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 CRIBRIFORM OCCLUDER 9-ASD-MF-018-US manufactured by Aga Medical Corporation.
[184662000]
An event of embolization of a device implanted in 2013 and off label use of a cribriform device to close a pfo was reported. The results of the investigation are inconclusive since the device remains implanted 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. Please note, per the instructions for use, artmt 600218-010 revision b "contraindications: treatment of patients with patent foramen ovale (pfo) defects. This device has not been studied in patients with pfo defects. "
Patient Sequence No: 1, Text Type: N, H10
[184662001]
On an unknown date in 2013, a 18mm amplatzer asd mf occluder was implanted for a pfo. On an unknown date, the device embolized. There was no indication as to the time frame of the embolization. At the start of the procedure, the device was observed to be in the descending aorta under fluoroscopy. Access was gained via the femoral artery and a 6f gooseneck snare was used to grasp the embolized device. It was then observed under fluoroscopy that the device had epithelialized within the descending aorta tissues and removal of the 18mm asd mf was aborted. The pfo was closed using a 35mm pfo occluder successfully.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2135147-2020-00133 |
| MDR Report Key | 9866473 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-23 |
| Date of Report | 2020-03-23 |
| Date Mfgr Received | 2020-02-24 |
| 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 CRIBRIFORM OCCLUDER |
| Generic Name | TRANSCATHETER SEPTAL OCCLUDER |
| Product Code | MLV |
| Date Received | 2020-03-23 |
| Model Number | 9-ASD-MF-018-US |
| 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 | 2020-03-23 |