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

Catalog Number DSF2633

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Atrial Perforation (2511); Blood Loss (2597)

Event Date 02/19/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).The 26 fr gore® dryseal flex sheath is intended for insertion into an external iliac artery with a minimum outside diameter of 9.5 mm, as it was reported the patient¿s right external iliac artery measured 6.5 ¿ 7.0 mm in diameter, the 26 fr sheath was oversized and therefore use was outside of ifu.

Event Description

The following information was reported to gore through the pivotal study for the gore® tag® thoracic branch endoprosthesis (tbe device): on (b)(6) 2018, the patient underwent endovascular treatment of a 55 mm descending thoracic aortic (zone 2) aneurysm, distal to the left common carotid artery ostium and proximal to the left subclavian artery, with two gore® tag® thoracic branch endoprostheses.According to the report, the left subclavian artery was the intended branch vessel to be treated.Successful access and delivery to the intended implantation site and retrieval of the device delivery system was reported.A spinal drain was reportedly placed to prevent paraplegia.Reportedly, during withdrawal of the 26 fr gore® dryseal flex sheath, minimal resistance was noted.It was reported, intra-operative imaging revealed the right external iliac artery, measuring 6.5-7.0 mm in diameter, had ruptured.The physician reported the iliac artery was minimally calcified and tortuous.Blood loss of 400 ml.Was reported and a transfusion of 500 ml of blood products was administered.According to the report, an iliac extender component and two gore® viabahn® endoprostheses were implanted into the right external iliac artery and the rupture was reported to have been resolved without sequelae.Final angiography confirmed exclusion of the aneurysm, repair of the rupture, and full patency of all devices.The procedure was concluded with no further adverse events reported and the patient tolerated the procedure.

• Brand Name: GORE® DRYSEAL FLEX INTRODUCER 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: charlene cooper ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 7302989
• MDR Text Key: 101163704
• Report Number: 3007284313-2018-00073
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160254
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: study
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/07/2019
• Device Catalogue Number: DSF2633
• Device Lot Number: 17609964
• 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: 12/07/2017
• 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
• Treatment: MEDICATIONS: CLOPIDOGREL AND ASPIRIN.
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 79 YR
• Patient Weight: 82