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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 DSF2433
Device Problems Malposition of Device (2616); Patient Device Interaction Problem (4001)
Patient Problems Rupture (2208); Obstruction/Occlusion (2422); Vascular Dissection (3160)
Event Date 04/15/2022
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
The following was reported to gore: on an unknown date, the patient underwent an endovascular treatment of a thoracic aortic aneurysm using gore® tag® conformable thoracic endoprosthesis. On an unknown date, a proximal type i endoleak and an aneurysm enlargement (amount unknown) were observed. On (b)(6) 2022, a reintervention was performed to treat the proximal type i endoleak and the aneurysm enlargement. A gore® dryseal flex introducer sheath (24fr) was inserted from the left femoral artery. Then, a gore® tag® conformable thoracic stent graft with active control system (tgm454515j) was implanted proximally of the initial gore® tag® conformable thoracic endoprosthesis. The left subclavian artery was embolized as planned. After touch-up ballooning, an angiography revealed the proximal type i endoleak remained slightly. The physician decided to monitor it. Above information is captured in (b)(4). Upon the confirmation of the access site, a rupture of the left common iliac artery (cia) was observed. A gore® excluder® aaa endoprosthesis (iliac extender endoprosthesis) was implanted from the origin of the left cia with covering the left internal iliac artery. And a stent (smart) was implanted distally. After access site closure, the patient blood pressure decreased and the pulse of the right limb was weak. An echo and an angiography revealed a dissection and/or rupture in the thoracic aorta where the distal of the initial implanted gore® tag® conformable thoracic endoprosthesis. A gore® tag® conformable thoracic stent graft with active control system (31mm x 200mm) was implanted distally. An autologous blood recovery system (cell saver) was used. An angiography for peripheral vessel revealed that the blood flow of the left superficial femoral artery (sfa) was not able to be confirmed. A gore® viabahn® endoprosthesis was implanted in the left sfa and a touch-up ballooning was performed, then the blood flow was improved. When the access site was attempted to close again, but the pulse of the left limb was weak, so the angiography was performed. The angiography revealed that the blood flow of the sfa to external iliac artery was not able to be observed due to a possible dissection and/or thrombus scattered. Two stents (smart) were implanted from the gore® viabahn® endoprosthesis to proximal. After poba, it was confirmed the blood flow was well. The procedure was concluded and the patient tolerated the procedure. The physician stated below. The initial gore® tag® conformable thoracic endoprosthesis had been implanted in just above tortuous site. It is possible that the catheter of the tgm454515j injured the descending aorta, during the when a leading olive of the tgm454515j caught on the initial gore® tag® conformable thoracic endoprosthesis and there was difficulty to pass through the initial device. Regarding the peripheral vessel, the left cia rupture occurred when the 24fr sheath was advanced. However, it was not sure about the possible peripheral artery dissection.
 
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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 PHOENIX 1 B/P
32360 n. north valley parkway
phoenix AZ 85085
Manufacturer Contact
samir kulovic
1505 n. fourth street
flagstaff, AZ 86004
9285263030
MDR Report Key14403800
MDR Text Key293262174
Report Number3007284313-2022-01912
Device Sequence Number1
Product Code DYB
UDI-Device Identifier00733132630950
UDI-Public00733132630950
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 Foreign,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 05/15/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/15/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberDSF2433
Device Catalogue NumberDSF2433
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/15/2022
Was Device Evaluated by Manufacturer? No
Date Device Manufactured10/22/2021
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: 05/15/2022 Patient Sequence Number: 1
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