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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Stenosis (2263)
Event Date 05/17/2019
Event Type  Injury  
Manufacturer Narrative
Manufacturing evaluation results will be provided once they are completed.
 
Event Description
On an unknown date the patient had an ascending aorta and aortic arch replacement with the elephant trunk technique. On (b)(6) 2016, the patient had a thoracic endovascular aortic repair (tevar) to the elephant trunk. On (b)(6) 2019, the patient underwent an endovascular procedure using conformable gore® tag® thoracic endoprostheses to exclude a leak from an anastomosis of the surgical graft used for the elephant trunk. The devices were implanted successfully at the intended position. The final angiography showed no issues and the access vessels were open, therefore the physician elected to conclude the procedure. After closure of the access site at the left femoral artery, it was noted that blood flow to the lower extremity was poor. The physician attempted to anastomose the access site multiple times; however the blood flow did not improve. The access site was replaced with a surgical graft to improve the blood flow. No further issues were observed, and the patient tolerated the procedure.
 
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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
sara collum
1500 n. 4th street
9285263030
MDR Report Key8701414
MDR Text Key148074372
Report Number3007284313-2019-00177
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 company representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/18/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/14/2019
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 Number20427936
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: 06/14/2019 Patient Sequence Number: 1
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