MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES AORTIC TAG THORACIC ENDOPROSTHESIS (CTAG); SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Catalog Number	TGU343415
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	01/18/2019
Type of Reportable Event	Malfunction
Event or Problem Description
On april 10, 2019 a medwatch (mw5085320) was sent via email stating, ¿emergent surgery for ruptured thoracic aortic aneurysm.Determined later in her stat that likely delivery system (olive tip) of tevar placed emergently during active cpr was retained at the level of aortic bifurcation into left common iliac artery.No harm.¿ further information provided by the physician stated the patient was initially a ¿stable rupture¿ of taaa, who upon being in the or for a few minutes, with anesthesia preparation, developed over rupture requiring cpr.During the procedure they physician had to rapidly gain access and place the device.The sheath was reported to be one size smaller than ideal, but the device went up without difficulty and was deployed saving her life at that time.It was not recognized at that time that any problem occurred with device removal.The olive tip was recognized one month later on a ct scan.The olive remained in the patient and reportedly did not cause any adverse outcome.
Additional Manufacturer Narrative
H1: updated reportable event to malfunction.

• Brand Name: AORTIC TAG THORACIC ENDOPROSTHESIS (CTAG)
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 8596643
• Report Number: 2017233-2019-00330
• Device Sequence Number: 13862845
• Product Code: MIH
• UDI-Device Identifier: 00733132618156
• UDI-Public: 00733132618156
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P040043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/21/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/18/2021
• Device Catalogue Number: TGU343415
• Device Lot Number: 18316657
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/09/2019
• Supplement Report FDA Received Date: 08/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Weight: 39