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

Catalog Number	DSF1065
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/28/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 was reported to gore: on (b)(6) 2009, the patient underwent an unknown endovascular procedure utilizing gore® excluder® aaa endoprosthesis.On an unknown date, the patient was brought in a for reintervention on the right side where the contralateral leg (pxc141000) was implanted for a type 1b endoleak which was coil embolized then extended distally with a flared limb.On (b)(6) 2025, the patient underwent an endovascular reintervention procedure to treat an common and internal iliac aneurysm utilizing a gore® dryseal flex introducer sheath as an accessory.Reportedly, the main body trunk ipsilateral graft had migrated down by 5cm from the renals leading to a type 1b endoleak on the left contralateral (pxc201400) with aneurysm growth in the common iliac artery (size unknown).Reintervention was done to treat the endoleak with ipsilateral ibe and to preserve the internal iliac artery.During the gore® excluder® iliac branch endoprosthesis (ibe) procedure, a contralateral side up and over the flow divider of the ibe device was done by basically delivering a gore® viabahn® vbx balloon expandable endoprosthesis (vbx) into the distal part of the internal iliac artery.The deployment of all gore devices went well, however, the vbx was not as distal the physician wanted it so physician used a 6x90 cook sheath but at some point while using that, there was a hole in the gore sheath resulting in the wiring becoming unraveled in the distal part of it and breaking into pieces.Then they had to snare it with in-snare to get the parts and physician was able to remove all pieces successfully.While the definitive cause was not established, physician suspects it was the cook sheath that damaged the gore sheath.Procedure was completed and patient is doing.
Additional Manufacturer Narrative
H6: code c19 - a review of the manufacturing records indicated the lot met all pre-release specifications.Engineering evaluation summary: the reported breaking apart of the sheath was confirmed through evaluation of the returned device.The sheath presented with damage in multiple locations, the distal end of the sheath was broken from the sheath not returned, and the sheath¿s reinforcing wire had started to unravel at the distal end.The physician suspected the dryseal sheath interacted with a cook sheath leading to the confirmed damage, but the specific cause for the sheath breaking apart could not be established with the available information.There is insufficient information available for gore to reasonably draw conclusions related to aspects of the event, therefore conclusion code ¿d15: cause not established¿ is being used.Insufficient information may include limited or missing relevant medical records, involvement of multiple implanted devices (including non-gore devices) in the field of treatment, patient non-compliance, and/or a general lack of available detail or specificity related to an adverse event and/or device.".

• 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: jaskaran parhar ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 21713780
• Report Number: 3007284313-2025-03859
• Device Sequence Number: 10010333
• Product Code: DYB
• UDI-Device Identifier: 00733132628261
• UDI-Public: (01)00733132628261(17)250821
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• 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: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/14/2025

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: 08/21/2025
• Device Catalogue Number: DSF1065
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2025
• Supplement Date Received by Manufacturer: 04/29/2025
• Initial Report FDA Received Date: 03/27/2025
• Supplement Report FDA Received Date: 05/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/21/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 83 YR
• Patient Sex: Male