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 2020-03-23 for AMPLATZER SEPTAL OCCLUDER 9-ASD-008 manufactured by Aga Medical Corporation.
[184662412]
Further information regarding this event has been requested. The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.
Patient Sequence No: 1, Text Type: N, H10
[184662413]
On (b)(6) 2020, a 8mm amplatzer septal occluder (9-asd-008 lot #7017005) was selected for implant to close an asd in the patient. Upon deployment the left atrial disk was "cobra" maligned. The physician tried several different techniques to get the device to deploy but was unsuccessful. The device was resheathed and removed from the patient. The physician exchanged the device for a 8mm amplatzer septal occluder (9-asd-008 lot #7054723) and successfully closed the defect with no problem. There was no clinically significant delay in the procedure and the patient remained hemodynamically stable throughout the procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2135147-2020-00097 |
| MDR Report Key | 9869456 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-23 |
| Date of Report | 2020-03-30 |
| Date of Event | 2020-02-24 |
| Date Mfgr Received | 2020-03-24 |
| Device Manufacturer Date | 2019-05-28 |
| Date Added to Maude | 2020-03-23 |
| 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 | 2020-03-23 |
| Returned To Mfg | 2020-03-16 |
| Model Number | 9-ASD-008 |
| Catalog Number | 9-ASD-008 |
| Lot Number | 7017005 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| 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 | 2020-03-23 |