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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
Model Number DSF1633
Device Problem Use of Device Problem (1670)
Patient Problem Aortic Dissection (2491)
Event Date 01/27/2020
Event Type  Injury  
Manufacturer Narrative
The instructions for use (ifu) for the gore® dryseal flex introducer sheath 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 (table 1), major bleeding, vessel damage, or serious injury to the patient, including death, may result. The diameter of the left external iliac artery ranged 5mm - 7. 5mm. The nominal outer diameter of the dsf used in this event is 6. 1mm. 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) 2020, this patient underwent endovascular treatment for an abdominal aortic aneurysm and was implanted with gore® excluder® aaa endoprostheses. A 16fr gore® dryseal flex introducer sheath was used for delivery and advancement to the intended location, all stent grafts were deployed successfully. When the sheath was removed, a dissection in the left external iliac artery was noted. The physician chose to monitor the dissection. 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
laura crawford
1500 n. 4th street
9285263030
MDR Report Key9719937
MDR Text Key188877857
Report Number3007284313-2020-00047
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
Report Date 01/27/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/18/2020
Is this an Adverse Event Report? Yes
Device Operator
Device Expiration Date08/26/2021
Device Model NumberDSF1633
Device Catalogue NumberDSF1633
Device Lot Number18628923
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 Manufactured08/27/2018
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: 02/18/2020 Patient Sequence Number: 1
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