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

Model Number DSF2233

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hemothorax (1896)

Event Date 02/23/2021

Event Type  Death  

Event Description

The following information was reported to gore: on (b)(6) 2021, this patient underwent emergency endovascular treatment using two gore® tag® conformable thoracic stent grafts with active control system (ctag) for a threatened rupture of a thoracic aneurysm.A gore® dryseal flex introducer sheath (dsf) was used for access.As a concomitant procedure, one arterial debranching was performed.A 22fr dsf was inserted from the right and advanced smoothly.The first ctag ac was deployed distally without reported issues.A stent graft was delivered to the left common carotid artery as chimney device, and the second ctag ac was deployed in a position where the partially uncovered stent intentionally covered the brachiocephalic artery.Blood flow to the brachiocephalic artery was good, but it was suspected that the sleeve of the second ctag ac covered the brachiocephalic artery, so a non-gore stent was deployed in the brachiocephalic artery.It was reported that no endoleak was observed.Access angiography revealed a dissection in the right external iliac artery.A femoro-femoral cross-over bypass was created because the guide wire had been removed and could not be reinserted.It was reported that it took about 90 minutes.The patient tolerated the procedure.About 30 minutes after being transferred to the intensive care unit, the patient exhibited shock, and expired.Echo examination revealed retention in the left thoracic cavity, which was considered to be blood retention from circumstances.It was reported that the cause of death was unknown.No autopsy has been reported.The physician stated as follows; the cause of the death was unknown.Echo examination revealed retention in the left thoracic cavity.However, there was no postoperative endoleak.The fsa stated as follows; in my opinion, the cause of death is unknown, same as the physician.Endoleak could have occurred, but no endoleak was observed on postoperative computer tomography image.Migration in a short period of time might have occurred resulting in endoleak.

Manufacturer Narrative

H.6.Results code 1: 213: a review of the manufacturing records for the device verified the lot met all pre-release specifications.

Manufacturer Narrative

B2: yes to 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
• Manufacturer (Section G): MEDICAL WOODY SPRINGS B/P; 3450 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: heidi inskeep ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 11476196
• MDR Text Key: 239523637
• Report Number: 2017233-2021-01718
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/11/2022
• Device Model Number: DSF2233
• Device Catalogue Number: DSF2233
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/10/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/12/2019
• 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: 91 YR
• Patient Sex: Male