ZILVER 635 BILIARY SELF EXPANDING METAL STENT
Report
- Report Number
- 3001845648-2017-00464
- Event Type
- Injury
- Date Received
- October 11, 2017
- Report Date
- October 11, 2017
- Manufacturer
- COOK IRELAND LTD
- Product Code
- FGE
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
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: BILATERAL METAL STENTS FOR HILAR BILIARY OBSTRUCTION USING A 6FR DELIVERY SYSTEM: OUTCOMES FOLLOWING BILATERAL AND SIDE-BY-SIDE STENT DEPLOYMENT. CITATION: DIG DIS SCI. 2013; 58(9):2667-2672. AUTHORS: LAW R, BARON TH. STUDY TYPE: SINGLE-CENTER, RETROSPECTIVE REVIEW # OF PATIENTS: 24. OBJECTIVE: TO REPORT EXPERIENCE WITH BILATERAL ENDOSCOPIC BILIARY STENT PLACEMENT IN PATIENTS WITH MALIGNANT HILAR BILIARY OBSTRUCTION. ALL STENTS WERE ZILVER 635® BILIARY STENTS OF 40 MM, 60 MM, OR 80 MM LENGTHS. ADVERSE EVENTS: 12 PATIENTS REQUIRED RE-INTERVENTION. ONE PATIENT DEVELOPED PANCREATITIS AFTER STENT PLACEMENT. DURING THE FOLLOW UP PERIOD, REPEAT INTERVENTION WAS PERFORMED IN 12 OF THE 24 PATIENTS ((B)(4)) AT A MEDIAN OF 98 DAYS AFTER INITIAL ZILVER SEMS PLACEMENT. THE INDICATION FOR REPEAT INTERVENTIONS WAS ABNORMAL LIVER CHEMISTRIES AND CONCERN FOR CHOLANGITIS WITH ONE PATIENT REQUIRING INTERVENTION AT (B)(6) DAYS AFTER THE INDEX PROCEDURE. 11 OF THE 12 PATIENTS UNDERWENT ERCP AND 3 REQUIRED PTBD. SUCCESSFUL RE-INTERVENTION OCCURRED IN 9 OF THE 11 PATIENTS. TUMOR PROGRESSION LEADING TO CHOLESTASIS AND OR CHOLANGITIS WAS THE MOST COMMON REASON FOR STENT OCCLUSION NECESSITATING RE-INTERVENTION. TUMOR INGROWTH WAS THE CAUSE OF OCCLUSION IN 6/11 PATIENTS ((B)(4)). TUMOR PROGRESSION/OVERGROWTH WAS NOTED AT A NEW LOCATION IN 4 / 11 PATIENTS ((B)(4)) AND CHOLEDOCHOLITHIASIS OR BILIARY SLUDGE WAS OBSERVED IN 2/11 PATIENTS ((B)(4)). ERCP INTERVENTIONS INCLUDED ADDITIONAL SEMS PLACEMENT IN FIVE CASES, DUCT STRIPPING IN FIVE CASES, BALLOON DILATION IN FOUR CASES AND PLACEMENT OF A 10F PLASTIC STENT IN 3 CASES. ONE PATIENT DEVELOPED MILD POST ERCP PANCREATITIS.
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 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 PATIENT, AND WERE NOT AVAILABLE FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT BASED INVESTIGATION WAS CONDUCTED. 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, PANCREATITIS, CHOLANGITIS AND TUMOR INGROWTH ARE KNOWN POSSIBLE ADVERSE EVENTS FROM THE USE OF ZILVER BILIARY 635 DEVICES AND ERCP (ENDOSCOPIC RETROGRADE CHOLANGIO-PANCREATOGRAPHY) PROCEDURES. 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: ¿PLACEMENT OF BILATERAL SEMS (SELF-EXPANDING METAL STENT) WITH A SMALL CALIBER DELIVERY SYSTEM IN EITHER SBS (SIDE-BY-SIDE) OR SIS (STENT-INSTENT) CONFIGURATION IS SAFE, TECHNICALLY FEASIBLE, AND EFFECTIVE FOR DRAINAGE OF MALIGNANT HILAR OBSTRUCTION; HOWEVER, THE DURATION OF STENT PATENCY AND PROCEDURE-FREE SURVIVAL REMAINS VARIABLE.¿ 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. FROM THE CLINICAL PAPER, IT IS KNOWN THAT 12 PATIENTS REQUIRED RE-INTERVENTION. ONE PATIENT DEVELOPED PANCREATITIS AFTER STENT PLACEMENT. 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: BILATERAL METAL STENTS FOR HILAR BILIARY OBSTRUCTION USING A 6FR DELIVERY SYSTEM: OUTCOMES FOLLOWING BILATERAL AND SIDE-BY-SIDE STENT DEPLOYMENT. CITATION: DIG DIS SCI. 2013; 58(9):2667-2672. AUTHORS: LAW R, BARON TH. STUDY TYPE: SINGLE-CENTER, RETROSPECTIVE REVIEW. # OF PATIENTS: 24. OBJECTIVE: TO REPORT EXPERIENCE WITH BILATERAL ENDOSCOPIC BILIARY STENT PLACEMENT IN PATIENTS WITH MALIGNANT HILAR BILIARY OBSTRUCTION. ALL STENTS WERE ZILVER 635® BILIARY STENTS OF 40 MM, 60 MM, OR 80 MM LENGTHS. ADVERSE EVENTS: 12 PATIENTS REQUIRED RE-INTERVENTION. ONE PATIENT DEVELOPED PANCREATITIS AFTER STENT PLACEMENT. DURING THE FOLLOW UP PERIOD, REPEAT INTERVENTION WAS PERFORMED IN 12 OF THE 24 PATIENTS (50%) AT A MEDIAN OF 98 DAYS AFTER INITIAL ZILVER SEMS PLACEMENT. THE INDICATION FOR REPEAT INTERVENTIONS WAS ABNORMAL LIVER CHEMISTRIES AND CONCERN FOR CHOLANGITIS WITH ONE PATIENT REQUIRING INTERVENTION AT <30 DAYS AFTER THE INDEX PROCEDURE. 11 OF THE 12 PATIENTS UNDERWENT ERCP AND 3 REQUIRED PTBD. SUCCESSFUL RE-INTERVENTION OCCURRED IN 9 OF THE 11 PATIENTS. TUMOR PROGRESSION LEADING TO CHOLESTASIS AND OR CHOLANGITIS WAS THE MOST COMMON REASON FOR STENT OCCLUSION NECESSITATING RE-INTERVENTION. TUMOR INGROWTH WAS THE CAUSE OF OCCLUSION IN 6/11 PATIENTS (55%). TUMOR PROGRESSION/OVERGROWTH WAS NOTED AT A NEW LOCATION IN 4 / 11 PATIENTS (36%) AND CHOLEDOCHLITHIASIS OR BILIARY SLUDGE WAS OBSERVED IN 2/11 PATIENTS (18%). ERCP INTERVENTIONS INCLUDED ADDITIONAL SEMS PLACEMENT IN FIVE CASES, DUCT STRIPPING IN FIVE CASES, BALLOON DILATION IN FOUR CASES AND PLACEMENT OF A 10F PLASTIC STENT IN 3 CASES. ONE PATIENT DEVELOPED MILD POST ERCP PANCREATITIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 720024 | 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 | Other |