Brand Name | ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT DISTAL BIFURCATED BODY |
Type of Device | MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT |
Manufacturer (Section D) |
WILLIAM A. COOK AUSTRALIA, PTY LTD |
95 brandl street |
eight mile plains |
brisbane QLD 4 113 |
AS QLD 4113 |
|
MDR Report Key | 15284573 |
MDR Text Key | 298505527 |
Report Number | 3005580113-2022-00094 |
Device Sequence Number | 1 |
Product Code |
MIH
|
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Distributor
|
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
08/24/2022 |
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 Catalogue Number | ZFEN-D-12-28-76-C |
Device Lot Number | UNKNOWN |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
Yes
|
Date Report Sent to FDA | 08/24/2022 |
Distributor Facility Aware Date | 07/31/2022 |
Event Location |
Hospital
|
Date Report to Manufacturer | 08/23/2022 |
Initial Date Manufacturer Received |
Not provided |
Initial Date FDA Received | 08/24/2022 |
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) |
Required Intervention;
|
Patient Age | 70 MO |
Patient Sex | Female |
|
|