MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES AORTIC INTRODUCER SHEATH (DRYSEAL VER 3.0); INTRODUCER, CATHETER

Catalog Number DSL2628

Device Problems Physical Resistance (2578); Device Operates Differently Than Expected (2913)

Patient Problems Aneurysm (1708); Extravasation (1842); Low Blood Pressure/ Hypotension (1914)

Event Date 03/06/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).The review of the manufacturing paperwork verified that this lot met all pre-release specifications.

Event Description

On (b)(6) 2017, the patient underwent a procedure using a conformable gore® tag® thoracic endoprostheses to treat a descending aortic aneurysm during a thoracic aortic repair (tevar).It was reported during advancement of a gore® dryseal sheath with hydrophilic coating (dsl2628/ 15798230) in the left common femoral artery there was mild resistance noted.The ctag devices were then advanced and deployed at the intended position with no reported issues.The physician attempted to remove the sheath and the patient experienced hypotension.An arteriogram was performed and there was extravasation in the vicinity of the external iliac artery.The physician expeditiously placed a coda balloon up the lunderquist wire and obtained proximal control.The physician performed a cut down on the left retro peritoneum and encircled the external iliac artery and then removed all wires and catheters and clamped and obtained proximal control.An 8mm dacron graft was then tunneled between the two ends of the artery and sewn into place, ballooning was done at the proximal anastomosis due to a local flap.The patient tolerated the procedure.

Manufacturer Narrative

Patient medications: aspirin-acetaminophen, aspirin, and clopidogrel click this button to edit the record.

Manufacturer Narrative

Follow-up medwatch # 2 manufacturer report # 3007284313-2017-00064 was sent in error.Seroma is not a reportable event.

Event Description

The following information was reported to gore: on (b)(6) 2017, the patient underwent a procedure using a conformable gore® tag® thoracic endoprostheses to treat a descending aortic aneurysm during a thoracic aortic repair (tevar).It was reported during advancement of a gore® dryseal sheath with hydrophilic coating (b)(4) in the left common femoral artery there was mild resistance noted.The ctag devices were then advanced and deployed at the intended position with no reported issues.The physician attempted to remove the sheath and the patient experienced hypotension.An arteriogram was performed and there was extravasation in the vicinity of the external iliac artery.The physician expeditiously placed a coda balloon up the lunderquist wire and obtained proximal control.The physician performed a cut down on the left retro peritoneum and encircled the external iliac artery and then removed all wires and catheters and clamped and obtained proximal control.An 8mm dacron graft was then tunneled between the two ends of the artery and sewn into place, ballooning was done at the proximal anastomosis due to a local flap.The patient tolerated the procedure.On (b)(6) 2017 the patient exhibited a seroma in the left groin following vascular trauma.On (b)(6) 2017 the seroma was recorded as resolved without sequelae.

• Brand Name: AORTIC INTRODUCER SHEATH (DRYSEAL VER 3.0)
• 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: heidi inskeep ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 6433092
• MDR Text Key: 70858395
• Report Number: 3007284313-2017-00064
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093791
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,study
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 04/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/15/2019
• Device Catalogue Number: DSL2628
• Device Lot Number: 15798230
• 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: 12/15/2016
• 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