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

Catalog Number DSF2233

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Perforation of Vessels (2135); Stenosis (2263)

Event Date 02/05/2024

Event Type  Injury  

Event Description

The following information was reported to gore: on (b)(6) 2024, this patient underwent an endovascular treatment for a thoracic aneurysm with chronic type b dissection using a gore® tag® conformable thoracic stent graft with active control system and a gore® dryseal flex introducer sheath as an accessory.Tavi (transcatheter aortic valve implantation) was also performed at the same endovascular treatment.A 22 fr sheath was inserted from the right common femoral artery.During the insertion, resistance was noted at the right external iliac artery.Access angiography confirmed an access vessel injury in the right external iliac artery.As a treatment, a gore® viabahn® endoprosthesis with heparin bioactive surface (vsx 9 x 10 cm) was implanted.The 22 fr sheath was attempted to reinsert, but it went through only up to the right external iliac artery.Another non-gore sheath was used as a replacement, and a ctagac was implanted in the thoracic aorta.After the placement, a proximal type i endoleak was observed, but the patient was decided to be monitored.Access angiography showed residual extravascular leakage at the right external iliac artery.An additional vsx (9 x 5 cm) was implanted in the distal side for hemostasis.A puncture site stenosis at the right access site was also confirmed and it was repaired surgically.The patient tolerated the procedure.Reportedly the right access vessel diameters measured about 7.1-8.4 mm.

Manufacturer Narrative

H.6:investigation findings code c19: a review of manufacturing records verified that the lot involved in this complaint met all pre-release specifications.As reported by (b)(6) the lot met all pre-release specifications.H.6: type of investigation: code b15: as reported by (b)(6) the lot met all pre-release specifications.H.6.: type of investigation: b14: the device was discarded at the treating facility and was therefore not available for analysis.H.6.: investigation conclusions: code d12 and d1102: according to the gore® dryseal flex introducer sheath instructions for use, the ifu caution: do not continue advancement or retraction of the catheter or other device into or out of the sheath if there is resistance.Determine the cause of resistance before proceeding.According to the gore® dryseal flex sheath instructions for use, adverse events with may occur and/or require intervention including, but not limited to, vascular trauma.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.

• 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 86001 ; 9285263030
• MDR Report Key: 18813192
• MDR Text Key: 336619154
• Report Number: 3007284313-2024-03072
• Device Sequence Number: 1
• Product Code: DYB
• 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: 02/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/29/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: DSF2233
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/05/2024
• Date Device Manufactured: 10/06/2023
• 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): Required Intervention
• Patient Age: 80 YR
• Patient Sex: Female