MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES AORTIC INTRODUCER SHEATH (DRYSEAL FLEX VER 4.0); INTRODUCER, CATHETER

Catalog Number DSF2433

Device Problem Off-Label Use (1494)

Patient Problem Vascular Dissection (3160)

Event Date 08/02/2019

Event Type  Injury  

Manufacturer Narrative

The review of the manufacturing paperwork verified that this lot met all pre-release specifications.The gore® dryseal flex introducer sheath instruction for use (ifu) states ¿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.¿ per ifu, if vessel size is smaller than the nominal body outer diameter, major bleeding, vessel damage, or serious injury to the patient, including death, may result.Additionally, per 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.).

Event Description

On (b)(6) 2019, the patient underwent endovascular repair of a thoracic aortic aneurysm with a conformable gore® tag® thoracic endoprosthesis using a gore® dryseal flex introducer sheath.The sheath was inserted into the patient from the right femoral artery.After the deployment of the endoprosthesis and removal of the sheath, an injury was observed at the right femoral artery.The cut down site and where and the injury to the femoral artery were located and sutured.After suturing the femoral artery, the artery reportedly narrowed and the physician then ballooned the artery open back to the original size.The patient reportedly tolerated the procedure.The reported vessel diameters for the right femoral artery were approximately 7.0 mm ¿ 8.0 mm.The physician stated, ¿there was a resistance during the advancement of the sheath in the right femoral artery.The diameter of the access vessel was small.¿.

• Brand Name: AORTIC INTRODUCER SHEATH (DRYSEAL FLEX VER 4.0)
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• Manufacturer (Section G): MEDICAL PHOENIX 1 B/P; 32360 n. north valley parkway; phoenix AZ 85085
• Manufacturer Contact: sara collum ; 1500 n. 4th street; 9285263030
• MDR Report Key: 8913541
• MDR Text Key: 155787575
• Report Number: 3007284313-2019-00257
• 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
• Report Date: 08/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/23/2022
• Device Catalogue Number: DSF2433
• Device Lot Number: 20300480
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/24/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 85 YR