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

Catalog Number DSL1828J

Device Problems Occlusion Within Device (1423); Difficult to Advance (2920)

Patient Problem Tissue Damage (2104)

Event Date 01/06/2015

Event Type  Injury  

Event Description

On (b)(6), the patient underwent endovascular repair of an abdominal aortic aneurysm using gore® excluder® aaa endoprostheses.It was reported that the left iliac artery was circumferentially calcified and stenosed.The diameter of the iliac artery is reportedly unknown.Angioplasty was performed on the left external iliac artery prior to the insertion of the gore® dryseal sheath ((b)(4)).When the sheath was inserted, some resistance was felt around the bifurcation of the left iliac artery.However, the sheath was advanced to the intended position and the delivery catheter of the trunk ipsilateral leg component was inserted.As the catheter reached around the accessory renal artery, it could not advance further.The physician withdraw the delivery catheter, and angiography showed the abnormal calcification around the tip of the sheath which blocked the advancement of the delivery catheter.The physician suspected that it was a piece of the intima decorticated from the left iliac artery.An open abdominal surgery was performed whereby the damaged left iliac artery and the abdominal aorta were repaired with a surgical graft.The patient tolerated the procedure.It was reported that during the open repair, the damage to the left common iliac artery and the cylindrical intima from the artery were confirmed.

Manufacturer Narrative

Manufacturing evaluation performed.A review of the manufacturing records for the device verified that the lot met all pre-release specifications.According to the gore® dryseal sheath instructions for use (ifu), adequate vessel access is required to introduce the sheath into the vasculature.Careful evaluation of vessel size, anatomy, tortuosity, and disease state (including calcification, plaque, and thrombus) is required to ensure successful sheath introduction and subsequent withdrawal.If vessel is not adequate for access, major bleeding, vessel damage, or serious injury to the patient, including death, may result.

• 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: kanae rikimaru ; 1500 n. 4th street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 4472557
• MDR Text Key: 5324730
• Report Number: 3007284313-2015-00011
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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
• Report Date: 01/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2015
• 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: DSL1828J
• Device Lot Number: 13064091
• 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: 09/29/2014
• 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: 80 YR