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

Model Number DSF2265

Device Problems Improper or Incorrect Procedure or Method (2017); Patient-Device Incompatibility (2682); Difficult to Advance (2920)

Patient Problems Death (1802); Embolism (1829); No Code Available (3191)

Event Date 08/30/2020

Event Type  Death  

Manufacturer Narrative

Please note: the gore® tag® thoracic endoprostheses in this event have been reported separately on mfr report #2017233-2020-01309.It should be noted that the gore® dryseal flex introducer sheath instructions for use (ifu) states ¿adequate vessel access is required to introduce the sheath into the vasculature.Careful evaluation of vessel size, anatomy, tortuosity, and disease state (including calcification, plaque, and thrombus) is required to ensure successful sheath introduction and subsequent withdrawal.If vessel is not adequate for access, major bleeding, vessel damage, or serious injury to the patient, including death, may result.¿ per the gore® dryseal flex introducer sheath ifu, adverse events that may occur and / or require intervention include, but are not limited to embolization (micro or macro) with transient or permanent ischemia, and death.

Event Description

On (b)(6) 2020, the patient underwent endovascular treatment of a thoracic aortic aneurysm using a gore® tag® conformable thoracic endoprosthesis, gore® tag® conformable thoracic stent graft with active control system, and a gore® dryseal flex introducer sheath.The ¿pull-through¿ technique between the right brachial artery and the left common femoral artery was used because the site of the existing elephant trunk graft in the transverse aorta was severely tortuous.Percutaneous transluminal angioplasty (pta) was performed to the left common femoral artery because the access vessel was reportedly calcified.The 22fr sheath was advanced from the left common femoral artery up to the level of the elephant trunk, but reportedly would not cross the anastomosis site due to vessel tortuosity.According to the report, the gore® tag® conformable thoracic stent graft with active control system was advanced outside the sheath and was successfully navigated through the anastomosis site.The gore® tag® conformable thoracic stent graft with active control system was implanted successfully at the target location.The gore® tag® conformable thoracic endoprosthesis was then successfully implanted distally.The procedure was concluded without any further reported complications.The patient tolerated the procedure.On (b)(6) 2020, the patient¿s condition reportedly declined.It was reported the patient¿s blood pressure and breathing were not able to be controlled.On(b)(6) 2020, follow-up ct imaging reportedly revealed occlusion of the left hepatic artery, splenic infarction, and stenosis of a hemodialysis shunt in the left arm.On (b)(6) 2020, the patient expired due to multiple organ failure.According to the physician, manipulation of the sheath with excessive force across the anastomosis site may have caused an embolic shower; however, this opinion could not be verified by ct imaging or blood examination.

Manufacturer Narrative

G5: added pma/510(k) number; h6: results and conclusion coding updated; h6: code 213 ¿ a review of the manufacturing records for the device verified that the lot met all pre-release specifications.It should be noted that the gore® dryseal flex introducer sheath instructions for use (ifu) states ¿adequate vessel access is required to introduce the sheath into the vasculature.Careful evaluation of vessel size, anatomy, tortuosity, and disease state (including calcification, plaque, and thrombus is required to ensure successful sheath introduction and subsequent withdrawal.If vessel is not adequate for access, major bleeding, vessel damage, or serious injury to the patient, including death, may result.¿ per the gore® dryseal flex introducer sheath ifu, adverse events that may occur and / or require intervention include, but are not limited to embolization (micro or macro) with transient or permanent ischemia, and death.

• 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
• MDR Report Key: 10607327
• MDR Text Key: 209194946
• Report Number: 2017233-2020-01310
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00733132628384
• UDI-Public: 00733132628384
• Combination Product (y/n): N
• PMA/PMN Number: K160254
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 11/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/02/2022
• Device Model Number: DSF2265
• Device Catalogue Number: DSF2265
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 79 YR