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

Model Number DSF2233

Device Problems Malposition of Device (2616); Patient-Device Incompatibility (2682)

Patient Problems Obstruction/Occlusion (2422); Vascular Dissection (3160)

Event Date 11/11/2022

Event Type  Injury  

Manufacturer Narrative

The medical device was discarded at facility.Return not possible.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

On (b)(6) 2022, this patient underwent emergency endovascular treatment using gore® dryseal flex introducer sheath (dsf) and gore® tag® conformable thoracic stent graft with active control system for ruptured aortic arch aneurysm.It was suspect the aneurysm was infected.An attempt was made to insert the dsf through the right common femoral artery, but it was not able to be inserted.The dsf was inserted through the right external iliac artery, and strong resistance was noted.The stent graft was deployed without reported issues.Local dissection was suspected in the right common iliac artery, so gore® viabahn® vbx balloon expandable endoprosthesis (vbx) was deployed from the common iliac artery to the external iliac artery.The right internal iliac artery was intentionally covered by vbx.Since the external iliac artery and the common femoral artery may have been damaged, it was replaced with artificial blood vessel.A distal portion of the vbx was cut and directly anastomosed with the artificial blood vessel.Since the pinched part by the forceps of vbx was compressed, it was re-expanded with a balloon.The patient tolerated the procedure.

Manufacturer Narrative

Emdr section h6 c and d codes updated to reflect investigation findings, code b14 added.

• 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: samir kulovic ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 15951024
• MDR Text Key: 305174840
• Report Number: 3007284313-2022-02255
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00733132630073
• UDI-Public: 00733132630073
• 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: 03/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: DSF2233
• Device Catalogue Number: DSF2233
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/08/2022
• 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): Required Intervention
• Patient Age: 79 YR
• Patient Sex: Female