MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES GORE® EXCLUDER® AAA ENDOPROSTHESIS; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Catalog Number PXC121000

Device Problems Premature Activation (1484); Material Separation (1562); Malposition of Device (2616)

Patient Problem Occlusion (1984)

Event Date 11/30/2015

Event Type  Injury  

Manufacturer Narrative

Concomitant products: patient medications: albuterol, prevecal, singulair, clonamax, hydrocodine, nitro-time, methimazole, procardin.The review of the manufacturing paperwork verified that the lot(s) met all pre-release specifications.(b)(4).

Event Description

On (b)(6) 2015, the patient was treated for an abdominal aortic aneurysm.It was reported that during the procedure a pxc121000 came apart at the trailing olive, which caused the graft and the leading olive to separate and the device to deploy prematurely in a location other than intended.It was reported the patient had very small vessels, and the physician had previously dilated the access vessels by implanting gore viabahn endoprosthesis.A 12fr sheath was used but could not be pushed to the intended location.It was reported the physician could not get device into the gate of the gore excluder aaa endoprosthesis so the pxc121000 was pulled back and that is when the device leading olive separated and the device deployed in an unintended location at the bifurcation covering the hypogastric artery.The physician snared the leading olive and catheter, he then bridged another endoprosthesis from the bifurcation to the gore excluder aaa endoprosthesis.The physician is choosing to wait and see how the patient tolerates the covered hypo gastric artery.The physician has requested a response from gore.The device catheter will be returned to gore for evaluation.

Manufacturer Narrative

According to the gore® excluder® aaa endoprosthesis instructions for use (ifu), iliac artery treatment diameter range of 8 ¿ 18.5 mm and iliac distal vessel seal zone length of at least 10 mm.Additionally the ifu states; do not rotate the contralateral leg delivery catheter during delivery, positioning or deployment.Catheter breakage or premature deployment may occur.Do not advance the device outside of the sheath.The sheath will protect the device from catheter breakage or premature deployment while tracking it into position.Do not continue advancing any portion of the delivery system if resistance is felt during advancement of the guidewire, sheath, or catheter.Stop and assess the cause of resistance.Vessel or catheter damage may occur.Do not attempt to withdraw any un-deployed endoprosthesis through the introducer sheath.The sheath and catheter must be removed together.

Manufacturer Narrative

Added engineering evaluation results: as part of the investigation of this event, an engineering evaluation has been completed.The pxc12100 was returned to gore for evaluation, the evaluation revealed the following: the leading end of the catheter had separated from the catheter body at the trailing olive.The guidewire lumen had fractured at the trailing olive bond on the catheter.There was a twist in the guidewire lumen which is indicative of the device being rotated.The root cause for the broken leading end of the catheter could not be determined with the currently available information, however, used outside the gore® excluder® aaa endoprosthesis instructions for use (ifu) likely contributed to the event.

• Brand Name: GORE® EXCLUDER® AAA ENDOPROSTHESIS
• Type of Device: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• Manufacturer (Section G): MEDICAL SUNNYVALE B/P; 1327 orleans drive; sunnyvale CA 94089
• Manufacturer Contact: natalie putnam ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 5323028
• MDR Text Key: 34968524
• Report Number: 2953161-2015-00153
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P020004
• 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: 01/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2018
• Device Catalogue Number: PXC121000
• Device Lot Number: 14131687
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/23/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 01/04/2016; 01/26/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/13/2015
• 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 Age: 79 YR
• Patient Weight: 41