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

Model Number	RLT281414
Medical Device Problem Code	Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/21/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The following information was requested but was not made available: patient weight, medications and comorbidities (b)(4).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 or Problem Description
On (b)(6) 2022, the patient was admitted for treatment of an abdominal aortic aneurysm.As reported, during the procedure a gore® excluder® aaa endoprosthesis, trunk ipsilateral leg component (rlt281414) was used with a 18 fr gore® dryseal flex introducer sheath (dsf).As reported, there was an attempt to push the gore® excluder® aaa endoprosthesis through the sheath but ¿the anchoring pin that holds the reshaping mechanism became dislodged from the white nosecone and pierced the valve of the sheath¿.As reported, the device was removed, and it was noted that the same protrusion that had punctured the valve was extended out from the tip of the catheter.An image of the protrusion was provided for consideration.As reported, an alternate gore® dryseal flex introducer sheath and gore® excluder® aaa endoprosthesis were used to complete the procedure.As reported, the procedure was completed without issue.
Additional Manufacturer Narrative
H1 / h2: type of reportable event (check all that apply) if follow up what type.Serious injury replaced with product malfunction.
Additional Manufacturer Narrative
H6.Code c20, no findings available and h6.Code d15, cause not established.An engineering evaluation of the event was performed.The device evaluation was performed based on an event description as reported to gore and a photo attached to the smartsolve case as the device was not returned for analysis.The evaluation of the photo showed that the lock pin appears to be dislodged from its seating in the leading olive.Based on the findings from this evaluation, the physician¿s observation that ¿the anchoring pin that holds the reshaping mechanism became dislodged from the white nosecone¿ was confirmed.The physician¿s observation that the wire ¿pierced the valve of the sheath¿ could not be confirmed from the provided image.The likely cause for the dislodged lock pin and pierced valve of the sheath could not be determined with the available information.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.B7.The event description was updated to include additional details of the event as communicated.G3/g4.Date received by manufacturer was updated to 30-aug-2022 as evaluation activities were completed in full on this day.H6.Code 3233, results pending completion of investigation was replaced with code c20, no findings available.
Event or Problem Description
On (b)(6), 2022, the patient was admitted for treatment of an abdominal aortic aneurysm.As reported, during the procedure a gore® excluder® aaa endoprosthesis, trunk ipsilateral leg component (rlt281414) was used with a 18 fr gore® dryseal flex introducer sheath (dsf).As reported, there was an attempt to push the gore® excluder® aaa endoprosthesis through the sheath but ¿the anchoring pin that holds the reshaping mechanism became dislodged from the white nosecone and pierced the valve of the sheath¿.Reportedly, the surgical team kept pushing on the gore® excluder® aaa endoprosthesis for a time not realizing what had happened.As reported, the device was removed, and it was noted that the same protrusion that had punctured the valve was extended out from the tip of the catheter.An image of the protrusion was provided for consideration.As reported, there were no clinical issues related to the blood loss.As reported, the sheath was immediately twisted preventing blood loss while the replacement sheath was prepped.As reported, an alternate dsf and rlt281414 were used to complete the procedure.As reported, the procedure was completed without issue.

• Brand Name: GORE® EXCLUDER® AAA ENDOPROSTHESIS
• Common Device Name: 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: breanna cox ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 15060649
• Report Number: 3007284313-2022-02038
• Device Sequence Number: 14835070
• Product Code: MIH
• UDI-Device Identifier: 00733132622535
• UDI-Public: 00733132622535
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/04/2024
• Device Model Number: RLT281414
• Device Catalogue Number: RLT281414
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/21/2022
• Supplement Date Received by Manufacturer: 06/21/2022; 08/30/2022
• Initial Report FDA Received Date: 07/19/2022
• Supplement Report FDA Received Date: 07/19/2022; 08/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/05/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 75 YR
• Patient Sex: Male