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 2020-03-30 for AMPLATZER DUCT OCCLUDER 9-PDA-009 manufactured by Aga Medical Corporation.
[186212528]
An event of? A device premature release with subsequent embolization when attempting to retract the device after it failed to fully occlude the defect was reported. The results of the investigation are inconclusive since the device remains implanted and was not accessible for analysis. The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications. Please note, per the instructions for use artmt100092302 rev. A, "the amplatzer? Duct occluder is a percutaneous, transcatheter occlusion device intended for the nonsurgical closure of a patent ductus arteriosus (pda)," and is not indicated for closure of a ruptured sinus of valsalva aneurysm. This may have contributed to the reported residual shunt. The cause of the device release and subsequent embolization could not be conclusively determined.
Patient Sequence No: 1, Text Type: N, H10
[186212529]
Reference manufacturing report number: 2135147-2020-00140. On (b)(6) 2020, a 16-14 amplatzer duct occluder was selected for implant for a sinus valsalva aneurysm with an 8f/45 torqvue delivery system. After deploying the device and prior to release, the physician was not satisfied with the positioning of the device. The physician attempted to retract the device, but it prematurely released from the delivery system and embolized to the pulmonary artery. A 10f/45 torqvue delivery system was used to retrieve the device without success. The patient was stable when referred to surgery to retrieve the device and close the defect. There were no patient consequences. No additional information.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2135147-2020-00139 |
| MDR Report Key | 9900927 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-30 |
| Date of Event | 2020-03-05 |
| Date Mfgr Received | 2020-03-05 |
| Device Manufacturer Date | 2017-05-18 |
| Date Added to Maude | 2020-03-30 |
| 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 | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AMPLATZER DUCT OCCLUDER |
| Generic Name | TRANSCATHETER SEPTAL OCCLUDER |
| Product Code | MLV |
| Date Received | 2020-03-30 |
| Model Number | 9-PDA-009 |
| Lot Number | 5993660 |
| 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 | 2020-03-30 |