATOM HI-TECH CO., LTD., BEIJING, CHINA) WITH A DIAMETER OF 0.8 MM AND LENGTH OF 4.5±0.5 MM WERE USED. PROCEDURE: FIRST, THE 125I SEED STRAND WAS DELIVERED THROUGH THE BRANCH PASSAGE OF THE Y-CONNECTOR, AND THE SELF-EXPANDING STENT WAS THEN FOLLOWED FROM THE MAIN PASSAGE, RIGHT BEHIND THE STRAND IN THE CATHETER. SECOND, THE STRAND WAS PUSHED BY THE STENT AND THEN DELIVERED TO THE TARGET POSITION. THE SUTURE (LONG ENOUGH TO EXTEND FROM THE OBSTRUCTION TO THE Y-CONNECTOR) FROM THE BRANCH PASSAGE OF THE Y-CONNECTOR WAS GRASPED BY THE OPERATOR IN CASE OF TRANSLOCATION. THIRD, THE STRAND WAS KEPT AT THE TARGET POSITION, THEN THE CATHETER WAS RETRACTED TO EXPOSE THE WHOLE STENT, AND THE STENT WAS PUSHED TO THE TARGET POSITION PARALLEL TO THE STRAND (STRAND SUTURE WAS STILL GRASPED). FOURTH, CHOLANGIOGRAPHY WAS PERFORMED TO RECONFIRM THE STRAND AND STENT. THEN, THE STENT WAS RELEASED, AND THE STRAND WAS COMPRESSED IMMEDIATELY BETWEEN THE STENT AND THE OBSTRUCTIVE BILE DUCT WALL. FIFTH, CHOLANGIOGRAPHY WAS PERFORMED AGAIN TO EVALUATE THE DISTRIBUTION, AND THE GUIDE WIRE AND CATHETER WERE WITHDRAWN (SUTURE WAS CLIPPED, AND THE RESIDUAL REMAINED IN THE PUNCTURE TRACT). THIS FILE WILL CAPTURE: USER ERROR: IODINE SEED STRAND INSERTION 58 PATIENTS WITH NO REPORTED ADVERSE EFFECTS 3. SECTION 10. MEDICAL DEVICE PROBLEM CODE (ANNEX A)-- CHANGED FROM: A2304 - OFF-LABEL USE CHANGED TO: A2303 - IMPROPER OR INCORRECT PROCEDURE OR METHOD 4. SECTION 10. COMPONENT CODE (ANNEX G)-- CHANGED FROM: G07001 - PART/COMPONENT/SUB-ASSEMBLY TERM NOT APPLICABLE CHANGED TO: G04122 - STENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2154069 | ZILVER 635 SELF-EXPANDING BILIARY STENT | FGE CATHETER, BILIARY, DIAGNOSTIC - BILIARY STENT - METAL | FGE | COOK IRELAND LTD |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR | Male |