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

Device Problem Contamination (1120)

Patient Problem Unspecified Infection (1930)

Event Date 11/24/2021

Event Type  Injury  

Event Description

It was reported to gore that a gore® excluder® iliac branch endoprosthesis 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

No patient specific details have been provided.Therefore, the patient initials reflect the w.L.Gore internal case number.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.Information has been requested from the physician regarding event dates, patient information, device identification and more detailed event description.

Manufacturer Narrative

Explant scientist observations from the report provided by third party investigator: the abluminal surfaces were generally devoid to tissue with minimal, scattered plaques of red/brown tissue present.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.Segment 1: the segment was either a segment of a trunk or iliac branch component (ibc) endoprosthesis (unable to distinguish with the information/images provided).The proximal aspect was circumferentially transected, proximal to the area of bifurcation.The ipsilateral leg was circumferentially transected near the distal aspect.Another device segment was present, seated within the ipsilateral leg (unable to distinguish with the information/images provided).An area of stent frame displacement was present on the ipsilateral leg.Segment 2: the segment was either a trunk or ibc endoprosthesis (unable to distinguish with the information/images provided).A partial, transverse transection was present at the proximal aspect.The ipsilateral leg had a slight bend.Segment 3: the segment was either a segment of a trunk or ibc endoprosthesis (unable to distinguish with the information/images provided) with an ie or cl endoprosthesis (unable to distinguish with the information/images provided) seated within and extending from the cl gate.The ipsilateral leg and constraint sleeve were circumferentially transected just distal to the cl gate.Two areas of stent frame displacement were present on the trunk/ibc segment.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 (x2).Gore® excluder® iliac branch endoprosthesis - stent graft iliac branch component endoprosthesis (x2).Gore® excluder® iliac branch endoprosthesis - stent graft internal iliac component endoprosthesis.H6: added investigation conclusions codes 4315 and 22.Per gore® excluder® iliac branch 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® ILIAC BRANCH 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: 12961336
• MDR Text Key: 284290152
• Report Number: 3007284313-2021-01696
• 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