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

Device Problem Contamination (1120)

Patient Problem Unspecified Infection (1930)

Event Date 11/24/2021

Event Type  Injury  

Manufacturer Narrative

The date of incident is unknown.Therefore, the date of which the incident was received from a third party investigator is used as date of event.The medical device returned to a third party for investigation.The analysis report was shared with gore and evaluated appropriately.

Event Description

It was reported to gore that a gore® excluder® aaa endoprostheses was implanted in another center in order to treat an aneurysm (date unknown).On (b)(6) 2021, the endoprosthesis was explanted due to infection.

Manufacturer Narrative

Explant scientist observations from the report provided by third party investigator (geprovas): the abluminal surfaces were generally devoid to tissue with minimal, scattered plaques of red/brown tissue present.A foci of tan/brown tissue was present near the distal aspect of segment 2.The luminal surfaces were generally devoid of tissue, except for minimal red/brown tissue being present.A few segments had areas of dark red tissue accumulation (presumptive sedimented blood) inside of the lumen.All the lumens were widely patent.The first segment consisted of the distal, tapered aspect of a cl.The segment was circumferentially transected at the proximal aspect.Alignment of the proximal edge could not be achieved with any other fragment with the information/images provided.Per geprovas, "some stent crowns are not structured anymore." however, no defects in the stent structure/attachment to the segment were observable by the ei.The second segment was a cl endoprosthesis.No material disruptions were identified.The segment presented with a slight, s-shaped bend.Material disruptions (i.E., transections, stent frame displacement) were consistent with those caused by interaction with surgical instrumentation (i.E., scalpel/scissors, forceps/clamps), which were likely used during the explant process.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.D10: concomitant medical products: gore® excluder® aaa endoprosthesis - stent graft contralateral leg endoprosthesis.Gore® excluder® iliac branch endoprosthesis - stent graft iliac branch component endoprosthesis (x3).Gore® excluder® iliac branch endoprosthesis - stent graft internal iliac component endoprosthesis.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).Corrected h6: removed type of investigation code 4119 - insufficient information available.Updated investigation findings code to 213 - no device problem found.Code 3221 is no longer applicable.Removed investigation conclusions code 11 - conclusion not yet available.

• Brand Name: GORE® EXCLUDER® AAA 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 PHOENIX 2 B/P; 32470 n. north valley parkway; phoenix AZ 85085
• Manufacturer Contact: ida simson ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 12961324
• MDR Text Key: 281926504
• Report Number: 3007284313-2021-01695
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P020004
• 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
• Report Date: 03/03/2022

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: 11/24/2021
• Initial Date FDA Received: 12/08/2021
• Supplement Dates Manufacturer Received: 02/03/2022
• Supplement Dates FDA Received: 03/03/2022
• 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
• Treatment: SEE H10
• Patient Outcome(s): Other
• Patient Age: 74 YR
• Patient Sex: Male