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 2020-03-03 for AMPLATZER SEPTAL OCCLUDER 9-ASD-018 manufactured by Aga Medical Corporation.
[183945610]
An event of embolization of the 18mm occluder with subsequent implant of a larger, 24mm device 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 at the time of commercialization. Based on the information received, the device was potentially undersized; however, the extent to which this contributed to the subsequent embolization could not be conclusively determined. Information from the field indicated that the device was removed 1 month after embolization. Please note, per the instructions for use artmt100116885 rev. A, "embolized devices must be removed because they may cause patient harm. Embolized devices should not be withdrawn through intracardiac structures unless they have been collapsed within a sheath. "
Patient Sequence No: 1, Text Type: N, H10
[183945611]
On (b)(6) 2020, an 18 mm amplatzer septal occluder was implanted. The following day, the device embolized to the left atrium. The patient did not present any symptoms. On (b)(6), the physician removed the embolized device percutaneously. On (b)(6), a 24mm amplatzer septal occluder was successfully implanted. The patient is currently stable.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2135147-2020-00087 |
| MDR Report Key | 9783081 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-03 |
| Date of Report | 2020-03-03 |
| Date of Event | 2020-01-04 |
| Date Mfgr Received | 2020-02-04 |
| Device Manufacturer Date | 2019-01-31 |
| Date Added to Maude | 2020-03-03 |
| 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 SEPTAL OCCLUDER |
| Generic Name | TRANSCATHETER SEPTAL OCCLUDER |
| Product Code | MLV |
| Date Received | 2020-03-03 |
| Model Number | 9-ASD-018 |
| Catalog Number | 9-ASD-018 |
| Lot Number | 6837013 |
| 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. Other; 2. Required No Informationntervention | 2020-03-03 |