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

Model Number DSF2433

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Perforation of Vessels (2135)

Event Date 11/17/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).It should be noted the gore® dryseal flex introducer sheath instructions for use (ifu) state ¿adequate vessel access is required to introduce the sheath into the vasculature.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.¿ per ifu, vessel size is smaller than the nominal body outer diameter, major bleeding, vessel damage, or serious injury to the patient, including death, may result.

Event Description

On (b)(6) 2021, the patient underwent endovascular treatment of an ascending aorta aneurysm.A 24fr gore® dryseal flex introducer sheath (nominal body outer diameter: 8.8mm) was used for access during the procedure.The sheath was inserted and advanced from right femoral artery.According to the report, resistance was felt as the sheath was advanced.The physician reported that the access vessel was small (external iliac artery measurement ranged from 5.7mm to 6.2mm in diameter).Upon withdrawal of the sheath, it was reported the patient¿s blood pressure decreased, and procedural angiography showed a ruptured access vessel.Three additional stent grafts were placed from the aortic bifurcation down to the right external iliac artery to treat the rupture.A leak at the end of the most distal stent graft was reportedly observed on a confirmation angiograph.The physician cut down the right femoral artery, and it was reportedly noted that the distal end of the stent graft protruded outside the vessel in a region where the sheath was suspected to have contributed to the vessel trauma.The vessel tear was surgically repaired, and final angiography confirmed there was no bleeding.The procedure was concluded with no further reported complications, and the patient tolerated the procedure.

Manufacturer Narrative

Added g3/g4, h1/h2 corrected h6: investigation conclusion.It should be noted the gore® dryseal flex introducer sheath instructions for use (ifu) state ¿adequate vessel access is required to introduce the sheath into the vasculature.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.¿ per ifu, vessel size is smaller than the nominal body outer diameter, 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
• Manufacturer (Section G): MEDICAL PHOENIX 1 B/P; 32360 n. north valley parkway; phoenix AZ 85085
• Manufacturer Contact: damon jackson ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 12960480
• MDR Text Key: 281916331
• Report Number: 3007284313-2021-01689
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00733132630950
• UDI-Public: 00733132630950
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K160254
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: DSF2433
• Device Catalogue Number: DSF2433
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/25/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 81 YR
• Patient Sex: Female