MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-19 for AMPLATZER ADOII AS 4X2MM IDE LONG PKG ST 9-PDA2ASIDE-04-02 manufactured by Aga Medical Corporation.
[139299412]
An event of embolization was reported. The results of this investigation confirmed the device met functional and dimensional specifications when analyzed at (b)(4). The device history record was reviewed to ensure that each manufacturing and inspection operation was performed. The cause of the reported event remains unknown.
Patient Sequence No: 1, Text Type: N, H10
[139299413]
On (b)(6) 2018, a 4/2mm amplatzer duct occluder ii additional size (adoiias) was selected for implant. After the user performed the tug test, the device was released from the delivery cable and the device embolized from the pda to the middle pulmonary artery. The user snared the device to the inferior vena cava and removed the device. During retrieval, the tricuspid valve was injured and echo revealed moderate to severe tricuspid valve regurgitation with a segment of flailing leaflet. The user successfully implanted a 5mm adoiias (b)(4). Possible medical management is planned to reduce tricuspid valve regurgitation and improve forward flow. The user attributes the embolization event to device sizing. Of note, prior to procedure, the patient had low hemocrit and platelets so the patient was given a transfusion prior to procedure and during procedure when prolonged due to event. On (b)(6) 2018, the patient was observed with right bundle branch block (rbbb). Per site, lbbb is not related to device, but to implant procedure. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2135147-2019-00078 |
| MDR Report Key | 8435060 |
| Date Received | 2019-03-19 |
| Date of Report | 2019-03-19 |
| Date of Event | 2018-11-12 |
| Date Mfgr Received | 2019-02-22 |
| Device Manufacturer Date | 2018-07-30 |
| Date Added to Maude | 2019-03-19 |
| 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 | STEPHANIE O' SULLIVAN |
| Manufacturer Street | 5050 NATHAN LANE NORTH |
| 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 | 0 |
| Brand Name | AMPLATZER ADOII AS 4X2MM IDE LONG PKG ST |
| Generic Name | CARDIAC OCCLUDER |
| Product Code | MAE |
| Date Received | 2019-03-19 |
| Model Number | 9-PDA2ASIDE-04-02 |
| Lot Number | 6552079 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| 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. Hospitalization; 2. Required No Informationntervention | 2019-03-19 |