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

Catalog Number DSF2465

Device Problems Malposition of Device (2616); Patient Device Interaction Problem (4001)

Patient Problem Obstruction/Occlusion (2422)

Event Date 06/29/2023

Event Type  Injury  

Manufacturer Narrative

H3: code "other" was selected as 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) 2015, this patient underwent an endovascular treatment for an abdominal aortic aneurysm using gore® excluder® aaa endoprosthesis.The patient tolerated the procedure.On (b)(6), 2023, this patient underwent another endovascular treatment for a thoracic descending aortic aneurysm using gore® tag® conformable thoracic stent graft with active control system (ctag ac) and gore® dryseal flex introducer sheath.Two ctag acs were placed as planned.Then, an access site angiography showed a vessel injury in the right external iliac artery (eia).For treatment, an iliac extender component (pll161007j) of excluder was additionally placed.This covered the right internal iliac artery and it was an unplanned coverage of the vessel.Still, there was leakage at the injured site; therefore, another iliac extender (pll161207j) was added distal to the pll161007j.There was a minor endoleak, so ballooning was performed.The endoleak almost disappeared, but there was a type iiia endoleak between the pll161007j which was implanted this time and plc161000j which had been implanted on (b)(6), 2015; therefore, additional contralateral leg (plc181000j) was implanted.The type iiia endoleak disappeared, but minor leakage around the injured site remained; therefore, a gore® viabahn® endoprosthesis was additionally placed distal to the excluder legs.The leakage around the injured site seemed to disappear; however, the physician was not sure about this.As the patient¿s vital signs were stable, the physician judged no additional treatment was needed and the procedure was concluded.The patient tolerated the procedure.In the evening on the same day, the patient developed paraparesis after the procedure.Also, inflammation was observed around the right groin.At the time of this report, the paraparesis was tending to recover by rehabilitation therapy.Reportedly, patient¿s shaggy aorta and unintentional coverage of the right internal iliac artery were possible causes of the paraparesis.

• 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: 17404665
• MDR Text Key: 319842873
• Report Number: 3007284313-2023-02663
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00733132628407
• UDI-Public: 00733132628407
• 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
• Report Date: 07/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: DSF2465
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/29/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/29/2022
• 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: 84 YR
• Patient Sex: Male