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

Catalog Number DSF1633

Device Problems Positioning Failure (1158); Insufficient Information (3190)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 11/28/2023

Event Type  Injury  

Manufacturer Narrative

H.6.: code b22: results pending completion of investigation.H.6.: code c21: results pending completion of investigation.H.6.: d16: conclusion not yet available.H.6.: code a26: results pending completion of investigation.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

The following information was reported to gore: on (b)(6) 2023, this patient underwent an endovascular treatment for an abdominal aortic aneurysm and iliac artery aneurysms using gore® excluder® aaa endoprostheses, gore® excluder® iliac branch endoprostheses and gore® dryseal flex introducer sheaths as accessories.A 16fr sheath was inserted through the right femoral artery and an iliac branch component (ibc) was placed in the right common iliac artery.During cannulation from the contralateral side into the right internal iliac artery, a blood leakage was observed from the sheath and the dry seal valve was found to be damaged.It was handled by twisting the valve and the procedure was continued.After placement of an internal iliac component (iic) in the right internal iliac artery, the guidewire became tangled, and the first iic migrated 3cm distally when a second iic was attempted to be placed on the distal side.The second iic could no longer be inserted and was temporarily removed.An attempt was made to raise the first iic with a balloon but unsuccessful.The second iic was accidentally defiled after removal.Two gore® viabahn® vbx balloon expandable endoprostheses were implanted proximally and distally one by one.A blood transfusion was performed since it took a while for ibe placement and the blood leakage occurred from the dry seal valve.After placement of the contralateral leg in the left external iliac artery, the distal side was pulled into the aneurysm and migrated.An additional stent graft was implanted as a treatment.The procedure was completed without endoleak.

Manufacturer Narrative

H.6.: code a26 updated to a150201 h.6.Type of investigation code b22 updated to code b14, b15 with completion of phr review and imaging evaluation.H.6.Investigation findings: code c21 updated to code c19 with completion of phr review and engineering evaluation.H.6.Investigation conclusions: code d16 updated to code d15 and d12 according to the gore® dryseal flex sheath instructions for use, adverse events with may occur and/or require intervention including, but not limited to: blood loss, bleeding, hematoma.H.6.: code b01: the device evaluation showed the following: the engineering evaluation confirmed the dryseal valve does not hold pressure.The root cause of the valve leakage was found to be a tear in the gore® dryseal (gds) film tube.The root cause of the gds film tube tear could not be confirmed with the available information.

• Brand Name: GORE® DRYSEAL FLEX INTRODUCER SHEATH
• Type of Device: 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: 18387299
• MDR Text Key: 331287817
• Report Number: 3007284313-2023-02977
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00733132630028
• UDI-Public: 00733132630028
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K160254
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: DSF1633
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/02/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/10/2023
• 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
• Patient Outcome(s): Other
• Patient Age: 83 YR
• Patient Sex: Female