FDA Adverse Event
Malfunction
Summary report: N
FLUENCY PLUS ENDOVASCULAR STENT GRAFT
MDR report key: 9957789
·
Received April 14, 2020
Report
- Report Number
- 2020394-2020-02659
- Event Type
- Malfunction
- Date Received
- April 14, 2020
- Report Date
- April 14, 2020
- Manufacturer
- BARD PERIPHERAL VASCULAR, INC.
- Product Code
- PFV
- UDI-DI
- 04049519008707
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE LOT NUMBER FOR THE MALFUNCTION WAS PROVIDED AND A LOT HISTORY REVIEW WILL BE PERFORMED. THE DEVICE FOR THIS MALFUNCTION HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION, HOWEVER, AN IMAGE WAS PROVIDED. PER THE IMAGE REVIEW, THE REPORTED FAILURES ARE INCONCLUSIVE. BASED UPON THE AVAILABLE INFORMATION, THE DEFINITIVE ROOT CAUSE IS UNKNOWN. THE DEVICE IS LABELED FOR SINGLE USE.
Description of Event or Problem · 1
THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL FEM14080 ENDOVASCULAR STENT GRAFT ALLEGEDLY EXPERIENCED MATERIAL DEFORMATION AND POSITIONING PROBLEM. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THIS MALFUNCTION INVOLVED ONE PATIENT WITH NO CONSEQUENCES. THE WEIGHT OF (B)(6) YEAR OLD MALE IS (B)(6) POUNDS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 423130 | FLUENCY PLUS ENDOVASCULAR STENT GRAFT | ENDOVASCULAR STENT GRAFT | PFV | BARD PERIPHERAL VASCULAR, INC. | FEM14080 | ANDW2162 | 04049519008707 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |