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

Catalog Number DSL1228

Device Problem Occlusion Within Device (1423)

Patient Problem Extravasation (1842)

Event Date 08/12/2016

Event Type  Injury  

Manufacturer Narrative

(b)(6).The review of the manufacturing paperwork verified that this lot met all pre-release specifications.

Event Description

It was reported to gore that on (b)(6) 2016, the patient underwent treatment of a ¿presumed primary aortoenteric fistula¿ with two gore® excluder® aaa endoprostheses and a gore® viabahn® endoprosthesis.It was reported that after deployment of gore® excluder® aaa endoprostheses and during slight withdrawal of a 12 fr gore® dryseal sheath advanced on the left side, a small area of extravasation was noted, but the patient reportedly remained hemodynamically stable.It was reported the patient had high-grade stenosis on the left side.It was reported a gore® viabahn® endoprosthesis (11x5) was deployed overlapping within the contralateral leg component and covering the left internal iliac artery.A completion angiogram reportedly showed no leak on the left side.The procedure was concluded with no further adverse events.

Manufacturer Narrative

(b)(4).

• Brand Name: GORE® DRYSEAL 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: claire west ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 6648934
• MDR Text Key: 77823373
• Report Number: 3007284313-2017-00157
• 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
• Report Date: 06/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/27/2019
• Device Catalogue Number: DSL1228
• Device Lot Number: 15015643
• 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: 04/27/2016
• 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: 76 YR
• Patient Weight: 69