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

Model Number	DSF2265
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	09/17/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the manufacturing records for the device will be conducted.The evaluation is in process.The sheath was discarded at the facility and is not available for investigation.
Event or Problem Description
On (b)(6) 2020, the patient underwent endovascular treatment for an arch aorta aneurysm and an abdominal aortic aneurysm with a gore® tag® conformable thoracic stent graft with active control system and a gore® excluder® aaa endoprosthesis utilizing gore® dryseal flex introducer sheaths (dsf).The dsf2265 was inserted from the right common femoral artery.While advancing at the right external iliac artery, a strong resistance was felt since the right external iliac artery was tortuous, but the procedure was continued.When the dsf2265 was removed, the patient's blood pressure was decreased, and the intra-operative imaging revealed a vessel damage at the right external iliac artery.An additional stent graft was placed to cover the vessel damaged area and the pressure hemostasis was performed using occlusion balloon.The exact vessel measurement at the right side where the vessel damage occurred is unknown, but the proximal side was 9.1mm and the distal side was 10.1mm.According to the physician, the landing place was tortuous that might be caused the event.The procedure was completed.The patient tolerated the procedure.
Additional Manufacturer Narrative
H.6.Code 213: a review of the manufacturing record for the device verified the lot met all pre-release specifications.The sheath was discarded at the facility and not available for analysis.According to the gore® dryseal flex introducer sheath instructions for use (ifu), 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.According to the ifu size guide, a 22fr sheath minimum id is 7.3mm-8.2mm.The exact vessel measurement at the right side where the vessel damage occurred is unknown, but the proximal side was 9.1mm and the distal side was 10.1mm.Do not attempt to advance the introducer sheath or dilator if resistance is felt.Continued advancement or retraction against resistance may result in major bleeding, vessel damage, serious injury to the patient, or damage to the other device.According to the gore® dryseal flex introducer sheath instructions for use (ifu), adverse events that may occur and / or require intervention include, but are not limited to vascular trauma (i.E., dissection, rupture, perforation, tear, etc.).

• 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
• MDR Report Key: 10665252
• Report Number: 3007284313-2020-01103
• Device Sequence Number: 11752265
• Product Code: DYB
• UDI-Device Identifier: 00733132628384
• UDI-Public: 00733132628384
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K160254
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/19/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/19/2023
• Device Model Number: DSF2265
• Device Catalogue Number: DSF2265
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/17/2020
• Supplement Date Received by Manufacturer: 10/16/2020
• Initial Report FDA Received Date: 10/12/2020
• Supplement Report FDA Received Date: 10/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other; Required Intervention
• Patient Age: 86 YR