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

Model Number DSF2433

Device Problem Device Handling Problem (3265)

Patient Problem Aneurysm (1708)

Event Date 08/21/2020

Event Type  Injury  

Manufacturer Narrative

According to the instructions for use (ifu) for the gore® dryseal flex introducer sheath, 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.If vessel size is smaller than the nominal body od, major bleeding, vessel damage, or serious injury to the patient, including death, may result.Do not attempt to advance or withdraw guidewire, catheter, or other device through the introducer sheath or dilator if resistance is felt.Use fluoroscopy to determine the cause.Continued advancement or retraction against resistance may result in major bleeding, vessel damage, serious injury to the patient, or damage to / breakage of the guidewire, catheter, or other device.The nominal body od for the 24fr sheath is 8.8mm.

Event Description

On (b)(6) 2020, this patient underwent endovascular treatment for a descending thoracic aortic aneurysm and was implanted with a gore® tag® conformable thoracic endoprosthesis, and a gore® tag® conformable thoracic stent graft with active control system.A 24fr gore® dryseal flex introducer sheath was used for advancement and delivery of the devices and resistance during advancing the 24fr sheath was reported.Post implant of all devices the when the sheath was removed the patient's dorsalis pedis pulse was reported to be weak.Angiography at this time revealed a dissection of the left common iliac artery (lcia) dissection and left femoral artery.The left femoral artery dissection was located about 1cm lower than the insertion site of the 24fr sheath was treated with a graft.The physician chose to not treat the lcia dissection and will monitor the patient.The physician suggests the cause of the left femoral artery dissection may have been caused by the taping site being pulled excessively during insertion the 24fr sheath and calcification of the lcia.The patient's left common femoral artery and lcia was reported to measure 6.7 - 7.0 mm in diameter.The patient tolerated the procedure with improved blood flow reported at the conclusion of the procedure.

Manufacturer Narrative

H6: code 213- a review of the manufacturing records for the device(s) verified that the lot(s) met all pre-release specifications.

• 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: 10449387
• MDR Text Key: 204242122
• Report Number: 3007284313-2020-01045
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00733132630950
• UDI-Public: 00733132630950
• 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
• Remedial Action: Patient Monitoring
• Type of Report: Initial,Followup
• Report Date: 09/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/12/2023
• Device Model Number: DSF2433
• Device Catalogue Number: DSF2433
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/21/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 80 YR