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

Device Problems Contamination (1120); Patient-Device Incompatibility (2682)

Patient Problems Aneurysm (1708); Unspecified Infection (1930)

Event Date 03/24/2021

Event Type  Injury  

Event Description

It was reported to gore that an endoprosthesis was implanted on (b)(6) 2021 in order to treat a rupture of an aortic isthmus.About 6 weeks later, on (b)(6) 2021, the endoprosthesis was explanted due to an infection.A type i endoleak was also noticed.According to the reported information, the surgeon believe the brand and model of the graft being gore® excluder® aaa endoprostheses.Upon closer investigation by gore, the reported endoprosthesis is believed to be a gore® tag® conformable thoracic endoprosthesis.

Manufacturer Narrative

No patient specific details have been provided.Therefore, the patient initials reflect the w.L.Gore internal case number.The exact date of event is unknown, therefore, the date of which the explant took place was used as date of event.The medical device returned to a third party for investigation.The analysis report was shared with gore and will be evaluated appropriately.(b)(4).

Manufacturer Narrative

Explant scientist observations from the report provided by third party investigator (geprovas): the abluminal surface was generally devoid of tissue, except for scattered plaques of tan/brown tissue.Yellow staining (presumptive antiseptic solution) was also present on the abluminal surface.The luminal surface was generally devoid of tissue, except for minimal scattered plaques amounts to tan/brown tissue.The lumen was patent.No material disruptions were identified.A review of the manufacturing records for the device could not be conducted because the serial/lot number remains unknown.Multiple attempts have been made to acquire additional information to classify any possible specific device problem, device identification, and event dates.No additional information has been provided.H6: added investigation conclusions codes 4315 and 22.Per gore® excluder® aaa endoprosthesis instructions for use (ifu), adverse events that may occur and/or require intervention include, but are not limited to: infection (e.G., aneurysm, device or access sites), and endoleak.Corrected b1: selected adverse event.Corrected b3: date of event (b)(6) 2021.Remove d4: unique identifier (udi) # (b)(4) as it was inadvertently entered.Corrected h6: updated investigation findings code to 213 - no device problem found.Code 3233 is no longer applicable.Removed investigation conclusions code 11 - conclusion not yet available.

Manufacturer Narrative

Explant scientist observations from the report provided by third party investigator (geprovas): the device was returned to geprovas for investigation.Submitted in formalin was a conformable gore® tag® thoracic endoprosthesis.Corrected h6: remove health effect - clinical code 1708 as it was inadvertently entered.Added type of investigation code 4119 - insufficient information available.Explanation: the reported complications may be the result of the patient¿s disease progression or disease symptoms, co-morbidities and conditions and surgical technique, however, this is unknown as, despite multiple attempts to obtain further information, no further information has been provided to gore.Corrected ifu statement: per gore® tag® conformable thoracic endoprosthesis instructions for use (ifu), adverse events that may occur and/or require intervention include, but are not limited to: infection (e.G., aneurysm, device or access sites), and endoleak.

• Brand Name: CONFORMABLE GORE® TAG®THORACIC ENDOPROSTHESIS
• Type of Device: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• Manufacturer (Section G): MEDICAL WOODY SPRINGS B/P; 3450 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: ida simson ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 13391912
• MDR Text Key: 288180246
• Report Number: 2017233-2022-02700
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P040043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/05/2022

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/19/2022
• Initial Date FDA Received: 01/31/2022
• Supplement Dates Manufacturer Received: 03/04/2022; 05/04/2022
• Supplement Dates FDA Received: 04/01/2022; 05/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 69 YR
• Patient Sex: Male