FDA Adverse Event
Injury
Summary report: N
AMPLATZER CRIBRIFORM OCCLUDER
MDR report key: 9862917
·
Received March 20, 2020
Report
- Report Number
- 2135147-2020-00130
- Event Type
- Injury
- Date Received
- March 20, 2020
- Date of Event
- March 13, 2020
- Report Date
- March 20, 2020
- Manufacturer
- AGA MEDICAL CORPORATION
- Product Code
- MLV
- UDI-DI
- 00811806010298
- PMA / PMN Number
- P000039
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
AN EVENT OF DEVICE EMBOLIZATION WAS REPORTED. THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE DEVICE HISTORY RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED AND THE PRODUCT MET ALL SPECIFICATIONS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED.
Description of Event or Problem · 1
ON (B)(6) 2020, A 25MM AMPLATZER CRIBRIFORM OCCLUDER WAS SELECTED FOR IMPLANT. AFTER THE DEVICE WAS IMPLANTED, THE DEVICE EMBOLIZED INTO THE AORTA. THE DEVICE WAS SNARED AND FULLY RETRACTED WITH A GOOSE NECK SNARE. A 24MM AMPLATZER SEPTAL OCCLUDER (LOT # 6935515) WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 324093 | AMPLATZER CRIBRIFORM OCCLUDER | TRANSCATHETER SEPTAL OCCLUDER | MLV | AGA MEDICAL CORPORATION | 9-ASD-MF-025 | 7224726 | 00811806010298 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |