ZILVER 635 SELF-EXPANDING BILIARY STENT
Report
- Report Number
- 3001845648-2022-00665
- Event Type
- Malfunction
- Date Received
- September 28, 2022
- Date of Event
- June 18, 2019
- Report Date
- April 7, 2023
- Manufacturer
- COOK IRELAND LTD
- Product Code
- FGE
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
PMA/510(K) # (B)(4). INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.
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: 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. PR 372357/ 3001845648-2022-00590 CAPTURES THE ORIGINAL DEVICE ISSUE WHICH LED TO THE PLACEMENT OF THE SECOND STENT. 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. MANUFACTURING RECORDS REVIEW COULD NOT BE COMPLETED AS THE LOT NUMBER IS UNKNOWN. HISTORICAL DATA WAS NOT REVIEWED AS THE LOT NUMBER IS UNKNOWN. IT SHOULD BE NOTED THAT THE INSTRUCTIONS FOR USE (IFU0040) STATES THE FOLLOWING: ¿THE DEVICE IS NOT INTENDED TO BE DEPLOYED THROUGH THE WALL OF A PREVIOUSLY PLACED OR EXISTING METAL STENT. DOING SO COULD RESULT IN DIFFICULTY OR INABILITY TO REMOVE THE INTRODUCER¿. 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. FROM THE ARTICLE IT IS KNOWN THAT THE STENT WAS PLACED THROUGH THE WALL OF A PREVIOUSLY PLACED STENT. THE IFU STATES ¿THE DEVICE IS NOT INTENDED TO BE DEPLOYED THROUGH THE WALL OF A PREVIOUSLY PLACED OR EXISTING METAL STENT. DOING SO COULD RESULT IN DIFFICULTY OR INABILITY TO REMOVE THE INTRODUCER¿. SUMMARY: THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. THE COMPLAINT WAS RAISED FROM THE ATTACHED POST-MARKET CLINICAL STUDY ¿ZILVER 635 BILIARY SELF-EXPANDING METAL STENT & STENT SETS¿. THERE WERE NO ADVERSE EVENTS REPORTED AS A RESULT OF THIS OCCURRENCE. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.
PMA/510(K) # 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) / MDR REF#3001845648-2022-00585, (B)(4) / MDR REF#3001845648-2023-00218, (B)(4) / MDR REF#3001845648-2022-00580, (B)(4) / MDR REF#3001845648-2022-00581 (B)(4) / MDR REF#3001845648-2022-00601, (B)(4) / MDR REF#3001845648-2022-00600, (B)(4) / MDR REF#3001845648-2022-00592, (B)(4) / MDR REF#3001845648-2022-00590, (B)(4) / MDR REF#3001845648-2022-00591 AND (B)(4) / MDR REF#3001845648-2022-00593. 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. MANUFACTURING RECORDS REVIEW COULD NOT BE COMPLETED AS THE LOT NUMBER IS UNKNOWN. HISTORICAL DATA WAS NOT REVIEWED AS THE LOT NUMBER IS UNKNOWN. IT SHOULD BE NOTED THAT THE INSTRUCTIONS FOR USE (IFU0040) STATES THE FOLLOWING: ¿THE DEVICE IS NOT INTENDED TO BE DEPLOYED THROUGH THE WALL OF A PREVIOUSLY PLACED OR EXISTING METAL STENT. DOING SO COULD RESULT IN DIFFICULTY OR INABILITY TO REMOVE THE INTRODUCER¿. 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 REVIEW A DEFINITIVE ROOT CAUSE OF THE USER NOT READING OR FOLLOWING THE INSTRUCTIONS FOR USE CAN BE CONCLUDED BASED ON THE INFORMATION PROVIDED. FROM THE ARTICLE IT IS KNOWN THAT THE STENT WAS DEPLOYED THROUGH THE WALL OF A PREVIOUSLY PLACED OR EXISTING METAL STENT. THE IFU STATES ¿THE DEVICE IS NOT INTENDED TO BE DEPLOYED THROUGH THE WALL OF A PREVIOUSLY PLACED OR EXISTING METAL STENT. DOING SO COULD RESULT IN DIFFICULTY OR INABILITY TO REMOVE THE INTRODUCER¿. SUMMARY THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. THE COMPLAINT WAS RAISED FROM THE ATTACHED POST-MARKET CLINICAL STUDY ¿ZILVER 635 BILIARY SELF-EXPANDING METAL STENT & STENT SETS¿. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EVENTS AS A RESULT OF THIS OCCURRENCE. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.
DEVICE ISSUE ( BILIARY STENT): SECOND PROTHESIS ASTRIDE (SIDE-BY-SIDE) THE FIRST ONE (CBD) WHICH WAS NOT AT THE EXACT PLACE. PATIENT OUTCOME: RESOLVED (PATIENT RECOVERED/STABILIZED). CC FORM RECEIVED (B)(6) 2022: (B)(4): DEVICE ISSUE (BILIARY STENT): FIRST STENT NOT AT THE EXACT PLACE. (PR (B)(4) THE SITE ENTERED THE AE AS FOLLOWS, ¿SECOND PROSTHESIS ASTRIDE THE FIRST ONE WHICH WAS NOT AT THE EXACT PLACE¿. SITE ASSESSED EVENT AS NOT RELATED TO THE STUDY STENT, HOWEVER, STATED THAT THE EVENT WAS DUE TO A DEVICE DEFICIENCY AND ONLY NOTED THE FOLLOWING, ¿DEFECTIVE DEVICE¿. PATIENT OUTCOME: THE SITE MARKED ¿NO TREATMENT¿ ON THE CRF; HOWEVER, IT APPEARS THAT TREATMENT WOULD BE CONSIDERED PLACEMENT OF THE SECOND STENT ¿ASTRIDE THE FIRST¿ STENT (PER PROCEDURE FORM, 2ND STENT WAS PLACED BOTH SIDE-BY-SIDE AND THROUGH THE WALL OF ANOTHER STENT - OFF LABEL USE. (PR (B)(4). THE EVENT WAS CONSIDERED RESOLVED (PATIENT RECOVERED/STABILIZED). THIS FILE WILL CAPTURE THE OFF LABEL USE OF THE SECOND STENT (RPN UNKNOWN) WHICH WAS PLACED BOTH SIDE-BY-SIDE AND THROUGH THE WALL OF ANOTHER STENT. RESOLVED (PATIENT RECOVERED/STABILIZED).
SUPPLEMENTAL REPORT IS BEING SUBMITTED AS QE CONFIRMED ON 28-FEB-2023 THAT DEPLOYMENT THROUGH THE WALL/MESH OF AN EXISTING STENT IS A USER ERROR RATHER THAN OFF LABEL USE. BRIEF DESCRIPTION, A CODE AND G CODE UPDATED TO REMOVE REFERENCE TO OFF-LABEL USE.
SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 06-JAN-2023.
SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE RE-INVESTIGATION ON 07-APR-2023.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1827332 | ZILVER 635 SELF-EXPANDING BILIARY STENT | FGE CATHETER, BILIARY, DIAGNOSTIC - BILIARY STENT - METAL | FGE | COOK IRELAND LTD | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 74 YR | Female |