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 2020-03-12 for AMPLATZER PICCOLO OCCLUDER 9-PDAP-05-04-L manufactured by Aga Medical Corporation.
[183949427]
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
[183949428]
On (b)(6) 2019, a 5/4mm amplatzer piccolo occluder was implanted in a pda (patent ductus arteriosus) that was 12mm long with minimal diameter of 3. 2mm at the pulmonic end and a dieter of ranging from 2. 8mm to 4mm on echocardiogram in a premature infant weighing (b)(6) kg. During the first deployment, the device dropped into the lpa; the device was recapture and a second deployment was performed. After the second deployment the device was released however, the device dropped into the lpa and the physician decided to not try to retrieve and reposition the device. Post procedure increase gradient was reported but 6 weeks post procedure the gradient had decreased. The patient was reported to be in stable condition and the physician will continue to monitor. Additional information was requested but cannot be obtained.
Patient Sequence No: 1, Text Type: D, B5
[184391882]
An event of protrusion into the left pulmonary artery causing an increased gradient 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. Measurements were received from the field. Based solely on the measurements provided, the correct size device per instructions for use (ifu) arten600042307 ver. A, table t3 was 9-pdap-04-02-l. This oversizing of the device may have contributed to the reported event. Please note, per the ifu, "for small infants (=2 kg), the length of the occluder may be shorter than the length of the pda to minimize the potential for protrusion into the aorta or left pulmonary artery. For small infants, find the appropriate occluder size in t3. For small infants, the occluder is chosen so that the entire device including the retention discs is implanted within the duct (intraductal placement). "
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2135147-2020-00111 |
| MDR Report Key | 9825527 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-12 |
| Date of Report | 2020-03-19 |
| Date Mfgr Received | 2020-03-17 |
| Date Added to Maude | 2020-03-12 |
| 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 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AMPLATZER PICCOLO OCCLUDER |
| Generic Name | TRANSCATHETER SEPTAL OCCLUDER |
| Product Code | MLV |
| Date Received | 2020-03-12 |
| Model Number | 9-PDAP-05-04-L |
| Catalog Number | 9-PDAP-05-04-L |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2020-03-12 |