ZILVER 635 SELF-EXPANDING BILIARY STENT
Report
- Report Number
- 3001845648-2022-00583
- Event Type
- Injury
- Date Received
- August 26, 2022
- Date of Event
- September 8, 2014
- Report Date
- January 13, 2023
- Manufacturer
- COOK IRELAND LTD
- Product Code
- FGE
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- 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. INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.
PMA/510(K) #K182980. DEVICE EVALUATION: THE ZIB6-40-10-8.0 DEVICE OF LOT NUMBER C950985 INVOLVED IN THIS COMPLAINT WAS NOT AVAILABLE FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT-BASED INVESTIGATION WAS CONDUCTED. DOCUMENT REVIEW: PRIOR TO DISTRIBUTION ALL ZIB6-40-10-8.0 DEVICES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL INSPECTION TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE MANUFACTURING RECORDS DID NOT REVEAL ANY DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT ISSUE. THE REVIEW OF THE RELEVANT MANUFACTURING RECORDS CONFIRMS THE FAILURE MODE HAS NOT PREVIOUSLY OCCURRED FOR THIS WORK ORDER. IT SHOULD BE NOTED THAT THE INSTRUCTIONS FOR USE (IFU0040) LISTS STENT MIGRATION AS A POTENTIAL ADVERSE EVENT. THERE IS NO EVIDENCE TO SUGGEST THE USER DID NOT FOLLOW THE IFU. THERE IS NO 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 COULD NOT BE DETERMINED HOWEVER A POSSIBLE ROOT CAUSE COULD BE ATTRIBUTED TO KNOWN POTENTIAL COMPLICATIONS. THE IFU LISTS STENT MIGRATION AS A POTENTIAL ADVERSE EVENT. 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 MIGRATION MAY HAVE CAUSED BLEEDING. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.
STENT PARTIALLY DISLOCATED. RESOLVED. NEW STENT PLACED.
SUPPLEMENTAL MDR BEING SUBMITTED DUE TO RECEIPT OF UPDATED CC FORM RECEIVED 26-AUG-22. LOT#, PATIENT INFO, PATIENT OUTCOME (E CODE) AND EVENT DESCRIPTION UPDATED: STENT PARTIALLY DISLOCATED. CC FORM RECEIVED ON 26-AUG-22: MDR-2098: OTHER DEVICE ISSUE (BILIARY STENT): STENT PARTIALLY DISLOCATED; IDENTIFIED ON IMAGING SITE ASSESSED EVENT AS POSSIBLY RELATED TO THE STUDY STENT AND NOTED THE FOLLOWING, ¿STENT WAS DISLOCATED MAYBE THE CAUSE OF BLEEDINGS¿ SITE INDICATED THAT THE EVENT WAS NOT DUE TO A DEVICE DEFICIENCY.
SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 13-JAN-2023.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 472221 | ZILVER 635 SELF-EXPANDING BILIARY STENT | FGE CATHETER, BILIARY, DIAGNOSTIC - BILIARY STENT - METAL | FGE | COOK IRELAND LTD | C9509985 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Female | Required Intervention |