MAUDE Adverse Event Report: W. L, GORE ASSOC INC. GORE TAG; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Model Number TGU343415

Device Problem Material Fragmentation (1261)

Patient Problems Aneurysm (1708); Rupture (2208); Device Embedded In Tissue or Plaque (3165)

Event Date 01/18/2019

Event Type  malfunction  

Event Description

Emergent surgery for ruptured thoracic aortic aneurysm.Determined later in her stay that likely delivery system (olive tip) of tevar placed emergently during active cpr was retained at the level of aortic bifurcation into the left common iliac artery.No harm.

• Brand Name: GORE TAG
• Type of Device: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W. L, GORE ASSOC INC.
• MDR Report Key: 8464533
• MDR Text Key: 140603711
• Report Number: MW5085320
• 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: Voluntary
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2019
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: TGU343415
• Device Catalogue Number: TGU343415
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 0
• Patient Outcome(s): Other
• Patient Age: 93 YR