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 2019-04-12 for AMPLATZER DUCT OCCLUDER 9-PDA-006 manufactured by Aga Medical Corporation.
[141915801]
Acute ascending aortic dissection was reported in an article. In a retrospective review, the amplatzer duct occluder "may have been slightly deformed. " the results of the investigation are inconclusive since the device was not returned for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. According to the article, other contributing factors may have been "damage to the aortic wall due to the aortic side of the device, uneven elasticity of the arterial wall, and uncontrolled excessively high blood pressure. "
Patient Sequence No: 1, Text Type: N, H10
[141915802]
The following was published in the journal of cardiology in an article titled: "acute ascending aortic dissection due to transcatheter patent ductus arteriosus closure in the elderly: an extremely rare complication of transcatheter patent ductus arteriosus closure. " a (b)(6) woman with a pda with focal calcification at the aortic orifice of the ampulla with a minimum diameter of 4. 0 mm and length of 14. 8 mm, was treated with a 10/8-mm amplatzer duct occluder (ado) (st. Jude medical corp, st. Paul, mn, usa). After device implantation, systolic blood pressure (bp) increased to approximately 220 mmhg from 130 mmhg. She experienced transient dyspnea from hypertensive heart failure, which improved through continuous infusion of antihypertensive agents. She suddenly felt pressure on her chest 12 h post-procedure and collapsed. Surgical thoracotomy revealed an ascending aortic dissection into the pericardial space. In retrospective review, the ado may have been slightly deformed by fluoroscopy. The complication may have been triggered by the resilience caused by device deformation, damage to the aortic wall due to the aortic side of the device, uneven elasticity of the arterial wall, and uncontrolled excessively high blood pressure. Ascending aortic replacement was performed and she recovered without neurological deficits. Yamamoto h, shinke t, otake h, tanaka h, matsumoto k, hirata k-i. "acute ascending aortic dissection due to transcatheter patent ductus arteriosus closure in the elderly: an extremely rare complication of transcatheter patent ductus arteriosus closure. " journal of cardiology cases. Doi:10. 1016/j. Jccase. 2018. 12. 002.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2135147-2019-00101 |
| MDR Report Key | 8511878 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-04-12 |
| Date of Report | 2019-04-12 |
| Date Mfgr Received | 2019-03-26 |
| Date Added to Maude | 2019-04-12 |
| 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 | 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 | 3 |
| Brand Name | AMPLATZER DUCT OCCLUDER |
| Generic Name | OCCLUDER, PATENT DUCTUS, ARTERIOSUS |
| Product Code | MAE |
| Date Received | 2019-04-12 |
| Model Number | 9-PDA-006 |
| 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 | 2019-04-12 |