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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
Device Problems Malposition of Device (2616); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Obstruction/Occlusion (2422); Vascular Dissection (3160)
Event Date 06/24/2022
Event Type  Injury  
Manufacturer Narrative
The medical device was discarded at facility. Return not possible. (b)(4).
 
Event Description
On (b)(6) 2022, this patient underwent endovascular treatment of a thoracic aorta lesion. A gore® dryseal flex introducer sheath was used for access. It was reported that the access vessel angiography revealed a dissection at the right external iliac artery and the right internal iliac artery showed occlusion. Since the internal iliac artery was already occluded, an additional stent graft was placed from the right common iliac artery down to the right external iliac artery to treat the dissection. The patient tolerated the procedure. It was also reported that the access vessel was narrow and resistance was felt while advancing the 24fr dsf sheath. The dissection caused the intima to turn up and occlude the internal iliac artery.
 
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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
samir kulovic
1505 n. fourth street
flagstaff, AZ 86004
9285263030
MDR Report Key15084098
MDR Text Key296382586
Report Number3007284313-2022-02045
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 Foreign,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 07/22/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/22/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/24/2022
Was Device Evaluated by Manufacturer? No
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: 07/22/2022 Patient Sequence Number: 1
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