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 Intimal Dissection (1333); Aortic Dissection (2491); Blood Loss (2597); Vascular Dissection (3160)

Event Date 12/11/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Medical devices: the patient¿s medications include; acetaminophen, atorvastatin, cholecalciferol, clopidogrel, colace, cyanocobalamin, ferrous furamate, levetiracetam, levothyroxine, losartan, metoprolol succinate, oxycodone, plavix and vitamin b-12.The review of the manufacturing paperwork verified that this lot met all pre-release specifications.According to the gore® dryseal flex introducer sheath instructions for use (ifu), 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, vascular trauma (i.E., dissection, rupture, perforation, tear, etc.), or serious injury to the patient may result.

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) 2017, pre-implantation imaging identified a zone 0/1 aortic aneurysm with a maximum diameter of 66mm and a length of 7cm.It was reported the right external iliac/femoral artery measured 10mm in diameter.On (b)(6) 2017, the patient underwent treatment of the aortic aneurysm, with two gore® tag® thoracic branch endoprostheses.According to the report, a 26 fr gore® dryseal flex sheath was advanced through the right external iliac artery and both endoprostheses were positioned and deployed without issue.Successful access and delivery to the intended implantation site and retrieval of the device delivery system was reported.Intra-procedural angiography confirmed exclusion of the aneurysm and full patency of the aortic and side branch components.According to the report, after removing the sheath, there was an apparent significant disruption of the intimal anterior wall of the right common femoral artery.Blood loss of greater than 1 liter was reported and a transfusion of 2 units of blood products was administered.An additional procedure was performed consisting of localized endarterectomy, with transection of the torn femoral artery and interposition repair of the artery with implantation of an advanta¿ vxt ptfe vascular graft (10mmx80cm).At the conclusion of the procedure, it was reported the patient had palpable pulses with strong pulse volume recording signals.No further complications were reported and the patient tolerated the procedure.According to the report, no resistance was encountered during the advancement or withdrawal of the sheath.The exact cause of the dissection is reportedly unknown, however it was reported the patient's right common femoral artery was reported as "friable".

• 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: 7179046
• MDR Text Key: 96869824
• Report Number: 3007284313-2018-00009
• 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: 12/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/02/2020
• Device Catalogue Number: DSF2633
• Device Lot Number: 1V400175
• 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: 05/30/2017
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 76 YR
• Patient Weight: 75