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

Device Problem Microbial Contamination of Device (2303)

Patient Problems Bacterial Infection (1735); Ischemia (1942)

Event Date 05/13/2023

Event Type  Injury  

Manufacturer Narrative

D10 concomitant medical products: ore® viabahn® endoprosthesis with propaten bioactive surface.A unique device identification number was not provided, therefore the manufacturing date and/or production details cannot be determined.H6-b13: additional information to the event, the infection, and treatment modalities have been requested from the physician.The answers are captured in section b5.H6-b17 and h3: the physician has sent the explanted device to an independent 3rd party for evaluation.Investigation (macroscopic and microscopic analysis of the explanted vascular graft after cleaning) was performed by the third party.The explanted device was not returned to gore for evaluation.Instead, they provided analysis results to gore, which is being reviewed by gore explant scientists.W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute a legal admission by anyone that the product described in this report has any defects or has malfunctioned, as defined from a legal standpoint.These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.

Event Description

It has been reported to gore that the patient presented with an abdominal aortic aneurysm was treated with a gore® excluder® aaa endoprosthesis on (b)(6) 2023.It remains unknown if apposition/seal of the device to the aortic wall achieved at the completion of the procedure.After the procedure, in (b)(6) 2023, there was a complication at the right puncture site with a positive sample for staphylococcus aureus.It remains unknown if the patient has had a history of pre-existing infection in the field of treatment.The patient was given antibiotic therapy (pyostacine).Reportedly on (b)(6) 2023, a gore® viabahn® endoprosthesis with propaten bioactive surface has been implanted in order to treat a type ib endoleak originating from the right limb (reported to fda with report number 3007284313-2023-02721).On (b)(6) 2023, both devices have been explanted due to an infection.An allograft has been implanted to treat the lesion.Reportedly the explantation procedure was complicated by ischaemia-reperfusion syndrome and haemorrhagic septic shock.Subsequently ischaemic colitis was diagnosed.On (b)(6) 2023 the patient died due to multivisceral failure.

Manufacturer Narrative

B1: the exact onset date of the infection remains unknowns.Therefore the date of the explantation was used was a best estimate.B3: updated event description.Cause investigation and conclusion the physician has sent the explanted devices to an independent 3rd party for evaluation.The 3rd party provided gore with their macroscopic analysis results of the explanted devices.A request was sent to the physician to further clarify details of the implant procedure, serial number of the device, and patient symptoms.The answer is captured in section 3.A unique device identification number was not provided, therefore the manufacturing date and/or production details cannot be determined.No further information was provided neither on details of the implant procedure, nor patient symptoms.The explanted device enabling direct assessment of product performance was not returned to gore for evaluation.Analysis results provided by the 3rd party were reviewed by gore explant scientists instead.The evaluation summary states the following: minimal, scattered red/brown and tan tissue was present on the observable abluminal surfaces of the overlapping devices/fragment.The observable lumens were generally devoid of tissue.However, the lumens were generally unobservable, and the patency of the specimens could not be determined with the information/images provided within the 3rd party analysis report.The distal legs of the system presented in a ballerina configuration.The conlateral leg (clf, presumptive) was contained within and extending from the contralateral gate of the trunk.Clf was transected at the distal extremity.Gore® viabahn® endoprosthesis was contained within the ipsilateral leg of the trunk, with only a small portion extending from the distal aspect of the ipsilateral leg.From gross images all material disruptions (i.E., material transection), appear to be consistent with cutting by sharp surgical instruments (i.E., scalpel or scissors), likely used during the explant procedure.No information was provided to confirm the presence or absence of the reported infection and no determination can be made from the provided information.Based on the incident description and the subsequent investigation, no further information was provided to gore, we are unable to determine the cause of the reported infection and assign a root cause.No potential new or different reasonably foreseeable risks related to the device or its use were identified based on this event.Ongoing risk/benefit assessment affirms risk acceptability based on current performance.No corrective measures are needed as a result of this event.Gore will continue to monitor post-market data closely to ensure that the risk assessment remains accurate.It was reported that after the procedure, in (b)(6) 2023, a complication at the right puncture site has occurred.A positive sample for staphylococcus aureus was taken.The patient was given antibiotic therapy (pyostacine) to treat the infection.No further information was provided to gore.It remains unknown if the patient has had a history of pre-existing infection in the field of treatment.The available information reported in the event description reasonably suggests infection of the incision site during or shortly after the procedure.Infection represents a known complication or adverse event that can occur when using stent-graft endovascular devices and can arise as a result of a multitude of factors, including intraprocedural technical considerations, post-operative follow-up and treatment regimen, and patient-related risk factors.The instructions for use (ifu) for the appropriate region and time-period was reviewed.It states the following: potential device or procedure-related adverse events adverse events that may occur and / or require intervention or additional intraoperative procedure time include, but are not limited to: infection (e.G., aneurysm, device or access sites); wound complications (e.G., infection, dehiscence).

Event Description

It has been reported to gore that the patient presented with an abdominal aortic aneurysm was treated with a gore® excluder® aaa endoprosthesis on (b)(6) 2023.It remains unknown if apposition/seal of the device to the aortic wall achieved at the completion of the procedure.After the procedure, in (b)(6) 2023, there was a complication at the right puncture site with a positive sample for staphylococcus aureus.It remains unknown if the patient has had a history of pre-existing infection in the field of treatment.The patient was given antibiotic therapy (pyostacine).Reportedly on (b)(6) 2023, a gore® viabahn® endoprosthesis with propaten bioactive surface has been implanted in order to treat a type ib endoleak originating from the right limb (reported to fda with report number 3007284313-2023-02721, which was retracted later on).On (b)(6) 2023, both devices have been explanted due to an infection.An allograft has been implanted to treat the lesion.Reportedly the explantation procedure was complicated by ischaemia-reperfusion syndrome and haemorrhagic septic shock.Subsequently ischaemic colitis was diagnosed.On (b)(6) 2023 the patient died due to multivisceral failure.

• 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: sibylle staerk ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 17628920
• MDR Text Key: 322023491
• Report Number: 3007284313-2023-02722
• 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,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/17/2023

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?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/31/2023
• Initial Date FDA Received: 08/27/2023
• Supplement Dates Manufacturer Received: 11/16/2023
• Supplement Dates FDA Received: 11/17/2023
• 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 Age: 71 YR
• Patient Sex: Male