AMPLATZER SEPTAL OCCLUDER Adverse Event — Injury (MDR 2135147-2020-00173)
AMPLATZER SEPTAL OCCLUDER Adverse Event — Injury (MDR 2135147-2020-00173) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: AMPLATZER SEPTAL OCCLUDER; Generic name: TRANSCATHETER SEPTAL OCCLUDER; Manufacturer: AGA MEDICAL CORPORATION.
| Device | AMPLATZER SEPTAL OCCLUDER |
|---|---|
| Generic name | TRANSCATHETER SEPTAL OCCLUDER |
| Manufacturer | AGA MEDICAL CORPORATION |
| Report number | 2135147-2020-00173 |
| Event type | Injury |
| Product problem | N |
| Date received | 2020-04-27 |
| Report source | FOREIGN, HEALTH PROFESSIONAL, L |
| Narrative | AN EVENT OF RESIDUAL SHUNT WAS REPORTED. THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE REMAINS IMPLANTED AND WAS NOT ACCESSIBLE FOR ANALYSIS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED. AN INITIAL REVIEW OF COMPLAINTS DATA WAS REVIEWED AS A COMPONENT OF THE COMPLAINT HANDLING RISK REVIEW PER WI (B)(4). THE MEDICAL |
| Source | openFDA MAUDE (device adverse events) |
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