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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 DSF2433
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Death (1802); Vascular Dissection (3160)
Event Date 09/30/2020
Event Type  Death  
Manufacturer Narrative
The review of the manufacturing paperwork verified that this lot met all pre-release specifications; according to the gore® dryseal flex sheath instructions for use, adverse events with may occur and/or require intervention including, but not limited to, vascular trauma and death.
 
Event Description
The patient was treated for a thoracic aortic aneurysm. The fsa and clinical specialist recommended that the device be implanted from the patient's right side, as there were concerns about the suitability of access vessels on the left side. The physician decided that implant from the left would be less difficult from the left, as there was a stent in the right side. The physician proceeded to successfully implant and deploy two gore® tag® conformable thoracic stent graft with active control system endoprostheses. He then began to withdraw the ore® dryseal sheath with hydrophilic coating that was used to implant the devices. As the sheath was withdrawn, it dissected the left common femoral artery, left external iliac and left common iliac. The physician implanted two gore® viabahn® endoprostheses to stop the blood loss from the dissection, and felt that the distal portion was sealed. However, there was significant blood loss. The patient was in serious condition after the procedure. Additional information from fsa reported that patient expired on (b)(6) 2020.
 
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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
greg rawlings
1505 n. fourth street
flagstaff, AZ 86004
9285263030
MDR Report Key10740402
MDR Text Key213200302
Report Number3007284313-2020-01129
Device Sequence Number1
Product Code DYB
UDI-Device Identifier00733132630950
UDI-Public00733132630950
Combination Product (y/n)N
Reporter Country CodeUS
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 10/27/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/27/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberDSF2433
Device Catalogue NumberDSF2433
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 Received09/30/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured01/17/2020
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: 10/27/2020 Patient Sequence Number: 1
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