ZILVER 635 BILIARY SELF EXPANDING METAL STENT
Report
- Report Number
- 3001845648-2017-00463
- Event Type
- Injury
- Date Received
- October 11, 2017
- Report Date
- October 10, 2017
- Manufacturer
- COOK IRELAND LTD
- Product Code
- FGE
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- PHYSICIAN
Narratives
PMA/510(K) # K020788. COOK IRELAND LTD (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI)(IMPORTER). EXEMPTION NUMBER: E2016031. INFORMATION PERTAINING TO SECTION G. 1 AS FOLLOWS: IMPORTER SITE CONTACT AND ADDRESS: (B)(4) COOK MEDICAL INCORPORATED (CMI) 1025 ACUFF ROAD P.O BOX 4195 BLOOMINGTON INDIANA 47402-4195. IMPORTER SITE ESTABLISHMENT REGISTRATION NUMBER: 3005580113. INVESTIGATION IS PENDING. A FOLLOW UP MDR WILL BE SUBMITTED WITH THE INVESTIGATION CONCLUSIONS.
AS REPORTED TO CUSTOMER RELATIONS, " ARTICLE: INITIAL PERFORMANCE PROFILE OF A NEW 6F SELF-EXPANDING METAL STENT FOR PALLIATION OF MALIGNANT HILAR BILIARY OBSTRUCTION. CITATION: GASTROINTEST ENDOSC. 2010;72(3):632-636. AUTHORS: CHENNAT J, WAXMAN I. STUDY TYPE: SINGLE-CENTER, RETROSPECTIVE REVIEW. # OF PATIENTS: 16. OBJECTIVE: TO REPORT THE FEASIBILITY OF BILATERAL BILIARY STENT PLACEMENT FOR PATIENTS WITH MALIGNANT HILAR BILIARY OBSTRUCTION. PATIENTS UNDERWENT UNILATERAL, UNILATERAL OVERLAPPING, OR BILATERAL (SIDE-BY-SIDE) ENDOSCOPIC STENT PLACEMENT; SOME PATIENTS HAD AN ADDITIONAL STENT PLACED TO BRIDGE THE AMPULLA. ALL STENTS WERE ZILVER 635® BILIARY STENTS OF 40 MM, 60 MM, OR 80 MM LENGTHS. ADVERSE EVENTS: ONE PATIENT (6%) EXPERIENCED EARLY STENT OCCLUSION (DUE TO MUCUS/SLUDGE) AND 3 PATIENTS (19%) EXPERIENCED LATE STENT OCCLUSION (DUE TO TUMOR INGROWTH).
PMA/510(K) # K020788. (B)(4). EXEMPTION NUMBER: E2016031 (B)(4). THIS FOLLOW UP REPORT IS BEING SUBMITTED DUE TO THE COMPLETION AND THE CONCLUSION OF THIS INVESTIGATION. THE ZILBS-635 DEVICES OF UNKNOWN RPN AND LOT NUMBER INVOLVED IN THIS COMPLAINT WERE IMPLANTED IN THE PATIENTS, AND WERE NOT AVAILABLE FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT BASED INVESTIGATION WAS CONDUCTED. THERE ARE TWO COMPLAINT FILES OPENED IN RELATION TO THE CLINICAL PAPER. COMPLAINT FILE (B)(4) RELATES TO EARLY STENT OCCLUSION (DUE TO MUCUS/SLUDGE). COMPLAINT FILE PR 203842 RELATES TO LATE STENT OCCLUSION (DUE TO TUMOUR INGROWTH). THERE IS NO EVIDENCE TO SUGGEST THAT THIS INCIDENT DID NOT OCCUR. THEREFORE, THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. FROM THE PRODUCT INSTRUCTIONS FOR USE, TUMOUR INGROWTH IS A KNOWN POSSIBLE ADVERSE EVENT FROM THE USE OF ZILVER BILIARY 635 DEVICES AND ERCP (ENDOSCOPIC RETROGRADE CHOLANGIO-PANCREATOGRAPHY) PROCEDURES. FROM THE CLINICAL PAPER, IT IS KNOWN THAT THE PATIENTS EXPERIENCED STENT OCCLUSION DUE TO TUMOUR INGROWTH. HOWEVER, AS THE CIRCUMSTANCES OF USE CANNOT BE REPLICATED IN A LABORATORY ENVIRONMENT, A DEFINITIVE ROOT CAUSE FOR THIS OCCURRENCE CANNOT BE DETERMINED. THERE IS NO EVIDENCE TO SUGGEST THAT THE CUSTOMER DID NOT FOLLOW THE PRODUCT INSTRUCTIONS FOR USE. IT MAY BE NOTED THAT FROM THE LITERATURE REVIEW, THE FOLLOWING WAS CONCLUDED: "MALIGNANT HILAR BILIARY OBSTRUCTION ENDOSCOPIC PALLIATION WITH THE ZILVER 635 SEMS (SELF-EXPANDING METAL STENTS) OFFERS ACCEPTABLE INITIAL FEASIBILITY, SAFETY, AND EFFICACY PROFILES. THE CURRENT DESIGN FACILITATES SMALLER BILE DUCT NEGOTIATION AND MORE PRECISE INTRAHEPATIC PLACEMENT. EXPANDING AVAILABLE LENGTHS WOULD ALLOW TRANSPAPILLARY BRIDGED BILATERAL SEMS PLACEMENT FOR FUTURE REOBSTRUCTED BILIARY ACCESS. FURTHER LONG-TERM STUDIES ARE REQUIRED FOR COMPARATIVE OUTCOMES WITH OTHER CURRENT SEMS TECHNOLOGY." AS THE RPN AND LOT NUMBERS OF THE COMPLAINT STENTS ARE UNKNOWN, A REVIEW OF THE RELEVANT MANUFACTURING RECORDS CANNOT BE CONDUCTED. HOWEVER, PRIOR TO DISTRIBUTION ALL ZILVER BILIARY 635 DEVICES ARE SUBJECT TO VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS. -
PMA/510(K) # K020788. COOK IRELAND LTD (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF (B)(4). EXEMPTION NUMBER: E2016031. (B)(4). THIS FOLLOW UP REPORT IS BEING SUBMITTED TO INCLUDE THE ATTACHED EXCEL SPREADSHEET WITH A SUMMARIZED LIST OF ALL EVENTS REPORTED RELATED TO THIS LITERATURE ARTICLE. THE ZILBS-635 DEVICES OF UNKNOWN RPN AND LOT NUMBER INVOLVED IN THIS COMPLAINT WERE IMPLANTED IN THE PATIENTS, AND WERE NOT AVAILABLE FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT BASED INVESTIGATION WAS CONDUCTED. THERE ARE TWO COMPLAINT FILES OPENED IN RELATION TO THE CLINICAL PAPER. COMPLAINT FILE PR (B)(4) RELATES TO EARLY STENT OCCLUSION (DUE TO MUCUS/SLUDGE). COMPLAINT FILE PR (B)(4) RELATES TO LATE STENT OCCLUSION (DUE TO TUMOUR INGROWTH). THERE IS NO EVIDENCE TO SUGGEST THAT THIS INCIDENT DID NOT OCCUR. THEREFORE, THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. FROM THE PRODUCT INSTRUCTIONS FOR USE, TUMOUR INGROWTH IS A KNOWN POSSIBLE ADVERSE EVENT FROM THE USE OF ZILVER BILIARY 635 DEVICES AND ERCP (ENDOSCOPIC RETROGRADE CHOLANGIO-PANCREATOGRAPHY) PROCEDURES. FROM THE CLINICAL PAPER, IT IS KNOWN THAT THE PATIENTS EXPERIENCED STENT OCCLUSION DUE TO TUMOUR INGROWTH. HOWEVER, AS THE CIRCUMSTANCES OF USE CANNOT BE REPLICATED IN A LABORATORY ENVIRONMENT, A DEFINITIVE ROOT CAUSE FOR THIS OCCURRENCE CANNOT BE DETERMINED. THERE IS NO EVIDENCE TO SUGGEST THAT THE CUSTOMER DID NOT FOLLOW THE PRODUCT INSTRUCTIONS FOR USE. IT MAY BE NOTED THAT FROM THE LITERATURE REVIEW, THE FOLLOWING WAS CONCLUDED: "MALIGNANT HILAR BILIARY OBSTRUCTION ENDOSCOPIC PALLIATION WITH THE ZILVER 635 SEMS (SELF-EXPANDING METAL STENTS) OFFERS ACCEPTABLE INITIAL FEASIBILITY, SAFETY, AND EFFICACY PROFILES. THE CURRENT DESIGN FACILITATES SMALLER BILE DUCT NEGOTIATION AND MORE PRECISE INTRAHEPATIC PLACEMENT. EXPANDING AVAILABLE LENGTHS WOULD ALLOW TRANSPAPILLARY BRIDGED BILATERAL SEMS PLACEMENT FOR FUTURE REOBSTRUCTED BILIARY ACCESS. FURTHER LONG-TERM STUDIES ARE REQUIRED FOR COMPARATIVE OUTCOMES WITH OTHER CURRENT SEMS TECHNOLOGY." AS THE RPN AND LOT NUMBERS OF THE COMPLAINT STENTS ARE UNKNOWN, A REVIEW OF THE RELEVANT MANUFACTURING RECORDS CANNOT BE CONDUCTED. HOWEVER, PRIOR TO DISTRIBUTION ALL ZILVER BILIARY 635 DEVICES ARE SUBJECT TO VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS. (B)(4).
THIS FOLLOW UP REPORT IS BEING SUBMITTED DUE TO THE COMPLETION AND THE CONCLUSION OF THIS INVESTIGATION. INITIAL REPORT DETAILS: ARTICLE: INITIAL PERFORMANCE PROFILE OF A NEW 6F SELF-EXPANDING METAL STENT FOR PALLIATION OF MALIGNANT HILAR BILIARY OBSTRUCTION. CITATION: GASTROINTEST ENDOSC. 2010;72(3):632-636. AUTHORS: CHENNAT J, WAXMAN I. STUDY TYPE: SINGLE-CENTER, RETROSPECTIVE REVIEW. # OF PATIENTS: 16. OBJECTIVE: TO REPORT THE FEASIBILITY OF BILATERAL BILIARY STENT PLACEMENT FOR PATIENTS WITH MALIGNANT HILAR BILIARY OBSTRUCTION. PATIENTS UNDERWENT UNILATERAL, UNILATERAL OVERLAPPING, OR BILATERAL (SIDE-BY-SIDE) ENDOSCOPIC STENT PLACEMENT; SOME PATIENTS HAD AN ADDITIONAL STENT PLACED TO BRIDGE THE AMPULLA. ALL STENTS WERE ZILVER 635® BILIARY STENTS OF 40 MM, 60 MM, OR 80 MM LENGTHS. ADVERSE EVENTS: ONE PATIENT (6%) EXPERIENCED EARLY STENT OCCLUSION (DUE TO MUCUS/SLUDGE) AND 3 PATIENTS (19%) EXPERIENCED LATE STENT OCCLUSION (DUE TO TUMOR INGROWTH).
THIS FOLLOW UP REPORT IS BEING SUBMITTED TO INCLUDE THE ATTACHED EXCEL SPREADSHEET WITH A SUMMARIZED LIST OF ALL EVENTS REPORTED RELATED TO THIS LITERATURE ARTICLE. INITIAL REPORT DETAILS: ARTICLE: INITIAL PERFORMANCE PROFILE OF A NEW 6F SELF-EXPANDING METAL STENT FOR PALLIATION OF MALIGNANT HILAR BILIARY OBSTRUCTION. CITATION: GASTROINTEST ENDOSC. 2010;72(3):632-636. AUTHORS: CHENNAT J, WAXMAN I. STUDY TYPE: SINGLE-CENTER, RETROSPECTIVE REVIEW. # OF PATIENTS: 16. OBJECTIVE: TO REPORT THE FEASIBILITY OF BILATERAL BILIARY STENT PLACEMENT FOR PATIENTS WITH MALIGNANT HILAR BILIARY OBSTRUCTION. PATIENTS UNDERWENT UNILATERAL, UNILATERAL OVERLAPPING, OR BILATERAL (SIDE-BY-SIDE) ENDOSCOPIC STENT PLACEMENT; SOME PATIENTS HAD AN ADDITIONAL STENT PLACED TO BRIDGE THE AMPULLA. ALL STENTS WERE ZILVER 635® BILIARY STENTS OF 40 MM, 60 MM, OR 80 MM LENGTHS. ADVERSE EVENTS: ONE PATIENT (6%) EXPERIENCED EARLY STENT OCCLUSION (DUE TO MUCUS/SLUDGE) AND 3 PATIENTS (19%) EXPERIENCED LATE STENT OCCLUSION (DUE TO TUMOR INGROWTH).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 720194 | ZILVER 635 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 |