MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES AORTIC INTRODUCER SHEATH (DRYSEAL FLEX VER 4.0); INTRODUCER, CATHETER

Catalog Number DSF2233

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Death (1802); Exsanguination (1841); Perforation of Vessels (2135)

Event Date 07/25/2019

Event Type  Death  

Manufacturer Narrative

Multiple attempts were made to obtain the device lot number, and the lot number was unable to be obtained.No device history review was able to be completed.According to the gore® dryseal flex introducer sheath instructions for use (ifu), potential adverse events that may occur and/or require intervention include, but are not limited to, vascular trauma (i.E., rupture or perforation), blood loss, bleeding, and death.

Event Description

On (b)(6) 2019 the patient underwent endovascular repair of a thoracic aortic aneurysm using a gore® dryseal flex sheath as an accessory in the procedure.Two conformable gore® tag® thoracic endoprostheses with active control were being used to treat the thoracic aortic aneurysm.The 22fr.Gore® dryseal flex sheath was advanced on the patient's right side.It was noted that the sheath caught slightly on advancement through the patient's mid-common iliac artery, but advanced without issue.The patient's access vessel was noted to be 7.5mm in diameter.No excessive tortuosity or thrombus was noted.Both conformable gore® tag® thoracic endoprostheses with active control were successfully implanted.No resistance was noted upon advancement of the devices.The devices deployed with no reported issues.The device delivery catheters were removed from the gore® dryseal flex sheath with no reported issues.The gore® dryseal flex sheath was removed.No resistance was noted upon removal.An issue with the patient's blood pressure was noted, and an angiogram was performed.It was reported that the patient's right external iliac artery had ruptured.Blood extravasation was reported.Intermittent chest compressions were performed.A gore® viabahn® endoprosthesis was advanced up and over the patient's aortic bifurcation.The gore® viabahn® endoprosthesis was successfully placed in an attempt to treat the ruptured right external iliac artery.Chest compressions were continued.The patient reportedly expired due to blood loss.The physician reported that the death was not related to the conformable gore® tag® thoracic endoprostheses with active control, and noted that the patient's death was access related.

Manufacturer Narrative

According to the gore® dryseal flex introducer sheath instructions for use (ifu), 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 size is smaller than the introducer sheath outer diameter major bleeding, vessel damage, or serious injury to the patient, including death, may result.The nominal sheath outer diameter for the 22fr.Gore® dryseal flex introducer sheath is 8.3mm, and the reported access vessel was noted to be 7.5mm in diameter.

• Brand Name: AORTIC INTRODUCER SHEATH (DRYSEAL FLEX VER 4.0)
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• Manufacturer (Section G): MEDICAL PHOENIX 1 B/P; 32360 n. north valley parkway; phoenix AZ 85085
• Manufacturer Contact: jenna lopez ; 9285263030
• MDR Report Key: 8928056
• MDR Text Key: 155464951
• Report Number: 3007284313-2019-00260
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160254
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2019
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: DSF2233
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Death
• Patient Age: 86 YR
• Patient Weight: 57