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

Catalog Number DSL1828

Device Problem Occlusion Within Device (1423)

Patient Problems Occlusion (1984); Thrombus (2101)

Event Date 09/02/2015

Event Type  Injury  

Manufacturer Narrative

A separate medwatch has been submitted for the gore excluder aaa endoprostheses involved in this event.(b)(4).

Event Description

On (b)(6), 2015, the patient underwent treatment of an abdominal aortic aneurysm using four gore excluder aaa endoprostheses.During advancement and withdrawal of an 18 fr gore dryseal sheath for implant of the rlt261218, there was some reported resistance due to a small access vessel size (~ 6 mm).However, it was reported the devices were implanted with no issues, and intra- and post-operative imaging showed no evidence of vessel trauma or other clinical issues.The patient tolerated the procedure with no adverse events.On an unknown date, the patient presented emergently to another hospital with leg pain.A ct scan reportedly showed a dissection and occlusion of the right external iliac artery (reia) with thrombus accumulation within the rlt261218 and pxl161207.It was reported the exact cause of the dissection is unknown.However, the intervening physician reported that the dissection may have occurred during sheath advancement and withdrawal during the implant procedure, causing an occlusion of the reia and thrombus accumulation in the rlt261218 and pxl161207.It is reportedly unknown if there was complete occlusion of the rlt261218 and pxl161207.Around (b)(6), 2015, an additional procedure was performed to treat the external iliac dissection whereby a femoral-femoral bypass was performed.Final angiography showed good distal perfusion, and the patient tolerated the procedure.No further information is available.

Manufacturer Narrative

The review of the manufacturing paperwork verified that this lot met all pre-release specifications.The cause of the dissection is reportedly unknown.

• 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: claire west ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 5135420
• MDR Text Key: 27841200
• Report Number: 3007284313-2015-00105
• 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: Followup
• Report Date: 10/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2017
• Device Catalogue Number: DSL1828
• Device Lot Number: 13053915
• 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: 09/26/2014
• 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
• Patient Weight: 100