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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 DSF1633
Device Problems Improper or Incorrect Procedure or Method (2017); Patient-Device Incompatibility (2682)
Patient Problems Death (1802); Perforation of Vessels (2135); Blood Loss (2597)
Event Date 08/05/2020
Event Type  Death  
Manufacturer Narrative
Patient weight: asked but unavailable. Other relevant history, including preexisting medical conditions: asked but unavailable. Concomitant medical products and therapy dates: asked but unavailable.
 
Event Description
On (b)(6) 2020 the patient underwent endovascular treatment of an abdominal pseudoaneurysm. An endoconduit technique was used to make a secure access site on the patient's left side. For the endoconduit technique, two gore® viabahn® vbx balloon expandable endoprostheses (vbx) were placed in the patient's left external iliac artery. Post-ballooning was performed using a boston mustang 8mm pta balloon. During ballooning, vessel damage occurred at the implant site in the patient's left external iliac artery. The patient's blood vessels were reported as severely calcified. It was reported that excessive post-ballooning may have caused the vessel damage. It was also noted by the product specialist that the vbx devices looked expanded larger, and may be associated with the damage. The specific cause of vessel damage was unable to be determined as the bleeding was controlled with the vbx devices a 16fr gore® dryseal flex introducer sheath was inserted from the endoconduit access site, but was unable to be advanced. With multiple insertion attempts, the distal vbx device was unintentionally moved proximally. Bleeding (amount unknown) occurred from the site of vessel damage. The physician reported that the introducer sheath was forcefully inserted, and that the vessel may have been further damaged by insertion of the introducer sheath. As a treatment, two additional vbx devices were implanted. No further bleeding was noted. The endovascular treatment was discontinued and the procedure was completed. On (b)(6) 2020 the patient expired. It was reported that, upon returning to the icu after the procedure, the patient's hemodynamics were unstable, and the patient's condition did not recover. Reportedly the physician was unable to determine a specific cause of death. It was also noted that the physician was unable to confirm bleeding after the procedure. No autopsy was performed, and therefore the cause of patient death was not identified. According to the physician, the relationship between the patient's death and the gore devices could not be denied. Reportedly, either the vbx devices, the gore sheath, and/or the non-gore balloon may have caused vessel damage, which led to the bleeding during the procedure. The bleeding, treated with the second set of vbx devices placed very close to the patient's common femoral artery, may not have been enough to completely stop the bleeding even though the physician did not find any bleeding at the end of the procedure. It was also noted by the product specialist that the patient had a ventricular fibrillation (vf) during the procedure, and blood pressure dropped due to the noted bleeding. The vf was treated and the patient's blood pressure recovered. Although the patient did not have additional bleeding noted, and was stable at the end of the procedure, the patient became hemodynamically unstable after returning to the icu, followed by death. Intestinal necrosis was also noted. The physician reported that the intestinal necrosis may have caused or contributed to the patient's death, and that necrosis may have occurred due to reduced intestinal blood flow. One suspected cause of reduced intestinal blood flow was suggested to be occlusion of the patient's internal iliac artery as the patient's left internal iliac artery was intentionally covered with the proximal vbx device.
 
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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 WOODY SPRINGS B/P
3450 w. kiltie lane
flagstaff AZ 86005
Manufacturer Contact
jenna lopez
1505 n. fourth street
flagstaff, AZ 86004
9285263030
MDR Report Key10492022
MDR Text Key205638217
Report Number2017233-2020-01220
Device Sequence Number1
Product Code DYB
UDI-Device Identifier00733132630028
UDI-Public00733132630028
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 09/15/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/03/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
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 Received09/10/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/04/2020
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: 09/03/2020 Patient Sequence Number: 1
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