MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-10 for AMPLATZER PFO OCCLUDER 9-PFO-025 manufactured by Aga Medical Corporation.
[183947758]
An event of embolism 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.
Patient Sequence No: 1, Text Type: N, H10
[183947759]
During a pfo procedure, a 9-pfo-025 (lot. 7270612) was placed with delivery 9-itv09f45/80 (lot. 7218636). Following verification of the correct positioning of the device, the device was released. After the release the right disc crossed the septum secundum. It was therefore decided to recapture the device with a 35mm goose neck. Once hooked the device with the goose neck the hooked the device migrated to the left atrium and after a short time it lost contact with the goose neck and migrated to the descending aorta. A right femoral artery access was then taken, a 9-itv12f45/80 (lot. 6284858) was inserted. With a 35mm goose neck the device was recaptured and it was brought in the delivery sheath and removed by the patient. The pfo was then closed by positioning a 9-pfo-035 (lot. 7241144) with delivery 9-itv09f45/80 (lot. 7218636). Following verification of the correct positioning of the device, the device was released. Following release, the device was correctly positioned.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2135147-2020-00069 |
| MDR Report Key | 9813728 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-10 |
| Date of Report | 2020-03-10 |
| Date of Event | 2020-02-17 |
| Date Mfgr Received | 2020-02-17 |
| Device Manufacturer Date | 2019-11-12 |
| Date Added to Maude | 2020-03-10 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | PAMELA YIP |
| Manufacturer Street | 5050 NATHAN LANE N |
| Manufacturer City | PLYMOUTH MN 55442 |
| Manufacturer Country | US |
| Manufacturer Postal | 55442 |
| Manufacturer Phone | 6517565400 |
| Manufacturer G1 | AGA MEDICAL CORPORATION |
| Manufacturer Street | 5050 NATHAN LANE NORTH |
| Manufacturer City | PLYMOUTH MN 55442 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55442 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AMPLATZER PFO OCCLUDER |
| Generic Name | TRANSCATHETER SEPTAL OCCLUDER |
| Product Code | MLV |
| Date Received | 2020-03-10 |
| Model Number | 9-PFO-025 |
| Catalog Number | 9-PFO-025 |
| Lot Number | 7270612 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AGA MEDICAL CORPORATION |
| Manufacturer Address | 5050 NATHAN LANE NORTH PLYMOUTH MN 55442 US 55442 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-10 |