MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES AORTIC INTRODUCER SHEATH (DRYSEAL FLEX VER 4.0); INTRODUCER, CATHETER

Catalog Number DSF2033

Device Problems Inadequacy of Device Shape and/or Size (1583); Improper or Incorrect Procedure or Method (2017)

Patient Problem Vascular Dissection (3160)

Event Date 06/06/2019

Event Type  Injury  

Manufacturer Narrative

The review of the manufacturing paperwork verified that this lot met all pre-release specifications.According to the gore® dryseal sheath instruction for use (ifu), the access vessel should be of adequate size and appropriate tortuosity of the insertion of the introducer sheath.If the vessel is too small, major bleeding, vessel rupture/perforation, and serious injury to the patient may result.The nominal sheath outer diameter is 7.5 for a gore® dryseal sheath (dsf2033), and the patients femoral artery measured 7mm.

Event Description

On (b)(6) 2019, the patient underwent endovascular treatment using gore® dryseal flex introducer sheath with conformable gore® tag® thoracic endoprosthesis for the prevention of an aorto-esophageal fistula caused by esophageal cancer invasion.The sheath was inserted through the patient's right femoral artery, and it was reported that the physician felt a slight resistance.The femoral artery was measured at 7mm and the required nominal sheath outer diameter is 7.5.The stent graft was then deployed successfully.An angiography of the access vessel was performed, and a dissection was observed near the origin of the right external iliac artery.The dissection was treated with a non-gore (epic) stent.The procedure was completed without reported issue and the patient reportedly tolerated the procedure.

• Brand Name: AORTIC INTRODUCER SHEATH (DRYSEAL FLEX VER 4.0)
• 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: sara collum ; 1500 n. 4th street; 9285263030
• MDR Report Key: 8760892
• MDR Text Key: 150027888
• Report Number: 3007284313-2019-00189
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00733132630066
• UDI-Public: 00733132630066
• 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
• Report Date: 06/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/22/2022
• Device Catalogue Number: DSF2033
• Device Lot Number: 20269296
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/23/2019
• 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: 64 YR