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

Catalog Number DSF1245

Device Problems Difficult to Insert (1316); Human-Device Interface Problem (2949)

Patient Problems Intimal Dissection (1333); Aortic Dissection (2491); Vascular Dissection (3160)

Event Date 12/07/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

On (b)(6) 2017, the patient underwent endovascular treatment of bilateral common iliac artery aneurysms using gore® excluder® iliac branch endoprostheses.According to the report, after deployment of gore® excluder® iliac branch and internal iliac branch components on the patient¿s left side, a 12 fr gore® dryseal flex sheath was advanced from the left side for placement of a gore® excluder® iliac branch component within the patient¿s right common iliac artery.During advancement the sheath reportedly caught on the edge of the left internal iliac branch component, however, the physician was reported to have continued with advancement of the sheath.It was reported, after deployment of all devices, intra-procedural imaging revealed a dissection of the left external iliac artery, which was reported to have measured 7.8-9 mm in diameter.According to the report, there was no noted resistance encountered during the advancement or withdrawal of the sheath.A loss of blood which resulted in hemodynamic impairment or required an intra-operative transfusion of blood products was not reported.Additionally, there was nothing about the patient¿s anatomy that caused or contributed to the dissection.According to the physician, the dissection occurred when the sheath caught on the left internal iliac branch component during advancement.An iliac extender component was implanted and the dissection was reported to have been successfully repaired.Final angiography showed exclusion of the aneurysms, and the patient was reported to have tolerated the procedure.

Manufacturer Narrative

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), adverse events that may occur and/or require intervention include, but are not limited to vascular trauma (i.E., dissection, rupture, perforation, tear, etc.).

• 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: 7150641
• MDR Text Key: 95908629
• Report Number: 3007284313-2017-00318
• Device Sequence Number: 1
• Product Code: DYB
• 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: company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/07/2018
• Device Catalogue Number: DSF1245
• Device Lot Number: 1V404569
• 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: 07/05/2017
• 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: 68 YR