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

Model Number	DSF1245
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	06/30/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2022, a patient underwent endovascular treatment of bilateral common iliac artery aneurysms using gore® excluder® aaa endoprostheses, gore® excluder® iliac branch endoprostheses (ibe) and gore® dryseal flex introducer sheath (sheath).During treatment, a 12fr sheath was inserted from a right-sided access site, then advanced over the aortic bifurcation to the left side to implant ibe devices.According to the report, the physician stated that he felt "rubbing" against the vessel wall when inserting the sheath.After all gore® excluder® devices were implanted, an intra-operative angiograph reportedly revealed a minor type ii endoleak.Access angiography also reportedly revealed a pooling of contrast in the right external iliac artery distal to the ipsilateral limb.The pooling of contrast was thought to be a dissection or pseudoaneurysm formation.To treat the possible vessel injury, an additional stent graft was implanted distally.The issue was resolved, and the patient tolerated the procedure.The physician did not comment on the potential cause of the access vessel trauma.It was reported the right external iliac artery measured 7.1mm to 8.1mm in diameter in the region of injury (within recommendations in the instructions for use).It was also reported that a ct scan revealed the patient's vasculature was significantly calcified, which may have been a contributing factor.
Additional Manufacturer Narrative
A review of the manufacturing records for the device verified that the lot met all pre-release specifications.The device was discarded at the facility and, therefore, was not available for direct analysis by gore.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.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
• Common Device Name: 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: 15089873
• Report Number: 3007284313-2022-02048
• Device Sequence Number: 19847544
• Product Code: DYB
• UDI-Device Identifier: 00733132628117
• UDI-Public: 00733132628117
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K160254
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/22/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/12/2024
• Device Model Number: DSF1245
• Device Catalogue Number: DSF1245
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/30/2022
• Initial Report FDA Received Date: 07/22/2022
• Date Device Manufactured: 02/11/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 82 YR
• Patient Sex: Male