MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-14 for 5-4 AMPLATZER DUCT OCCLUDER II manufactured by Abbott Medical.
[138811131]
Neonatal pda closure, device placed in correct location with no arch obstruction or pulmonary artery narrowing. One week after placement, ph dropped precipitously, patient became unstable. Echo showed that the device had shifted slightly posteriorly causing coarctation. Stent placement initiated across the arch-placement was successful.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5084915 |
| MDR Report Key | 8421034 |
| Date Received | 2019-03-14 |
| Date of Report | 2019-03-13 |
| Date of Event | 2018-12-27 |
| Date Added to Maude | 2019-03-14 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 5-4 AMPLATZER DUCT OCCLUDER II |
| Generic Name | OCCLUDER , PATENT DUCTUS, ARTERIOSUS |
| Product Code | MAE |
| Date Received | 2019-03-14 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT MEDICAL |
| Manufacturer Address | US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2019-03-14 |