MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a study report with the FDA on 2019-11-29 for AORTIC TAG THORACIC ENDOPROSTHESIS (CTAG WITH ACTIVE CONTROL) TGM373720E manufactured by W.l. Gore & Associates.
[168443838]
The review of the manufacturing paperwork verified that this lot met all pre-release specifications.
Patient Sequence No: 1, Text Type: N, H10
[168443839]
It was reported that on (b)(6) 2018, the patient presented with a descending thoracic aneurysm with a local dissection and was treated with two gore? Tag? Conformable thoracic stent grafts with active control system. On (b)(6) 2018, a small type ii endoleak from a small thyrocervical trunk vessel was identified. The vessel was coiled without complications and the endoleak successfully solved.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2017233-2019-01195 |
| MDR Report Key | 9391787 |
| Report Source | STUDY |
| Date Received | 2019-11-29 |
| Date of Report | 2019-10-31 |
| Date of Event | 2018-10-27 |
| Device Manufacturer Date | 2018-04-05 |
| Date Added to Maude | 2019-11-29 |
| 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 | JOERG KERSTEN |
| Manufacturer Street | 1500 N. 4TH STREET |
| Manufacturer City | AZ |
| Manufacturer Phone | 9285263030 |
| Manufacturer G1 | MEDICAL WOODY SPRINGS B/P |
| Manufacturer Street | 3450 W. KILTIE LANE |
| Manufacturer City | FLAGSTAFF AZ 86005 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 86005 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AORTIC TAG THORACIC ENDOPROSTHESIS (CTAG WITH ACTIVE CONTROL) |
| Generic Name | SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT |
| Product Code | MIH |
| Date Received | 2019-11-29 |
| Catalog Number | TGM373720E |
| Lot Number | 18065838 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | W.L. GORE & ASSOCIATES |
| Manufacturer Address | FLAGSTAFF AZ |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-11-29 |