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U.S. Department of Health and Human Services

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

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W. L. GORE & ASSOCIATES, INC. GORE DRYSEAL FLEX INTRODUCER SHEATH INTRODUCER, CATHETER Back to Search Results
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.
 
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Brand NameGORE DRYSEAL FLEX INTRODUCER SHEATH
Type of DeviceINTRODUCER, 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
damon jackson
1505 n. fourth street
flagstaff, AZ 86004
9285263030
MDR Report Key10607327
MDR Text Key209194946
Report Number2017233-2020-01310
Device Sequence Number1
Product Code DYB
UDI-Device Identifier00733132628384
UDI-Public00733132628384
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K160254
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
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 Received09/30/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date10/02/2022
Device Model NumberDSF2265
Device Catalogue NumberDSF2265
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/24/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/03/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 09/30/2020 Patient Sequence Number: 1
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