EVOLUTION® BILIARY CONTROLLED-RELEASE STENT - FULLY COVERED
Report
- Report Number
- 3001845648-2022-00655
- Event Type
- Injury
- Date Received
- September 20, 2022
- Report Date
- April 13, 2023
- Manufacturer
- COOK IRELAND LTD
- Product Code
- FGE
- PMA / PMN Number
- K121430
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.
THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED AS A CANCELLATION PR IS NO LONGER REQUIRED AND WILL BE CAPTURED UNDER (B)(4) (3001845648-2022-00654).
KOBAYASHI ET AL 2021 ¿COMPARISON OF PLASTIC STENT VERSUS METAL STENT IN PREOPERATIVE BILIARY DRAINAGE FOR PANCREATIC HEAD CANCER WITH NEOADJUVANT CHEMORADIOTHERAPY¿. IN THE PS GROUP, 7- FR, 7- CM STRAIGHT TYPE BILIARY STENTS (FLEXIMA; BOSTON SCIENTIFIC, NATICK, MA, USA) OR BOTH- END PIGTAIL- TYPE BILIARY STENTS (ZIMMON; COOK MEDICAL, BLOOMINGTON IN, USA) WERE USED WITHOUT ENDOSCOPIC SPHINC-TEROTOMY (EST). IN THE MS GROUP, 8- MM, 8- CM FULLY- COVERED SELF- EXPANDABLE METAL STENTS (FCSEMS, WALL FLEX; BOSTON SCIENTIFIC, BONASTENT; MEDICO¿S HIRATA OR EVOLUTION; COOK MEDICAL) WERE PLACED AFTER PERFORMING EST. THERE WERE 22 PATIENTS IN THE PS GROUP AND 21 PATIENTS IN THE MS GROUP. RE- INTERVENTIONAL DRAINAGE (MS GROUP).
THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED AS A CANCELLATION PR IS NO LONGER REQUIRED AND WILL BE CAPTURED UNDER (B)(4) (3001845648-2022-00654).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2502198 | EVOLUTION® BILIARY CONTROLLED-RELEASE STENT - FULLY COVERED | FGE CATHETER, BILIARY, DIAGNOSTIC - BILIARY STENT - METAL | FGE | COOK IRELAND LTD | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR | Unknown | Required Intervention |