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

Catalog Number DSF2033

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Vascular Dissection (3160)

Event Date 04/17/2022

Event Type  Injury  

Event Description

On (b)(6) 2022, a patient underwent emergency endovascular treatment of an infected thoracic aortic aneurysm using a gore® tag® conformable thoracic stent graft with active control system, and a 20fr gore® dryseal flex introducer sheath.During the treatment, the 20fr sheath was inserted from the right external iliac artery.According to the report, resistance was felt when the sheath was inserted into access vessel.The gore® tag® device was successfully implanted, however, a delayed proximal type i endoleak was reportedly observed.No touch up or other further treatment was performed, and the physician elected to monitor the endoleak.After the sheath was removed, decreased blood flow was reportedly observed.An intra-operative angiograph revealed an access vessel dissection.An additional stent graft was implanted to treat the dissection.The procedure was concluded without any further reported complications, and the patient tolerated the procedure.The physician commented that the patient¿s right external iliac artery was both fragile and narrow (measurement not available), and the dissection may have occurred due to sheath insertion maneuvers inside the narrow vessel.

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.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
• 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: 14381040
• MDR Text Key: 291641177
• Report Number: 3007284313-2022-01907
• Device Sequence Number: 1
• Product Code: DYB
• 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: 05/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: DSF2033
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/17/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 80 YR
• Patient Sex: Female