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 2020-03-16 for AMPLATZER SEPTAL OCCLUDER 9-ASD-010 manufactured by Aga Medical Corporation.
[184306946]
The reported event of deformation upon deployment of the 10mm occluder could not be confirmed. A smaller, 8mm, device was then successfully implanted. 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. The instructions for use artmt100116885 rev. A allows for selection of one size larger than the diameter of the defect, consistent with the reported event. Based on the information received, the cause of the reported incident, could not be conclusively determined.
Patient Sequence No: 1, Text Type: N, H10
[184306947]
On (b)(6) 2020, a 10mm amplatzer septal occluder was selected for implant. During deployment a cobra deformation was reported. The occluder was resheathed and removed. A 8mm amplatzer septal occluder was successfully implanted. The procedure was completed without any complications. The patient was reported to be in stable condition.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2135147-2020-00096 |
| MDR Report Key | 9834816 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-16 |
| Date of Report | 2020-03-16 |
| Date of Event | 2020-01-24 |
| Date Mfgr Received | 2020-02-26 |
| Device Manufacturer Date | 2019-08-26 |
| Date Added to Maude | 2020-03-16 |
| 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 | 2020-03-16 |
| Model Number | 9-ASD-010 |
| Catalog Number | 9-ASD-010 |
| Lot Number | 7150613 |
| 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 | 2020-03-16 |