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 2020-03-17 for AORTIC VALVE GRAFT 502AG29 manufactured by Medtronic, Inc..
[183753607]
Product analysis: the product remains implanted; therefore, no product was returned. Conclusion: without the return of the product, no definitive conclusion can be made regarding the clinical observation. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[183753608]
Medtronic received information that during the implant of this 29mm aortic mechanical valved conduit as part of a bentall procedure, it was reported that the case was complex and took more time than usual. At the latter part of the procedure, the surgeon reported that the graft hemashield was porous and this does not occur in more straightforward cases. A reoperation was performed on the same day to perform hemostasis. No additional adverse patient effects were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008592544-2020-00020 |
| MDR Report Key | 9842993 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-17 |
| Date of Report | 2020-03-17 |
| Date of Event | 2019-11-18 |
| Date Mfgr Received | 2020-03-03 |
| Device Manufacturer Date | 2014-08-14 |
| Date Added to Maude | 2020-03-17 |
| 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 | AORTIC VALVE GRAFT |
| Generic Name | HEART-VALVE, MECHANICAL |
| Product Code | LWQ |
| Date Received | 2020-03-17 |
| Model Number | 502AG29 |
| Catalog Number | 502AG29 |
| Device Expiration Date | 2019-08-13 |
| 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 | 2020-03-17 |