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

Catalog Number DSL2228J

Device Problems Difficult to Remove (1528); Difficult to Advance (2920)

Patient Problem Rupture (2208)

Event Date 12/16/2016

Event Type  Injury  

Manufacturer Narrative

The review of the manufacturing paperwork verified that this lot met all pre-release specifications.According to 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).(b)(4).

Event Description

On (b)(6) 2016, the patient underwent endovascular repair of an aneurysm of the distal aortic arch and descending thoracic aorta using conformable gore® tag® thoracic endoprostheses.The physician elected to pre-dilate the access vessel in the right side using an 8-mm non-gore manufactured balloon catheter.A 22-fr gore® dryseal sheath with hydrophilic coating (dsl2228j/15342952) was then advanced, but some resistance was still met.The introducer sheath was placed in an intended site and two endoprostheses were successfully deployed just distal to the left subclavian artery.Upon retrieval of the introducer sheath, the right external iliac artery was ruptured.The physician placed an occlusion balloon catheter in the area proximal to the iliac artery rupture and implanted a gore® excluder® aaa endoprosthesis contralateral leg component to repair the rupture.Additionally, the access vessel distal to the contralateral leg component was replaced with a surgical graft.The patient tolerated the procedure.It was reported that the patient¿s access vessel was small in diameter, which may have contributed to the iliac artery 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: 6224603
• MDR Text Key: 63918517
• Report Number: 3007284313-2017-00001
• 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
• Report Date: 12/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/03/2019
• Device Catalogue Number: DSL2228J
• Device Lot Number: 15342952
• 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: 08/03/2016
• 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): Other; Required Intervention
• Patient Age: 69 YR