MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE DRYSEAL FLEX INTRODUCER SHEATH; INTRODUCER, CATHETER

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.

Manufacturer Narrative

H.6.Results code 1 updated.H.6.Conclusions code 1 updated.H.6.Conclusions code 2 added.H.6.Conclusions code 2: code 22 - according to the gore® dryseal flex introducer sheath instructions for use (ifu), potential adverse events that may occur and/or require intervention include, but are not limited to, vascular trauma (i.E., dissection, rupture, perforation, tear, etc.), blood loss or bleeding, and death.Furthermore, the gore® dryseal flex introducer sheath ifu states that 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.

• Brand Name: GORE DRYSEAL FLEX INTRODUCER SHEATH
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• MDR Report Key: 10492022
• MDR Text Key: 205638217
• Report Number: 2017233-2020-01220
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00733132630028
• UDI-Public: 00733132630028
• Combination Product (y/n): N
• PMA/PMN Number: K160254
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 09/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/04/2023
• Device Model Number: DSF1633
• Device Catalogue Number: DSF1633
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/05/2020
• Initial Date FDA Received: 09/03/2020
• Supplement Dates Manufacturer Received: 09/10/2020
• Supplement Dates FDA Received: 09/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 64 YR