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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 DSF2233
Device Problem Use of Device Problem (1670)
Patient Problem Aortic Dissection (2491)
Event Date 06/03/2019
Event Type  Injury  
Manufacturer Narrative
According to the instructions for use (ifu) for the gore® dryseal flex introducer sheath; adverse events that may occur include, but are not limited to include: vascular trauma (i. E. , dissection, rupture, perforation, tear, etc. ). Additionally, the 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. If vessel size is smaller than the nominal body od, major bleeding, vessel damage, or serious injury to the patient, including death, may result. Per the instructions for use (ifu), the size gore® dryseal flex introducer sheath associated with this event has a nominal sheath outer diameter of 8. 3mm. A review of the manufacturing records for the device(s) verified that the lot(s) met all pre-release specifications.
 
Event Description
On (b)(6) 2019, this patient underwent endovascular treatment for a stanford type b chronic aortic dissection and was implanted with a conformable gore® tag® thoracic endoprosthesis. The device was advanced using a gore® dryseal flex introducer sheath and deployed with no reported issues. Intra-procedure angiography identified a dissection at the origin of the left common and external iliac arteries. A bare metal stent was implanted to treat the dissection. The patient tolerated the procedure with no further issues reported. It was reported that the access vessel at the left side was shaggy, and measured 6. 4-7. 8mm in diameter.
 
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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
laura crawford
1500 n. 4th street
9285263030
MDR Report Key8687944
MDR Text Key147629064
Report Number3007284313-2019-00172
Device Sequence Number1
Product Code DYB
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 06/21/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/11/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date02/28/2022
Device Catalogue NumberDSF2233
Device Lot Number20427689
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 Manufactured03/01/2019
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: 06/11/2019 Patient Sequence Number: 1
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