MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-29 for AMPLATZER SEPTAL OCCLUDER 9-ASD-016 manufactured by Aga Medical Corporation.
[185441060]
An event of the occluder appearing "constrained" while deployed and the septum and deploying deformed outside the body was reported. The investigation confirmed the device met functional and dimensional specifications when analyzed at abbott. The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications. The cause of the reported incident could not be conclusively determined.
Patient Sequence No: 1, Text Type: N, H10
[185441061]
On (b)(6) 2020, a 16mm asd device was advanced in usual fashion to the inter atrial septum after balloon sizing revealed a 15mm asd. The device was deployed on the septum however the occluder appeared to be constrained while deployed correctly on the inter atrial septum. The device was recaptured and removed and exchanged for a 14mm asd device which was subsequently deployed successfully and released and remains implanted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2135147-2020-00127 |
| MDR Report Key | 9895068 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-29 |
| Date of Report | 2020-03-29 |
| Date of Event | 2020-03-05 |
| Date Mfgr Received | 2020-03-05 |
| Device Manufacturer Date | 2019-07-05 |
| Date Added to Maude | 2020-03-29 |
| 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 |
| Remedial Action | RL |
| 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 | 2020-03-29 |
| Returned To Mfg | 2020-03-12 |
| Model Number | 9-ASD-016 |
| Catalog Number | 9-ASD-016 |
| Lot Number | 7076148 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| 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 | 2020-03-29 |