FDA Adverse Event
Injury
Summary report: N
WALLFLEX ENTERAL DUODENAL STENT
MDR report key: 1328270
·
Received February 27, 2009
Report
- Report Number
- 3005099803-2009-00884
- Event Type
- Injury
- Date Received
- February 27, 2009
- Report Date
- January 30, 2009
- Manufacturer
- BOSTON SCIENTIFIC IRELAND, LTD.
- Product Code
- MUM
- PMA / PMN Number
- K062750
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE MANUFACTURE DATE AND EXPIRATION DATE ARE UNK SINCE THE LOT # IS UNK. THE DEVICE IS NOT AVAILABLE. A DEVICE ANALYSIS CANNOT BE PERFORMED; THEREFORE, THE CAUSE OF THE REPORTED EVENT IS UNDETERMINED.
Description of Event or Problem · 1
NOTE: DATE OF EVENT IS UNK. ON JANUARY 30, 2009, A BOSTON SCIENTIFIC EMPLOYEE BECAME AWARE OF A CLINICAL STUDY ARTICLE, "COMBINED ENDOSCOPIC STENT INSERTION IN MALIGNANT BILIARY AND DUODENAL OBSTRUCTION", BY M. MUTIGNANI, ET AL. ACCORDING TO THE ARTICLE, THE WALLFLEX ENTERAL DUODENAL STENT WAS USED IN A COMBINED ENDOSCOPIC STENT INSERTION. THE PT DEVELOPED RECURRENT VOMITING DUE TO TUMOR INGROWTH. THE PT WAS TREATED ENDOSCOPICALLY BY RE-STENTING. THERE IS NO FURTHER INFO FROM THE ARTICLE REGARDING THE STATUS OF THE PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | WALLFLEX ENTERAL DUODENAL STENT | MUM | BOSTON SCIENTIFIC IRELAND, LTD. | UNK | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |