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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 CATHETER, PERCUTANEOUS

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W. L. GORE & ASSOCIATES, INC. GORE DRYSEAL FLEX INTRODUCER SHEATH CATHETER, PERCUTANEOUS Back to Search Results
Model Number DSF1633
Device Problem Positioning Problem (3009)
Patient Problem Aneurysm (1708)
Event Date 12/09/2020
Event Type  Injury  
Manufacturer Narrative

According to the instructions for use (ifu) for the gore® dryseal flex introducer sheath, adverse events that may occur and / or require intervention include but are not limited to: vascular trauma (ie. , dissection, rupture,perforation, tear, etc. ) 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 using a gore® dryseal flex introducer sheath (dsf) as a conduit for the insertion of the endoprostheses to the intended deployment location. It was reported that the patient¿s left access vessels were significantly tortuous. Strong resistance was reported upon insertion of a 16fr dsf, and advancement required some force. Upon deployment of the contralateral leg endoprosthesis to extend the left limb, it was reported that the graft unintentionally moved distally some. An additional stent graft was deployed to reinforce the junction. A gore® molding & occlusion balloon (mob) was used for touch up angioplasty and during use it ruptured, no over inflation was reported. The mob was removed from the patient and another balloon catheter was used to complete touch up angioplasty. Post deployment of all stent grafts, angiography was performed and revealed a dissection in the tortuous part of the left external iliac artery (leia). An additional stent graft was deployed to treat the dissection. The patient tolerated the procedure. The physician stated that dsf had been inserted with force due to the tortuosity of the leia.

 
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Brand NameGORE DRYSEAL FLEX INTRODUCER SHEATH
Type of DeviceCATHETER, PERCUTANEOUS
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
laura crawford
1505 n. fourth street
flagstaff, AZ 86004
9285263030
MDR Report Key11057390
MDR Text Key223194832
Report Number3007284313-2020-01207
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeJA
PMA/PMN NumberK160254
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 06/18/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/22/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberDSF1633
Device Catalogue NumberDSF1633
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/09/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured06/11/2020
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 12/22/2020 Patient Sequence Number: 1
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