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 2020-03-29 for OPEN PIVOT STANDARD AORTIC HEART VALVE 500FA manufactured by Medtronic, Inc..
[185605206]
Citation: agrawal am et al. Intraoperative right coronary artery obstruction due to aortic root prosthesis mismatch after aortic valve replacement? A case report. Journal of cardiac surgery. 2019; 34:1396-1398. Doi: 10. 1111/jocs. 14227 earliest date of publish used for event date. No unique device identifier (serial/lot) numbers were provided; without this information it could not be determined whether these observations have been previously reported. Without return of the product no definitive conclusion can be made regarding the clinical observations. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[185605207]
Medtronic received information via literature regarding a (b)(6)-year-old female patient with severe aortic stenosis, an aortic orifice area of 0. 6cm? , and a peak gradient of 94mmhg who underwent implant of an 18mm medtronic open pivot mechanical aortic valve. No serial numbers were provided. Upon removing the patient from cardiopulmonary bypass (cpb), there was right ventricle distension and coronary artery ostial occlusion caused by patient-prosthesis mismatch. A saphenous vein graft was anastomosed to the proximal right coronary artery to correct the occlusion. No additional adverse patient effects or product performance issues were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008592544-2020-00026 |
| MDR Report Key | 9896187 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-29 |
| Date of Report | 2020-03-29 |
| Date of Event | 2019-08-23 |
| Date Mfgr Received | 2020-03-13 |
| Date Added to Maude | 2020-03-29 |
| 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 | PAULA BIXBY |
| Manufacturer Street | 8200 CORAL SEA STREET NE |
| Manufacturer City | MOUNDS VIEW MN 55112 |
| Manufacturer Country | US |
| Manufacturer Postal | 55112 |
| Manufacturer Phone | 7635055378 |
| Manufacturer G1 | MEDTRONIC, INC. |
| Manufacturer Street | 3800 ANNAPOLIS LANE |
| Manufacturer City | MINNEAPOLIS MN 55447 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55447 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OPEN PIVOT STANDARD AORTIC HEART VALVE |
| Generic Name | HEART-VALVE, MECHANICAL |
| Product Code | LWQ |
| Date Received | 2020-03-29 |
| Model Number | 500FA |
| Catalog Number | 500FA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC, INC. |
| Manufacturer Address | 3800 ANNAPOLIS LANE MINNEAPOLIS MN 55447 US 55447 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-29 |