AMPLATZER PFO OCCLUDER Adverse Event — Injury (MDR 2135147-2020-00181)
AMPLATZER PFO OCCLUDER Adverse Event — Injury (MDR 2135147-2020-00181) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: AMPLATZER PFO OCCLUDER; Generic name: TRANSCATHETER SEPTAL OCCLUDER; Manufacturer: AGA MEDICAL CORPORATION.
| Device | AMPLATZER PFO OCCLUDER |
|---|---|
| Generic name | TRANSCATHETER SEPTAL OCCLUDER |
| Manufacturer | AGA MEDICAL CORPORATION |
| Report number | 2135147-2020-00181 |
| Event type | Injury |
| Date received | 2020-04-27 |
| Report source | FOREIGN, HEALTH PROFESSIONAL, L |
| Narrative | AS REPORTED IN A RESEARCH ARTICLE, A PATIENT HAD A RESIDUAL SHUNT AND A STROKE 5 MONTHS AFTER IMPLANTATION WITH AN AMPLATZER PFO OCCLUDER. THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED 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 |
| Source | openFDA MAUDE (device adverse events) |
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