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

Catalog Number DSL1428J

Device Problem Physical Resistance (2578)

Patient Problem Rupture (2208)

Event Date 01/29/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

On (b)(6) 2017, the patient underwent endovascular repair of an infectious descending thoracic aortic aneurysm and an abdominal aortic rupture.First, the physician implanted a conformable gore® tag® thoracic endoprosthesis to repair the descending thoracic aortic aneurysm.Next, the physician elected to implant gore® excluder® aaa endoprostheses featuring c3® delivery system to repair the abdominal aortic rupture.A trunk-ipsilateral leg component was advanced from the left side and its proximal portion was deployed.Then, a 14-fr gore® dryseal sheath with hydrophilic coating (dsl1428j/15472863) was inserted from the right side and cannulated into the contralateral gate.All the endoprostheses were deployed, and upon withdrawal of the introducer sheath, the right external iliac artery was ruptured.An iliac extender component was implanted in the ruptured area, and the patient tolerated the procedure.It was reported that resistance was met while the introducer sheath was being inserted from the right side.There existed calcium in the right iliac artery, which could have contributed to the external iliac artery rupture.

Manufacturer Narrative

The review of the manufacturing paperwork verified that this lot met all pre-release specifications.According to the instructions for use (ifu) of the gore® dryseal sheath with hydrophilic coating, adverse events that may occur and / or require intervention include, but are not limited to vascular trauma (rupture).

• Brand Name: GORE® DRYSEAL SHEATH
• 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: yutaka uchiya ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 6360330
• MDR Text Key: 68379752
• Report Number: 3007284313-2017-00042
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K093791
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/13/2019
• Device Catalogue Number: DSL1428J
• Device Lot Number: 15472863
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/13/2016
• 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: 73 YR