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

Catalog Number DSL2028

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Rupture (2208)

Event Date 01/06/2017

Event Type  Death  

Manufacturer Narrative

(b)(4).The instructions for use (ifu) for the gore® dryseal sheath with hydrophilic coating, states potential adverse events: events that may occur and / or require intervention include, but are not limited to: vascular trauma (i.E., dissection, rupture, perforation, tear, etc.), death.

Event Description

On (b)(6) 2017, this patient underwent endovascular treatment for an aorto enteric fistula with gross hematemesis and was implanted with a conformable gore® tag® thoracic endoprostheses.It was reported that the patient suffered a rupture of the right iliac artery (ria).During closing of the arteriotomy site the removal of a 20 fr.Gore® dryseal sheath caused a rupture of the ria.The patent expired.An autopsy was performed and the results are pending.Implant of the conformable gore® tag® thoracic endoprostheses was reported to have been successful and uneventful, with no allegations of device deficiency.

Manufacturer Narrative

A review of the manufacturing records for the device verified that the lot met all pre-release specifications.

• Brand Name: GORE® DRYSEAL SHEATH
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• Manufacturer (Section G): MEDICAL DEER VALLEY B/P; 24416 n. 19th avenue; phoenix AZ 85085
• Manufacturer Contact: laura crawford ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 6281406
• MDR Text Key: 65877800
• Report Number: 3007284313-2017-00019
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2017
• 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: DSL2028
• Device Lot Number: 13958978
• 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: 06/08/2015
• 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): Death
• Patient Age: 71 YR
• Patient Weight: 80