Brand Name | RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM |
Type of Device | STENT, ENDOVASCULAR GRAFT, AORTIC |
Manufacturer (Section D) |
BOLTON MEDICAL, INC. |
799 international parkway |
sunrise FL 33325 |
|
Manufacturer Contact |
megan
indeglia
|
799 international parkway |
sunrise, FL 33325
|
9548389699
|
|
MDR Report Key | 7899422 |
MDR Text Key | 121071643 |
Report Number | 2247858-2018-00165 |
Device Sequence Number | 1 |
Product Code |
MIH
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | P110038 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
09/21/2018 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Expiration Date | 07/04/2019 |
Device Catalogue Number | 28-M338100382490U |
Device Lot Number | 160706208 |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
08/24/2018
|
Initial Date FDA Received | 09/21/2018 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 07/04/2016 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Death;
|
Patient Age | 66 YR |
|
|