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U.S. Department of Health and Human Services

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

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W.L. GORE & ASSOCIATES AORTIC INTRODUCER SHEATH (DRYSEAL FLEX VER 4.0) INTRODUCER, CATHETER Back to Search Results
Catalog Number DSF1833
Device Problem Insufficient Information (3190)
Patient Problems Stenosis (2263); Vascular Dissection (3160)
Event Date 04/08/2019
Event Type  Injury  
Manufacturer Narrative
A review of the manufacturing records for the device verified the lot met all pre-release specifications. Additional information and the images were requested but were not available. According to the gore® dryseal flex introducer sheath instructions for use (ifu), additional considerations for patient selection include but are not limited to patient¿s anatomical suitability for endovascular repair. 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. Additionally, the ifu states, adverse events that may occur and / or require intervention include, but are not limited to vascular trauma (i. E. , dissection, rupture, perforation, tear, etc. ). Please note that the medwatch with mfr report # 3007284313-2019-00124 was emailed to fda on april 29, 2019 to cover the component migration, endoleak and aneurysm enlargement related with the gore® excluder® aaa endoprosthesis.
 
Event Description
On (b)(6) 2017, this patient underwent an endovascular repair of an abdominal aortic aneurysm using a gore® excluder® aaa endoprosthesis. No issues were observed, and the patient tolerated the procedure. On an unknown date, follow-up imaging identified a distal migration of the trunk-ipsilateral leg component (distance: about 40mm), and subsequent a proximal type i endoleak and the aneurysm enlargement (amount unknown). The trunk portion reportedly fell into the aneurysm sac. It was reported that the patient¿s proximal neck diameter pre-operatively was 23. 4-26. 7mm, while the post-operative infrarenal aortic diameter was 27. 2-33. 2mm. On (b)(6) 2019, gore® excluder® aaa endoprosthesis aortic extender components and non-gore devices were implanted to extend the trunk portion proximally to repair the migration and the proximal type i endoleak. The endoleak was reportedly resolved. During the re-intervention, pertaining to a gore® dryseal flex introducer sheath (dsf1833/19978519), the left access vessel (external iliac artery) was dissected, and therefore repaired with a bare metal stent. It was reported that where the dissection occurred in the external iliac artery had stenosis prior to the procedure; however its diameter was unknown. The patient tolerated the re-intervention.
 
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Brand NameAORTIC INTRODUCER SHEATH (DRYSEAL FLEX VER 4.0)
Type of DeviceINTRODUCER, 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
nataliya baramzina
1500 n. 4th street
9285263030
MDR Report Key8563141
MDR Text Key143527503
Report Number3007284313-2019-00123
Device Sequence Number1
Product Code DYB
UDI-Device Identifier00733132630042
UDI-Public00733132630042
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 06/25/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/29/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date11/06/2021
Device Catalogue NumberDSF1833
Device Lot Number19978519
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/07/2018
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: 04/29/2019 Patient Sequence Number: 1
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