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

Catalog Number DSF2033

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Stenosis (2263)

Event Date 04/06/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).The review of the manufacturing paperwork verified that this lot met all pre-release specifications.The gore® dryseal flex introducer sheath instructions for use (ifu) states that adequate vessel access is required to introduce the sheath into the vasculature.Adverse events that may occur and/or require intervention include, but are not limited to: vascular trauma (i.E., rupture).If the vessel size is smaller than the introducer sheath outer diameter (8.3mm for a 22fr and 6.6mm for a 20fr sheath), then vessel damage may result.(b)(4).

Event Description

On (b)(6) 2018, the patient underwent treatment of a thoracic aortic pseudoaneurysm with conformable gore tag® thoracic endoprosthesis using gore® dryseal flex introducer sheath.An access was made from the left groin.It was reported the physician made several attempts to advance a 22fr sheath (dsf2233/17609098), however, was not able to advance the 22fr sheath due to resistance.The physician then advanced a 20fr sheath (dsf2033/17773216), and was able to advance it with no resistance.The physician removed the 20fr sheath from the patient and made another attempt to advance the 22fr sheath again, however, was not able to advance the 22fr sheath.The physician then advanced the 20fr sheath again and implanted the endoprosthesis successfully.After the 20fr sheath was removed from the patient, an angiography showed there was a suspected dissection from the left common iliac artery to the left external iliac artery.In order to treat the dissection, two bare metal stents (epic 12mm x 60mm, 10mm x 60mm) were implanted from the left common iliac artery to the left external iliac artery.The procedure was finished without further reported issues.The physician stated that the access vessel was access vessel was partially stenosed due to thrombus and calcification and was less than 6 mm in diameter, so the access vessel trauma had been expected.The clinical specialist reported that the dissection had been caused with the 20fr sheath since the physician was only able to advance the tip (the distal end) of the 22fr sheath.

• 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: rachael chascsa ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 7481820
• MDR Text Key: 107189124
• Report Number: 3007284313-2018-00143
• 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
• Report Date: 04/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/09/2021
• Device Catalogue Number: DSF2033
• Device Lot Number: 17773216
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/02/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/10/2018
• 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: 77 YR