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

Catalog Number TGT2610

Device Problem Therapy Delivered to Incorrect Body Area (1508)

Patient Problem No Code Available (3191)

Event Date 11/27/2014

Event Type  Injury  

Event Description

On (b)(6) 2014, the patient was to be implanted with a gore® tag® thoracic endoprosthesis (item#: tgt2610, lot#:11722078) for treatment of a thoracic aortic aneurysm.The tag® device was advanced though a 20fr gore® dryseal sheath (item#:sdv2028, lot#:12837316).According to the report, the tag® device automatically and unintentionally deployed at a location other than intended during advancement.No branch vessels were covered by the deployed device.According to the physician, the unintentional deployment may have been caused by excessive calcification.After considering the patient¿s calcified anatomy and the duration of spinal anaesthesia, the physician opted to end the procedure.

Manufacturer Narrative

The review of the manufacturing records verified that this lot met all pre-release specifications.Per the gore® tag® thoracic endoprosthesis instructions for use (ifu), w.L.Gore & associates recommends additional considerations for patient selection before use of the gore® tag® thoracic endoprosthesis include but are not limited to that the morphology (minimal thrombus, calcium and / or tortuosity) should be compatible with vascular access techniques and accessories.

Manufacturer Narrative

(b)(4).Per the gore® tag® thoracic endoprosthesis instructions for use (ifu), complications associated with the use of the gore® tag® thoracic endoprosthesis may include but are not limited to: endoprosthesis: improper placement.

• Brand Name: GORE® TAG® THORACIC ENDOPROSTHESIS
• Type of Device: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• Manufacturer (Section G): MEDICAL WOODY SPRINGS B/P; 3450 w. kiltie lane; flagstaff AZ 86001
• Manufacturer Contact: helen huang ; 1500 n. 4th street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 4372622
• MDR Text Key: 5288561
• Report Number: 2017233-2014-00683
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: P040043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/07/2015

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
• Device Expiration Date: 07/31/2016
• Device Catalogue Number: TGT2610
• Device Lot Number: 11722078
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/30/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/09/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/23/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 68 YR
• Patient Weight: 50