ZILVER SELF-EXPANDING BILIARY STENT
Report
- Report Number
- 3001845648-2024-00012
- Event Type
- Malfunction
- Date Received
- January 4, 2024
- Report Date
- July 16, 2024
- Manufacturer
- COOK IRELAND LTD
- Product Code
- FGE
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
PMA/510(K) # K182980 INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.
PMA/510(K) # K182980. DEVICE EVALUATION: 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. THE ZIB ZILVER SELF-EXPANDING BILIARY STENT OF LOT NUMBER AND RPN UNKNOWN INVOLVED IN THIS COMPLAINT WAS IMPLANTED IN THE PATIENT AND WAS NOT AVAILABLE FOR 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 WAS RAISED FROM ATTACHED LITERATURE PAPER ¿ALBUQUERQUE 2011 - INTRACRANIAL VENOUS SINUS STENTING FOR BENIGN INTRACRANIAL HYPERTENSION: CLINICAL INDICATIONS, TECHNIQUE, AND PRELIMINARY RESULTS¿. THIS COMPLAINT CAPTURES THE OFF-LABEL USE OF THE DEVICE AND THE POSSIBILITY OF THE INCORRECT WIRE GUIDE USED WITH THE DEVICE. MANUFACTURING RECORDS: PRIOR TO DISTRIBUTION ALL ZIB DEVICES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL INSPECTION TO ENSURE DEVICE INTEGRITY. AS THE LOT NUMBER IS UNKNOWN A REVIEW OF MANUFACTURING RECORDS COULD NOT BE PERFORMED. INSTRUCTIONS FOR USE/LABEL: IT SHOULD BE NOTED THAT THE INSTRUCTIONS FOR USE IFU0042 STATES THE FOLLOWING: ¿THE ZILVER 518 AND 635 BILIARY STENTS ARE INTENDED FOR PALLIATION OF MALIGNANT NEOPLASMS IN THE BILIARY TREE¿. IT ALSO STATES: ¿THE USE OF AN EXTRA SUPPORT WIRE GUIDE IS RECOMMENDED. ¿ 0.018 INCH (0.46MM) FOR ZILVER 518 ¿ 0.035 INCH (0.89MM) FOR ZILVER 635.¿ THERE IS EVIDENCE TO SUGGEST THAT THE CUSTOMER DID NOT FOLLOW THE INSTRUCTIONS FOR USE IMAGE REVIEW: AN IMAGE WAS NOT RETURNED FOR EVALUATION. ROOT CAUSE REVIEW: A DEFINITIVE ROOT CAUSE OF OFF LABEL USE WAS DETERMINED FROM THE AVAILABLE INFORMATION. FROM THE INFORMATION THAT WAS PROVIDED, IT IS KNOWN THAT THE TYPE OF PROCEDURE BEING PERFORMED WAS INTRACRANIAL VENOUS SINUS STENTING FOR BENIGN INTRACRANIAL HYPERTENSION AND THE ZILVER BILIARY STENTS WERE USED FOR 19 VENOUS SINUS STENTING PROCEDURES. THE USER HAS NOT COMPLIED WITH THE REQUIREMENTS OF THE IFU WITH RESPECT TO THE INTENDED USE OF THE DEVICE. OFF LABEL USE COMPLAINTS ARE CONSIDERED TO BE UNFORESEEN MISUSE. AS THE DEVICE HAS NOT BEEN TESTED IN THIS AREA, IT IS UNKNOWN HOW THE DEVICE WILL PERFORM. ALSO, IT SHOULD BE NOTED THAT, IT IS KNOWN THAT THE ZILVER DEVICE WAS NAVIGATED TO THE TARGET REGION WITH THE USE OF A 0.018-INCH WIRE GUIDE. IF THE DEVICES USED, WERE ZILVER 635 DEVICES, THIS WOULD BE REGARDED AS USER ERROR AS ZIB6 DEVICES REQUIRE THE USE OF A 0.035 INCH WIRE GUIDE. HOWEVER, AS THE RPN OF THE DEVICES IS UNKNOWN, IT CANNOT BE DETERMINED WHETHER THE RECOMMENDED SIZE WIRE GUIDE WAS USED WITH THE DEVICES. SHOULD THIS INFORMATION BECOME AVAILABLE IN THE FUTURE, THE FILE CAN BE UPDATED ACCORDINGLY. CONFIRMATION OF COMPLAINT: COMPLAINT IS CONFIRMED BASED ON CUSTOMER AND/OR REP TESTIMONY. CORRECTIVE ACTION/CORRECTION: COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR SIMILAR EVENTS. SUMMARY: ACCORDING TO THE INITIAL REPORTER, THIS FILE WAS RAISED FROM LITERATURE PAPER ¿ALBUQUERQUE 2011 - INTRACRANIAL VENOUS SINUS STENTING FOR BENIGN INTRACRANIAL HYPERTENSION: CLINICAL INDICATIONS, TECHNIQUE, AND PRELIMINARY RESULTS¿. AND CAPTURES THE OFF-LABEL USE OF THE DEVICE AND THE POSSIBILITY OF THE INCORRECT WIRE GUIDE USED WITH THE DEVICE. CONFIRMED QUANTITY OF 19 DEVICES, CONFIRMED USED. ACCORDING TO THE INITIAL REPORTER, NO ADVERSE EFFECTS TO THE PATIENT WERE REPORTED DUE TO THIS OCCURRENCE. INVESTIGATION FINDINGS CONCLUDE A DEFINITIVE ROOT CAUSE OF OFF LABEL USE WAS DETERMINED. THE USER HAS NOT COMPLIED WITH THE REQUIREMENTS OF THE INSTRUCTIONS FOR USE WITH RESPECT TO THE INTENDED USE OF THE DEVICE.
ALBUQUERQUE 2011 - INTRACRANIAL VENOUS SINUS STENTING FOR BENIGN INTRACRANIAL HYPERTENSION: CLINICAL INDICATIONS, TECHNIQUE, AND PRELIMINARY RESULTS A LONG (60 CM) 8 FR ARROW-FLEX SHEATH (ARROW INTERNATIONAL INC.; READING,PENNSYLVANIA, USA) WAS PLACED IN THE VENOUS CIRCULATION CONTRALATERAL TO THE SITE OF ARTERIAL ACCESS. THROUGH THIS SHEATH, A COAXIAL SYSTEM CONSISTING OF A 6 FR, 90-CM COOK SHUTTLE (COOK INCORPORATED; BLOOMINGTON, INDIANA, USA) OVER A 110-CM, 4 FR UNIVERSITY OF CALIFORNIA¿SAN FRANCISCO (UCSF) CATHETER (CORDIS INCORPORATED; MIAMI LAKES, FLORIDA, USA) OVER A GLIDEWIRE (TERUMO INCORPORATED; SOMERSET,NEWJERSEY, USA), WAS NAVIGATED TO THE TARGET JUGULAR BULB. WE CHOSE THE ZILVER BILIARY STENT SYSTEM (BLOOMINGTON, INDIANA, USA) FOR ALL PATIENTS BECAUSE OF ITS RELATIVE FLEXIBILITY IN COMPARISON WITH OTHER STENT DELIVERY DEVICES. DURING THE PAST 2.5 YEARS, WE PERFORMED 19 VENOUS SINUS STENTING PROCEDURES IN 18 PATIENTS WITH BIH (15 WOMEN, 3 MEN, MEAN AGE 31 YEARS, AGE RANGE 12¿51 YEARS). THIS FILE WILL CAPTURE THE 18 CASES WITH OFF LABEL USAGE BASED ON ANATOMICAL LOCATION (VENOUS SINUS STENTING (VSS)) AND UNDER AGE (SOME PATIENTS (2,7,9) WERE BELOW THE LEGAL AGE OF 18). THIS FILE ALSO CAPTURES THE USER ERROR OF INCORRECT SIZE WIRE GUIDE USED. PATIENT OUTCOME: NO ADVERSE EFFECTS.
A SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO COMPLETION OF THE INVESTIGATION ON 07/16/2024.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1501969 | ZILVER SELF-EXPANDING BILIARY STENT | FGE CATHETER, BILIARY, DIAGNOSTIC - BILIARY STENT - METAL | FGE | COOK IRELAND LTD | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 31 YR | Female |