Brand Name | GORE® ACUSEAL VASCULAR GRAFT |
Type of Device | PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER |
Manufacturer (Section D) |
W. L. GORE & ASSOCIATES, INC. |
1505 n. fourth street |
flagstaff AZ 86004 |
|
Manufacturer (Section G) |
MEDICAL WEST B/P |
1505 n. fourth street |
|
flagstaff AZ 86004 |
|
Manufacturer Contact |
heidi
inskeep
|
1505 n. fourth street |
flagstaff, AZ 86004
|
9285263030
|
|
MDR Report Key | 11155992 |
MDR Text Key | 226316914 |
Report Number | 2017233-2021-01594 |
Device Sequence Number | 1 |
Product Code |
DSY
|
Combination Product (y/n) | Y |
Reporter Country Code | IN |
PMA/PMN Number | K130215 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Literature,Company Representative |
Reporter Occupation |
Physician
|
Type of Report
| Initial,Followup,Followup |
Report Date |
11/09/2021 |
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
|
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
01/12/2021
|
Initial Date FDA Received | 01/12/2021 |
Supplement Dates Manufacturer Received | 01/12/2021 11/09/2021
|
Supplement Dates FDA Received | 01/12/2021 11/09/2021
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Is the Device Single Use? |
Yes
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Hospitalization;
Required Intervention;
Other;
|
Patient Age | 79 YR |
Patient Sex | Female |