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

Catalog Number	TGU212110
Medical Device Problem Codes	Material Separation (1562); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/15/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The review of the manufacturing paperwork verified that the lot met all pre-release specifications.The device is undergoing an evaluation but has not yet been completed.
Event or Problem Description
On (b)(6) 2019 the patient was being treated for a penetrating aortic ulcer (pau) using a conformable gore® tag® thoracic endoprosthesis.It was reported that the physician used a non-gore (cook) sheath and during removal of the delivery system, the distal olive tip caught the sheath and dislodged.The physician reported resistance in trying to get past the valve in the cook sheath.When the physician pulled against the resistance, the olive tip came off in the sheath.The physician reportedly pushed the wire forward and that dislodged the olive from the sheath and down into the patient¿s groin.Reportedly a cut down instead of percutaneous closure was performed to ensure the olive did not get caught on pre-close sutures.The patient reportedly tolerated the procedure.
Additional Manufacturer Narrative
H.1.Type of reportable event corrected.H.6.Results code 2 updated.H.6.Results code 2: code 213 - the device evaluation showed the following: attempts were made to obtain the device, but the device was not returned so no device evaluation could be performed, and therefore the event description could not be confirmed.The ifu states ¿the gore® tag® thoracic endoprosthesis is only compatible with the gore® dryseal sheath¿ and ¿do not continue advancement or retraction of the guidewire, sheath, or delivery catheter if resistance is felt.¿ therefore the device was not used per the ifu.The device met all pre-release specifications, and there are no capas or ncrs related to olives for this lot.Although a failure mode could not be confirmed with a device evaluation as the device was not returned, the likely failure modes of the olive breakage are use error: user uses incompatible introducer sheath and use error: user uses excessive force through introducer sheath.There is no information to suggest a manufacturing deficiency.H.6.Conclusions code 1 updated.H.6.Conclusions code 1: code 22 - according to the conformable gore® tag® thoracic endoprosthesis instructions for use (ifu), the gore® tag® thoracic endoprosthesis is only compatible with the gore® dryseal sheath.Compatibility with other sheaths has not been established.If an incompatible introducer sheath is used, damage may occur to the endoprosthesis, delivery system, or catheter, which may cause premature or inadvertent deployment, or breakage.Please refer to specific sheath ifu for instructions for use.Furthermore, the ifu states: do not continue advancement or retraction of the guidewire, sheath, or delivery catheter if resistance is felt.Stop and assess the cause of resistance.Vessel, endoprosthesis, or delivery catheter damage may occur.Complications associated with the use of the gore® tag® thoracic endoprosthesis may include, but are not limited to, surgical conversion.
Additional Manufacturer Narrative
D.6.Date implanted corrected.H.6.Conclusions code 2 added.H.6.Conclusions code 2: code 18 - according to the conformable gore® tag® thoracic endoprosthesis instructions for use (ifu), the gore® tag® thoracic endoprosthesis is only compatible with the gore® dryseal sheath.Compatibility with other sheaths has not been established.If an incompatible introducer sheath is used, damage may occur to the endoprosthesis, delivery system, or catheter, which may cause premature or inadvertent deployment, or breakage.Please refer to specific sheath ifu for instructions for use.Furthermore, the ifu states: do not continue advancement or retraction of the guidewire, sheath, or delivery catheter if resistance is felt.Stop and assess the cause of resistance.Vessel, endoprosthesis, or delivery catheter damage may occur.Complications associated with the use of the gore® tag® thoracic endoprosthesis may include, but are not limited to, surgical conversion.

• 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: 9159387
• Report Number: 2017233-2019-00996
• Device Sequence Number: 16594575
• Product Code: MIH
• UDI-Device Identifier: 00733132617777
• UDI-Public: 00733132617777
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/03/2020

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: 11/07/2020
• Device Catalogue Number: TGU212110
• Device Lot Number: 17690232
• 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; Not provided
• Initial Report FDA Received Date: 10/04/2019
• Supplement Report FDA Received Date: 01/03/2020; 01/03/2020
• 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: Required Intervention
• Patient Age: 63 YR