FDA Adverse Event
Injury
Summary report: N
AMPLATZER CRIBRIFORM OCCLUDER
MDR report key: 1930511
·
Received December 16, 2010
Report
- Report Number
- 2135147-2010-00181
- Event Type
- Injury
- Date Received
- December 16, 2010
- Date of Event
- December 2, 2010
- Report Date
- December 16, 2010
- Manufacturer
- AGA MEDICAL CORPORATION
- Product Code
- MLV
- PMA / PMN Number
- P000039/S013
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
AGA MEDICAL COULD NOT EVALUATE THE ACO INVOLVED IN THIS INCIDENT SINCE IT WAS NOT RETURNED TO US BUT DISCARDED BY THE HOSPITAL.
Description of Event or Problem · 1
ACCORDING TO THE INITIAL INFORMATION RECEIVED, THE 25MM AMPLATZER CRIBRIFORM OCCLUDER (ACO) EMBOLIZED AND WAS PERCUTANEOUSLY SNARED FROM THE DESCENDING AORTA. THE PATIENT HAD A NORMAL RECOVERY AND WAS DISCHARGED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, INCLUDING IMAGING OF THE IMPLANT PROCEDURE AND DEVICE SERIAL NUMBER, BUT HAS NOT YET BEEN RECEIVED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AMPLATZER CRIBRIFORM OCCLUDER | CARDIAC OCCLUSION DEVICE | MLV | AGA MEDICAL CORPORATION | 9-ASD-MF-025 | 1009106988 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |