Brand Name | ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG |
Type of Device | MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT |
Manufacturer (Section D) |
COOK INC |
750 daniels way |
bloomington IN 47404 |
|
Manufacturer (Section G) |
COOK INC |
750 daniels way |
|
bloomington IN 47404 |
|
Manufacturer Contact |
jason
crouch
|
750 daniels way |
bloomington, IN 47404
|
8123392235
|
|
MDR Report Key | 19051635 |
MDR Text Key | 339493940 |
Report Number | 1820334-2024-00474 |
Device Sequence Number | 1 |
Product Code |
MIH
|
UDI-Device Identifier | 10827002552422 |
UDI-Public | (01)10827002552422(17)270205(10)15882862 |
Combination Product (y/n) | N |
PMA/PMN Number | P020018 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Other,Foreign,Health Professional,User Facility,Company Representative |
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
04/05/2024 |
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? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | N/A |
Device Catalogue Number | ZSLE-20-74-ZT |
Device Lot Number | 15882862 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
04/02/2024
|
Initial Date FDA Received | 04/05/2024 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 02/05/2024 |
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 |
Treatment | COOK RPN: ZIMB-24-84, LOT 15822305; COOK RPN: ZSLE-16-74-ZT, LOT 15842662 |
Patient Outcome(s) |
Required Intervention;
Hospitalization;
|
Patient Age | 79 YR |
Patient Sex | Male |