FDA Adverse Event
Malfunction
Summary report: N
ZILVER 635 SELF-EXPANDING BILIARY STENT
MDR report key: 15310878
·
Received August 29, 2022
Report
- Report Number
- 3001845648-2022-00591
- Event Type
- Malfunction
- Date Received
- August 29, 2022
- Report Date
- September 1, 2022
- Manufacturer
- COOK IRELAND LTD
- Product Code
- FGE
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 0
PMA/510(K) # K163018. THE INVESTIGATION IS IN PROGRESS AND A FOLLOW UP MDR WILL BE SUBMITTED.
Additional Manufacturer Narrative · 0
PMA/510(K) # K163018 CANCELLATION MDR BEING SUBMITTED BASED ON CONFIRMATION RECEIVED ON (B)(6)2022 THAT ONLY ONE CASE OF STENT MIGRATION NOTED IN THE PMCF STUDY. THIS WILL BE CAPTURED UNDER (B)(4) (MDR REF#3001845648-2022-00583).
Description of Event or Problem · 0
THE THIRD DEVICE DEFICIENCY WAS A STENT MIGRATION IDENTIFIED VIA STANDARD OF CARE IMAGING PERFORMED DURING THE FOLLOW-UP PERIOD.
Description of Event or Problem · 0
CANCELLATION MDR BEING SUBMITTED BASED ON CONFIRMATION RECEIVED ON 01-SEP-2022 THAT ONLY ONE CASE OF STENT MIGRATION NOTED IN THE PMCF STUDY. THIS WILL BE CAPTURED UNDER (B)(4) (MDR REF#3001845648-2022-00583).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2129332 | 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 | Unknown |