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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 DSF2233
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Rupture (2208)
Event Date 05/20/2022
Event Type  Injury  
Manufacturer Narrative
W. L. Gore & associates, inc. (gore) is submitting this report to comply with 21 c. F. R. Part 803, the medical device reporting regulation. This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda. Blank fields present on this report include required fields and fields determined to be not applicable. Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable. This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report. In particular, this report does not constitute a legal admission by anyone that the product described in this report has any defects or has malfunctioned, as defined from a legal standpoint. These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803. This statement should be included with any information or report disclosed to the public under the freedom of information act.
 
Event Description
On (b)(6) 2022, this patient underwent a semi-emergent endovascular treatment for a type ib endoleak attributed to a previously implanted valiant stent graft using gore® tag® conformable thoracic stent grafts with active control system (ctag/ac), gore® viabahn® endoprosthesis (vsx) and gore® dryseal flex introducer sheath (dsf). At the time of the procedure, the patient¿s aneurysmal sac diameter was 90 mm. When the physician attempted to insert the dsf into the right common femoral artery, there was strong resistance, and he could not advance the sheath. Therefore, he inflated a balloon in the access vessels, but there was still resistance in advancing the sheath. The physician had no choice but to advance the dsf to the aorta forcefully. Reportedly, although there was no data on access vessels¿ diameter, the right external iliac artery seemed narrow and highly calcified based on 3d imaging. Two ctag/ac devices were implanted successfully in the thoracoabdominal area, and two vsx devices were implanted in the celiac artery and the superior mesenteric artery. Blood flow into these arteries had no issues. Angiography for the access site revealed a rupture of the right common iliac artery (cia). To treat the rupture, a gore® viabahn® vbx balloon expandable endoprosthesis (vbx) was placed from the cia to the external iliac artery (eia). However, even after the vbx was implanted, the patient¿s blood pressure decreased to 30. The dsf was removed from the patient while balloon occlusion was performed. It was found that the vascular intima was separating from the vessel. Therefore, the vbx device was removed and graft replacement for the cia and eia was performed. The patient tolerated the procedure. The reporting physician commented as follows: the access site vessels were severely calcified and there was strong resistance force during dsf insertion; however, it was needed to advance it forcefully considering a risk of aneurysmal rupture.
 
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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
douglas rhodes
1505 n. fourth street
flagstaff, AZ 86004
9285263030
MDR Report Key14690102
MDR Text Key294884766
Report Number3007284313-2022-01969
Device Sequence Number1
Product Code DYB
UDI-Device Identifier00733132630073
UDI-Public00733132630073
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,Followup,Followup
Report Date 10/06/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/14/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberDSF2233
Device Catalogue NumberDSF2233
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/06/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/31/2021
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: 06/14/2022 Patient Sequence Number: 1
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