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

Model Number DSF2433

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Rupture (2208)

Event Date 04/28/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

On (b)(6) 2022, this patient underwent endovascular treatment using gore® tag® conformable thoracic stent graft with active control system (ctag/ac) and gore® dryseal flex introducer sheath (dsf) for a thoracic aortic aneurysm.As concomitant procedure, total aortic arch replacement and frozen elephant trunk technique were performed.When the first ctag/ac was deployed, proximal movement was observed.No adverse event due to the movement was reported.The second ctag/ac was successfully deployed on the proximal side.Angiography after removal of the dsf revealed traumatic injury of the right external iliac artery.After dilating the occlusion balloon catheter to intercept blood flow, and two additional stent grafts were deployed from the right common iliac artery to the right external iliac artery.The patient tolerated the procedure.Reportedly, the patient's external iliac artery had a small diameter (6.5-7 mm) and resistance was noted while the sheath was being advanced.The nominal outer diameter of the 24fr dryseal sheath is 9.1mm.

Manufacturer Narrative

H6: code 3331, 213.

• 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: douglas rhodes ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 14523329
• MDR Text Key: 292818921
• Report Number: 3007284313-2022-01939
• 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: Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: DSF2433
• Device Catalogue Number: DSF2433
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/07/2022
• 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 Sex: Female