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

Catalog Number DSF2433

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

Patient Problems Aneurysm (1708); Death (1802)

Event Date 08/23/2019

Event Type  Death  

Manufacturer Narrative

A review of the manufacturing records for the device verified the lot met all pre-release specifications.According to the gore® dryseal flex 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 is not adequate for access, major bleeding, vessel damage, or serious injury to the patient, including death, may result.

Event Description

The following was reported to gore: on (b)(6) 2019, the patient underwent endovascular repair of a thoracic aortic aneurysm.During the procedure, a 24-fr gore® dryseal flex introducer sheath (dsf2433/20368042) was used.The sheath was inserted from the left femoral artery.After all stent grafts were placed, the sheath was withdrawn.During the withdrawal, the left external iliac artery/ left femoral artery ruptured.A stent graft was placed in the ruptured site, however, bleeding (amount unknown) was not resolved.Therefore, abdominal aorta was occluded with a balloon to block blood flow into the ruptured vessel.The rupture was repaired surgically, but it took a bit of time for the surgical treatment.During the treatment, the patient became shock disease and cardiac arrest was caused.Cardiac massage was performed while repairing the ruptured vessel.Bleeding was resolved but heart rate was not recovered.The physician gave up keeping the procedure and the patient was transferred to an intensive care unit (icu).The patient expired in the icu on the same day.It was reported that the physician thought there was a risk of access vessel rupture before the procedure since outer diameter of the 24fr sheath was 8.8mm and diameter of the left external iliac artery was around 7mm to 8mm.

• 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: angela brown ; 1500 n. 4th street; 9285263030
• MDR Report Key: 9096286
• MDR Text Key: 159310045
• Report Number: 3007284313-2019-00290
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00733132630950
• UDI-Public: 00733132630950
• 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: company representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2019
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/03/2022
• Device Catalogue Number: DSF2433
• Device Lot Number: 20368042
• 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
• Date Device Manufactured: 02/04/2019
• 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: 77 YR