FDA Adverse Event
Injury
Summary report: N
ATRIUM ICAST COVERED STENT
MDR report key: 4814401
·
Received June 2, 2015
Report
- Report Number
- 1219977-2015-00161
- Event Type
- Injury
- Date Received
- June 2, 2015
- Date of Event
- January 26, 2015
- Report Date
- May 26, 2015
- Manufacturer
- ATRIUM MEDICAL CORP.
- Product Code
- JCT
- PMA / PMN Number
- K050814
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ON COMPLETION OF THE INVESTIGATION A FOLLOW UP REPORT WILL BE SUBMITTED. ASSOCIATED FILE: 1219977-2015-001756.
Description of Event or Problem · 1
DURING AORTIC STENT GRAFT PROCEDURE THE PHYSICIAN WAS DEPLOYING A STENT IN THE LEFT RENAL ARTERY WHEN THE STENT BECAME LOOSE ON THE BALLOON. THE PHYSICIAN WAS ABLE TO "SHIMMY" THE STENT ON THE BALLOON AND IMPLANTED IT AT THE TARGET RENAL ARTERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 353747 | ATRIUM ICAST COVERED STENT | PROSTHESIS, TRACHEAL, EXPANDABLE | JCT | ATRIUM MEDICAL CORP. | 85453 | 218655 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |