MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE® DRYSEAL FLEX INTRODUCER SHEATH; INTRODUCER, CATHETER

Catalog Number	DSF1245
Medical Device Problem Code	Unintended Collision (1429)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Hypovolemic Shock (1917)
Date of Event	09/06/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H.6 code b13: a review of the manufacturing records indicated the device met pre-release specifications.H.6 code b14: the device remains implanted and was therefore not available for engineering evaluation.H.6.: code c19: a review of manufacturing records verified that the lot involved in this complaint met all pre-release specifications.H.6.: code b20: device remains implanted and therefore not available for direct analysis.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
The following information was reported to gore: on (b)(6) 2023, this patient underwent an endovascular treatment for abdominal aortic aneurysm using gore® excluder® conformable aaa endoprosthesis with active control system (excc), gore® excluder® aaa endoprosthesis and gore® excluder® iliac branch endoprosthesis (ibe).Instead of internal iliac component of ibe, gore® viabahn® vbx balloon expandable endoprosthesis (vbx) was used.When delivering the vbx, a guidewire fell out from the internal iliac artery, therefore, the physician attempted to withdraw the vbx once to advance the guidewire again.The delivery catheter was removed from the patient, but the physician noticed that the constrained stent graft was dislodged inside the patient.It was found in the trunk of excc.Therefore, the physician attempted to remove the dislodged stent graft by a snare catheter; however, the attempt failed.In addition, the snare catheter caused damage on the valve of gore® dryseal flex introducer sheath, resulting in massive bleeding (approximately 1 l) from the valve and the patient fell into shock vitals.The damaged sheath was removed and another one was inserted.An occlusion balloon was inflated in the aorta and blood transfusion was performed.The patient¿s blood pressure stabilized.An aortic extender component was deployed to repair the dislodged vbx inside the aorta.Thereafter, another vbx device was implanted in the internal iliac artery successfully.The patient tolerated the procedure.The reporting physician commented as follows: the vbx was dislodged inside the 12 fr sheath at angulated site.
Additional Manufacturer Narrative
H.6.: type of investigation: b14: the device was discarded at the treating facility and was therefore not available for analysis.H.6.: type of investigation: b20: the device was discarded at the treating facility and was therefore not available for analysis.

• Brand Name: GORE® DRYSEAL FLEX INTRODUCER SHEATH
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• Manufacturer (Section G): MEDICAL PHOENIX 1 B/P; 32360 n. north valley parkway; phoenix AZ 85085
• Manufacturer Contact: kathryn irwin ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 17865217
• Report Number: 3007284313-2023-02797
• Device Sequence Number: 17624682
• Product Code: DYB
• UDI-Device Identifier: 00733132628117
• UDI-Public: 00733132628117
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K160254
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/04/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/27/2025
• Device Catalogue Number: DSF1245
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/06/2023
• Supplement Date Received by Manufacturer: 10/04/2023
• Initial Report FDA Received Date: 10/03/2023
• Supplement Report FDA Received Date: 10/04/2023
• Date Device Manufactured: 04/27/2023
• 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: 79 YR
• Patient Sex: Male