FDA Adverse Event
Injury
Summary report: N
PALMAZ STENT UNKNOWN
MDR report key: 1397038
·
Received May 28, 2009
Report
- Report Number
- 9610978-2009-00125
- Event Type
- Injury
- Date Received
- May 28, 2009
- Date of Event
- March 1, 2009
- Report Date
- May 1, 2009
- Manufacturer
- CORDIS EUROPA, N.V.
- Product Code
- FGE
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION HAS BEEN REQUESTED, AND WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.
Description of Event or Problem · 1
PHYSICIAN CALLED FOR MEDICAL INFORMATION AND REPORTED ADVERSE EVENTS. A NEWBORN UNDERWENT ENDOVASCULAR CATHETERIZATION AFTER STAGED NORWOOD PROCEDURE WITH PLACEMENT OF UNSPECIFIED PALMAZ STENT IN THE MEDIAL AORTA IN 2009. PHYSICIAN REPORTS THAT PATIENT EXPERIENCED, "MULTIPLE STROKES, BOTH LEFT AND RIGHT SIDES WITH SEQUELAE." PHYSICIAN IS AWARE OF THESE ONGOING EVENTS AND NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PALMAZ STENT UNKNOWN | ENDOVASCULAR SDS/STENTS (FGE) | FGE | CORDIS EUROPA, N.V. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 2 MO |